chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Pain
Clinical narrative: Case number PHHY2016US007528 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604138) on 18 Jan 2016. This report refers to a 60 year old female patient. Her medical history included smoking and chronic back pain and current conditions were type 2 diabetes mellitus, high blood pressure and high cholesterol. Her concomitant medications were ZANAFLEX 4 mg capsule at a dose of 1 capsule every 8 hours as needed, PROTONIX 40 mg tablet delayed/extended release at a dose of 1 tablet twice daily and STARLIX 120 mg tablet at a dose of 1 tablet via oral route twice daily before meal. She was vaccinated with FLUVIRIN (batch number: 1411301) intramuscularly in the right arm on 15 Oct 2015. On the same day, she experienced chills, body aches and shortness of breath (SOB). The final outcome of events was reported as complete recovery. The events were reported as non-serious, but the event SOB was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US007566 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604165) on 18 Jan 2016. This report refers to a 70 year old female patient. Her medical history was not reported and she never had any past problems with flu shots (manufacturer and batch number: not reported). She had no current conditions. Her concomitant medications were unknown. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 12 Oct 2015. On 13 Oct 2015, within 24 hours of vaccination, she experienced hives all over. She took BENADRYL. The events resolved approximately 24 hours later. The final outcome of event was reported as complete recovery. The event was reported as non-serious, but the event hives all over was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Rash, Vomiting
Clinical narrative: Case number PHHY2016US007588 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604190) on 18 Jan 2016. This report refers to a 61 year old female patient. Her current conditions included hypothyroidism, bipolar disorder and menopause. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1515201) in the right arm, PNEUMOVAX (other manufacturer, batch number: L003227) in the left arm and ADACEL (other manufacturer, batch number: U52138A) in the left arm; all vaccines administered on 23 Sep 2015. On the same day after vaccination, the patient had vomiting, shivering and rash. The patient went to the emergency room. The final outcome of events was reported as complete recovery. The event was reported as non serious, but the events were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported. Batch review report (reference number: 1011398) received from quality assurance department on 21 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1515201) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up received via quality assurance department (QA reference number: 1011398) on 25 Jan 2016: QA number added. Non significant follow up report received from a Quality Assurance department (QA reference number: 1011398) on 21 Feb 2016: Added batch review report.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Throat irritation
Clinical narrative: Case number PHHY2016US007613 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604262) on 18 Jan 2016. This report refers to a 27 year old female patient. Her medical history was not reported. She had no current conditions and her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1516001) intramuscularly in the right arm on 08 Oct 2015. On the same day after vaccination, the patient had itching throat and sweating. The final outcome of events was reported as complete recovery. The event was reported as non-serious, but the events were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Influenza like illness
Clinical narrative: Case number PHHY2016US007553, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604560) on 18 Jan 2016. This report refers to a 17 years old female patient. Medical history was not reported. Concomitant medications included ACANYA and minocycline. The patient was vaccinated with FLUVIRIN (batch number: 158001) intramuscularly on 19 Oct 2015. On 23 Oct 2015 the patient experienced flu like symptoms and pain around the sternum area. The patient was afebrile. Outcome of the events was unknown. The case was assessed as non serious. Causality of the events was not reported. Seriousness assessment of "chest pain" was upgraded based on information in the source document. Batch review report (reference number: 1011446) received from quality assurance department on 21 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (158001) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up received via quality assurance department (QA reference number: 1011446) on 25 Jan 2016: QA number updated. Non significant follow up report received from a Quality Assurance department (QA reference number: 1011446) on 21 Feb 2016: Added batch review report.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Flushing, Nausea
Clinical narrative: Case number PHHY2016US007830, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604570) on 18 Jan 2016. This report refers to a 64 years old female patient. Medical history was none. The patient had no current illness. Concomitant medication included levothyroxine 100 mcg daily. The patient was vaccinated with FLUVIRIN (batch number: 158302) intramuscularly into left arm on 23 Oct 2015. On the same day after vaccination the patient presented flushing, blood pressure increase, nausea, faint feeling and warmth. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "blood pressure increase", "nausea", "faint feeling", "flushing" and "warmth" was upgraded based on information in the source document.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Throat tightness
Clinical narrative: Case number PHHY2016US008214, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604697) on 18 Jan 2016. This report refers to a 56 years old female patient. Medical history was not reported. Historical drug included Penicillin. Concurrent illness was none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517701) intramuscularly into left arm on 23 Oct 2015. Within 10 minutes of vaccination the patient had increased heart rate and felt throat was closing. The patient went to emergency room for BENADRYL injection. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "heart rate increased" and "throat tightness" was upgraded based on information in the source document.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Throat tightness
Clinical narrative: Case number PHHY2015US172081, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 605123) website on 29 Dec 2015. This report refers to a 54 years old female patient. The patient had no known allergies and no current illness. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157803) intramuscularly into left arm on 25 Oct 2015 at 06:00 hours. At 06:30 hours the patient developed lip swelling and throat tightness. The patient was admitted to emergency department (ED) for treatment. The symptoms resolved with intravenous BENADRYL and "one other med" (as reported). The patient was discharged from ED at 07:40 hours. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "lip swelling" and throat tightness" was upgraded based on information in the source document.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Activities of daily living impaired, Anal incontinence, Anxiety, Back pain
Clinical narrative: Case number PHHY2015US172077 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605414) on 29 Dec 2015. This report refers to a 47 year old female patient. Her current condition included food sensitivity and low thyroid. Her concomitant medication included unspecified thyroid medication. She was vaccinated with FLUVIRIN (batch number: not reported) on 20 Sep 2013. It was reported that after vaccination, she experienced onset of a number of symptoms which incapacitated her from continuing her work in a medical office. Shortly after vaccination, she experienced pins and needles, numbness in her hands, feet, fingers and toes and weakness in her legs that spread to her arms and hands. She also had dizziness that impaired her gait and difficulty in speaking (her tongue was messed up). In addition, she remembered having cramping abdominal pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure and difficulty in breathing. These symptoms were associated with persisted severe fatigue, unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, in-coordination and lower extremity weakness. She stated that she had trouble being understood due to effects on the tongue. The dizziness, being off balance, on and off numbness in legs, arms and hands, weakness in the legs and easy fatigue were persistent. She stated that her physician told her that the symptoms were compatible with Guillain Barre Syndrome. Her cognitive functions also impaired and she had trouble in reading and understanding what she read and she never had this problem before. She also had back pain with a severity of 6 to 7 on a 0 to 10 numeric rating scale of intensity and she sought chiropractic care. The pain interfered while bending, walking, standing longer than 10 to 15 minutes, sitting without moving for longer than 30 minutes, completing household chores and participating in social, religious and recreational activities. The pain affected her ability to stand and balance herself and she described her back pain as sharp, stabbing, tingling and numbing. She went to the emergency room due to these events. The events outcome was reported as condition unchanged. The events were reported as life-threatening and disabling. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Cognitive disorder, Coordination abnormal, Depression, Disturbance in attention
Clinical narrative: Case number PHHY2015US172077 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605414) on 29 Dec 2015. This report refers to a 47 year old female patient. Her current condition included food sensitivity and low thyroid. Her concomitant medication included unspecified thyroid medication. She was vaccinated with FLUVIRIN (batch number: not reported) on 20 Sep 2013. It was reported that after vaccination, she experienced onset of a number of symptoms which incapacitated her from continuing her work in a medical office. Shortly after vaccination, she experienced pins and needles, numbness in her hands, feet, fingers and toes and weakness in her legs that spread to her arms and hands. She also had dizziness that impaired her gait and difficulty in speaking (her tongue was messed up). In addition, she remembered having cramping abdominal pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure and difficulty in breathing. These symptoms were associated with persisted severe fatigue, unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, in-coordination and lower extremity weakness. She stated that she had trouble being understood due to effects on the tongue. The dizziness, being off balance, on and off numbness in legs, arms and hands, weakness in the legs and easy fatigue were persistent. She stated that her physician told her that the symptoms were compatible with Guillain Barre Syndrome. Her cognitive functions also impaired and she had trouble in reading and understanding what she read and she never had this problem before. She also had back pain with a severity of 6 to 7 on a 0 to 10 numeric rating scale of intensity and she sought chiropractic care. The pain interfered while bending, walking, standing longer than 10 to 15 minutes, sitting without moving for longer than 30 minutes, completing household chores and participating in social, religious and recreational activities. The pain affected her ability to stand and balance herself and she described her back pain as sharp, stabbing, tingling and numbing. She went to the emergency room due to these events. The events outcome was reported as condition unchanged. The events were reported as life-threatening and disabling. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: Case number PHHY2015US172077 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605414) on 29 Dec 2015. This report refers to a 47 year old female patient. Her current condition included food sensitivity and low thyroid. Her concomitant medication included unspecified thyroid medication. She was vaccinated with FLUVIRIN (batch number: not reported) on 20 Sep 2013. It was reported that after vaccination, she experienced onset of a number of symptoms which incapacitated her from continuing her work in a medical office. Shortly after vaccination, she experienced pins and needles, numbness in her hands, feet, fingers and toes and weakness in her legs that spread to her arms and hands. She also had dizziness that impaired her gait and difficulty in speaking (her tongue was messed up). In addition, she remembered having cramping abdominal pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure and difficulty in breathing. These symptoms were associated with persisted severe fatigue, unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, in-coordination and lower extremity weakness. She stated that she had trouble being understood due to effects on the tongue. The dizziness, being off balance, on and off numbness in legs, arms and hands, weakness in the legs and easy fatigue were persistent. She stated that her physician told her that the symptoms were compatible with Guillain Barre Syndrome. Her cognitive functions also impaired and she had trouble in reading and understanding what she read and she never had this problem before. She also had back pain with a severity of 6 to 7 on a 0 to 10 numeric rating scale of intensity and she sought chiropractic care. The pain interfered while bending, walking, standing longer than 10 to 15 minutes, sitting without moving for longer than 30 minutes, completing household chores and participating in social, religious and recreational activities. The pain affected her ability to stand and balance herself and she described her back pain as sharp, stabbing, tingling and numbing. She went to the emergency room due to these events. The events outcome was reported as condition unchanged. The events were reported as life-threatening and disabling. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Headache, Heart rate increased, Hypoaesthesia, Hypotension
Clinical narrative: Case number PHHY2015US172077 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605414) on 29 Dec 2015. This report refers to a 47 year old female patient. Her current condition included food sensitivity and low thyroid. Her concomitant medication included unspecified thyroid medication. She was vaccinated with FLUVIRIN (batch number: not reported) on 20 Sep 2013. It was reported that after vaccination, she experienced onset of a number of symptoms which incapacitated her from continuing her work in a medical office. Shortly after vaccination, she experienced pins and needles, numbness in her hands, feet, fingers and toes and weakness in her legs that spread to her arms and hands. She also had dizziness that impaired her gait and difficulty in speaking (her tongue was messed up). In addition, she remembered having cramping abdominal pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure and difficulty in breathing. These symptoms were associated with persisted severe fatigue, unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, in-coordination and lower extremity weakness. She stated that she had trouble being understood due to effects on the tongue. The dizziness, being off balance, on and off numbness in legs, arms and hands, weakness in the legs and easy fatigue were persistent. She stated that her physician told her that the symptoms were compatible with Guillain Barre Syndrome. Her cognitive functions also impaired and she had trouble in reading and understanding what she read and she never had this problem before. She also had back pain with a severity of 6 to 7 on a 0 to 10 numeric rating scale of intensity and she sought chiropractic care. The pain interfered while bending, walking, standing longer than 10 to 15 minutes, sitting without moving for longer than 30 minutes, completing household chores and participating in social, religious and recreational activities. The pain affected her ability to stand and balance herself and she described her back pain as sharp, stabbing, tingling and numbing. She went to the emergency room due to these events. The events outcome was reported as condition unchanged. The events were reported as life-threatening and disabling. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired driving ability, Impaired work ability, Muscular weakness, Paraesthesia, Reading disorder
Clinical narrative: Case number PHHY2015US172077 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605414) on 29 Dec 2015. This report refers to a 47 year old female patient. Her current condition included food sensitivity and low thyroid. Her concomitant medication included unspecified thyroid medication. She was vaccinated with FLUVIRIN (batch number: not reported) on 20 Sep 2013. It was reported that after vaccination, she experienced onset of a number of symptoms which incapacitated her from continuing her work in a medical office. Shortly after vaccination, she experienced pins and needles, numbness in her hands, feet, fingers and toes and weakness in her legs that spread to her arms and hands. She also had dizziness that impaired her gait and difficulty in speaking (her tongue was messed up). In addition, she remembered having cramping abdominal pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure and difficulty in breathing. These symptoms were associated with persisted severe fatigue, unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, in-coordination and lower extremity weakness. She stated that she had trouble being understood due to effects on the tongue. The dizziness, being off balance, on and off numbness in legs, arms and hands, weakness in the legs and easy fatigue were persistent. She stated that her physician told her that the symptoms were compatible with Guillain Barre Syndrome. Her cognitive functions also impaired and she had trouble in reading and understanding what she read and she never had this problem before. She also had back pain with a severity of 6 to 7 on a 0 to 10 numeric rating scale of intensity and she sought chiropractic care. The pain interfered while bending, walking, standing longer than 10 to 15 minutes, sitting without moving for longer than 30 minutes, completing household chores and participating in social, religious and recreational activities. The pain affected her ability to stand and balance herself and she described her back pain as sharp, stabbing, tingling and numbing. She went to the emergency room due to these events. The events outcome was reported as condition unchanged. The events were reported as life-threatening and disabling. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder, Tongue disorder, Urinary incontinence, Weight decreased
Clinical narrative: Case number PHHY2015US172077 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605414) on 29 Dec 2015. This report refers to a 47 year old female patient. Her current condition included food sensitivity and low thyroid. Her concomitant medication included unspecified thyroid medication. She was vaccinated with FLUVIRIN (batch number: not reported) on 20 Sep 2013. It was reported that after vaccination, she experienced onset of a number of symptoms which incapacitated her from continuing her work in a medical office. Shortly after vaccination, she experienced pins and needles, numbness in her hands, feet, fingers and toes and weakness in her legs that spread to her arms and hands. She also had dizziness that impaired her gait and difficulty in speaking (her tongue was messed up). In addition, she remembered having cramping abdominal pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure and difficulty in breathing. These symptoms were associated with persisted severe fatigue, unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, in-coordination and lower extremity weakness. She stated that she had trouble being understood due to effects on the tongue. The dizziness, being off balance, on and off numbness in legs, arms and hands, weakness in the legs and easy fatigue were persistent. She stated that her physician told her that the symptoms were compatible with Guillain Barre Syndrome. Her cognitive functions also impaired and she had trouble in reading and understanding what she read and she never had this problem before. She also had back pain with a severity of 6 to 7 on a 0 to 10 numeric rating scale of intensity and she sought chiropractic care. The pain interfered while bending, walking, standing longer than 10 to 15 minutes, sitting without moving for longer than 30 minutes, completing household chores and participating in social, religious and recreational activities. The pain affected her ability to stand and balance herself and she described her back pain as sharp, stabbing, tingling and numbing. She went to the emergency room due to these events. The events outcome was reported as condition unchanged. The events were reported as life-threatening and disabling. The causality of the events was not reported.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Case number PHHY2015US172367, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 605657) website on 29 Dec 2015. This report refers to a 48-year-old male patient. Past medical history included reference to primary care provider (no further details provided). Current illness was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515301) into the right arm on 16 Oct 2015. On 20 Oct 2015, four days after vaccination, the patient experienced systemic rash. It was reported that the patient had experienced bumps all over and was itching. The patient did not seek immediate care but was advised by a pharmacist to take BENADRYL orally. The patient took the medication and said it had helped to relieve the symptoms. On 27 Oct 2015, the patient visited primary care for an "annual physical" and brought up the concern. The patient was advised to let the rash and itching run its natural course and take BENADRYL PRN. No further worsening of symptoms reported to date on 28 Oct 2015. Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Malaise
Clinical narrative: Case number PHHY2016US114252, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 605835) website on 18 Aug 2016. This report refers to a 53 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with H1N1 influenza monovalent vaccine (batch number: not reported) on an unknown date. On an unknown date, the patient reported that shot made her ill. The outcome, seriousness and causality of the events were not reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Case number PHHY2016US008409, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 605929) website on 18 Jan 2016. This report refers to a 51 years old female patient. Past medical history included as allergy to seafood, mold, BACITRACIN, Glutaraldehyde, Thiuram mix (unspecified) and Sorbitol. Concomitant medication included as ZYRTEC. The patient was vaccinated with FLUVIRIN (batch number: 15753P) intramuscularly on 01 Oct 2015. On the same day after vaccination, the patient experienced skin red rashes with itching on face, back, neck and upper chest. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness assessment of rash erythematous and pruritus generalized was upgraded to medically significant based on the information available in the source document.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Hypoaesthesia
Clinical narrative: Case number PHHY2016US006966, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 606000) website on 18 Jan 2016. This report refers to a 52 year old male patient. Medical history was not reported. Concomitant medication included atenolol (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 157603) intramuscular on an unknown date. On an unknown date, the patient experienced momentary numbness of hand/left arm/left cheek and dizziness. Both the events were passed after 1 to 2 minutes. The blood pressure was measured as 164/104 (not specified). The patient received atenolol (manufacture unknown) and stopped 2 weeks earlier. The patient was advised by physician to restart blood pressure medication. The final outcome of the events was complete recovery on an unknown date. The seriousness was reported as non serious and causality was not reported. The seriousness assessment of the events hypoaesthesia, dizziness and hypertension was upgraded based on the information available in the source document. Batch review report (reference number [1011510] received from quality assurance department on 11 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number [157603] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non-significant follow-up information from quality assurance department received on 27 Jan 2016: Added QA reference number only 1011510. Non-significant follow-up information from quality assurance department received on 11 Feb 2016: Added QA summary.
Age: 58.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Case number PHHY2016US029723, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 606074) website on 29 Feb 2016. This report refers to a 58 years old female patient. Past medical history was not reported. Current condition included as cancer. Concomitant medications included as losartan (manufacturer unknown), trazodone (manufacturer unknown), atorvastatin (manufacturer unknown) and lansoprazole (manufacturer unknown). Prior vaccination history included administration of unspecified vaccine (manufacturer unknown, batch number: not reported) on an unknown date. The patient was vaccinated with FLUVIRIN (batch number: 157925) intramuscularly and PREVNAR 13 vaccine (other manufacture, batch number: L99262) into left arm, intramuscularly both received on 21 Oct 2015. On 22 Oct 2015, the patient' right upper area became swollen and red at injection site, rash developed on right arm, chest, left arm, torso, and private areas. Outcome of the events was reported as complete recovery on an unknown date. Seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of rash generalised was upgraded to medically significant based on the information available in the source document.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Nausea, Syncope
Clinical narrative: Case number PHHY2016US006328, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 606493) website on 18 Jan 2016. This case also contains QA reference number: 1011522. This report refers to a 09 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157804) into left arm, intramuscularly on 01 Nov 2015. On the same day after vaccination within 05 minutes, the patient experienced fainted in store. The patient had dizzy and felt like throwing up and felt like hot. The patients breathing was fine and no symptoms of anaphylaxis when paramedics arrived. The patient visited to the emergency room. The final outcome of the events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness assessment of fainted, dizziness, nausea was upgraded to medically significant based on the information available in the source document. The quality assurance department reported that, batch review report (reference number: 1011522) received from quality assurance department on 26 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 157804, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non significant follow up report from the QA department (QA reference number: 1011522) received on 28 Jan 2016: Updated QA reference number only. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1011522) on 26 Feb 2016: Updated batch review report (Conclusion added).
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Case number PHHY2015US173807, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 607162) on 29 Dec 2015. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced flu-like illness. Final outcome, seriousness and causality were not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Swelling face
Clinical narrative: Case number PHHY2015US172368, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 607427) website on 29 Dec 2015. This report refers to a 55-year-old female patient. Historical condition included positive TB skin test. The patient had no current illness. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515401) intramuscularly into the left arm on 30 Oct 2015. On the same day one-half hour after vaccination, the patient experienced pain that went up her neck and the left side of the face had swelled up. The patient recovered from the events by the following day. It was reported that a student had administered the vaccine to the patient under the supervision of nursing instructor. The injection was given into the deltoid muscle approximately 2 inches below the acromion process in the left deltoid muscle. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Toothache
Clinical narrative: Case number PHHY2016US012145, is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 607748) on 18 Jan 2016. This report refers to a 63-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1557701) intramuscularly into the left arm on 28 Oct 2015. On the same day 45 minutes after vaccination, the patient experienced teeth pain and pressure in chest. The patient went to emergency room. Final outcome of events was recovered. Events were reported as non-serious. Causality was not reported. Seriousness of the event was upgraded based on information available in the source document.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Myalgia, Petechiae
Clinical narrative: Case number PHHY2016US008377, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 608131) on 18 Jan 2016. This report refers to a 59 years old male patient. Past medical history was not reported. Current conditions included not known drug allergy, chronic cough (occupational exposure to dust at cement plant work), type 2 diabetes, dyslipidemia and allergic rhinitis. Concomitant medications included Albuterol sulfate, atorvastatin (manufacturer unknown) cetirizine hydrochloride (manufacturer unknown). He was vaccinated with sixth dose of FLUVIRIN (batch number: 157801, expiry date: not reported) intramuscularly into the right arm on 20 Oct 2015. After vaccination, on 30 Oct 2015, he experienced swelling 2 hours at the injection site and also a papular and petechial rash on both upper arms (bicep) area, confluent red rash just below the neck posterior and anterior upper torso, rash was evident and border of Band-Aid and was visible along with a more defined circular rash in the area where injection was placed and muscle pain. He had a history of weight lifting as well. He received treatment with naproxen (manufacturer unknown) for muscle pain on 06 Nov 2015 and a Band-Aid was applied for rash where vaccine was given. The outcome of the events was reported as complete recovery on an unknown date. Seriousness of the events was reported as non serious. Causality was not reported. The seriousness assessment of the events rash papular, petechiae, rash erythematous, and vaccination site rash were upgraded (medically significant) based on the information available in the source document.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Case number PHHY2016US008377, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 608131) on 18 Jan 2016. This report refers to a 59 years old male patient. Past medical history was not reported. Current conditions included not known drug allergy, chronic cough (occupational exposure to dust at cement plant work), type 2 diabetes, dyslipidemia and allergic rhinitis. Concomitant medications included Albuterol sulfate, atorvastatin (manufacturer unknown) cetirizine hydrochloride (manufacturer unknown). He was vaccinated with sixth dose of FLUVIRIN (batch number: 157801, expiry date: not reported) intramuscularly into the right arm on 20 Oct 2015. After vaccination, on 30 Oct 2015, he experienced swelling 2 hours at the injection site and also a papular and petechial rash on both upper arms (bicep) area, confluent red rash just below the neck posterior and anterior upper torso, rash was evident and border of Band-Aid and was visible along with a more defined circular rash in the area where injection was placed and muscle pain. He had a history of weight lifting as well. He received treatment with naproxen (manufacturer unknown) for muscle pain on 06 Nov 2015 and a Band-Aid was applied for rash where vaccine was given. The outcome of the events was reported as complete recovery on an unknown date. Seriousness of the events was reported as non serious. Causality was not reported. The seriousness assessment of the events rash papular, petechiae, rash erythematous, and vaccination site rash were upgraded (medically significant) based on the information available in the source document.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US173690 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 608179) on 29 Dec 2015. This report refers to a 70 year old female patient. The patient had no medical history or current conditions and her concomitant medications were not reported. She was vaccinated with H1N1 monovalent influenza vaccine (pandemic influenza vaccine, manufacturer and batch number: not reported) on an unknown date. After vaccination she experienced sore arm. The outcome, seriousness and causality of the event were not reported. She was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) following which she experienced injection site pain (see related case number: PHHY2015US173689). No further information was provided.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2015US173690 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 608179) on 29 Dec 2015. This report refers to a 70 year old female patient. The patient had no medical history or current conditions and her concomitant medications were not reported. She was vaccinated with H1N1 monovalent influenza vaccine (pandemic influenza vaccine, manufacturer and batch number: not reported) on an unknown date. After vaccination she experienced sore arm. The outcome, seriousness and causality of the event were not reported. She was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) following which she experienced injection site pain (see related case number: PHHY2015US173689). No further information was provided.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Case number PHHY2016US011324, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 608580) website on 18 Jan 2016. This report refers to a 51 years old female patient. Historical conditions included leg pain from arthritis, with pain medication patient's pain level usually at 02 (on a scale of 0 to 10). Current condition included muscle pain. Concomitant medication included Hydrocodone/APAP, citalopram, hydrochlorothiazide, diazepam, PROAIR HFA inhaler, diclofenac EC. The patient was vaccinated with FLUVIRIN (batch number: 151470) intramuscularly into left arm on 31 Oct 2015. On same day after vaccination, the patient got extremely tired and cannot seemed to be up for more than 3 hours at a time, also had severe leg pain (even with medication, pain scale at 08 five days later when patient reported these symptoms (usually it was 02 on pain scale with pain medications). The patient reported that she was doing better but still very tired and leg pain has gone down. The outcome of the events was reported as condition improving. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the event pain in extremity was upgraded based on the available information in the source documents. Following an internal review done on 02 Feb 2016, for the data received on 18 Jan 2016: Non serious event Severe leg pain (pain scale at 8) was upgraded to serious (medically significant).
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Cough, Fatigue, Headache, Hypersomnia
Clinical narrative: Case number PHHY2016US009328, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608780) website on 18 Jan 2016. This report refers to a 38 years old male patient. Past medical history included hemoglobinemia and monoclonal gammopathy. Current condition included benign hypertension. Concomitant medications included Multivitamin and COQ10. He was vaccinated with FLUVIRIN (batch number: 157804) intramuscularly in left arm on 02 Nov 2015. On 03 Nov 2015, he experienced headache and tiredness upon waking up that lasted all day. On 04 Nov 2015, experienced headache, cough, tiredness, swelling under arm upon waking up that lasted all day. He slept the entire day. On 05 Nov 2015, lost use of left arm upon waking that lasted all day. He also experienced, severe swelling, pain and was unable to sleep due to pain. On 06 Nov 2015, experienced severe pain, could not use left arm and tiredness upon waking up that lasted all day. On 07 Nov 2015, experienced tiredness, increased but limited use of arm, pain in left side of chest that lasted all day. On 08 Nov 2015, he experienced decreased swelling and pain with arm movement upon waking up that lasted all day. On 09 Nov 2015, experienced moderate swelling and mild pain upon waking up that lasted all day. On 10 Nov 2015, experienced mild to moderate swelling. He visited the emergency room. The final outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness of the event chest pain and injected limb mobility decreased were upgraded to medically significant based on the information available in the source document. The quality assurance department reported that, batch review report (reference number: 1011552) received from quality assurance department on 26 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 157804, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non-significant follow-up information from quality assurance department received on 28 Jan 2016: Added QA reference number only (1011552). Non significant follow up report received from a Quality Assurance Department (QA reference number: 1011552) on 26 Feb 2016: Updated batch review report (conclusion added).
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Peripheral swelling, Sleep disorder
Clinical narrative: Case number PHHY2016US009328, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608780) website on 18 Jan 2016. This report refers to a 38 years old male patient. Past medical history included hemoglobinemia and monoclonal gammopathy. Current condition included benign hypertension. Concomitant medications included Multivitamin and COQ10. He was vaccinated with FLUVIRIN (batch number: 157804) intramuscularly in left arm on 02 Nov 2015. On 03 Nov 2015, he experienced headache and tiredness upon waking up that lasted all day. On 04 Nov 2015, experienced headache, cough, tiredness, swelling under arm upon waking up that lasted all day. He slept the entire day. On 05 Nov 2015, lost use of left arm upon waking that lasted all day. He also experienced, severe swelling, pain and was unable to sleep due to pain. On 06 Nov 2015, experienced severe pain, could not use left arm and tiredness upon waking up that lasted all day. On 07 Nov 2015, experienced tiredness, increased but limited use of arm, pain in left side of chest that lasted all day. On 08 Nov 2015, he experienced decreased swelling and pain with arm movement upon waking up that lasted all day. On 09 Nov 2015, experienced moderate swelling and mild pain upon waking up that lasted all day. On 10 Nov 2015, experienced mild to moderate swelling. He visited the emergency room. The final outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness of the event chest pain and injected limb mobility decreased were upgraded to medically significant based on the information available in the source document. The quality assurance department reported that, batch review report (reference number: 1011552) received from quality assurance department on 26 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 157804, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non-significant follow-up information from quality assurance department received on 28 Jan 2016: Added QA reference number only (1011552). Non significant follow up report received from a Quality Assurance Department (QA reference number: 1011552) on 26 Feb 2016: Updated batch review report (conclusion added).