chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Neutrophil percentage decreased, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Plasmapheresis
Clinical narrative: This report to VAERS provides the following narrative: A report has been received from consumer via VAERS concerning a 9 year old female patient. The patient's concurrent disease included allergic rhinitis. Concomitant medications included cetirizine hydrochloride. Patient had been receiving FLUMIST (intranasal) started on 10-Jan-2013. Odd gait when walking, running on 01-Apr-2013. Feet tingled on 02-Apr-2013. Limping on 03-Apr-2013 and began falling frequently. ER on 07-Apr-2013 and diagnosed with Guillain-Barre Syndrome on 08-Apr-2013. The following information was obtained through follow-up and/or provided by the government. 13-Jun-2013 Hospital records and discharge summary received. Service dates 07-Apr-2013 to 16-Apr-2013, 24-Apr-2013 to 09-May-2013. Diagnosis: Guillain-Barre Syndrome, axonal variant, with associated lower extremity weakness, relapse. Acute demyelinating polyneuropathy. Patient diagnosed with GBS 2 weeks prior, clumsiness, difficulties walking, foot numbness/tingling. IVIG administration. Using walker, discharged to outpatient PT/OT. Now presenting with worsening weakness in lower extremities and new tingling in feet. Blurred/double vision and weakness in EOM, CN 6 Palsy. Areflexia lower extremities with weakness in hips, knees, ankles. Back/neck pain. Potential Miller-Fisher. Gabapentin PO. Trouble sleeping. Urinary retention, bladder distended, probable neurogenic bladder. Plasmapheresis catheter placement, PLEX. 6/14/13 Neurology Consultation records received. Service dates 16-Apr-2013 to 02-May-2013. Additional Information Abstracted: Diagnosis: Guillain-Barre Syndrome. Worsening balance, difficulty walking, worsening weakness lower extremities. Weakness noted involving bilateral upper extremities. Emesis, pain in hips and neck, neuropathic pain, headache after IVIG, transient hypotension, anxious. Keratosis pilaris. Plasma exchanges. CT Scan. Full blood work. MRI and spinal tap. The following information was obtained through follow-up and/or provided by the government. 13-Jun-2013, 21-Jun-2013, 24-Jun-2013 Labs and Diagnostics: CSF - Abnormal, Protein 135 mg/dl. CBC / RBC 3.74 M/mm3 (L) HGB 11.0 g/dl (L) HCT 32.4% (L) RDW 16.1% (H) Seg 35.8% (L) Mono 11.0% (H) Lymph 48.6% (H). Sed Rate 86 mm/hr (H). Fibrinogen 143 mg/dl (L). CHEM - Calcium Ionized 1.35 mm/L (H) ALT 68 (H) AST 56 (H). Urinalysis - Cloudy, Leukocytes trace, Amorphous crystals few, Gram Stain positive cocci in pairs, Gram negative coccobacilli. EMG/NCS report with graphs - Abnormal. MRI Spine - Abnormal, enhancement of lumbosacral/cauda equina nerve roots, small cystic benign appearing lesion within pedicle of L3 ve. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event to be serious with seriousness criteria of Life threatening and Hospitalization.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width increased, Urinary retention, VIth nerve paralysis
Clinical narrative: This report to VAERS provides the following narrative: A report has been received from consumer via VAERS concerning a 9 year old female patient. The patient's concurrent disease included allergic rhinitis. Concomitant medications included cetirizine hydrochloride. Patient had been receiving FLUMIST (intranasal) started on 10-Jan-2013. Odd gait when walking, running on 01-Apr-2013. Feet tingled on 02-Apr-2013. Limping on 03-Apr-2013 and began falling frequently. ER on 07-Apr-2013 and diagnosed with Guillain-Barre Syndrome on 08-Apr-2013. The following information was obtained through follow-up and/or provided by the government. 13-Jun-2013 Hospital records and discharge summary received. Service dates 07-Apr-2013 to 16-Apr-2013, 24-Apr-2013 to 09-May-2013. Diagnosis: Guillain-Barre Syndrome, axonal variant, with associated lower extremity weakness, relapse. Acute demyelinating polyneuropathy. Patient diagnosed with GBS 2 weeks prior, clumsiness, difficulties walking, foot numbness/tingling. IVIG administration. Using walker, discharged to outpatient PT/OT. Now presenting with worsening weakness in lower extremities and new tingling in feet. Blurred/double vision and weakness in EOM, CN 6 Palsy. Areflexia lower extremities with weakness in hips, knees, ankles. Back/neck pain. Potential Miller-Fisher. Gabapentin PO. Trouble sleeping. Urinary retention, bladder distended, probable neurogenic bladder. Plasmapheresis catheter placement, PLEX. 6/14/13 Neurology Consultation records received. Service dates 16-Apr-2013 to 02-May-2013. Additional Information Abstracted: Diagnosis: Guillain-Barre Syndrome. Worsening balance, difficulty walking, worsening weakness lower extremities. Weakness noted involving bilateral upper extremities. Emesis, pain in hips and neck, neuropathic pain, headache after IVIG, transient hypotension, anxious. Keratosis pilaris. Plasma exchanges. CT Scan. Full blood work. MRI and spinal tap. The following information was obtained through follow-up and/or provided by the government. 13-Jun-2013, 21-Jun-2013, 24-Jun-2013 Labs and Diagnostics: CSF - Abnormal, Protein 135 mg/dl. CBC / RBC 3.74 M/mm3 (L) HGB 11.0 g/dl (L) HCT 32.4% (L) RDW 16.1% (H) Seg 35.8% (L) Mono 11.0% (H) Lymph 48.6% (H). Sed Rate 86 mm/hr (H). Fibrinogen 143 mg/dl (L). CHEM - Calcium Ionized 1.35 mm/L (H) ALT 68 (H) AST 56 (H). Urinalysis - Cloudy, Leukocytes trace, Amorphous crystals few, Gram Stain positive cocci in pairs, Gram negative coccobacilli. EMG/NCS report with graphs - Abnormal. MRI Spine - Abnormal, enhancement of lumbosacral/cauda equina nerve roots, small cystic benign appearing lesion within pedicle of L3 ve. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event to be serious with seriousness criteria of Life threatening and Hospitalization.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Vision blurred, Vomiting, Walking aid user, White blood cells urine positive
Clinical narrative: This report to VAERS provides the following narrative: A report has been received from consumer via VAERS concerning a 9 year old female patient. The patient's concurrent disease included allergic rhinitis. Concomitant medications included cetirizine hydrochloride. Patient had been receiving FLUMIST (intranasal) started on 10-Jan-2013. Odd gait when walking, running on 01-Apr-2013. Feet tingled on 02-Apr-2013. Limping on 03-Apr-2013 and began falling frequently. ER on 07-Apr-2013 and diagnosed with Guillain-Barre Syndrome on 08-Apr-2013. The following information was obtained through follow-up and/or provided by the government. 13-Jun-2013 Hospital records and discharge summary received. Service dates 07-Apr-2013 to 16-Apr-2013, 24-Apr-2013 to 09-May-2013. Diagnosis: Guillain-Barre Syndrome, axonal variant, with associated lower extremity weakness, relapse. Acute demyelinating polyneuropathy. Patient diagnosed with GBS 2 weeks prior, clumsiness, difficulties walking, foot numbness/tingling. IVIG administration. Using walker, discharged to outpatient PT/OT. Now presenting with worsening weakness in lower extremities and new tingling in feet. Blurred/double vision and weakness in EOM, CN 6 Palsy. Areflexia lower extremities with weakness in hips, knees, ankles. Back/neck pain. Potential Miller-Fisher. Gabapentin PO. Trouble sleeping. Urinary retention, bladder distended, probable neurogenic bladder. Plasmapheresis catheter placement, PLEX. 6/14/13 Neurology Consultation records received. Service dates 16-Apr-2013 to 02-May-2013. Additional Information Abstracted: Diagnosis: Guillain-Barre Syndrome. Worsening balance, difficulty walking, worsening weakness lower extremities. Weakness noted involving bilateral upper extremities. Emesis, pain in hips and neck, neuropathic pain, headache after IVIG, transient hypotension, anxious. Keratosis pilaris. Plasma exchanges. CT Scan. Full blood work. MRI and spinal tap. The following information was obtained through follow-up and/or provided by the government. 13-Jun-2013, 21-Jun-2013, 24-Jun-2013 Labs and Diagnostics: CSF - Abnormal, Protein 135 mg/dl. CBC / RBC 3.74 M/mm3 (L) HGB 11.0 g/dl (L) HCT 32.4% (L) RDW 16.1% (H) Seg 35.8% (L) Mono 11.0% (H) Lymph 48.6% (H). Sed Rate 86 mm/hr (H). Fibrinogen 143 mg/dl (L). CHEM - Calcium Ionized 1.35 mm/L (H) ALT 68 (H) AST 56 (H). Urinalysis - Cloudy, Leukocytes trace, Amorphous crystals few, Gram Stain positive cocci in pairs, Gram negative coccobacilli. EMG/NCS report with graphs - Abnormal. MRI Spine - Abnormal, enhancement of lumbosacral/cauda equina nerve roots, small cystic benign appearing lesion within pedicle of L3 ve. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter assessed the event to be serious with seriousness criteria of Life threatening and Hospitalization.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 3x3" red itchy area at site of injection. Pt used ALLEGRA with good results.
Sex: F
Vaccine: FLUX, HEPA, HPV4
Symptoms: Disability, Exposure during pregnancy, Pyelonephritis, Ultrasound antenatal screen abnormal
Clinical narrative: Case number PHHY2015US028230, is an initial spontaneous report received from a physician via the Vaccine Adverse Event Reporting System (VAERS, reference number: 554463) website on 05 Mar 2015, with a follow up report received on 10 Aug 2015. This report refers to an approximately 16 year old female patient. Her medical history was not reported. Concurrent condition included pyelonephritis which was treated in the past. Concomitant medication included unspecified birth control medication. Her vaccination history included administration of GARDASIL (batch numbers: not reported) first dose on 22 Feb 2010 and second dose on 22 Aug 2013. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported), GARDASIL (batch number: not reported) third dose and a hepatitis A vaccine (other manufacturer, batch number: not reported) on 07 Nov 2014. On 10 Nov 2014, she experienced pyelonephritis. A medical attention was sought and she was hospitalized. On the same day an ultrasound scan was performed and she was found to be pregnant. Patient's last menstrual period was on 09 Aug 2014 and estimated delivery date was 16 May 2015. She was exposed to vaccines at 13 weeks of pregnancy. Physician stated that the patient was currently disabled and incapacitated as she was receiving an unspecified intravenous pain medication along with an unspecified antibiotic as treatment. Outcome of the event was not reported. Event was reported as serious (disability). Causality assessment was not provided. No additional follow up was received. This case was considered lost to follow up. Follow up report received on 10 Aug 2015: added lost to follow up information.
Age: 43.0
Sex: M
Vaccine: HEPA, IPV, TDAP, HEPA, IPV, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Based on additional information received on 28 May 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 19 February 2015. A 43 years old male patient, whose medical history had egg allergy, body temperature 98.3 degree at the time of vaccination and concomitant medications were not reported, had received a dose of ADACEL (batch number - U5030AA) (expiration date, dose, dose number were not reported) via Intra muscular route in left deltoid on 18 February 2015 at 13:30pm, also received a dose of IPOL (batch number- J1406-1), (expiration date, dose, dose number were not reported) via Intra muscular route in right deltoid on 18 February 2015 at 13:30pm and also received a dose of HEPATITIS A VACCINE (batch number- K011095) (expiration date, dose, dose number were not reported) via Intra muscular route in right deltoid on 18 February 2015 at 13:30pm. It was reported that on 19 February 2015 at 6:00 am the patient experienced mild achey feeling and developed fever (100.7 degrees - 101.4 degrees) and also said there was no nausea, vomiting, diarrhoea. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was unknown. Documents held by sender: none. Follow-up information received from a nurse on 28 May 2015. The expiry date for ADACEL reported as 01 May 2017, IPOL reported as 20 July 2015 and HEPATITIS A VACCINE reported as 17 January 2016. Documents held by sender: none. Follow up information received from a physician on 22 June 2015. It was reported that, patient had no treatment. No new information reported.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Autoimmune disorder, Death, Eating disorder, Respiratory disorder
Clinical narrative: Case number PHHY2015US082694, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 576974) website on 07 Jul 2015, with a follow up report received from the Quality Assurance Department (QA, reference number: 1002996) on 15 Jul 2015, with a follow up report received from the QA department on 10 Aug 2015. This report refers to 79 year old female patient. Medical history was not reported. Concurrent condition included mild rash to a new detergent. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1412301) in arm on 08 Oct 2014. On 09 Oct 2014, she developed autoimmune disease which "kept her from eating and eventually her airway". She was taken to an emergency room for medical support. The patient was hospitalized as the events were life threatening. On 25 Mar 2015, the events led her to death. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1412301) vaccine was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up report received from the QA Department on 15 Jul 2015: Updated QA reference number only. Follow up received from the QA department on 10 Aug 2015: updated batch review report in the narrative.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Apparent life threatening event, Autoimmune disorder, Death, Feeding disorder, Respiratory disorder
Clinical narrative: Case number PHHY2015US082694, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 576974) website on 07 Jul 2015, with a follow up report received from the Quality Assurance Department (QA, reference number: 1002996) on 15 Jul 2015, with a follow up report received from the QA department on 10 Aug 2015. This report refers to 79 year old female patient. Medical history was not reported. Concurrent condition included mild rash to a new detergent. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1412301) in arm on 08 Oct 2014. On 09 Oct 2014, she developed autoimmune disease which "kept her from eating and eventually her airway". She was taken to an emergency room for medical support. The patient was hospitalized as the events were life threatening. On 25 Mar 2015, the events led her to death. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1412301) vaccine was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up report received from the QA Department on 15 Jul 2015: Updated QA reference number only. Follow up received from the QA department on 10 Aug 2015: updated batch review report in the narrative.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Ageusia, Anosmia, Computerised tomogram head, Deafness unilateral, Influenza like illness
Clinical narrative: Case number PHHY2015US100905 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS ID 577069) received on 11 Aug 2015. This report refers to a 76-year-old male patient. Medical history was not reported. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 12 Oct 2014. On 05 Jan 2015 he felt as if coming down with flu like symptoms and did so 2 days later. Then 2 more days subsequent, she lost hearing in right ear and total loss of smell and taste. He went to primary doctor who then sent him to an ENT Specialist and from ENT to a Neurologist. He has regained full hearing, but still cannot smell nor taste. The outcome of the events was reported as not recovered. The event were reported as non-serious. Causality was not reported. Seriousness of lost hearing in right ear was upgraded based on NVS-IME list and seriousness of total loss of smell and taste was upgraded based on available information in the source document.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Ageusia, Anosmia, Deafness unilateral, Influenza like illness
Clinical narrative: Case number PHHY2015US100905 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS ID 577069) received on 11 Aug 2015. This report refers to a 76-year-old male patient. Medical history was not reported. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 12 Oct 2014. On 05 Jan 2015 he felt as if coming down with flu like symptoms and did so 2 days later. Then 2 more days subsequent, she lost hearing in right ear and total loss of smell and taste. He went to primary doctor who then sent him to an ENT Specialist and from ENT to a Neurologist. He has regained full hearing, but still cannot smell nor taste. The outcome of the events was reported as not recovered. The event were reported as non-serious. Causality was not reported. Seriousness of lost hearing in right ear was upgraded based on NVS-IME list and seriousness of total loss of smell and taste was upgraded based on available information in the source document.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Haematoma, Herpes zoster, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2015US099380, is an initial spontaneous report received from a consumer via vaccine adverse event reporting system (VAERS reference number: 579233) on 11 Aug 2015. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with seasonal Influenza vaccine (unknown manufacturer, batch number: not reported) along with pneumococcal vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On 25 Feb 2015, the patient experienced serious road traffic accident. The patient stated that the accident caused her hematoma reported as "her chest area filled with blood and turned red". On 04 Apr 2015, the patient was admitted to the hospital as the patient experienced severe pain in the shoulder and in the injury area. On 06 Apr 2015, the patient was found to have herpes zoster. The patient stated that she was in the seventh week of herpes zoster and the patient was still in pain and the symptoms did not subside despite taking gabapentin. The outcome of the herpes zoster was not recovered and outcome of the events was unknown. Causality was not reported.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Road traffic accident
Clinical narrative: Case number PHHY2015US099380, is an initial spontaneous report received from a consumer via vaccine adverse event reporting system (VAERS reference number: 579233) on 11 Aug 2015. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with seasonal Influenza vaccine (unknown manufacturer, batch number: not reported) along with pneumococcal vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On 25 Feb 2015, the patient experienced serious road traffic accident. The patient stated that the accident caused her hematoma reported as "her chest area filled with blood and turned red". On 04 Apr 2015, the patient was admitted to the hospital as the patient experienced severe pain in the shoulder and in the injury area. On 06 Apr 2015, the patient was found to have herpes zoster. The patient stated that she was in the seventh week of herpes zoster and the patient was still in pain and the symptoms did not subside despite taking gabapentin. The outcome of the herpes zoster was not recovered and outcome of the events was unknown. Causality was not reported.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Haematoma, Herpes zoster, Injury, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US099380, is an initial spontaneous report received from a consumer via vaccine adverse event reporting system (VAERS reference number: 579233) on 11 Aug 2015. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with seasonal Influenza vaccine (unknown manufacturer, batch number: not reported) along with pneumococcal vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On 25 Feb 2015, the patient experienced serious road traffic accident. The patient stated that the accident caused her hematoma reported as "her chest area filled with blood and turned red". On 04 Apr 2015, the patient was admitted to the hospital as the patient experienced severe pain in the shoulder and in the injury area. On 06 Apr 2015, the patient was found to have herpes zoster. The patient stated that she was in the seventh week of herpes zoster and the patient was still in pain and the symptoms did not subside despite taking gabapentin. The outcome of the herpes zoster was not recovered and outcome of the events was unknown. Causality was not reported.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cough, Erythema of eyelid, Eyelid oedema, Hypersensitivity, Tongue pruritus
Clinical narrative: Initial unsolicited report received from a Consumer (patient's parent) on 29-May-2015. A 5 years old male patient, had received a fifth dose of DAPTACEL in the left arm (batch number: C4761AA, expiry date: 03-Jul-2017, route of administration was not reported) and fourth dose of IPOL in the left arm (batch number, route of administration was not reported) both on 26-May-2015. There was no illness at the time of vaccination. The pre-existing physician diagnosed allergies, birth defects, medical conditions including severe dairy allergy, moderate egg allergy and asthma. There were no concomitant medications reported. He received 4 previous doses of DAPTACEL vaccine and 3 previous doses of IPOL vaccine. The patient required Emergency Room/Doctor Visit. On 26-May-2015, immediately after vaccination, he developed tongue burning, his eyes were swollen, he had a running nose and asthmatic cough. His mother give him oral BENADRYL and took him to the medical center emergency room where he was monitored for 2 hours. He was prescribed oral BENADRYL every 6 hours. His left arm was still swollen and red. Laboratory investigations were not provided. At the time of this report, the outcome was reported as unknown. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cough, Eye swelling, Glossodynia, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Initial unsolicited report received from a Consumer (patient's parent) on 29-May-2015. A 5 years old male patient, had received a fifth dose of DAPTACEL in the left arm (batch number: C4761AA, expiry date: 03-Jul-2017, route of administration was not reported) and fourth dose of IPOL in the left arm (batch number, route of administration was not reported) both on 26-May-2015. There was no illness at the time of vaccination. The pre-existing physician diagnosed allergies, birth defects, medical conditions including severe dairy allergy, moderate egg allergy and asthma. There were no concomitant medications reported. He received 4 previous doses of DAPTACEL vaccine and 3 previous doses of IPOL vaccine. The patient required Emergency Room/Doctor Visit. On 26-May-2015, immediately after vaccination, he developed tongue burning, his eyes were swollen, he had a running nose and asthmatic cough. His mother give him oral BENADRYL and took him to the medical center emergency room where he was monitored for 2 hours. He was prescribed oral BENADRYL every 6 hours. His left arm was still swollen and red. Laboratory investigations were not provided. At the time of this report, the outcome was reported as unknown. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site swelling, Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a Consumer (patient's parent) on 29-May-2015. A 5 years old male patient, had received a fifth dose of DAPTACEL in the left arm (batch number: C4761AA, expiry date: 03-Jul-2017, route of administration was not reported) and fourth dose of IPOL in the left arm (batch number, route of administration was not reported) both on 26-May-2015. There was no illness at the time of vaccination. The pre-existing physician diagnosed allergies, birth defects, medical conditions including severe dairy allergy, moderate egg allergy and asthma. There were no concomitant medications reported. He received 4 previous doses of DAPTACEL vaccine and 3 previous doses of IPOL vaccine. The patient required Emergency Room/Doctor Visit. On 26-May-2015, immediately after vaccination, he developed tongue burning, his eyes were swollen, he had a running nose and asthmatic cough. His mother give him oral BENADRYL and took him to the medical center emergency room where he was monitored for 2 hours. He was prescribed oral BENADRYL every 6 hours. His left arm was still swollen and red. Laboratory investigations were not provided. At the time of this report, the outcome was reported as unknown. Documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Injection site urticaria
Clinical narrative: Case number PHEH2015US011925 is an initial spontaneous report received from a physician on 08 Jun 2015 with follow-up received from physician on 11 Aug 2015. This report refers to an 18 years old male patient. Medical history included bone marrow transplant. Concurrent condition included sickle cell disease. Concomitant medications were not reported. His vaccination status was reported as re- vaccinated for all. The patient was vaccinated with first dose of BEXSERO (batch number: 146101) into left arm and GARDASIL (batch number: not reported) into right arm; both at a dose of 0.5 ml intramuscularly on 27 May 2015. On the same day after vaccination the patient experienced hives up the arm, neck and proximal to vaccine site. One day later the patient experienced mouth swelling. One week later there was a little reaction on his lip. Outcome of hives proximal to vaccine site and mouth swelling was reported as recovered in 3 to 4 days. The physician assessed hives proximal to vaccine site and mouth swelling as non-serious. Outcome and seriousness of the events hives on neck and reaction on lip were not reported. Causality of the events was not reported. Seriousness assessment of mouth swelling was upgraded based on information in the source document. Follow-up information received from a physician on 11 Aug 2015: Patient's demographics (age, gender, height and weight), concurrent condition, procedures, BEXSERO details (dose, site, route and batch), co-suspect vaccine, new events (hives proximal to vaccine site and mouth swelling), seriousness criteria and other clinically relevant information updated in the narrative.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Injection site urticaria, Lip disorder, Mouth swelling, Urticaria
Clinical narrative: Case number PHEH2015US011925 is an initial spontaneous report received from a physician on 08 Jun 2015 with follow-up received from physician on 11 Aug 2015. This report refers to an 18 years old male patient. Medical history included bone marrow transplant. Concurrent condition included sickle cell disease. Concomitant medications were not reported. His vaccination status was reported as re- vaccinated for all. The patient was vaccinated with first dose of BEXSERO (batch number: 146101) into left arm and GARDASIL (batch number: not reported) into right arm; both at a dose of 0.5 ml intramuscularly on 27 May 2015. On the same day after vaccination the patient experienced hives up the arm, neck and proximal to vaccine site. One day later the patient experienced mouth swelling. One week later there was a little reaction on his lip. Outcome of hives proximal to vaccine site and mouth swelling was reported as recovered in 3 to 4 days. The physician assessed hives proximal to vaccine site and mouth swelling as non-serious. Outcome and seriousness of the events hives on neck and reaction on lip were not reported. Causality of the events was not reported. Seriousness assessment of mouth swelling was upgraded based on information in the source document. Follow-up information received from a physician on 11 Aug 2015: Patient's demographics (age, gender, height and weight), concurrent condition, procedures, BEXSERO details (dose, site, route and batch), co-suspect vaccine, new events (hives proximal to vaccine site and mouth swelling), seriousness criteria and other clinically relevant information updated in the narrative.
Age: 17.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cataplexy, Condition aggravated, Electroencephalogram normal, Hypotonia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Case number PHHY2015US099118, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 580139) website on 11 Aug 2015. This report refers to a 17 year old female patient. Medical history included anxiety, fibromyalgia and was referred to a sleep centre after being diagnosed with narcolepsy and cataplexy. The narcolepsy symptoms began approximately four years prior to presenting to the clinic with excessive daytime sleepiness, sleep-related hallucinations and cataplexy but no sleep paralysis. A subsequent overnight polysomnogram revealed an Apnea-Hypopnea Index (AHI) more than 1, Periodic Limb Movement Index (PLMI) 14/hr, sleep latency of four minutes and sleep efficiency of 92 percent. The next morning MSLT (Multiple Sleep Latency Test) demonstrated a mean sleep latency of 2.6 minutes and 2 out of 5 sleep onset REM (Rapid Eye Movement) periods. She scored 20/24 on her Epworth Sleepiness scale. The patient was positive for DQBI*06:02 allele and CSF (Cerebrospinal Fluid) hypocretin levels were not obtained. Baseline electroencephalography (EEG) did not demonstrate straight epileptiform activity and brain MRI (Magnetic Resonance Imaging) was normal. In the fall of 2013, approximately four years after her first cataplexy symptoms, the patient received the influenza virus vaccine (manufacturer and batch number not provided). Within twenty minutes of influenza vaccination, she began experiencing cataplexy symptoms that lasted for approximately twenty-four hours. Her status cataplecticus manifested as episodic and instantaneous loss of tone in her lower extremities without loss of consciousness. The episodes were captured on home video. Her daytime sleepiness and cataplexy were much improved on sodium oxybate, armodafinil and sertraline. Reporter stated that the influenza vaccine may have served as a trigger of status cataplecticus in this patient with known narcolepsy. Outcome of the events was not reported. The events were reported as non-serious. Causality assessment was not reported. Seriousness of the event cataplexy and symptoms was upgraded based on information available in the source documents.
Age: 17.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Sleep study abnormal, Somnolence
Clinical narrative: Case number PHHY2015US099118, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 580139) website on 11 Aug 2015. This report refers to a 17 year old female patient. Medical history included anxiety, fibromyalgia and was referred to a sleep centre after being diagnosed with narcolepsy and cataplexy. The narcolepsy symptoms began approximately four years prior to presenting to the clinic with excessive daytime sleepiness, sleep-related hallucinations and cataplexy but no sleep paralysis. A subsequent overnight polysomnogram revealed an Apnea-Hypopnea Index (AHI) more than 1, Periodic Limb Movement Index (PLMI) 14/hr, sleep latency of four minutes and sleep efficiency of 92 percent. The next morning MSLT (Multiple Sleep Latency Test) demonstrated a mean sleep latency of 2.6 minutes and 2 out of 5 sleep onset REM (Rapid Eye Movement) periods. She scored 20/24 on her Epworth Sleepiness scale. The patient was positive for DQBI*06:02 allele and CSF (Cerebrospinal Fluid) hypocretin levels were not obtained. Baseline electroencephalography (EEG) did not demonstrate straight epileptiform activity and brain MRI (Magnetic Resonance Imaging) was normal. In the fall of 2013, approximately four years after her first cataplexy symptoms, the patient received the influenza virus vaccine (manufacturer and batch number not provided). Within twenty minutes of influenza vaccination, she began experiencing cataplexy symptoms that lasted for approximately twenty-four hours. Her status cataplecticus manifested as episodic and instantaneous loss of tone in her lower extremities without loss of consciousness. The episodes were captured on home video. Her daytime sleepiness and cataplexy were much improved on sodium oxybate, armodafinil and sertraline. Reporter stated that the influenza vaccine may have served as a trigger of status cataplecticus in this patient with known narcolepsy. Outcome of the events was not reported. The events were reported as non-serious. Causality assessment was not reported. Seriousness of the event cataplexy and symptoms was upgraded based on information available in the source documents.
Age: 17.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Apnoea test, Cataplexy, Condition aggravated, Electroencephalogram abnormal, Hypotonia
Clinical narrative: Case number PHHY2015US099118, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 580139) website on 11 Aug 2015. This report refers to a 17 year old female patient. Medical history included anxiety, fibromyalgia and was referred to a sleep centre after being diagnosed with narcolepsy and cataplexy. The narcolepsy symptoms began approximately four years prior to presenting to the clinic with excessive daytime sleepiness, sleep-related hallucinations and cataplexy but no sleep paralysis. A subsequent overnight polysomnogram revealed an Apnea-Hypopnea Index (AHI) more than 1, Periodic Limb Movement Index (PLMI) 14/hr, sleep latency of four minutes and sleep efficiency of 92 percent. The next morning MSLT (Multiple Sleep Latency Test) demonstrated a mean sleep latency of 2.6 minutes and 2 out of 5 sleep onset REM (Rapid Eye Movement) periods. She scored 20/24 on her Epworth Sleepiness scale. The patient was positive for DQBI*06:02 allele and CSF (Cerebrospinal Fluid) hypocretin levels were not obtained. Baseline electroencephalography (EEG) did not demonstrate straight epileptiform activity and brain MRI (Magnetic Resonance Imaging) was normal. In the fall of 2013, approximately four years after her first cataplexy symptoms, the patient received the influenza virus vaccine (manufacturer and batch number not provided). Within twenty minutes of influenza vaccination, she began experiencing cataplexy symptoms that lasted for approximately twenty-four hours. Her status cataplecticus manifested as episodic and instantaneous loss of tone in her lower extremities without loss of consciousness. The episodes were captured on home video. Her daytime sleepiness and cataplexy were much improved on sodium oxybate, armodafinil and sertraline. Reporter stated that the influenza vaccine may have served as a trigger of status cataplecticus in this patient with known narcolepsy. Outcome of the events was not reported. The events were reported as non-serious. Causality assessment was not reported. Seriousness of the event cataplexy and symptoms was upgraded based on information available in the source documents.
Age: 17.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging brain normal, Somnolence
Clinical narrative: Case number PHHY2015US099118, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 580139) website on 11 Aug 2015. This report refers to a 17 year old female patient. Medical history included anxiety, fibromyalgia and was referred to a sleep centre after being diagnosed with narcolepsy and cataplexy. The narcolepsy symptoms began approximately four years prior to presenting to the clinic with excessive daytime sleepiness, sleep-related hallucinations and cataplexy but no sleep paralysis. A subsequent overnight polysomnogram revealed an Apnea-Hypopnea Index (AHI) more than 1, Periodic Limb Movement Index (PLMI) 14/hr, sleep latency of four minutes and sleep efficiency of 92 percent. The next morning MSLT (Multiple Sleep Latency Test) demonstrated a mean sleep latency of 2.6 minutes and 2 out of 5 sleep onset REM (Rapid Eye Movement) periods. She scored 20/24 on her Epworth Sleepiness scale. The patient was positive for DQBI*06:02 allele and CSF (Cerebrospinal Fluid) hypocretin levels were not obtained. Baseline electroencephalography (EEG) did not demonstrate straight epileptiform activity and brain MRI (Magnetic Resonance Imaging) was normal. In the fall of 2013, approximately four years after her first cataplexy symptoms, the patient received the influenza virus vaccine (manufacturer and batch number not provided). Within twenty minutes of influenza vaccination, she began experiencing cataplexy symptoms that lasted for approximately twenty-four hours. Her status cataplecticus manifested as episodic and instantaneous loss of tone in her lower extremities without loss of consciousness. The episodes were captured on home video. Her daytime sleepiness and cataplexy were much improved on sodium oxybate, armodafinil and sertraline. Reporter stated that the influenza vaccine may have served as a trigger of status cataplecticus in this patient with known narcolepsy. Outcome of the events was not reported. The events were reported as non-serious. Causality assessment was not reported. Seriousness of the event cataplexy and symptoms was upgraded based on information available in the source documents.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Arthritis, Bone pain, Influenza, Malaise
Clinical narrative: Case number PHHY2015US101945, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 580428) on 11 Aug 2015. This report refers to an adult female patient. Medical history was not reported. Concurrent condition included asthma. Vaccination history included, administration of a seasonal influenza vaccine (manufacturer and batch number: not reported) and a tetanus shot (other manufacturer, batch number: not reported) in 1986 and experienced influenza (see case: PHHY2015US101946). It was also reported that every time the patient received a flu shot she felt really sick and also developed flu afterwards (no further details were given). On an unknown date (in 2007 or 2009, whenever H1N1 epidemic took place), the patient received a seasonal influenza vaccine (manufacturer and batch  number not reported). After vaccination, the patient experienced arthritis, sickness, bone pain and influenza. The patient thought that she might have developed fibromyalgia. But after checking (no further detail was given) it was confirmed that the patient did not have fibromyalgia. This event last for about 2 years and the patient had to go to doctor quite a bit. The outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of arthritis was upgraded to serious (medically significant) based on the information available in the source document. The reporter considered the events to be possibly related to the seasonal influenza vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever to 104, febrile seizure.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Chest X-ray normal, Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: Fever to 104, febrile seizure.
Age: 23.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Coma, Hemiplegia, Mobility decreased, Wheelchair user
Clinical narrative: Case number PHHY2015US100702, is an initial spontaneous received from a consumer via vaccine adverse event reporting system (VAERS reference number: 580676) on 11 Aug 2015. This report refers to a 23-year-old female patient. The patient's current condition included autoimmune disease acute disseminated encephalomyelitis and this had left the patient with lesions on brain and spinal cord. No concomitant medication was reported. The patient was vaccinated with Influenza vaccine (unknown manufacturer, batch number: not reported) on an unknown date. On an unknown date, three months after vaccination the patient had lapsed into a coma. The patient was in a wheelchair and had difficulty moving the left side of the body as she was left paralyzed. Laboratory investigation and corrective treatment were not reported. At the time of the reporting the outcome of the event coma was not reported and the patient had not recovered from other events. The events were reported as non-serious and causality was not reported. Seriousness of the events Coma and Hemiplegia were upgraded based on Novartis Important Medical Events list.
Age: 23.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Coma, Mobility decreased, Paralysis, Wheelchair user
Clinical narrative: Case number PHHY2015US100702, is an initial spontaneous received from a consumer via vaccine adverse event reporting system (VAERS reference number: 580676) on 11 Aug 2015. This report refers to a 23-year-old female patient. The patient's current condition included autoimmune disease acute disseminated encephalomyelitis and this had left the patient with lesions on brain and spinal cord. No concomitant medication was reported. The patient was vaccinated with Influenza vaccine (unknown manufacturer, batch number: not reported) on an unknown date. On an unknown date, three months after vaccination the patient had lapsed into a coma. The patient was in a wheelchair and had difficulty moving the left side of the body as she was left paralyzed. Laboratory investigation and corrective treatment were not reported. At the time of the reporting the outcome of the event coma was not reported and the patient had not recovered from other events. The events were reported as non-serious and causality was not reported. Seriousness of the events Coma and Hemiplegia were upgraded based on Novartis Important Medical Events list.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatic specific antigen normal, Prostatomegaly, Urine flow decreased, Vaccine positive rechallenge
Clinical narrative: Case number PHHY2015US099232 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) web site on 11 Aug 2015. This report refers to a 43 years old male patient. Concurrent condition included seasonal allergies. concomitant medications were not reported. His vaccination history included administration of seasonal Influenza vaccine (manufacturer and batch number: unknown) in early 2013 and in the Fall of 2013. After these vaccinations the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see cases: PHHY2015US099201 and PHHY2015US099231). The patient was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on 22 Oct 2014. On 24 Oct 2014 the patient started experiencing gradual restriction in urinary flow. Three days later, urinary flow was fully restricted. Urinary flow did not return to normal until over a month later. Laboratory examinations indicated enlarged prostate and normal prostatic specific antigen (PSA) test. Outcome of the events was recovered. Case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of enlarged prostate, anuria and urine flow decreased was upgraded based on information in the source document.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatic specific antigen normal, Prostatomegaly, Urine flow decreased
Clinical narrative: Case number PHHY2015US099232 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) web site on 11 Aug 2015. This report refers to a 43 years old male patient. Concurrent condition included seasonal allergies. concomitant medications were not reported. His vaccination history included administration of seasonal Influenza vaccine (manufacturer and batch number: unknown) in early 2013 and in the Fall of 2013. After these vaccinations the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see cases: PHHY2015US099201 and PHHY2015US099231). The patient was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on 22 Oct 2014. On 24 Oct 2014 the patient started experiencing gradual restriction in urinary flow. Three days later, urinary flow was fully restricted. Urinary flow did not return to normal until over a month later. Laboratory examinations indicated enlarged prostate and normal prostatic specific antigen (PSA) test. Outcome of the events was recovered. Case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of enlarged prostate, anuria and urine flow decreased was upgraded based on information in the source document.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatomegaly, Urine flow decreased
Clinical narrative: Case number PHHY2015US099232 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580753) web site on 11 Aug 2015. This report refers to a 43 years old male patient. Concurrent condition included seasonal allergies. concomitant medications were not reported. His vaccination history included administration of seasonal Influenza vaccine (manufacturer and batch number: unknown) in early 2013 and in the Fall of 2013. After these vaccinations the patient had a gradual restriction in urinary flow and further had a full restriction on urinary flow (see cases: PHHY2015US099201 and PHHY2015US099231). The patient was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on 22 Oct 2014. On 24 Oct 2014 the patient started experiencing gradual restriction in urinary flow. Three days later, urinary flow was fully restricted. Urinary flow did not return to normal until over a month later. Laboratory examinations indicated enlarged prostate and normal prostatic specific antigen (PSA) test. Outcome of the events was recovered. Case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of enlarged prostate, anuria and urine flow decreased was upgraded based on information in the source document.