chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Dysphagia, Electromyogram, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2015US031902, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 558098) website on 16 Mar 2015. This report refers to a 57 year old male patient. He had no drug, dust or mold allergy. Concurrent conditions included non-Hodgkin's lymphoma, hypertension, gastrooesophageal reflux disease, coronary artery disease and asthma. Concomitant medications included RITUXAN, diclofenac, COREG, ASA, omeprazole, vitamins NOS, fish oil, lysine, urinozinc, pravastatin, azelastine, affair, NASONEX, montelukast, TESSALON PERLES and albuterol, ZANTAC and BENADRYL. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in right arm on 31 Oct 2014. On 26 Nov 2014, he experienced progressive difficulty swallowing, weakness in left hand, arm, left and right leg. The treating physician diagnosed him with Guillain-Barre syndrome. He was hospitalized for 10 days and underwent plasmapheresis for five times. On unknown date, electromyogram, computerised tomogram, nuclear magnetic resonance imaging, blood work and lumbar puncture were performed (results were not given). Final outcome of the events were unknown. Events were reported as serious (life threatening and hospitalization). Causality was not reported.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging, Plasmapheresis
Clinical narrative: Case number PHHY2015US031902, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 558098) website on 16 Mar 2015. This report refers to a 57 year old male patient. He had no drug, dust or mold allergy. Concurrent conditions included non-Hodgkin's lymphoma, hypertension, gastrooesophageal reflux disease, coronary artery disease and asthma. Concomitant medications included RITUXAN, diclofenac, COREG, ASA, omeprazole, vitamins NOS, fish oil, lysine, urinozinc, pravastatin, azelastine, affair, NASONEX, montelukast, TESSALON PERLES and albuterol, ZANTAC and BENADRYL. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in right arm on 31 Oct 2014. On 26 Nov 2014, he experienced progressive difficulty swallowing, weakness in left hand, arm, left and right leg. The treating physician diagnosed him with Guillain-Barre syndrome. He was hospitalized for 10 days and underwent plasmapheresis for five times. On unknown date, electromyogram, computerised tomogram, nuclear magnetic resonance imaging, blood work and lumbar puncture were performed (results were not given). Final outcome of the events were unknown. Events were reported as serious (life threatening and hospitalization). Causality was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Dyspnoea, Erythema, Rash, Rash macular, Urticaria
Clinical narrative: Case number PHHY2015US111624, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 558591) website on 10 Sep 2015. This report refers to a 50 year old female patient. Historical drugs included Aspirin and codeine. Medical history and concomitant medication were not provided. Patient was vaccinated with FLUVIRIN (batch number: 146502) intramuscular on 03 Dec 2014. On the same day she also received PNEUMOVAX (other manufacturer, batch number: K007826) intramuscular and ZOSTAVAX (other manufacturer, batch number: K010968) subcutaneous. On 05 Dec 2014 patient experienced hives, rash, trouble in breathing, blotchy skin and red circles on face. Patient had visited emergency room. No information was provided regarding treatment. Outcome of the event reported to be complete recovery. Case was reported to be non-serious and causality of the event was not reported. Seriousness of the event "trouble in breathing, blotchy skin, hives, rash and red circles on face" are upgraded based on information available in the source document. No further information was provided.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Lip swelling, Throat tightness
Clinical narrative: Case number PHHY2015US140264, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 558781) on 23 Oct 2015. This report refers to a 20 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: K15402) in left arm on 16 Dec 2014. On the same day after vaccination, the patient had dizziness. Her condition worsened with swelling of lips, shortness of breath and throat tightening. An emergency call was made. The patient was treated with EPIPEN at a dose of 0.3 mg. Paramedic came and took the patient hospital but was not hospitalized. Outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of the events was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Local swelling, Rash generalised
Clinical narrative: Case number PHHY2015US111033, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559193) website on 10 Sep 2015. This report refers to a 29 years old male patient. Medical history and concurrent illness were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1412301A) into left arm intramuscularly on 05 Nov 2014. On the same day after vaccination the patient was also vaccinated with PNEUMOVAX (batch number: K007825, other manufacturer) into right arm intramuscularly. On 06 Nov 2014, 24 hours after vaccination the patient experienced swelling at site of injection and up to the base of neck. Further the patient also had full body rash. The patient had an emergency visit due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "full body rash" was upgraded based on information in the source document.
Age: 21.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Chest pain, Dyspnoea, Wheezing
Clinical narrative: Case number PHHY2015US111154 is an initial spontaneous report received via vaccine adverse events reporting system (VAERS reference number: 559388) on 10 Sep 2015. This report refers to a 21 year old male patient. He had no known medical history. His current condition included mild upper respiratory infection (URI) symptoms two to three days prior immunization. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145903) and BOOSTRIX (other manufacturer, batch number: 5SR2L); both vaccines administered intramuscularly in the right arm on 18 Dec 2014. On the same day, he also received MENACTRA (other manufacturer, batch number: U5026AA) intramuscularly in the left arm and BICILLIN (other manufacturer) injection. On 18 Dec 2014, approximately 5 minutes after receiving immunizations and BICILLIN injection, the patient stated that he was having chest pain and shortness of breath. He was immediately taken to the clinic provider. Audible wheezing was noted versus stable. The clinic provider called for emergency medical service (EMS), and gave patient 0.5 ml epinephrine subcutaneously and his wheezing and chest pain improved. The EMS arrived and the patient was put on IV. He was given BENADRYL 50 mg intravenously. He was transferred to emergency room for follow on treatment. The events outcome was reported as complete recovery. The events were reported as non-serious, but the events wheezing and chest pain were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Heart rate increased, Pallor
Clinical narrative: Case number PHHY2015US113462, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559530) website on 10 Sep 2015. This report refers to a 38 year old male patient. Medical history and concomitant medication were not provided. Patient was vaccinated with FLUVIRIN (batch number: 1414001) intramuscular into right arm on 17 Oct 2014 at 1:15 PM. On the same day post vaccination, patient placed on back with pink color with complaints of difficulty breathing. Patient got lightheaded and felt like throat was closing up. Patient was lied down on the floor and lung sounds and pulse were checked and pulse was 110 BPM. Patient stated that coworkers stated that he looked pale. No wheezes heard upon observation. At 1:20 PM, patient continued to explain of difficulty breathing with now complaint of tongue feeling too big, when offered grape juice. Epinephrine was given on right arm (1:1000) 0.5 given by lead nurse. At around 1:30 pm, patient remained stable with complaints of heavy chest lessened. Paramedics arrived at 1:35pm, patient walked with help to stretcher. Outcome of the events was unknown. Events were reported as non-serious and causality of the event was not reported. Seriousness of the event "difficulty breathing, tongue feeling too big, throat tightness, chest discomfort, pallor and dizziness" were upgraded based on information available in the source document. No further information was provided.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Case number PHHY2015US113462, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559530) website on 10 Sep 2015. This report refers to a 38 year old male patient. Medical history and concomitant medication were not provided. Patient was vaccinated with FLUVIRIN (batch number: 1414001) intramuscular into right arm on 17 Oct 2014 at 1:15 PM. On the same day post vaccination, patient placed on back with pink color with complaints of difficulty breathing. Patient got lightheaded and felt like throat was closing up. Patient was lied down on the floor and lung sounds and pulse were checked and pulse was 110 BPM. Patient stated that coworkers stated that he looked pale. No wheezes heard upon observation. At 1:20 PM, patient continued to explain of difficulty breathing with now complaint of tongue feeling too big, when offered grape juice. Epinephrine was given on right arm (1:1000) 0.5 given by lead nurse. At around 1:30 pm, patient remained stable with complaints of heavy chest lessened. Paramedics arrived at 1:35pm, patient walked with help to stretcher. Outcome of the events was unknown. Events were reported as non-serious and causality of the event was not reported. Seriousness of the event "difficulty breathing, tongue feeling too big, throat tightness, chest discomfort, pallor and dizziness" were upgraded based on information available in the source document. No further information was provided.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Nervousness, Pruritus, Rash macular, Urticaria
Clinical narrative: Case number PHHY2015US110684, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559558) website on 10 Sep 2015. This report refers to a 50 year old female patient. Medical history and concomitant medication were not provided. The patient was vaccinated with first dose of FLUVIRIN (batch number: 1412501) intramuscular on 28 Oct 2014 at around 12:03 PM. At 12:40 PM on the same day patient experienced itching and blotchy for about 10 minutes. By 12:57 PM she had increased itching and hives. Patient received two doses of epinephrine 0.3 ml subcutaneous one on right arm and other on right thigh. Patient was nervous, but stated she was okay. Patient had visited emergency room. Outcome of the events reported to be unknown. Case was reported to be non-serious and causality of the event was not reported. Seriousness of the event "blotchy" was upgraded based on information available in the source document. No further information was provided.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Lip swelling, Pruritus
Clinical narrative: Case number PHHY2015US110675, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559559) website on 10 Sep 2015. This report refers to a 67 years old male patient. The patient had no medical history and no concurrent conditions. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1414001) into left arm on 30 Oct 2014. On 31 Oct 2014 at 12:00 noon the patient developed lip swelling. It got worse throughout the day and by the evening his lip was three times the normal size. Further his both palms itched and stated he had a mild headache. The swelling in his lip went down by the morning, but not to normal. The patient was seen by his physician and was given prednisone. His lip continued to improve. Final outcome of the events were recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of lip swelling was upgraded based on information in the source document.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Heart rate increased, Lip swelling, Malaise, Nausea
Clinical narrative: Case number PHHY2015US111508, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559624) received on 10 Sep 2015. This report refers to a 53-year-old female patient. Historical conditions and current illness were none. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1411601) intramuscular into the left arm on 20 Nov 2014. On the same day after vaccination the patient requested to be looked as she was not feeling well. The patient stated that her heart was beating fast; felt a little tight around her throat and her lips felt a little swollen. Further she felt nauseous, temperature was 100 degrees Fahrenheit otic, pulse was 81 via pulse oximeter, respiratory rate was 20 and O2 saturation was 98-99% on room air. The patient refused epinephrine and emergency to be called. The patient was continuously monitored for any worsening the symptoms. The patient stated she was feeling better and was advised to see physician. The events were reported as non-serious and causality was not reported. Final outcome of the events was complete recovery. Seriousness of the events throat tightness and lip swelling was upgraded based on information available in the source document.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Case number PHHY2015US111508, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559624) received on 10 Sep 2015. This report refers to a 53-year-old female patient. Historical conditions and current illness were none. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1411601) intramuscular into the left arm on 20 Nov 2014. On the same day after vaccination the patient requested to be looked as she was not feeling well. The patient stated that her heart was beating fast; felt a little tight around her throat and her lips felt a little swollen. Further she felt nauseous, temperature was 100 degrees Fahrenheit otic, pulse was 81 via pulse oximeter, respiratory rate was 20 and O2 saturation was 98-99% on room air. The patient refused epinephrine and emergency to be called. The patient was continuously monitored for any worsening the symptoms. The patient stated she was feeling better and was advised to see physician. The events were reported as non-serious and causality was not reported. Final outcome of the events was complete recovery. Seriousness of the events throat tightness and lip swelling was upgraded based on information available in the source document.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure immeasurable, Flushing, Syncope
Clinical narrative: Case number PHHY2015US110966, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560087) website on 10 Sep 2015. This report refers to a 33 year old male patient. Medical history included fainting on various occasions after flu shot (see case: PHHY2015US111129). Concomitant medication was not provided. The patient was vaccinated with FLUVIRIN (batch number: 1412301A) intramuscular on 11 Nov 2014. Soon after administration patient became flush. He had a faint episode with forehead laid on table. Patient was laid flat on floor and monitored for vitals, pulse. Tried to measure blood pressure but could not report the results. Patient felt well after some time and advised to call emergency in case of any unusual or anaphylactic symptoms. No information was provided regarding treatment. Outcome of the events reported as complete recovery. Case was reported to be non-serious and causality of the event was not reported. Seriousness of the event "faint" was upgraded based on information available in the source document. No further information was provided.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Case number PHHY2015US037828, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560579) website on 30 Mar 2015, with the follow-up information received from the Quality Assurance Department (reference number: 362742) on 07 Apr 2015, with the follow-up information received from Quality Assurance Department (reference number: 362742) on 29 Apr 2015. This report refers to a 32 year old female patient. The patient was allergic to shellfish. Current illness included cold or cough and she was taking ibuprofen. She was vaccinated with FLUVIRIN (batch number: 1413001) on 07 Oct 2014. On 18 Nov 2014, the patient was unable to walk due to numbness and tingling in legs. She had sudden collapse and was unable to sit up without assistance. The patient underwent MRI and was diagnosed with transverse myelitis. The patient went to emergency room and was hospitalized due to the events on an unknown date. The hospitalization was prolonged due to the events and she stayed in hospital for 37 days. The outcome of the events was unknown. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1413001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 362742) on 07 Apr 2015: Updated QA reference number only. Non-significant follow-up information received from the Quality Assurance Department (reference number: 362742) on 29 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Posture abnormal, Syncope
Clinical narrative: Case number PHHY2015US037828, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560579) website on 30 Mar 2015, with the follow-up information received from the Quality Assurance Department (reference number: 362742) on 07 Apr 2015, with the follow-up information received from Quality Assurance Department (reference number: 362742) on 29 Apr 2015. This report refers to a 32 year old female patient. The patient was allergic to shellfish. Current illness included cold or cough and she was taking ibuprofen. She was vaccinated with FLUVIRIN (batch number: 1413001) on 07 Oct 2014. On 18 Nov 2014, the patient was unable to walk due to numbness and tingling in legs. She had sudden collapse and was unable to sit up without assistance. The patient underwent MRI and was diagnosed with transverse myelitis. The patient went to emergency room and was hospitalized due to the events on an unknown date. The hospitalization was prolonged due to the events and she stayed in hospital for 37 days. The outcome of the events was unknown. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1413001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 362742) on 07 Apr 2015: Updated QA reference number only. Non-significant follow-up information received from the Quality Assurance Department (reference number: 362742) on 29 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test abnormal, Burning sensation, Constipation, Fall, Incontinence
Clinical narrative: Case number PHHY2015US036988, is an initial spontaneous report from consumer received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 561055) website on 23 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 362057) on 01 Apr 2015 with the follow-up information received from Quality Assurance Department (reference number: 362057) on 29 Apr 2015. This report refers to a 67 years old male patient. Current condition included scoliosis. Concomitant medications included finasteride and fluoxetine. He was vaccinated with FLUVIRIN (batch number: 1308701) into the right arm intramuscularly on 24 Jan 2014. On 09 Feb 2014, the patient started experiencing weak and heavy legs and intense burning. His symptoms progressed to constipation and legs got weaker through Mar 2014. The patient visited physician and was diagnosed with neuropathy and started on gabapentin. The patient's legs continued getting weaker. He was referred to physician on 09 May 2014 and was still diagnosed with neuropathy. His condition got worse and MRI, blood work and a lumbar puncture showed possible multiple sclerosis (MS), tumor (unspecified) or transverse myelitis (TM). The patient was treated with IV steroids for 3 days in outpatient and oral prednisone for 2 weeks. On 07 Oct 2014, the patient started physiotherapy. He started to experience incontinence and falls and was referred to different neurologists, after another fall. He was hospitalized and spent 7 days with neurologists. Another MRI, blood work and lumbar puncture were done. Neurologists confirmed "TM due to flu shot". The patient received IV steroids again for 5 days. Outcome of other events reported as condition unchanged. Events reported as serious (disability and hospitalization). The causality of the event neuropathy was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1308701) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 362057) on 01 Apr 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 362057) on 29 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort, Lumbar puncture abnormal, Muscular weakness, Myelitis transverse, Neuropathy peripheral
Clinical narrative: Case number PHHY2015US036988, is an initial spontaneous report from consumer received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 561055) website on 23 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 362057) on 01 Apr 2015 with the follow-up information received from Quality Assurance Department (reference number: 362057) on 29 Apr 2015. This report refers to a 67 years old male patient. Current condition included scoliosis. Concomitant medications included finasteride and fluoxetine. He was vaccinated with FLUVIRIN (batch number: 1308701) into the right arm intramuscularly on 24 Jan 2014. On 09 Feb 2014, the patient started experiencing weak and heavy legs and intense burning. His symptoms progressed to constipation and legs got weaker through Mar 2014. The patient visited physician and was diagnosed with neuropathy and started on gabapentin. The patient's legs continued getting weaker. He was referred to physician on 09 May 2014 and was still diagnosed with neuropathy. His condition got worse and MRI, blood work and a lumbar puncture showed possible multiple sclerosis (MS), tumor (unspecified) or transverse myelitis (TM). The patient was treated with IV steroids for 3 days in outpatient and oral prednisone for 2 weeks. On 07 Oct 2014, the patient started physiotherapy. He started to experience incontinence and falls and was referred to different neurologists, after another fall. He was hospitalized and spent 7 days with neurologists. Another MRI, blood work and lumbar puncture were done. Neurologists confirmed "TM due to flu shot". The patient received IV steroids again for 5 days. Outcome of other events reported as condition unchanged. Events reported as serious (disability and hospitalization). The causality of the event neuropathy was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1308701) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 362057) on 01 Apr 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 362057) on 29 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: Case number PHHY2015US036988, is an initial spontaneous report from consumer received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 561055) website on 23 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 362057) on 01 Apr 2015 with the follow-up information received from Quality Assurance Department (reference number: 362057) on 29 Apr 2015. This report refers to a 67 years old male patient. Current condition included scoliosis. Concomitant medications included finasteride and fluoxetine. He was vaccinated with FLUVIRIN (batch number: 1308701) into the right arm intramuscularly on 24 Jan 2014. On 09 Feb 2014, the patient started experiencing weak and heavy legs and intense burning. His symptoms progressed to constipation and legs got weaker through Mar 2014. The patient visited physician and was diagnosed with neuropathy and started on gabapentin. The patient's legs continued getting weaker. He was referred to physician on 09 May 2014 and was still diagnosed with neuropathy. His condition got worse and MRI, blood work and a lumbar puncture showed possible multiple sclerosis (MS), tumor (unspecified) or transverse myelitis (TM). The patient was treated with IV steroids for 3 days in outpatient and oral prednisone for 2 weeks. On 07 Oct 2014, the patient started physiotherapy. He started to experience incontinence and falls and was referred to different neurologists, after another fall. He was hospitalized and spent 7 days with neurologists. Another MRI, blood work and lumbar puncture were done. Neurologists confirmed "TM due to flu shot". The patient received IV steroids again for 5 days. Outcome of other events reported as condition unchanged. Events reported as serious (disability and hospitalization). The causality of the event neuropathy was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1308701) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 362057) on 01 Apr 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 362057) on 29 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Case number PHHY2015US038383, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 561465) website on 30 Mar 2015. This report refers to a 66 year old male patient. Medical history and concomitant medication were not reported. Current illness was none. The patient was vaccinated with FLUVIRIN (batch number: 123225) intramuscularly into the left arm on 19 Nov 2012. On 01 Dec 2012, the patient experienced numbness, weakness in hands, feet, arms, legs, fingers, toes, fatigue/exhaustion and Guillain-Barre Syndrome. The patient was hospitalized for five days. The patient was treated with intravenous immunoglobulin (IVIG) infusions. The final outcome of the events was not recovered. Seriousness of the events was reported as life-threatening, hospitalization and permanent disability. Causality was not reported.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Hemiplegia, Malaise, Muscle spasms, Myelitis transverse
Clinical narrative: Case number PHHY2015US057775, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 561626) website on 12 May 2015 and with a follow-up information received from the Quality Assurance Department (reference number: 1000265) on 18 May 2015 with a follow up information received from the quality assurance department on 16 Jun 2015. This report refers to a 63-year-old male patient. The patient's concurrent conditions included diabetes and blood pressure (BP). No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701, expiry date: 30 Apr 2015) into the left arm on 24 Oct 2014. On 25 Nov 2014, the patient experienced spasms in back, shoulder, neck and both arms and had right side paralysis. Further, the patient was hospitalized. The patient was given a diagnosis of transverse myelitis. The patient was also sick at home for two weeks right after vaccination. The final outcome of the events was condition unchanged. The seriousness of the events was reported as life threatening and hospitalization. Causality was not reported. Based on the documents review performed, it was concluded that the FLUVIRIN batch 145701 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000265) on 18 May 2015: Updated QA reference number only. Non significant follow up information received from the quality assurance department on 16 Jun 2015: Batch summary and expiry date updated.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Syncope
Clinical narrative: Case number PHHY2015US057989, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 562009) website on 12 May 2015. This report refers to a 30 year old female patient. Her medical history included asthma in childhood. She was allergic to chlorhexidine. Concomitant medications were not reported. Her vaccination history included hepatitis B (other manufacturer) and experienced arm swelling and temporary paralysis. On 31 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly on right arm. On the same date after vaccination in the evening, the patient experienced dizziness, lightheadedness and fainting spell. Further patient had extreme fatigue for following two days. The patient was advised to take rest. Outcome of the events reported as complete recovery. The events were reported as non-serious. Seriousness assessment of fainting was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pharyngeal oedema, Urticaria
Clinical narrative: Case number PHHY2015US058010, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 562010) website on 12 May 2015. This report refers to a 34 year old female patient. The patient had no medical history and current illness. Concomitant medication included fluticasone nasal spray. On 09 Jan 2015, she was vaccinated with FLUVIRIN (batch number: 1412901) intramuscularly into the left arm. On 11 Jan 2015, the patient experienced hives and headache due to this the patient consulted physician. Again on 13 Jan 2015, the patient visited physician (ER) with the complaint of pharyngeal swelling and was treated with Epinephrine, DECADRON and BENADRYL. The outcome of the events was unknown. The events were reported as non-serious. Seriousness assessment of hives and pharyngeal edema was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Ear pain, Eating disorder, Eyelid ptosis, Hemiplegia
Clinical narrative: Case number PHHY2015US057942, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS: reference number: 562084) website on 12 May 2015 and with a follow-up information received from the Quality Assurance Department (reference number: 1000267) on 18 May 2015 with a follow up information received from the quality assurance department on 16 Jun 2015. This report refers to a 44 year old male patient. Medical history was not reported. Concurrent conditions included irritable bowel syndrome, diverticulum, seasonal allergy, mold allergy, tree pollen allergy and allergy to cat dander. Concomitant medications included ALAVERT. He was vaccinated with FLUVIRIN (batch number: 1413801, expiry date: 30 Jun 2015) intramuscularly in right arm on 17 Oct 2014. He went to a dance that evening. On 18 Oct 2014, in the evening, he lost the sense of taste when eating dinner. The next day morning, after waking up, he ate breakfast and again experienced loss of taste. He noticed a bit of paralysis on the left side of face which was not severe. He went to a doctor as it was not getting better even after an hour and a half. The doctor diagnosed Bell's palsy. He was put on antiviral and anti-inflammatory medications. But the symptoms became worse. He also developed eye drooping and watering, pain behind the ear, difficulty eating and speaking. After 5 to 6 weeks of onset he was about 75 percent recovered. He had somewhat plateaued. His condition continued to improve and some effects remained. He was almost 85 percent recovered. Events were reported as non-serious. Seriousness assessment of Bell's palsy was upgraded (medically significant) as per Novartis Vaccines Key Event list. Causality was not reported. Based on the documents review performed, it was concluded that the FLUVIRIN batch 1413801 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000267) on 18 May 2015: Updated QA reference number only. Non significant follow up information received from the quality assurance department on 16 Jun 2015: Batch summary updated.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Lacrimation increased, Speech disorder, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US057942, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS: reference number: 562084) website on 12 May 2015 and with a follow-up information received from the Quality Assurance Department (reference number: 1000267) on 18 May 2015 with a follow up information received from the quality assurance department on 16 Jun 2015. This report refers to a 44 year old male patient. Medical history was not reported. Concurrent conditions included irritable bowel syndrome, diverticulum, seasonal allergy, mold allergy, tree pollen allergy and allergy to cat dander. Concomitant medications included ALAVERT. He was vaccinated with FLUVIRIN (batch number: 1413801, expiry date: 30 Jun 2015) intramuscularly in right arm on 17 Oct 2014. He went to a dance that evening. On 18 Oct 2014, in the evening, he lost the sense of taste when eating dinner. The next day morning, after waking up, he ate breakfast and again experienced loss of taste. He noticed a bit of paralysis on the left side of face which was not severe. He went to a doctor as it was not getting better even after an hour and a half. The doctor diagnosed Bell's palsy. He was put on antiviral and anti-inflammatory medications. But the symptoms became worse. He also developed eye drooping and watering, pain behind the ear, difficulty eating and speaking. After 5 to 6 weeks of onset he was about 75 percent recovered. He had somewhat plateaued. His condition continued to improve and some effects remained. He was almost 85 percent recovered. Events were reported as non-serious. Seriousness assessment of Bell's palsy was upgraded (medically significant) as per Novartis Vaccines Key Event list. Causality was not reported. Based on the documents review performed, it was concluded that the FLUVIRIN batch 1413801 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 1000267) on 18 May 2015: Updated QA reference number only. Non significant follow up information received from the quality assurance department on 16 Jun 2015: Batch summary updated.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Diarrhoea, Dysphagia, Nausea
Clinical narrative: Case number PHHY2015US059064 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 562943) received on 12 May 2015 with the follow-up information received from Quality Assurance Department (reference number: 1000546) on 22 Jun 2015. This report refers to a 54-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 14584P) in her left arm on 20 Dec 2014. On 23 Dec 2014 she had nausea, vomiting, diarrhea, difficulty swallowing water, weakness and fever. The symptoms lasted 10 days. On 23 Dec 2014 she had elevated blood pressure and was hospitalized. Following the events she visited the emergency room. The final outcome of the events was reported as complete recovery. The event elevated blood pressure was reported as serious (hospitalization) and the remaining events were reported as non-serious. Causality assessment was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 14584P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up report from QA department received on 26 May 2015: Updated the QA reference number 1000546. Non significant follow-up information received from the Quality Assurance Department (reference number: 1000546) on 22 Jun 2015: Updated FLUVIRIN batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US059064 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 562943) received on 12 May 2015 with the follow-up information received from Quality Assurance Department (reference number: 1000546) on 22 Jun 2015. This report refers to a 54-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 14584P) in her left arm on 20 Dec 2014. On 23 Dec 2014 she had nausea, vomiting, diarrhea, difficulty swallowing water, weakness and fever. The symptoms lasted 10 days. On 23 Dec 2014 she had elevated blood pressure and was hospitalized. Following the events she visited the emergency room. The final outcome of the events was reported as complete recovery. The event elevated blood pressure was reported as serious (hospitalization) and the remaining events were reported as non-serious. Causality assessment was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 14584P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up report from QA department received on 26 May 2015: Updated the QA reference number 1000546. Non significant follow-up information received from the Quality Assurance Department (reference number: 1000546) on 22 Jun 2015: Updated FLUVIRIN batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Intensive care, Laboratory test, Lumbar puncture abnormal
Clinical narrative: Case number PHHY2015US059107 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 563327) received on 12 May 2015. This report refers to a 65-year-old male patient. Medical history was not reported. This poly medicated patient was vaccinated with FLURIVIN (batch number 1412901) onto his left arm on 01 Oct 2014. On 06 Nov 2014 he had lost use of legs and hands. Went to emergency room on 07 Nov 2014 at 3:00 AM. On 08 Nov 2014 he was diagnosed with Guillain Barre Syndrome via spinal tap. He remained in the intensive care unit for 4 weeks and had 20 treatments of plasmapheresis and from there he went to rehabilitation. He underwent 3 electromyograms, spinal taps and multitude of other tests. The final outcome of the events was reported as not recovered. The events were reported as serious (hospitalization). Causality was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal disorder, Plasmapheresis
Clinical narrative: Case number PHHY2015US059107 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 563327) received on 12 May 2015. This report refers to a 65-year-old male patient. Medical history was not reported. This poly medicated patient was vaccinated with FLURIVIN (batch number 1412901) onto his left arm on 01 Oct 2014. On 06 Nov 2014 he had lost use of legs and hands. Went to emergency room on 07 Nov 2014 at 3:00 AM. On 08 Nov 2014 he was diagnosed with Guillain Barre Syndrome via spinal tap. He remained in the intensive care unit for 4 weeks and had 20 treatments of plasmapheresis and from there he went to rehabilitation. He underwent 3 electromyograms, spinal taps and multitude of other tests. The final outcome of the events was reported as not recovered. The events were reported as serious (hospitalization). Causality was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Hypersensitivity, Pruritus generalised, Rash, Throat irritation
Clinical narrative: Case number PHHY2015US060384, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 563486) website on 12 May 2015. This report refers to a 32-year-old female patient. Historical conditions and current illness were none. Concomitant medications included LOESTRIN-FE and multivitamin. The patient was vaccinated with FLUVIRIN (batch number: 146321) intramuscularly into the left arm on 14 Oct 2014. On the same day after vaccination, the patient experienced rash, itching all over and hives. It was reported that the patient was clearing her throat and was hoarse when the patient was talking. The patient was taken to the emergency room due the acute allergic reaction. The patient was treated for acute allergic reaction and was given EPIPEN to go home with. The final outcome of the events was complete recovery. The events were reported as non-serious. Seriousness of the event acute allergic reaction was upgraded based on the information available in the source document. Causality was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US060384, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 563486) website on 12 May 2015. This report refers to a 32-year-old female patient. Historical conditions and current illness were none. Concomitant medications included LOESTRIN-FE and multivitamin. The patient was vaccinated with FLUVIRIN (batch number: 146321) intramuscularly into the left arm on 14 Oct 2014. On the same day after vaccination, the patient experienced rash, itching all over and hives. It was reported that the patient was clearing her throat and was hoarse when the patient was talking. The patient was taken to the emergency room due the acute allergic reaction. The patient was treated for acute allergic reaction and was given EPIPEN to go home with. The final outcome of the events was complete recovery. The events were reported as non-serious. Seriousness of the event acute allergic reaction was upgraded based on the information available in the source document. Causality was not reported.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Case number PHHY2015US059829, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 564521) website on 12 May 2015. This report refers to a 50-year-old male patient. The patient's concurrent conditions included chronic cough, emphysema, diabetes and hypertension. The patient had not disclosed allergies or developmental/neurological disorders. The patient stated that, he was not taking any steroid therapy, home infusion and had no acute illness at time of vaccination. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 146502) intramuscularly into the left arm, along with PNEUMOVAX (batch number: K007825) intramuscularly into the right arm on 03 Feb 2015. The patient had left pharmacy premises immediately after vaccination against the advice of the pharmacist. On the same day 10 minutes after vaccination, the patient experienced chest tightness, shortness of breath and felt faint. The patient was admitted in the hospital. The patient could not recall the name of medications he was treated with in the hospital. The patient was hospitalized for two days. On 06 Feb 2015, the patient was discharged from the hospital. The final outcome of the events was complete recovery. The seriousness of the events was reported as hospitalization. Causality was not reported.