chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Activities of daily living impaired, Blood test, Fatigue, Headache, Mononucleosis heterophile test negative
Clinical narrative: Case number PHHY2014US065790, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 528285) website on 28 May 2014. This report refers to a female patient of unknown age. Her medical history included allergy to guaifenesin. Concomitant medication was not reported. On 04 Nov 2013, she was vaccinated with MENVEO (batch number: unknown) and first dose of CERVARIX (batch number: PH43F, other manufacturer). On an unspecified time after vaccination she experienced fatigue. On 13 Jan 2014, she received second dose of CERVARIX (batch number: unknown, other manufacturer). At an unspecified time after second vaccination with CERVARIX, she experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. She was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. She was negative for mononucleosis. She went to a neurologist on 03 Mar 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unknown.
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: Case number PHHY2014US065790, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 528285) website on 28 May 2014. This report refers to a female patient of unknown age. Her medical history included allergy to guaifenesin. Concomitant medication was not reported. On 04 Nov 2013, she was vaccinated with MENVEO (batch number: unknown) and first dose of CERVARIX (batch number: PH43F, other manufacturer). On an unspecified time after vaccination she experienced fatigue. On 13 Jan 2014, she received second dose of CERVARIX (batch number: unknown, other manufacturer). At an unspecified time after second vaccination with CERVARIX, she experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. She was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. She was negative for mononucleosis. She went to a neurologist on 03 Mar 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unknown.
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Borrelia test negative, Culture urine negative, Cytomegalovirus test negative, Dizziness, Fatigue
Clinical narrative: Case number PHHY2014US065790, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 528285) website on 28 May 2014. This report refers to a female patient of unknown age. Her medical history included allergy to guaifenesin. Concomitant medication was not reported. On 04 Nov 2013, she was vaccinated with MENVEO (batch number: unknown) and first dose of CERVARIX (batch number: PH43F, other manufacturer). On an unspecified time after vaccination she experienced fatigue. On 13 Jan 2014, she received second dose of CERVARIX (batch number: unknown, other manufacturer). At an unspecified time after second vaccination with CERVARIX, she experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. She was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. She was negative for mononucleosis. She went to a neurologist on 03 Mar 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unknown.
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Full blood count normal, Headache, Mononucleosis heterophile test negative, Red blood cell sedimentation rate normal, Thyroid function test normal
Clinical narrative: Case number PHHY2014US065790, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 528285) website on 28 May 2014. This report refers to a female patient of unknown age. Her medical history included allergy to guaifenesin. Concomitant medication was not reported. On 04 Nov 2013, she was vaccinated with MENVEO (batch number: unknown) and first dose of CERVARIX (batch number: PH43F, other manufacturer). On an unspecified time after vaccination she experienced fatigue. On 13 Jan 2014, she received second dose of CERVARIX (batch number: unknown, other manufacturer). At an unspecified time after second vaccination with CERVARIX, she experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. She was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. She was negative for mononucleosis. She went to a neurologist on 03 Mar 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unknown.
Sex: F
Vaccine: HPV2, HPV2, MNQ
Symptoms: Vertigo
Clinical narrative: Case number PHHY2014US065790, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 528285) website on 28 May 2014. This report refers to a female patient of unknown age. Her medical history included allergy to guaifenesin. Concomitant medication was not reported. On 04 Nov 2013, she was vaccinated with MENVEO (batch number: unknown) and first dose of CERVARIX (batch number: PH43F, other manufacturer). On an unspecified time after vaccination she experienced fatigue. On 13 Jan 2014, she received second dose of CERVARIX (batch number: unknown, other manufacturer). At an unspecified time after second vaccination with CERVARIX, she experienced fatigue aggravated, vertigo and headache all lasting more than 6 weeks. She was getting home schooled as a result. The healthcare professional considered the events were disabling. A blood test and a MRI were done. She was negative for mononucleosis. She went to a neurologist on 03 Mar 2014, who told her that it may be a delayed reaction to vaccination. At the time of reporting the outcome of the events was unknown.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test, Computerised tomogram, Computerised tomogram head, Dizziness, Fall
Clinical narrative: Case number PHHY2014US078732 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527859) website on 25 Jun 2014. This report refers to a 16-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal polysaccharide vaccine (manufacturer and batch number: not reported) in the right arm on 25 Mar 2014. On the same day within 5 to 10 minutes after vaccination, she felt nauseated and dizzy. She fainted and fell on the floor at the doctor's office. It was reported that ambulance came and took her to hospital. In the emergency room, she had blood work and Computerized Tomogram (CT) scan of head and back and the results were not reported. The event outcome was reported as complete recovery. The events were reported as non-serious by the reporter, but were internally assessed as medically significant by the company. The causality of the events was not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Syncope
Clinical narrative: Case number PHHY2014US078732 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527859) website on 25 Jun 2014. This report refers to a 16-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal polysaccharide vaccine (manufacturer and batch number: not reported) in the right arm on 25 Mar 2014. On the same day within 5 to 10 minutes after vaccination, she felt nauseated and dizzy. She fainted and fell on the floor at the doctor's office. It was reported that ambulance came and took her to hospital. In the emergency room, she had blood work and Computerized Tomogram (CT) scan of head and back and the results were not reported. The event outcome was reported as complete recovery. The events were reported as non-serious by the reporter, but were internally assessed as medically significant by the company. The causality of the events was not reported.
Age: 36.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US007018 is an initial spontaneous report received from a pharmacist on 07 Apr 2014 with a follow up report received from the pharmacist on 29 Apr 2014. This report refers to a 36 year old male patient. His medical history and concomitant medication were not reported. On 05 Apr 2014, he was vaccinated with an expired dose of MENVEO (batch number: M12009) intramuscularly at a dose of 0.5 ml. It was reported that, Men CWY liquid conjugate expiry date was Oct 2014 and Men A lyophilized powder expired in Feb 2014. No adverse event was reported following this administration error (expired vaccine used). Follow up report received from the pharmacist on 29 Apr 2014: Updated vaccination dose (0.5 ml).
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Aphasia, Deafness, Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Case number PHHY2014US112005 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 532642) website on 03 Sep 2014. This report refers to a 17 years old male patient. He had poor weight gain and his body mass index (BMI) was at fifth percentile. His concomitant medications were not reported. It was reported that in the day of vaccination, he had not had breakfast and had fear of needles. He was vaccinated with MENVEO (batch number: A12104) intramuscularly in the right arm and GARDASIL (other manufacturer, batch number: H020901) intramuscularly in the left arm on 29 May 2014. On the same day, immediately after vaccine administration, he turned pale and said that he was lightheaded. He was advised to lie down. As he lay down, he had near syncope episode. His eyes were open, but he was unable to speak or hear. He became alert and vocal in 8 to 10 seconds. His blood pressure and pulse rate for 30 seconds were monitored and results were not reported. He ate several (2) popsicles and was able to leave office by walk. He went home for food and it was reported that he was doing well at discharge without any symptoms. The final outcome was reported as complete recovery. The event was reported non-serious, but was internally upgraded by the company. The causality of the event was not reported.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Presyncope
Clinical narrative: Case number PHHY2014US112005 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 532642) website on 03 Sep 2014. This report refers to a 17 years old male patient. He had poor weight gain and his body mass index (BMI) was at fifth percentile. His concomitant medications were not reported. It was reported that in the day of vaccination, he had not had breakfast and had fear of needles. He was vaccinated with MENVEO (batch number: A12104) intramuscularly in the right arm and GARDASIL (other manufacturer, batch number: H020901) intramuscularly in the left arm on 29 May 2014. On the same day, immediately after vaccine administration, he turned pale and said that he was lightheaded. He was advised to lie down. As he lay down, he had near syncope episode. His eyes were open, but he was unable to speak or hear. He became alert and vocal in 8 to 10 seconds. His blood pressure and pulse rate for 30 seconds were monitored and results were not reported. He ate several (2) popsicles and was able to leave office by walk. He went home for food and it was reported that he was doing well at discharge without any symptoms. The final outcome was reported as complete recovery. The event was reported non-serious, but was internally upgraded by the company. The causality of the event was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2014US107593, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 532646) website on 27 Aug 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with meningococcal ACYW-135 vaccine (manufacturer and batch number: unknown) on an unknown date. On an unknown date, after vaccination his injection site became red and was tender to touch. He was diagnosed with cellulitis and treated with KEFLEX. The outcome of the events reported as complete recovery. The seriousness of the event was not reported, however the case was internally upgraded as medically significant by the company. The causality of the events was not reported.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US111530, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 532812) website on 03 Sep 2014. This report refers to a 12-year-old female patient. Past medical history and concomitant medication were not reported. On 02 Jun 2014, she was vaccinated with MENVEO (batch number: A12102), in the left arm, GARDASIL (other manufacturer, batch number: J006850) in the left arm, HAVRIX (other manufacturer, batch number: K4H7M) in the right arm and with sixth dose of ADACEL (other manufacturer, batch number: U4618AA) in the right arm. On the same date within five minutes after vaccinations, she fainted for about 15 seconds. The outcome of the event reported as complete recovery. The seriousness of the event reported as non-serious; however the case was internally upgraded as medically significant by the company. The causality of the event was not reported.
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US107708, is an initial spontaneous report received from a medical assistant via a sales representative via Vaccine Adverse Event Reporting System (VAERS reference number: 534337) website on 27 Aug 2014. This report refers to a male patient of an unknown age. Past medical history and concomitant medication were not reported. The patient was vaccinated with meningococcal ACYW-135 vaccine (manufacturer and batch number: unknown), first dose of GARDASIL (other manufacturer and batch number: unknown) and TDAP (other manufacturer and batch number: unknown) on an unknown date. It was reported that the patient fainted after receiving the first dose of GARDASIL on an unknown date. The outcome of the event reported as recovered on an unknown date. The seriousness of the event was not reported, however the case was internally upgraded as medically significant by the company. The causality of the event was not reported.
Sex: M
Vaccine: DTAP, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US107725, is an initial spontaneous report received from a medical assistant via a sales representative via Vaccine Adverse Event Reporting System (VAERS reference number: 534338) website on 27 Aug 2014. This report refers to male patient of an unknown age. Past medical history and concomitant medication were not reported. The patient was vaccinated with meningococcal ACYW-135 vaccine (manufacturer and batch number: unknown), first dose of GARDASIL (other manufacturer and batch number: unknown) and DTAP (other manufacturer and batch number: unknown) on an unknown date. It was reported that, the patient fainted after receiving the first dose of GARDASIL on an unknown date. The outcome of the event reported as recovered on an unknown date. The seriousness of the event was not reported, however the case was internally upgraded as medically significant by the company. The causality of the event was not reported.
Sex: M
Vaccine: HEPAB, MNQ
Symptoms: Anaphylactic shock, Antibody test positive, Blood cholesterol normal, Blood glucose normal, Blood group O
Clinical narrative: Case number PHHY2014US109553, is an initial spontaneous report received from a phase IV safety study via Vaccine Adverse Event Reporting System (VAERS reference number: 534477) website on 27 Aug 2014. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report refers to an adult male patient between the age of 19 to 24 years old. His medical history was not reported. The patient was administered Adenovirus type 4 and type 7 live vaccine (batch number: 34600018, other manufacturer) tablet, oral on 13 Jan 2012. On the same day he was vaccinated with FLUZONE (batch number: UT423AA, other manufacturer), IPOL (batch number: H1305, other manufacturer) and BOOSTRIX (batch number: AL52B0750A, other manufacturer). On 18 Jan 2012, he was vaccinated with Meningococcal A, C, Y, W polysaccharide vaccine (manufacturer and batch number unknown). On the same day he received Hepatitis A vaccine with hepatitis B vaccine (manufacturer and batch number unknown). Concomitant medications included ranitidine oral from 18 Jan 2012, paracetamol oral from 20 Jan 2012, until 19 Jan 2013; since 08 Feb 2012, till 18 Feb 2012, for pain and Ibuprofen oral, since 08 Feb 2012, until 09 Mar 2012, for pain. On 18 Jan 2012, he experienced other anaphylactic shock, NEC. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Treatment medication included prednisone 50mg PO, epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg inhalation and SOLU-MEDROL 125mg IV. Lab tests on 12 Jan 2012, Hepatitis B Virus AB: negative; Hepatitis A Virus AB: negative IU/L; ABO Group: O positive; varicella zoster AB: Immune; rubella virus AB: Immune; rubeola AB: Immune; G6 PD: 15.2 Unknown U/g and sickle cell screen: negative. On 25 Jan 2012, glucose: 80 mg/dL; hemoglobin: 15.2 g/dL; hematocrit: 44.7 percentage; cholesterol/HDL cholesterol: 3.6; cholesterol: 157 mg/dL; HDL: 44 mg/dL; LDL: 89 mg/dL; triglycerides: 119 mg/dL; hemolysis index: no hemolysis; Icterus index: 0; lipemia index: 47; urinalysis: negative, yellow, clear; Urobilinogen: 0.2 EU/dL; nitrate: negative; leukocyte esterase: negative; specific gravity: 1.020 and pH: 6.5. The outcome of the event anaphylactic shock was recovered on 19 Jan 2012 and the event pain was not reported. The medical monitor assessed the causality between other anaphylactic shock, NEC and Adenovirus vaccine as possible. Seriousness and causality assessment with meningococcal vaccine was not reported. However the case was internally upgraded as medically significant by the company.
Sex: M
Vaccine: HEPAB, MNQ
Symptoms: Blood test, Blood triglycerides normal, Glucose-6-phosphate dehydrogenase abnormal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Case number PHHY2014US109553, is an initial spontaneous report received from a phase IV safety study via Vaccine Adverse Event Reporting System (VAERS reference number: 534477) website on 27 Aug 2014. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report refers to an adult male patient between the age of 19 to 24 years old. His medical history was not reported. The patient was administered Adenovirus type 4 and type 7 live vaccine (batch number: 34600018, other manufacturer) tablet, oral on 13 Jan 2012. On the same day he was vaccinated with FLUZONE (batch number: UT423AA, other manufacturer), IPOL (batch number: H1305, other manufacturer) and BOOSTRIX (batch number: AL52B0750A, other manufacturer). On 18 Jan 2012, he was vaccinated with Meningococcal A, C, Y, W polysaccharide vaccine (manufacturer and batch number unknown). On the same day he received Hepatitis A vaccine with hepatitis B vaccine (manufacturer and batch number unknown). Concomitant medications included ranitidine oral from 18 Jan 2012, paracetamol oral from 20 Jan 2012, until 19 Jan 2013; since 08 Feb 2012, till 18 Feb 2012, for pain and Ibuprofen oral, since 08 Feb 2012, until 09 Mar 2012, for pain. On 18 Jan 2012, he experienced other anaphylactic shock, NEC. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Treatment medication included prednisone 50mg PO, epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg inhalation and SOLU-MEDROL 125mg IV. Lab tests on 12 Jan 2012, Hepatitis B Virus AB: negative; Hepatitis A Virus AB: negative IU/L; ABO Group: O positive; varicella zoster AB: Immune; rubella virus AB: Immune; rubeola AB: Immune; G6 PD: 15.2 Unknown U/g and sickle cell screen: negative. On 25 Jan 2012, glucose: 80 mg/dL; hemoglobin: 15.2 g/dL; hematocrit: 44.7 percentage; cholesterol/HDL cholesterol: 3.6; cholesterol: 157 mg/dL; HDL: 44 mg/dL; LDL: 89 mg/dL; triglycerides: 119 mg/dL; hemolysis index: no hemolysis; Icterus index: 0; lipemia index: 47; urinalysis: negative, yellow, clear; Urobilinogen: 0.2 EU/dL; nitrate: negative; leukocyte esterase: negative; specific gravity: 1.020 and pH: 6.5. The outcome of the event anaphylactic shock was recovered on 19 Jan 2012 and the event pain was not reported. The medical monitor assessed the causality between other anaphylactic shock, NEC and Adenovirus vaccine as possible. Seriousness and causality assessment with meningococcal vaccine was not reported. However the case was internally upgraded as medically significant by the company.
Sex: M
Vaccine: HEPAB, MNQ
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, High density lipoprotein decreased, High density lipoprotein normal, Icterus index decreased
Clinical narrative: Case number PHHY2014US109553, is an initial spontaneous report received from a phase IV safety study via Vaccine Adverse Event Reporting System (VAERS reference number: 534477) website on 27 Aug 2014. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report refers to an adult male patient between the age of 19 to 24 years old. His medical history was not reported. The patient was administered Adenovirus type 4 and type 7 live vaccine (batch number: 34600018, other manufacturer) tablet, oral on 13 Jan 2012. On the same day he was vaccinated with FLUZONE (batch number: UT423AA, other manufacturer), IPOL (batch number: H1305, other manufacturer) and BOOSTRIX (batch number: AL52B0750A, other manufacturer). On 18 Jan 2012, he was vaccinated with Meningococcal A, C, Y, W polysaccharide vaccine (manufacturer and batch number unknown). On the same day he received Hepatitis A vaccine with hepatitis B vaccine (manufacturer and batch number unknown). Concomitant medications included ranitidine oral from 18 Jan 2012, paracetamol oral from 20 Jan 2012, until 19 Jan 2013; since 08 Feb 2012, till 18 Feb 2012, for pain and Ibuprofen oral, since 08 Feb 2012, until 09 Mar 2012, for pain. On 18 Jan 2012, he experienced other anaphylactic shock, NEC. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Treatment medication included prednisone 50mg PO, epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg inhalation and SOLU-MEDROL 125mg IV. Lab tests on 12 Jan 2012, Hepatitis B Virus AB: negative; Hepatitis A Virus AB: negative IU/L; ABO Group: O positive; varicella zoster AB: Immune; rubella virus AB: Immune; rubeola AB: Immune; G6 PD: 15.2 Unknown U/g and sickle cell screen: negative. On 25 Jan 2012, glucose: 80 mg/dL; hemoglobin: 15.2 g/dL; hematocrit: 44.7 percentage; cholesterol/HDL cholesterol: 3.6; cholesterol: 157 mg/dL; HDL: 44 mg/dL; LDL: 89 mg/dL; triglycerides: 119 mg/dL; hemolysis index: no hemolysis; Icterus index: 0; lipemia index: 47; urinalysis: negative, yellow, clear; Urobilinogen: 0.2 EU/dL; nitrate: negative; leukocyte esterase: negative; specific gravity: 1.020 and pH: 6.5. The outcome of the event anaphylactic shock was recovered on 19 Jan 2012 and the event pain was not reported. The medical monitor assessed the causality between other anaphylactic shock, NEC and Adenovirus vaccine as possible. Seriousness and causality assessment with meningococcal vaccine was not reported. However the case was internally upgraded as medically significant by the company.
Sex: M
Vaccine: HEPAB, MNQ
Symptoms: Laboratory test normal, Low density lipoprotein normal, Measles antibody positive, Nitrite urine absent, Pain
Clinical narrative: Case number PHHY2014US109553, is an initial spontaneous report received from a phase IV safety study via Vaccine Adverse Event Reporting System (VAERS reference number: 534477) website on 27 Aug 2014. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report refers to an adult male patient between the age of 19 to 24 years old. His medical history was not reported. The patient was administered Adenovirus type 4 and type 7 live vaccine (batch number: 34600018, other manufacturer) tablet, oral on 13 Jan 2012. On the same day he was vaccinated with FLUZONE (batch number: UT423AA, other manufacturer), IPOL (batch number: H1305, other manufacturer) and BOOSTRIX (batch number: AL52B0750A, other manufacturer). On 18 Jan 2012, he was vaccinated with Meningococcal A, C, Y, W polysaccharide vaccine (manufacturer and batch number unknown). On the same day he received Hepatitis A vaccine with hepatitis B vaccine (manufacturer and batch number unknown). Concomitant medications included ranitidine oral from 18 Jan 2012, paracetamol oral from 20 Jan 2012, until 19 Jan 2013; since 08 Feb 2012, till 18 Feb 2012, for pain and Ibuprofen oral, since 08 Feb 2012, until 09 Mar 2012, for pain. On 18 Jan 2012, he experienced other anaphylactic shock, NEC. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Treatment medication included prednisone 50mg PO, epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg inhalation and SOLU-MEDROL 125mg IV. Lab tests on 12 Jan 2012, Hepatitis B Virus AB: negative; Hepatitis A Virus AB: negative IU/L; ABO Group: O positive; varicella zoster AB: Immune; rubella virus AB: Immune; rubeola AB: Immune; G6 PD: 15.2 Unknown U/g and sickle cell screen: negative. On 25 Jan 2012, glucose: 80 mg/dL; hemoglobin: 15.2 g/dL; hematocrit: 44.7 percentage; cholesterol/HDL cholesterol: 3.6; cholesterol: 157 mg/dL; HDL: 44 mg/dL; LDL: 89 mg/dL; triglycerides: 119 mg/dL; hemolysis index: no hemolysis; Icterus index: 0; lipemia index: 47; urinalysis: negative, yellow, clear; Urobilinogen: 0.2 EU/dL; nitrate: negative; leukocyte esterase: negative; specific gravity: 1.020 and pH: 6.5. The outcome of the event anaphylactic shock was recovered on 19 Jan 2012 and the event pain was not reported. The medical monitor assessed the causality between other anaphylactic shock, NEC and Adenovirus vaccine as possible. Seriousness and causality assessment with meningococcal vaccine was not reported. However the case was internally upgraded as medically significant by the company.
Sex: M
Vaccine: HEPAB, MNQ
Symptoms: Red blood cell analysis normal, Rubella antibody positive, Specific gravity urine normal, Urine analysis normal, Urine leukocyte esterase
Clinical narrative: Case number PHHY2014US109553, is an initial spontaneous report received from a phase IV safety study via Vaccine Adverse Event Reporting System (VAERS reference number: 534477) website on 27 Aug 2014. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report refers to an adult male patient between the age of 19 to 24 years old. His medical history was not reported. The patient was administered Adenovirus type 4 and type 7 live vaccine (batch number: 34600018, other manufacturer) tablet, oral on 13 Jan 2012. On the same day he was vaccinated with FLUZONE (batch number: UT423AA, other manufacturer), IPOL (batch number: H1305, other manufacturer) and BOOSTRIX (batch number: AL52B0750A, other manufacturer). On 18 Jan 2012, he was vaccinated with Meningococcal A, C, Y, W polysaccharide vaccine (manufacturer and batch number unknown). On the same day he received Hepatitis A vaccine with hepatitis B vaccine (manufacturer and batch number unknown). Concomitant medications included ranitidine oral from 18 Jan 2012, paracetamol oral from 20 Jan 2012, until 19 Jan 2013; since 08 Feb 2012, till 18 Feb 2012, for pain and Ibuprofen oral, since 08 Feb 2012, until 09 Mar 2012, for pain. On 18 Jan 2012, he experienced other anaphylactic shock, NEC. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Treatment medication included prednisone 50mg PO, epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg inhalation and SOLU-MEDROL 125mg IV. Lab tests on 12 Jan 2012, Hepatitis B Virus AB: negative; Hepatitis A Virus AB: negative IU/L; ABO Group: O positive; varicella zoster AB: Immune; rubella virus AB: Immune; rubeola AB: Immune; G6 PD: 15.2 Unknown U/g and sickle cell screen: negative. On 25 Jan 2012, glucose: 80 mg/dL; hemoglobin: 15.2 g/dL; hematocrit: 44.7 percentage; cholesterol/HDL cholesterol: 3.6; cholesterol: 157 mg/dL; HDL: 44 mg/dL; LDL: 89 mg/dL; triglycerides: 119 mg/dL; hemolysis index: no hemolysis; Icterus index: 0; lipemia index: 47; urinalysis: negative, yellow, clear; Urobilinogen: 0.2 EU/dL; nitrate: negative; leukocyte esterase: negative; specific gravity: 1.020 and pH: 6.5. The outcome of the event anaphylactic shock was recovered on 19 Jan 2012 and the event pain was not reported. The medical monitor assessed the causality between other anaphylactic shock, NEC and Adenovirus vaccine as possible. Seriousness and causality assessment with meningococcal vaccine was not reported. However the case was internally upgraded as medically significant by the company.
Sex: M
Vaccine: HEPAB, MNQ
Symptoms: Urobilinogen urine increased, pH urine normal
Clinical narrative: Case number PHHY2014US109553, is an initial spontaneous report received from a phase IV safety study via Vaccine Adverse Event Reporting System (VAERS reference number: 534477) website on 27 Aug 2014. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report refers to an adult male patient between the age of 19 to 24 years old. His medical history was not reported. The patient was administered Adenovirus type 4 and type 7 live vaccine (batch number: 34600018, other manufacturer) tablet, oral on 13 Jan 2012. On the same day he was vaccinated with FLUZONE (batch number: UT423AA, other manufacturer), IPOL (batch number: H1305, other manufacturer) and BOOSTRIX (batch number: AL52B0750A, other manufacturer). On 18 Jan 2012, he was vaccinated with Meningococcal A, C, Y, W polysaccharide vaccine (manufacturer and batch number unknown). On the same day he received Hepatitis A vaccine with hepatitis B vaccine (manufacturer and batch number unknown). Concomitant medications included ranitidine oral from 18 Jan 2012, paracetamol oral from 20 Jan 2012, until 19 Jan 2013; since 08 Feb 2012, till 18 Feb 2012, for pain and Ibuprofen oral, since 08 Feb 2012, until 09 Mar 2012, for pain. On 18 Jan 2012, he experienced other anaphylactic shock, NEC. Treatment was given at an outpatient visit, the patient received medication. The severity and seriousness of this visit was not assessed per the patient's electronic health record. Treatment medication included prednisone 50mg PO, epinephrine 0.3mg IM, BENADRYL 40mg IV, Albuterol 25mg inhalation and SOLU-MEDROL 125mg IV. Lab tests on 12 Jan 2012, Hepatitis B Virus AB: negative; Hepatitis A Virus AB: negative IU/L; ABO Group: O positive; varicella zoster AB: Immune; rubella virus AB: Immune; rubeola AB: Immune; G6 PD: 15.2 Unknown U/g and sickle cell screen: negative. On 25 Jan 2012, glucose: 80 mg/dL; hemoglobin: 15.2 g/dL; hematocrit: 44.7 percentage; cholesterol/HDL cholesterol: 3.6; cholesterol: 157 mg/dL; HDL: 44 mg/dL; LDL: 89 mg/dL; triglycerides: 119 mg/dL; hemolysis index: no hemolysis; Icterus index: 0; lipemia index: 47; urinalysis: negative, yellow, clear; Urobilinogen: 0.2 EU/dL; nitrate: negative; leukocyte esterase: negative; specific gravity: 1.020 and pH: 6.5. The outcome of the event anaphylactic shock was recovered on 19 Jan 2012 and the event pain was not reported. The medical monitor assessed the causality between other anaphylactic shock, NEC and Adenovirus vaccine as possible. Seriousness and causality assessment with meningococcal vaccine was not reported. However the case was internally upgraded as medically significant by the company.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Anaphylactic reaction, Dyspnoea, Speech disorder, Throat tightness
Clinical narrative: Case number PHHY2014US112583, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 534688) website on 03 Sep 2014. This report refers to a 15-year-old male patient. Past medical history included allergic to grass and cats. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: X13047) intramuscularly into the right arm, along with GARDASIL (batch number: J015378) intramuscularly into the left arm on 21 Jun 2014. On the same day after vaccination, he experienced anaphylaxis with throat tightness, shortness of breath and unable to talk (no hives). He was sent to emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the company. Causality was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Complication associated with device, Dizziness, Face and mouth X-ray normal, Face injury, Fall
Clinical narrative: Case number PHHY2014US115632, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 535363) website on 03 Sep 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication was not reported. He had no known drug allergies (NKDA). He was vaccinated with MENVEO (batch number: M13030) IM into right arm and BOOSTRIX (batch number: 4327T, other manufacturer) IM into left arm on 25 Jun 2014 at 03:30 PM. On the same day of vaccination he complained of lightheadedness. Nurse went to raise the head of exam table when he was sitting and he rolled forward off table and hit his face first on floor. Initially the patient was unresponsive then after several seconds he responded to his mother. Nurse called the emergency room. Blood was noted around the mouth and chin, as patient turned self to side there was a deep gash to chin and pressure applied. He complained of front teeth hurting and feeling that his braces were broken. No other complaints of head, neck or back pain. Nurse stayed with the patient until the emergency medical team (EMT) arrived, which was within ten minutes of incident. EMT's assessed patient as he was lying on the floor and he stood slowly with support to walk to the stretcher. Mother followed the ambulance in her car to the medical center at 3:45 PM. On 26 Jun 2014, at 1:30 PM he had 16 stitches to chin and facial x-ray was negative. He had an appointment with orthodontics on 30 Jun 2014. Cap had come off braces and complained of teeth being sore. His physician was aware of the situation. The final outcome of the event was completely recovered.  Seriousness and causality assessment was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Haemorrhage, Mouth haemorrhage, Suture insertion, Toothache, Unresponsive to stimuli
Clinical narrative: Case number PHHY2014US115632, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 535363) website on 03 Sep 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication was not reported. He had no known drug allergies (NKDA). He was vaccinated with MENVEO (batch number: M13030) IM into right arm and BOOSTRIX (batch number: 4327T, other manufacturer) IM into left arm on 25 Jun 2014 at 03:30 PM. On the same day of vaccination he complained of lightheadedness. Nurse went to raise the head of exam table when he was sitting and he rolled forward off table and hit his face first on floor. Initially the patient was unresponsive then after several seconds he responded to his mother. Nurse called the emergency room. Blood was noted around the mouth and chin, as patient turned self to side there was a deep gash to chin and pressure applied. He complained of front teeth hurting and feeling that his braces were broken. No other complaints of head, neck or back pain. Nurse stayed with the patient until the emergency medical team (EMT) arrived, which was within ten minutes of incident. EMT's assessed patient as he was lying on the floor and he stood slowly with support to walk to the stretcher. Mother followed the ambulance in her car to the medical center at 3:45 PM. On 26 Jun 2014, at 1:30 PM he had 16 stitches to chin and facial x-ray was negative. He had an appointment with orthodontics on 30 Jun 2014. Cap had come off braces and complained of teeth being sore. His physician was aware of the situation. The final outcome of the event was completely recovered.  Seriousness and causality assessment was not reported.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immune system disorder, Platelet count decreased, Rash
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 10-MAR-2016 (reported as "one week ago"), the patient was vaccinated with a shot of ZOSTAVAX (dose and lot#, unknown) subcutaneously. the patient's concomitant medication was not reported. On 10-MAR-2016 (reported as "one week ago"), after the shot, the patient had developed spots and had to be hospitalized. Unspecified treatment was given. The patient had subsequently been discharged. The outcome of the event was reported as recovering/resolving. The causality between the event and ZOSTAVAX was not reported. Follow up information was received on 14-APR-2016. On 14-APR-2016, a call was placed to the pharmacist but the phone number listed in the report was disconnected. The phone call was not able to be completed. Follow up information has been received from the pharmacist on 17-MAY-2016 referring to the 67 year old male patient with no medical history or drug allergies. The patient was received the first dose of ZOSTAVAX (L031273, subcutaneous, dose unknown) in the left arm on 26-FEB-2016 (previously reported as "10-MAR-2016"). There was no illness at time of vaccination. On 07-MAR-2016, the patient developed rash (previously reported as "spots") and platelet count "crashed". The patient was hospitalized on the same date. He stayed in the hospital for 6 days and recovered from the events on 14-MAR-2016. The patient was also prescribed with atorvastatin, lisinopril and celecoxib on unknown dates. Additional information is not expected since all scheduled follow up were completed. Reporter information, patient demographics, suspect therapy, adverse events and narrative were updated.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Platelet count decreased, Rash
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 10-MAR-2016 (reported as "one week ago"), the patient was vaccinated with a shot of ZOSTAVAX (dose and lot#, unknown) subcutaneously. the patient's concomitant medication was not reported. On 10-MAR-2016 (reported as "one week ago"), after the shot, the patient had developed spots and had to be hospitalized. Unspecified treatment was given. The patient had subsequently been discharged. The outcome of the event was reported as recovering/resolving. The causality between the event and ZOSTAVAX was not reported. Follow up information was received on 14-APR-2016. On 14-APR-2016, a call was placed to the pharmacist but the phone number listed in the report was disconnected. The phone call was not able to be completed. Follow up information has been received from the pharmacist on 17-MAY-2016 referring to the 67 year old male patient with no medical history or drug allergies. The patient was received the first dose of ZOSTAVAX (L031273, subcutaneous, dose unknown) in the left arm on 26-FEB-2016 (previously reported as "10-MAR-2016"). There was no illness at time of vaccination. On 07-MAR-2016, the patient developed rash (previously reported as "spots") and platelet count "crashed". The patient was hospitalized on the same date. He stayed in the hospital for 6 days and recovered from the events on 14-MAR-2016. The patient was also prescribed with atorvastatin, lisinopril and celecoxib on unknown dates. Additional information is not expected since all scheduled follow up were completed. Reporter information, patient demographics, suspect therapy, adverse events and narrative were updated.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 16 year old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 05-APR-2016, the patient was vaccinated with the second dose (of the three-dose regimen) of GARDASIL 9 injection (lot # L045711, dose reported as 1 shot; expiration date and route of administration were not reported). On the same day, 7 to 8 minutes after receiving the shot, the patient passed out. The patient did not seek medical attention. She was given water and had her blood pressure monitored. The patient fully recovered from the event on 05-APR-2016. The relatedness between the event and the therapy with GARDASIL 9 was not reported. Follow-up information was received from the physician's office employee (role unspecified) on 17-MAY-2016. The patient had no known drug allergies. On 05-APR-2016 at 10:10, the patient was vaccinated with the second dose of GARDASIL 9 injection, intramuscularly, by the reporter. On the same day at 10:15 (previously reported as 7 to 8 minutes after vaccination), the patient had partial loss of consciousness (previously reported as the patient passed out). She was able to sit down before this happened. The patient laid down with feet propped up. Subsequently, she regained consciousness and was able to leave the office with her mother. Upon internal review, the event of loss of consciousness was determined to be medically significant. Additional information is not expected as all information has already been received. Reporter, patient, product, event and narrative were updated.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dyskinesia, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Tics (tilts head to side - clusters of 4-5 tilts at a time - multiple times an hour - lots of sniffing, some blinking) has past history of tics.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Tic
Clinical narrative: Tics (tilts head to side - clusters of 4-5 tilts at a time - multiple times an hour - lots of sniffing, some blinking) has past history of tics.
Age: 6.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Corneal reflex decreased, Tic
Clinical narrative: Tics (tilts head to side - clusters of 4-5 tilts at a time - multiple times an hour - lots of sniffing, some blinking) has past history of tics.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Excruciating pain in upper arm of injection site (left arm) upper arm "hot" to touch. Chills. Swelling of upper arm (could not bend arm to 90 degrees because of redness/rash on upper arm, under arm, on chest/swelling). Bladder and bowel incontinence. Doctors visit (Acute Care) and ER.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anal incontinence, Chills, Erythema, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Excruciating pain in upper arm of injection site (left arm) upper arm "hot" to touch. Chills. Swelling of upper arm (could not bend arm to 90 degrees because of redness/rash on upper arm, under arm, on chest/swelling). Bladder and bowel incontinence. Doctors visit (Acute Care) and ER.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Excruciating pain in upper arm of injection site (left arm) upper arm "hot" to touch. Chills. Swelling of upper arm (could not bend arm to 90 degrees because of redness/rash on upper arm, under arm, on chest/swelling). Bladder and bowel incontinence. Doctors visit (Acute Care) and ER.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Urinary incontinence, White blood cell count increased
Clinical narrative: Excruciating pain in upper arm of injection site (left arm) upper arm "hot" to touch. Chills. Swelling of upper arm (could not bend arm to 90 degrees because of redness/rash on upper arm, under arm, on chest/swelling). Bladder and bowel incontinence. Doctors visit (Acute Care) and ER.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Throat irritation
Clinical narrative: Patient ate lunch and afterward began to feel lightheaded and complained of an itchy throat.  No stridor/voice change, shortness of breath, or other symptoms.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information was received from a physician via an internet article regarding cases in litigation concerning female patients of unknown age, who received vaccinations with GARDASIL (lot numbers, dates of vaccination, dosages, and routes of administration not reported). It was reported that between May 2009 and September 2010, 16 deaths occurred after GARDASIL vaccination (causes of deaths not reported). It was unknown if autopsies were performed. Upon internal review, 16 deaths was determined to be medically significant. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Disability
Clinical narrative: Information was received from a physician via an Internet article regarding cases in litigation concerning female patients of unknown ages, who were vaccinated with GARDASIL (lot numbers, dates, dosages, and routes of administration not reported). Between May 2009 and September 2010, there were reported to be 213 cases of permanent disability (unspecified) that occurred after GARDASIL vaccination. 213 cases of permanent disability was considered to be disabling. This is one of several reports from the same source. Additional information is not expected.