chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza virus test negative, Muscular weakness, Myalgia, Pyrexia, Streptococcus test negative
Clinical narrative: Case number PHHY2015US004304 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550101) website on 06 Jan 2015. This report refers to an eight year old female patient. Her past medical history and concomitant medications were not reported. On 24 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day, immediately after the vaccination, she had headache and stomach ache. She developed a fever with body temperature of 102.3, fatigue, red skin on face and vomiting. About three hours later, her fever rose with a body temperature of 103.6 with muscle pain and weakness. She was tired and her fever rose again with a body temperature of 104.2. She was treated with TYLENOL for fever which got the fever down to a body temperature of 103 but again rose to 104.6 within two hours. The patient visited the emergency room. She underwent flu and strep tests which were negative. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of fever was upgraded based on the information available in the source documents and causality of the events was not reported.    Case number PHHY2015US004304 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550101) website on 06 Jan 2015. This report refers to an eight year old female patient. Her past medical history and concomitant medications were not reported. On 24 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day, immediately after the vaccination, she had head ache and stomach ache. She developed a fever with body temperature of 102.3, fatigue, red skin on face and vomiting. About three hours later, her fever rose with a body temperature of 103.6 with muscle pain and weakness. She was tired and her fever rose again with a body temperature of 104.2. She was treated with TYLENOL for fever which got the fever down to a body temperature of 103 but again rose to 104.6 within two hours. The patient then visited the emergency room. She underwent flu and strep tests which were negative. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of fever was upgraded based on the information available in the source documents and causality of the events was not reported.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US004304 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550101) website on 06 Jan 2015. This report refers to an eight year old female patient. Her past medical history and concomitant medications were not reported. On 24 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day, immediately after the vaccination, she had headache and stomach ache. She developed a fever with body temperature of 102.3, fatigue, red skin on face and vomiting. About three hours later, her fever rose with a body temperature of 103.6 with muscle pain and weakness. She was tired and her fever rose again with a body temperature of 104.2. She was treated with TYLENOL for fever which got the fever down to a body temperature of 103 but again rose to 104.6 within two hours. The patient visited the emergency room. She underwent flu and strep tests which were negative. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of fever was upgraded based on the information available in the source documents and causality of the events was not reported.    Case number PHHY2015US004304 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550101) website on 06 Jan 2015. This report refers to an eight year old female patient. Her past medical history and concomitant medications were not reported. On 24 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day, immediately after the vaccination, she had head ache and stomach ache. She developed a fever with body temperature of 102.3, fatigue, red skin on face and vomiting. About three hours later, her fever rose with a body temperature of 103.6 with muscle pain and weakness. She was tired and her fever rose again with a body temperature of 104.2. She was treated with TYLENOL for fever which got the fever down to a body temperature of 103 but again rose to 104.6 within two hours. The patient then visited the emergency room. She underwent flu and strep tests which were negative. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of fever was upgraded based on the information available in the source documents and causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Catheter placement, Gastrointestinal tube insertion, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Case number PHHY2015US000984, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 550159) on 06 Jan 2015. This report refers to a 53 years old female patient. She was healthy strong and active. Concurrent condition included bipolar disorder. Concomitant medications included SEROQUEL XR, LAMICTAL, SYNTHROID, simvastatin, and Nadolol. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number unknown) and experienced muscle failure (see case: PHHY2015US000979). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 13 Dec 2010. In Dec 2010, within two days after vaccination, she experienced tingling, numbness and weakness in extremities. Within one week, she was completely paralyzed. She was hospitalized and diagnosed with Guillain-Barre Syndrome. She underwent blood transfusion, feeding tube insertion, tracheostomy, catheter placement, lumbar puncture, physical therapy, occupational therapy and speech therapy. She was treated with respirator and intravenous immunoglobulin treatments. Duration of the hospital was 60 days. Outcome of the events was condition unchanged. The case was assessed as serious (life threatening, permanent disability and hospitalization). Causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lumbar puncture, Mechanical ventilation, Muscular weakness, Paraesthesia, Paralysis
Clinical narrative: Case number PHHY2015US000984, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 550159) on 06 Jan 2015. This report refers to a 53 years old female patient. She was healthy strong and active. Concurrent condition included bipolar disorder. Concomitant medications included SEROQUEL XR, LAMICTAL, SYNTHROID, simvastatin, and Nadolol. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number unknown) and experienced muscle failure (see case: PHHY2015US000979). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 13 Dec 2010. In Dec 2010, within two days after vaccination, she experienced tingling, numbness and weakness in extremities. Within one week, she was completely paralyzed. She was hospitalized and diagnosed with Guillain-Barre Syndrome. She underwent blood transfusion, feeding tube insertion, tracheostomy, catheter placement, lumbar puncture, physical therapy, occupational therapy and speech therapy. She was treated with respirator and intravenous immunoglobulin treatments. Duration of the hospital was 60 days. Outcome of the events was condition unchanged. The case was assessed as serious (life threatening, permanent disability and hospitalization). Causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Tracheostomy, Transfusion
Clinical narrative: Case number PHHY2015US000984, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 550159) on 06 Jan 2015. This report refers to a 53 years old female patient. She was healthy strong and active. Concurrent condition included bipolar disorder. Concomitant medications included SEROQUEL XR, LAMICTAL, SYNTHROID, simvastatin, and Nadolol. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number unknown) and experienced muscle failure (see case: PHHY2015US000979). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 13 Dec 2010. In Dec 2010, within two days after vaccination, she experienced tingling, numbness and weakness in extremities. Within one week, she was completely paralyzed. She was hospitalized and diagnosed with Guillain-Barre Syndrome. She underwent blood transfusion, feeding tube insertion, tracheostomy, catheter placement, lumbar puncture, physical therapy, occupational therapy and speech therapy. She was treated with respirator and intravenous immunoglobulin treatments. Duration of the hospital was 60 days. Outcome of the events was condition unchanged. The case was assessed as serious (life threatening, permanent disability and hospitalization). Causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Muscle disorder
Clinical narrative: Case number PHHY2015US000984, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 550159) on 06 Jan 2015. This report refers to a 53 years old female patient. She was healthy strong and active. Concurrent condition included bipolar disorder. Concomitant medications included SEROQUEL XR, LAMICTAL, SYNTHROID, simvastatin, and Nadolol. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number unknown) and experienced muscle failure (see case: PHHY2015US000979). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 13 Dec 2010. In Dec 2010, within two days after vaccination, she experienced tingling, numbness and weakness in extremities. Within one week, she was completely paralyzed. She was hospitalized and diagnosed with Guillain-Barre Syndrome. She underwent blood transfusion, feeding tube insertion, tracheostomy, catheter placement, lumbar puncture, physical therapy, occupational therapy and speech therapy. She was treated with respirator and intravenous immunoglobulin treatments. Duration of the hospital was 60 days. Outcome of the events was condition unchanged. The case was assessed as serious (life threatening, permanent disability and hospitalization). Causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pyrexia
Clinical narrative: Case number PHHY2015US004324 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550372) website on 06 Jan 2015. This report refers to an 11 year old female patient. Her medical history and concomitant medications were not reported. On 24 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On 26 Oct 2014, she had high fever with body temperature of 104.7 accompanied by headache on the first day of onset. She was treated with MOTRIN every six hours and her fever was between 101 F and 102 F. The child was given ice-water and juice to drink. She was fed cold foods and was kept from school at home for two days until her fever broke. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of fever with body temperature of 104.7 was upgraded based on the information available in the source documents. Causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood test normal, Chest pain, Chills, Dyspnoea
Clinical narrative: Case number PHHY2015US002129, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550994) website on 06 Jan 2015. This report refers to a 29-year-old female patient. Historical conditions were not reported. Concomitant medications included methylphenidate (for five plus years) and meloxicam (for months). She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) into the right arm on 28 Oct 2014. On the same day after the vaccination at 09:00 PM, the patient was tired, weak and had chills. On the next day, the patient's fatigue and chills had increased. Further, the patient had numbness and tingling of limbs, swelling of tongue and throat, difficulty breathing, low fever and chest pain. The patient was sent to the emergency room. The patient's blood test was normal but the patient had higher blood pressure in the emergency room. The patient was treated with BENADRYL and the patient had relief from swelling symptoms. The outcome of the other events was unknown. The events were reported as non-serious. The events 'swelling of tongue and throat; difficulty breathing' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Hypertension, Hypoaesthesia, Paraesthesia, Pharyngeal oedema
Clinical narrative: Case number PHHY2015US002129, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550994) website on 06 Jan 2015. This report refers to a 29-year-old female patient. Historical conditions were not reported. Concomitant medications included methylphenidate (for five plus years) and meloxicam (for months). She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) into the right arm on 28 Oct 2014. On the same day after the vaccination at 09:00 PM, the patient was tired, weak and had chills. On the next day, the patient's fatigue and chills had increased. Further, the patient had numbness and tingling of limbs, swelling of tongue and throat, difficulty breathing, low fever and chest pain. The patient was sent to the emergency room. The patient's blood test was normal but the patient had higher blood pressure in the emergency room. The patient was treated with BENADRYL and the patient had relief from swelling symptoms. The outcome of the other events was unknown. The events were reported as non-serious. The events 'swelling of tongue and throat; difficulty breathing' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: Case number PHHY2015US002129, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550994) website on 06 Jan 2015. This report refers to a 29-year-old female patient. Historical conditions were not reported. Concomitant medications included methylphenidate (for five plus years) and meloxicam (for months). She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) into the right arm on 28 Oct 2014. On the same day after the vaccination at 09:00 PM, the patient was tired, weak and had chills. On the next day, the patient's fatigue and chills had increased. Further, the patient had numbness and tingling of limbs, swelling of tongue and throat, difficulty breathing, low fever and chest pain. The patient was sent to the emergency room. The patient's blood test was normal but the patient had higher blood pressure in the emergency room. The patient was treated with BENADRYL and the patient had relief from swelling symptoms. The outcome of the other events was unknown. The events were reported as non-serious. The events 'swelling of tongue and throat; difficulty breathing' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Dyspnoea, Feeling cold, Vomiting
Clinical narrative: Case number PHHY2015US001269, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551079) on 06 Jan 2015. This report refers to a 45 years old female patient. Concurrent conditions included anemia and allergy to pollen, mold, dogs, cats. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into right arm on 29 Oct 2014. On the same day, after vaccination, she experienced shortness of breath, chest pain, extreme cold and vomiting. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of shortness of breath and chest pain was upgraded based on information in the source document.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: Case number PHHY2015US004379 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 551103) website on 06 Jan 2015. This report refers to a 30 year old female patient. Her past medical history and concomitant medications were not reported. On 29 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into her right arm. On 29 Oct 2014, she had difficulty breathing, swelling of throat, chills, cough, headache, body ache and fatigue. The final outcome of the events was unknown. The events were reported as non serious but the seriousness of swelling of the throat and difficulty breathing was upgraded based on the information available in the source document. Causality of the events was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pharyngeal oedema
Clinical narrative: Case number PHHY2015US004379 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 551103) website on 06 Jan 2015. This report refers to a 30 year old female patient. Her past medical history and concomitant medications were not reported. On 29 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into her right arm. On 29 Oct 2014, she had difficulty breathing, swelling of throat, chills, cough, headache, body ache and fatigue. The final outcome of the events was unknown. The events were reported as non serious but the seriousness of swelling of the throat and difficulty breathing was upgraded based on the information available in the source document. Causality of the events was not reported.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Nausea, Rash, Rash erythematous, Swelling face
Clinical narrative: Case number PHHY2015US004390 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 551154) website on 06 Jan 2015. This report refers to a 69 year old male patient. His medical history included coronary artery disease. His concomitant medications included atorvastatin, prednisone, amlodipine besylate, atenolol, aspirin and multiple vitamins. His vaccination history included the first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) at the age of 66 years after which the patient was hospitalized. On 24 Oct 2014, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into his left arm. On the same day, after the vaccination, he developed chills, nausea, swelling of face and cheeks. The chills subsided within six hours of onset and nausea subsided the next day. On 25 Oct 2014, in the noon, the patient developed a red rash on his face and cheeks. He treated himself with BENADRYL when he had chills. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of facial swelling was upgraded based on the NVS-IME list and causality of the events was not reported.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal behaviour, Dyspnoea, Heart rate increased, Nausea, Pyrexia
Clinical narrative: Case number PHHY2015US001673 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551183) on 06 Jan 2015. This report refers to a 13 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 27 Oct 2014. On 28 Oct 2014, he experienced fever with body temperature of 101.9, rapid heartbeat, labored breathing and nausea. He showed strange behavior, saying things that did not make sense. The events outcome was reported as complete recovery. The events were reported as non-serious, but events labored breathing and rapid heartbeat was upgraded based on the information available in the source documents. The causality of the events was not reported.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Crying, Eyelid oedema, Irritability, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US001700 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551188) on 06 Jan 2015. This report refers to a 2 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with a dose of seasonal influenza vaccine (manufacturer and batch number: not reported) in Sep 2014 (reported as a month ago before second dose). She received second booster dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right leg on 28 Oct 2014. On 29 Oct 2014, at 11:00 am she became very fussy and cried a lot. She seldom cried that much. At 2:00 pm, she had right facial palsy, especially when smiling and swelling on both eyelids. The events outcome was reported as condition unchanged. The events were reported as non-serious, but events right facial palsy and swelling eyelid was upgraded based on the information available in the source documents. The causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Computerised tomogram, Ear pain, Eyelid ptosis, Hypoaesthesia oral, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2015US002187 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551305) on 06 Jan 2015. This report refers to a 27 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 23 Dec 2014. On the same date, she also received a dose of Tdap (other manufacturer, batch number: not reported) in the right arm. On 24 Dec 2014, she experienced sharp pain behind ear followed by an immediate drooping of left eyelid and left side of mouth. Her tongue was numb. She visited emergency room due to the symptoms similar to stroke. She underwent Magnetic Resonance Imaging (MRI) and Computerised Tomogram (CAT) scan in Dec 2014 and results were not reported. She was diagnosed with Bell's palsy/Cranial palsy in Dec 2014. She was treated with steroids. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event Bell's palsy was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US002187 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551305) on 06 Jan 2015. This report refers to a 27 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 23 Dec 2014. On the same date, she also received a dose of Tdap (other manufacturer, batch number: not reported) in the right arm. On 24 Dec 2014, she experienced sharp pain behind ear followed by an immediate drooping of left eyelid and left side of mouth. Her tongue was numb. She visited emergency room due to the symptoms similar to stroke. She underwent Magnetic Resonance Imaging (MRI) and Computerised Tomogram (CAT) scan in Dec 2014 and results were not reported. She was diagnosed with Bell's palsy/Cranial palsy in Dec 2014. She was treated with steroids. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event Bell's palsy was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Myalgia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US006496, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551385) website on 06 Jan 2015. This report refers to a 41-year-old male patient. The patient had no known allergies and medical conditions at the time of vaccination. Concomitant medications were none. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 30 Oct 2014. On the same day after the vaccination, the patient experienced wheezing and horrible muscle and body aches. The patient experienced uncontrollable vomiting between 11:00 AM and 04:00 PM. Further, the patient was unable to move the body by himself by 3:00 AM (non-paralyzed). At 04:33 PM, the patient had sore throat and low fever. The final outcome of the events was not reported. The events were reported as non-serious. The event 'wheezing' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting, Wheezing
Clinical narrative: Case number PHHY2015US006496, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551385) website on 06 Jan 2015. This report refers to a 41-year-old male patient. The patient had no known allergies and medical conditions at the time of vaccination. Concomitant medications were none. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 30 Oct 2014. On the same day after the vaccination, the patient experienced wheezing and horrible muscle and body aches. The patient experienced uncontrollable vomiting between 11:00 AM and 04:00 PM. Further, the patient was unable to move the body by himself by 3:00 AM (non-paralyzed). At 04:33 PM, the patient had sore throat and low fever. The final outcome of the events was not reported. The events were reported as non-serious. The event 'wheezing' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Chills, Dyspnoea, Headache, Myalgia
Clinical narrative: Case number PHHY2015US005116 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 551431) on 06 Jan 2015. This report refers to a 38 years old female patient. Her medical history included pneumonia in the fall from 15 Aug 2014 to 15 Sep 2014 and sinus infection diagnosed on 14 Oct 2014 which was treated with antibiotics. She had allergy testing on 22 Oct 2014 and was found strongly allergic to mold, trees and dust mites. Her antibiotic treatment ended on 24 Oct 2014. On 28 Oct 2014 she had stomach flu and fever from which she recovered on 29 Oct 2014. Her concomitant medications were Albuterol 90 mcg inhaler, FLONASE 50 mcg actuation nasal spray, ALLEGRA, omeprazole and PAXIL 12.5 mg. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm on 31 Oct 2014. On 31 Oct 2014, she had pain in back followed by vomiting and shortness of breath. She used the inhaler she had for pneumonia which helped her breathing a little. By midnight, she had chills, fever and more vomiting. On 01 Nov 2014 at 1 am, she had severe muscle pain. On 01 Nov 2014, during the day she experienced bad headache, nausea, chills and muscle aches. The outcome of events was reported as complete recovery. The events were reported as non-serious, but the event dyspnea was 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: F
Vaccine: FLUX
Symptoms: Nausea, Pneumonia, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US005116 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 551431) on 06 Jan 2015. This report refers to a 38 years old female patient. Her medical history included pneumonia in the fall from 15 Aug 2014 to 15 Sep 2014 and sinus infection diagnosed on 14 Oct 2014 which was treated with antibiotics. She had allergy testing on 22 Oct 2014 and was found strongly allergic to mold, trees and dust mites. Her antibiotic treatment ended on 24 Oct 2014. On 28 Oct 2014 she had stomach flu and fever from which she recovered on 29 Oct 2014. Her concomitant medications were Albuterol 90 mcg inhaler, FLONASE 50 mcg actuation nasal spray, ALLEGRA, omeprazole and PAXIL 12.5 mg. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm on 31 Oct 2014. On 31 Oct 2014, she had pain in back followed by vomiting and shortness of breath. She used the inhaler she had for pneumonia which helped her breathing a little. By midnight, she had chills, fever and more vomiting. On 01 Nov 2014 at 1 am, she had severe muscle pain. On 01 Nov 2014, during the day she experienced bad headache, nausea, chills and muscle aches. The outcome of events was reported as complete recovery. The events were reported as non-serious, but the event dyspnea was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Diarrhoea, Eructation, Nausea, Urticaria
Clinical narrative: Case number PHHY2015US006500, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551433) website on 06 Jan 2015. This report refers to a 37-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 21 Oct 2014. On 25 Oct 2014, the patient experienced chest pain, hives, vomiting and diarrhea. Further, the patient had egg burps and was nauseous. The patient was sent to emergency room. The final outcome of the events was not reported. The events were reported as non-serious. The events 'chest pain and hives' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US006500, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551433) website on 06 Jan 2015. This report refers to a 37-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 21 Oct 2014. On 25 Oct 2014, the patient experienced chest pain, hives, vomiting and diarrhea. Further, the patient had egg burps and was nauseous. The patient was sent to emergency room. The final outcome of the events was not reported. The events were reported as non-serious. The events 'chest pain and hives' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 1.8
Sex: M
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Urticaria
Clinical narrative: Case number PHHY2015US006565 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551761) on 06 Jan 2015. This report refers to a 1.8 years (21.6 months) old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right leg on 13 Oct 2014. On 13 Oct 2014, he had hives all over his body, on his face, arms, back and legs. The events outcome was reported as complete recovery. The events were 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 events was not reported.
Age: 0.7
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US006069 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 551827) website on 06 Jan 2015. This report refers to an eight months old male patient. His current conditions included diaper rash. His concomitant medications were not reported. On 03 Nov 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into his right leg. On 04 Nov 2014, he had hives which covered his complete body in three hours of onset. The patient visited the emergency room on an unspecified date. The final outcome of the event was not reported. The event was reported as non serious but the seriousness of hives was upgraded based on the information available in the source document. Causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Acute disseminated encephalomyelitis, Bedridden, Malaise
Clinical narrative: Case number PHHY2015US001817, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552005) website on 06 Jan 2014. This report refers to a female patient of an unknown age. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Nov 2013. On an unknown date, four days after vaccination she felt ill, was bedridden and could no longer walk and experienced acute disseminated encephalomyelitis. The outcome of the events was unknown. The events reported as non-serious. Seriousness assessment of the events (acute disseminated encephalomyelitis and its symptoms) was upgraded based on the NVS-IME list. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dysphonia, Eye swelling, Headache, Lip swelling
Clinical narrative: Case number PHHY2015US001862, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552100) website on 06 Jan 2015. This report refers to a 41-year-old female patient. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 13 Oct 2014. On the same date, after vaccination she experienced fever, headache, hoarseness, swelling of eyes and lips, hives, muscle aches, weakness and racing heart. The outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the events (hives, swelling of eyes and lips, racing heart and hoarseness) was upgraded based on the NVx key event list. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Palpitations, Pyrexia
Clinical narrative: Case number PHHY2015US001862, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552100) website on 06 Jan 2015. This report refers to a 41-year-old female patient. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 13 Oct 2014. On the same date, after vaccination she experienced fever, headache, hoarseness, swelling of eyes and lips, hives, muscle aches, weakness and racing heart. The outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the events (hives, swelling of eyes and lips, racing heart and hoarseness) was upgraded based on the NVx key event list. The causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chills, Incontinence, Pain in extremity, Somnolence
Clinical narrative: Case number PHHY2015US001876, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552180) website on 06 Jan 2015. This report refers to a 75-year-old female patient. Concomitant drugs included levothyroxine, propranolol, pravastatin and amlodipine. On 01 Oct 2014, she was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) along with pneumococcal polyvalent vaccine (other manufacturer and batch number: not reported). On the same date, after vaccination she experienced sudden onset of pain in right upper arm, severe shaking, severe chills, rare incontinency and fainting (totally rare). She began drinking fluids in excess. She was weak and sleepy the next day. The final outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the event (fainting) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Syncope, Thirst, Tremor
Clinical narrative: Case number PHHY2015US001876, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552180) website on 06 Jan 2015. This report refers to a 75-year-old female patient. Concomitant drugs included levothyroxine, propranolol, pravastatin and amlodipine. On 01 Oct 2014, she was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) along with pneumococcal polyvalent vaccine (other manufacturer and batch number: not reported). On the same date, after vaccination she experienced sudden onset of pain in right upper arm, severe shaking, severe chills, rare incontinency and fainting (totally rare). She began drinking fluids in excess. She was weak and sleepy the next day. The final outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the event (fainting) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US004867, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552478) website on 06 Jan 2015. This report refers to a 57-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 31 Oct 2014. On the same day after the vaccination, the patient experienced hives over entire body. The patient was sent to emergency room. The final outcome of the event was complete recovery. The event was reported as non-serious. The event 'hives over entire body' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Case number PHHY2015US014296, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 552500) website on 03 Feb 2015. This report refers to a 37 year old female patient. Historical condition was not reported. Concomitant medications included estradiol and NORCO. The patient was vaccinated with AGRIFLU (batch number: 015031A) intramuscularly in left arm on 07 Oct 2014. On 08 Oct 2014, she experienced severe numbness in hands and feet upon waking. On the same day by 11:00 AM, numbness progressed to knees. She went to an emergency room to see her family physician who admitted her to a hospital. She was diagnosed with Guillain-Barre Syndrome. During hospital stay lumbar puncture (twice), nuclear magnetic resonance imaging (MRI) and electromyogram (EMG) was done (results were not given). She was treated with intravenous immunoglobulins. The patient was hospitalized for 11 days. Final outcome of the event was condition unchanged. Events were reported as serious (hospitalization) and patient's condition was life threatening. Causality was not reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2015US014296, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 552500) website on 03 Feb 2015. This report refers to a 37 year old female patient. Historical condition was not reported. Concomitant medications included estradiol and NORCO. The patient was vaccinated with AGRIFLU (batch number: 015031A) intramuscularly in left arm on 07 Oct 2014. On 08 Oct 2014, she experienced severe numbness in hands and feet upon waking. On the same day by 11:00 AM, numbness progressed to knees. She went to an emergency room to see her family physician who admitted her to a hospital. She was diagnosed with Guillain-Barre Syndrome. During hospital stay lumbar puncture (twice), nuclear magnetic resonance imaging (MRI) and electromyogram (EMG) was done (results were not given). She was treated with intravenous immunoglobulins. The patient was hospitalized for 11 days. Final outcome of the event was condition unchanged. Events were reported as serious (hospitalization) and patient's condition was life threatening. Causality was not reported.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Case number PHHY2015US005109, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 552751) on 06 Jan 2015. This report refers to a 03 year old male patient. His medical history included bronchial spasms. Concurrent conditions included peanut allergy and cold from last two weeks. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Nov 2014. On the same day after vaccination, the patient developed difficulty breathing and wheezing. He was treated with Albuterol nebulizer at a dose of 3 times over the course of 12 hours. Final outcome of these events was complete recovery. These events were reported as non-serious. Seriousness assessment of difficulty breathing and wheezing was upgraded (medically significant) based on the information available in source document. Causality of these events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Chest discomfort, Inflammation, Injection site erythema, Injection site pruritus
Clinical narrative: Case number PHHY2015US005573 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 552781) website on 06 Jan 2015. This report refers to a 53 year old female patient. Her current conditions included asthma and she was allergic to gadolinium and shell fish. Her concomitant medications were not reported. On 07 Nov 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into her right arm. On the same day, after the vaccination, she developed an itch at the injection site, then redness and hives. The hives spread about across her arm to a patch of size approximately 4X5. She had increased inflammation and redness accompanied by tightness and pain in her left arm over the next couple of hours. She then had asthmatic symptoms like wheezing. She then visited the emergency room within another hour as instructed by her physician. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of the event "asthmatic symptoms like wheezing" was upgraded based on the information available in the source document. Causality of the events was not reported. Following an internal review for the data received on 06 Jan 2015 a significant correction was performed: the events "asthma and wheezing" were deleted and the reported verbatim "asthmatic symptoms like wheezing" was recoded to "asthmatic wheezing."
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site urticaria, Pain in extremity, Wheezing
Clinical narrative: Case number PHHY2015US005573 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 552781) website on 06 Jan 2015. This report refers to a 53 year old female patient. Her current conditions included asthma and she was allergic to gadolinium and shell fish. Her concomitant medications were not reported. On 07 Nov 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into her right arm. On the same day, after the vaccination, she developed an itch at the injection site, then redness and hives. The hives spread about across her arm to a patch of size approximately 4X5. She had increased inflammation and redness accompanied by tightness and pain in her left arm over the next couple of hours. She then had asthmatic symptoms like wheezing. She then visited the emergency room within another hour as instructed by her physician. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of the event "asthmatic symptoms like wheezing" was upgraded based on the information available in the source document. Causality of the events was not reported. Following an internal review for the data received on 06 Jan 2015 a significant correction was performed: the events "asthma and wheezing" were deleted and the reported verbatim "asthmatic symptoms like wheezing" was recoded to "asthmatic wheezing."
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye swelling, Herpes zoster, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Case number PHHY2015US002131, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552803) website on 06 Jan 2015. This report refers to a 74-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of shingles vaccine in mid May 2014 and on 10 Jun 2014, the patient experienced severe shingles. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into the left arm on 06 Nov 2014. On the same day after vaccination, the patient experienced swelling of eyes and face. The patient's throat was sore, swollen and had cough. Additionally, the patient had swollen sinus. The patient took BENADRYL and on the next day, the patient went to the emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious. The events 'swelling of eyes, face and throat' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported.