chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: FLUX, HEP, HEPA, MMR, PNC13
Symptoms: Erythema, Eye swelling, Hypersensitivity
Clinical narrative: Case number PHHY2017US014643 is an initial spontaneous report received from consumer (patient's mother) via Vaccine Adverse Event Reporting System (VAERS reference number: 664179) website on 23 Jan 2017. This report refers to 12 month old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer unknown), MMR vaccine, PREVNAR 13 and Hepatitis A and Hepatitis B (batch number, expiry date: not reported) vaccine on 24 Oct 2016. After vaccination, on an unknown date, the patient had an allergic reaction, the boy's face got red and his eyes got swollen. The mother mentioned the boy had had a peanut butter sandwich and was not sure if it was an allergic reaction to the food. No follow up attempts were possible. No further information was expected. The outcome of the events was unknown. The seriousness of the events was reported as non serious and causality was not reported. Seriousness of the event hypersensitivity was upgraded (medically significant) based on information available in the source document.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Neurological examination normal
Clinical narrative: Case number PHHY2017US015334, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 664202) website on 23 Jan 2017. This report refers to a 44 years old female patient. Past medical history was not reported. Current conditions included as waning viral infection with gastrointestinal (GI) symptoms. Concomitant medication included as Albuterol for asthma as needed. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into right arm on 16 Oct 2016. On 19 Oct 2016, the patient experienced symptoms as tingling and numbness presented intermittently at first, beginning in her feet and progressed up her legs, then included her hands, arms, face and mouth. Patient symptoms were progressive, becoming more sustained with less remittance. It was reported that, patient symptoms were experienced on both sides of my body, sometimes unilaterally and sometimes bilaterally. Patient had some subjective weakness on 19 Oct 2016 but neurology exam was clear. Patient went to the emergency room and then saw a neurologist in clinic. Since patient did not have compromised breathing and significant muscle weakness she was advised not to get a lumbar puncture (LP), Magnetic resonance imaging (MRI), or Electromyography (EMG) tests. Patient had probable mild Guillain Barre Syndrome on 19 Oct 2016. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported. The seriousness assessment of Guillain Barre Syndrome was upgraded serious (medically significant) based on the Novartis Important Medical Event list.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Case number PHHY2017US015334, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 664202) website on 23 Jan 2017. This report refers to a 44 years old female patient. Past medical history was not reported. Current conditions included as waning viral infection with gastrointestinal (GI) symptoms. Concomitant medication included as Albuterol for asthma as needed. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into right arm on 16 Oct 2016. On 19 Oct 2016, the patient experienced symptoms as tingling and numbness presented intermittently at first, beginning in her feet and progressed up her legs, then included her hands, arms, face and mouth. Patient symptoms were progressive, becoming more sustained with less remittance. It was reported that, patient symptoms were experienced on both sides of my body, sometimes unilaterally and sometimes bilaterally. Patient had some subjective weakness on 19 Oct 2016 but neurology exam was clear. Patient went to the emergency room and then saw a neurologist in clinic. Since patient did not have compromised breathing and significant muscle weakness she was advised not to get a lumbar puncture (LP), Magnetic resonance imaging (MRI), or Electromyography (EMG) tests. Patient had probable mild Guillain Barre Syndrome on 19 Oct 2016. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported. The seriousness assessment of Guillain Barre Syndrome was upgraded serious (medically significant) based on the Novartis Important Medical Event list.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood pressure increased, Nausea, Pyrexia
Clinical narrative: Case number PHHY2017US013701, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 664277) on 23 Jan 2017. This report refers to a 75-year-old male patient. Medical history was not reported. The patient had no reported current conditions. This poly-medicated patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) on 01 Nov 2016. On 02 Nov 2016, the patient developed weakness and fever of 102.5. He also felt like throwing up and his blood pressure was 173/115 on the same day. The patient fully recovered from the events on an unknown date. The events were reported as non-serious by the reporter. The causality of the events was not reported. Seriousness assessment of the event blood pressure increased was upgraded to medically significant based on the information available in the source document.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Case number PHHY2017US010362, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 664510) on 23 Jan 2017. This report refers to a 07 years old male patient. No medical history and current illness was reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 03 Nov 2016. On 07 Nov 2016 after vaccination, the patient experienced difficulty breathing and hives. The patient visited emergency room on an unknown date. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event dyspnoea was upgraded to medically significant based on the information available in the source document.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Injection site inflammation, Injection site swelling
Clinical narrative: Case number PHHY2017US011099, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 664706) website on 23 Jan 2017. This report refers to a 66 years old female patient. Past medical history was not reported. Concomitant medication included SYNTHROID. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 01 Sep 2016. On the same day after vaccination, the patient experienced inflammation and swelling of site with diameter of an egg for several days. The patient received treatment with ice. On an unspecified day after couple of days later the patient ended up with bruise same size. The outcome of events reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported. The seriousness assessment of the events contusion, vaccination site inflammation and vaccination site swelling was upgraded (medically significant) based on the information available in the source document.
Age: 31.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Eye pruritus, Eyelid oedema, Lip blister, Lip pain, Lip swelling
Clinical narrative: Case number PHHY2017US011989, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 665004) website on 23 Jan 2017. This report refers to a 31 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into arm on 07 Nov 2016. The patient also vaccinated with Tdap vaccine (other manufacture and batch number: not reported) into arm on 07 Nov 2016. On the same day after vaccination, the patient experienced puffy itchy eyes and sore blistering puffy lips. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of events (eye pruritus, eyelid oedema, lip blister, lip pain and lip swelling) was upgraded to serious (medically significant) based on the information available in the source document.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Chills, Dizziness, Headache, Insomnia
Clinical narrative: Case number PHHY2017US019508, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 665040) website on 23 Jan 2017. This report refers to a 39 years old male patient. Past medical history was not reported. Current condition included high blood pressure and high cholesterol. Concomitant medication included lisinopril, fish oil and Aspirin. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly in left arm on 04 Nov 2017. On 08 Nov 2017 at 19:00 after vaccination the patient experienced headache and fever, progressed to chills. On 09 Nov 2017, fever and headache continued, chills diminished overnight and experienced headache and fever, progressed to chills. On 09 Nov 2017, fever and headache continued, chills diminished overnight and experienced lower back pain and pain in thighs set in during the day and in the afternoon, dizziness set in for a few hours and in the overnight back pain became severe and patient could not sleep because of it. The patient received treatment with ADVIL and TYLENOL (manufacture unknown). On 10 Nov 2017, fevers seems to be gone. The symptoms were continuing still. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2017US019508, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 665040) website on 23 Jan 2017. This report refers to a 39 years old male patient. Past medical history was not reported. Current condition included high blood pressure and high cholesterol. Concomitant medication included lisinopril, fish oil and Aspirin. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly in left arm on 04 Nov 2017. On 08 Nov 2017 at 19:00 after vaccination the patient experienced headache and fever, progressed to chills. On 09 Nov 2017, fever and headache continued, chills diminished overnight and experienced headache and fever, progressed to chills. On 09 Nov 2017, fever and headache continued, chills diminished overnight and experienced lower back pain and pain in thighs set in during the day and in the afternoon, dizziness set in for a few hours and in the overnight back pain became severe and patient could not sleep because of it. The patient received treatment with ADVIL and TYLENOL (manufacture unknown). On 10 Nov 2017, fevers seems to be gone. The symptoms were continuing still. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal pain, Myositis, Pain, Pain in extremity
Clinical narrative: Case number PHHY2017US019816, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 665354) website on 23 Jan 2207. This report refers to a 68 years old female patient. Past medical history and concomitant medications were not reported. The patient also vaccinated with pneumococcal vaccine (other manufacturer, batch number: not reported) (reported as pneumonia shot) on 05 Nov 2016. On 06 Nov 2016, the patient experienced sore arm and thought nothing of it. Patient had some concern the next day when the pain became significantly greater, especially when lifting or moving her arm on 06 Nov 2016. Patient went to a local urgent care on day 4 when her arm and shoulder began to really bother her on an unknown date.  Patient was told it was probably a muscle inflammation on an unspecified date and given a sling and told to use warm compresses and take TYLENOL with Codeine No.3 (codeine phosphate, paracetamol) 1 table up to 4 times a day. The pain has now settled in her inner shoulder especially. It was now very difficult for her to lift arm without the help of her other arm. It was very painful to dress herself or do anything that she must raise her arm for or reach behind her like put her coat on. This was especially distressing to her because her husband had a stroke 03 years ago affecting his left arm and she is the person who helps him. This has become challenging. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Case number PHHY2017US019276, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting system (VAERS reference number: 665363) through pharmaceutical company (Pfizer, Manufacturer Report Number: 2016479847 website on 23 Jan 2017. This report refers to a 67 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unspecified date. The patient also vaccinated with pneumococcal vaccine )other manufacture, batch number: not reported) (reported as pneumo vaccine) on an unknown date. On an unspecified date, following vaccination, the patient felt as patient was in a fog, like patient pressure was up, cloud over patient head and she was not feeling well. The outcome of the events was not reported. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2017US019376 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 665369) website on 23 Jan 2017. This report refers to a 23 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown) on an unknown date. On an unspecified date, the patient experienced arm numbness. The outcome of the event was not reported; seriousness of the event was non serious and causality of the event was not reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Joint swelling, Musculoskeletal pain
Clinical narrative: Case number PHHY2017US020524, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 665407) website on 23 Jan 2017. This report refers to an 81 years old male patient. Past medical history was not reported. Current conditions included as drug allergy to morphine (manufacturer unknown), codeine derivatives, penicillin, Lisinopril (manufacturer unknown), clindamycin hydrochloride, hydrochlorothiazide and LIPITOR, drug hypersensitivity and prophylaxis. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into right arm on 04 Nov 2016. The patient also vaccinated with PNEUMOVAX 23 vaccine (other manufacture, batch number: not reported and expiry date: 03 Nov 2017) at a dose of 0.5 ml, intramuscularly on 04 Nov 2016. On 07 Nov 2016, as 03 days after vaccination, the patient experienced swelling on his left elbow and soreness in his left shoulder. The patient did not seek medical attention, received treatment for the events (unspecified treatment) and no laboratory test were performed. The outcome of the events was reported as condition improving on an unknown date. The seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Confusional state, Dizziness, Hypoaesthesia, Impaired driving ability, Injection site pain
Clinical narrative: Case number PHHY2017US019736, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 665458) website on 23 Jan 2017. This report refers to a 41 years old female patient. Past medical history included gastroesophageal reflux disease (GERD), inappropriate sinus tachycardia (IST) and supraventricular tachycardia (SVT). Current condition included allergies to shrimp and lobster and maple trees and dust mites allergy. Concomitant medications included metoprolol, loratadine and STRATTERA. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in left arm on 08 Nov 2016. On the same day after vaccination the patient experienced confusion and numbness followed by numbness on the left side of her face. She was told to go back to the exam room then became dizzy and the numbness ran through the rest of her face and whole body. Her face felt warm and had severe pain in her left arm (when lifting) where the injection was given. She was unable to drive and her speech was impaired. It was reported the patient had half dose of flu shot. The physician dismissed it as vasovagal. These symptoms subsided for a day and then returned on the tenth upon waking. The physician concluded it had lasted too long to be vasovagal and sent her to the emergency room (ER) to be checked for a mini stroke. The CT (computerized tomography) scan revealed no signs of a stroke and blood work came out fine. The ER said it was a reaction to the Flu shot. She was continuing to have these symptoms as of today the eleventh. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Skin warm, Speech disorder, Underdose
Clinical narrative: Case number PHHY2017US019736, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 665458) website on 23 Jan 2017. This report refers to a 41 years old female patient. Past medical history included gastroesophageal reflux disease (GERD), inappropriate sinus tachycardia (IST) and supraventricular tachycardia (SVT). Current condition included allergies to shrimp and lobster and maple trees and dust mites allergy. Concomitant medications included metoprolol, loratadine and STRATTERA. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in left arm on 08 Nov 2016. On the same day after vaccination the patient experienced confusion and numbness followed by numbness on the left side of her face. She was told to go back to the exam room then became dizzy and the numbness ran through the rest of her face and whole body. Her face felt warm and had severe pain in her left arm (when lifting) where the injection was given. She was unable to drive and her speech was impaired. It was reported the patient had half dose of flu shot. The physician dismissed it as vasovagal. These symptoms subsided for a day and then returned on the tenth upon waking. The physician concluded it had lasted too long to be vasovagal and sent her to the emergency room (ER) to be checked for a mini stroke. The CT (computerized tomography) scan revealed no signs of a stroke and blood work came out fine. The ER said it was a reaction to the Flu shot. She was continuing to have these symptoms as of today the eleventh. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Hyperhidrosis, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Case number PHHY2017US019618, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 665622) website on 23 Jan 2017. This report refers to a 73 years old female patient. Past medical history was not reported. Current condition included allergy to sulfa drugs. Concomitant medications included EVISTA. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 10 Nov 2016. On the same day after vaccination the patient experienced upset stomach, fever, profuse sweating, muscle ache and unable to move. The outcome of the event was reported as complete recovery on an unspecified date. The seriousness and causality of the event were not reported.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Rash generalised, Rash macular, Urticaria
Clinical narrative: Case number PHHY2017US011902, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 665631) website on 23 Jan 2017. This report refers to a 03 years old female patient (off label use). Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left leg, intramuscularly on 04 Oct 2016 when she was 03 years old. On the same day after vaccination within three hours, the patient got full hives and the patient experienced raised red, blotchy hives on her face and neck, sand-paper like rash on the rest of her body. It was reported that, physician was instructed to watch her and give her BENADRYL. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported. The seriousness assessment of the events rash macular, urticaria, erythema and rash generalised was upgraded to serious (medically significant) based on the information available in the source document.
Age: 1.4
Sex: M
Vaccine: FLUX
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Case number PHHY2017US011004, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 665648) on 23 Jan 2017. This report refers to a 1.4 years old male patient. Historical condition was not reported. Current condition included hypoxic ischemic encephalopathy (HIE). Concomitant medication was reported as none. The patient who was 1.4 years old (off label use) vaccinated with first dose of seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) in to left leg on 11 Nov 2016. On 12 Nov 2016 after vaccination, the patient experienced febrile seizure and fever with body temperature 101.3 (units not reported). The patient visited emergency room on an unknown date. The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious and causality was not reported. Seriousness assessment of the event febrile convulsion was upgraded to medically significant based on the information available in the source document.
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Erythema, Injection site nodule, Injection site pain, Local swelling, Skin warm
Clinical narrative: Case number PHHY2017US019699, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference  number: 665733) website on 23 Jan 2017. This report refers to a 49 years old female patient. Past vaccination history included she had lots of various vaccines (unspecified details). Current condition included diabetes. Concomitant medications included lisinopril, VYVANSE and metformin. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) into the left arm and TDAP (unknown manufacturer, batch  number not reported) into the right arm; on 10 Nov 2016. After vaccination, on the same day, she experienced red, hot and raised reaction at first which got hotter, bigger, raised and there was a huge know on her right arm where she received the tetanus shot. With flu shot on her left arm, she got the same symptoms but not nearly as severe. She had zero pain at the time of the flu shot and felt the tetanus (but was completely tolerable). 5 days later, there was still a very large bump (at least an inch high) and it was a very hard knot, hot and red although improved. It was very painful. It was reported that with previous vaccinations, she never had a reaction like that. She was waiting to go back to the doctor so she did not know the outcome. The outcome of the event a very large bump (at least an inch high) and it was a very hard knot was reported as condition improving. Final outcome of other events was condition unchanged. The seriousness and causality of the event were not reported.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Bone pain, Chills, Dizziness postural, Pain, Pyrexia
Clinical narrative: Case number PHHY2017US019570, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 665983) on 23 Jan 2017. This report refers to a 39 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 10 Nov 2016. On 11 Nov 2016, following day after vaccination, the patient experienced fever with body temperature 101, chills, body/bone aches, dizziness when standing for the night and day. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Muscle atrophy, Pain
Clinical narrative: Case number PHHY2017US019660 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 666343) website on 23 Jan 2017. This report refers to a 68 year old male patient. Medical history was not reported. Concomitant medications included benazepril, pravastatin, pantoprazole, terazosin, finasteride, Indomethacin and macular protect AREDS. The patient was vaccinated with first dose of seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into right arm on 14 Oct 2016. After vaccination on 15 Oct 2016, patient experienced very painful for a week, redness in bicep muscle for a bit over a week. It was reported that then the bicep shrank by 30 to 40 percent (still smaller) and tricep shrank by 50 percent and became very floppy and hangs down. It was reported that the patient works out and have had very firm arm muscles, the one with the shot was now very flimsy, not firm at all and hangs down (muscle) and the patient was very concerned about what it had done to his muscle(s). The outcome of the events pain, erythema and muscle atrophy was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Case number PHHY2017US019329 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 666568) website on 23 Jan 2017. This report refers to 45 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown) intramuscular into right arm on 12 Oct 2016. On the same day, patient had typical arm soreness that patient had experienced in years past with a flu shot also. However, the patient was still present to the right arm and range of motion was still not to baseline. The outcome of the events was condition unchanged; seriousness of the events was non serious and causality of the events was not reported.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Case number PHHY2017US016286, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 666668) website on 23 Jan 2017. This report refers to a 64 years old male patient. Past medical history was not reported. Procedure included as laminectomy spinal/laminectomy (slip disc surgery for herniated disc) since 08 Aug 2016 and ongoing. Concomitant medication included as gabapentin for spinal laminectomy. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 03 Oct 2016. The patient also vaccinated with single dose of PREVNAR 13 vaccine (other manufacture and batch number: not reported) into right arm on 07 Nov 2016 at 07:00 am. On 11 Nov 2016, the patient experienced that the injection site was all red and hard on his chest, neck and top of his back and breaking out of hives, swelling at the injection site and pain at the injection site. The patient received treatment only for injection site pain with TYLENOL. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of all events was upgraded to serious (medically significant) based on the information available in the source document.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: Case number PHHY2017US018065 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 666677) website on 23 Jan 2017. This report refers to a 62 years old female patient. It was reported that patient had no medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) intramuscularly into the left arm on 14 Nov 2016. On the same day after vaccination, patient experienced difficulty breathing, fast heartbeat, dizziness, weakness and it was reported that the heartbeat got progressively faster along with the difficulty to breathe and patient became weaker. It was reported that, on an unknown date the patient visited emergency room, received treatment (unspecified) and was seen by a physician. It was reported that on an unknown date patient underwent X ray and ECG (electrocardiogram) (results unspecified). The outcome of the events heart rate increased, dyspnea, dizziness and asthenia was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events dyspnea and dizziness (medically significant) was upgraded based on the information available in the source document.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: Case number PHHY2017US018065 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 666677) website on 23 Jan 2017. This report refers to a 62 years old female patient. It was reported that patient had no medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) intramuscularly into the left arm on 14 Nov 2016. On the same day after vaccination, patient experienced difficulty breathing, fast heartbeat, dizziness, weakness and it was reported that the heartbeat got progressively faster along with the difficulty to breathe and patient became weaker. It was reported that, on an unknown date the patient visited emergency room, received treatment (unspecified) and was seen by a physician. It was reported that on an unknown date patient underwent X ray and ECG (electrocardiogram) (results unspecified). The outcome of the events heart rate increased, dyspnea, dizziness and asthenia was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events dyspnea and dizziness (medically significant) was upgraded based on the information available in the source document.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2017US013642, is an initial spontaneous report received from via the Vaccine Adverse Event Reporting System (VAERS reference number: 667096) website on 23 Jan 2017. This report refers to a male patient of unspecified age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in 2002. On an unspecified date after vaccination, the patient experienced Guillain-Barre syndrome. The Guillain-Barre syndrome was described as weakness occurring and breathing problems. The patient went to the hospital (details unknown). The patient stated that, since 2002 he had various other immunizations but not the Flu shot and no adverse symptoms were occurred. However, there was no documentation of any vaccinations received for this patient since 2002. The outcome of the events was not reported. The seriousness and causality of the events were not reported. The seriousness assessment of the event Guillain-Barre syndrome was upgraded (medically significant) based on the Novartis Important Medical Events list.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Cough, Dysphonia, Dyspnoea
Clinical narrative: Case number PHHY2017US010564, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 667168) on 23 Jan 2017. This report refers to a 33 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) in to left arm on 17 Nov 2016. On same day after vaccination, the patient hoarseness, cough, red eyes, fever, aches, headache, backache, fatigue, weakness, difficulty breathing and fast heartbeat. The patient was treated with paracetamol, Eye drops (naphazoline hydrochloride) and antihistamine. The outcome of the events was not reported. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event dyspnoea was upgraded to medically significant based on the information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Heart rate increased, Ocular hyperaemia, Pain
Clinical narrative: Case number PHHY2017US010564, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 667168) on 23 Jan 2017. This report refers to a 33 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) in to left arm on 17 Nov 2016. On same day after vaccination, the patient hoarseness, cough, red eyes, fever, aches, headache, backache, fatigue, weakness, difficulty breathing and fast heartbeat. The patient was treated with paracetamol, Eye drops (naphazoline hydrochloride) and antihistamine. The outcome of the events was not reported. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event dyspnoea was upgraded to medically significant based on the information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2017US010564, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 667168) on 23 Jan 2017. This report refers to a 33 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) in to left arm on 17 Nov 2016. On same day after vaccination, the patient hoarseness, cough, red eyes, fever, aches, headache, backache, fatigue, weakness, difficulty breathing and fast heartbeat. The patient was treated with paracetamol, Eye drops (naphazoline hydrochloride) and antihistamine. The outcome of the events was not reported. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event dyspnoea was upgraded to medically significant based on the information available in the source document.
Sex: M
Vaccine: FLUX
Symptoms: Rash erythematous, Skin irritation, Skin warm
Clinical narrative: Case number PHHY2017US020276, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS: 667171) website on 23 Jan 2017. This report refers to a 54-year-old male patient. Family history included diabetes and hypertension. Historical condition was not reported. Current conditions included morbidly obese and hypertension. The patient had no known allergies, no birth defects. Concomitant medication was not reported (unspecified for hypertension)The patient was vaccinated with Seasonal Influenza virus vaccine INN (manufacturer unknown, batch  number: not reported) on 17 Nov 2016. On the same day of vaccination the patient experienced red rash around the neckline area and around the face. The neckline area was warm to the touch. Slight irritation felt in the neckline area. The patient's face and neckline remain red color as of 18 Nov 2016 at 1:50 pm. Outcome of the events were condition unchanged and seriousness was reported as non-serious and causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX, PPV
Symptoms: Blister, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2017US020750, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 667208) on 23 Jan 2017. This report refers to a 57-year-old female patient. Historical conditions included Hepatitis C and fibromyalgia. The patient vaccination history included influenza vaccine and the patient experienced swollen blistered arm/fevers. Please refer this case: (PHHY2017US022564). Current conditions included Rheumatoid arthritis, asthma and Chronic obstructive pulmonary disease (COPD). Concomitant medication was not reported. The patient was vaccinated with third dose of seasonal influenza virus vaccine (manufacturer unknown, batch number not reported) into left arm and second dose of pneumococcal vaccine, polyvalent (manufacturer unknown, batch number not reported) into left arm on 17 Nov 2016. On 18 Nov 2016 the patient woke up with severe pain in her left arm, the felt very ill and very cold. The patient checked her temperature and it read 100.9. The patient took her medications which included 1 LORTAB 7.5 mg, ibuprofen 800 mg and 1 OXYCONTIN 20 mg. After a couple of hours her fever started to spike and it went up to 102.9, the patient fever continued fluctuating between 102.9 to 100.9 and back up. The patient took her pain medication as directed along with her ibuprofen but that did not even touch the pain even taking an extra LORTAB still it did nothing to alleviate the excruciating pain in her arm. The patient continued to have had fever and severe excruciating pain in her left arm (where the shots were given), on through until this morning (on an unspecified date) at which time, (so far anyway), the patient had not yet ran a fever but her arm was still sore with a blistered type of look, red and swollen. The patient wanted to say though that looking at my arm today the redness is worse than in the beginning. The patient had slight cough. The patient was treated with COMBIVENT inhaler, DYMISTA, OXYCONTIN. Outcome of the events were unknown and seriousness was reported as non serious and causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX, PPV
Symptoms: Blister, Cough, Erythema, Feeling cold, Injection site pain
Clinical narrative: Case number PHHY2017US020750, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 667208) on 23 Jan 2017. This report refers to a 57-year-old female patient. Historical conditions included Hepatitis C and fibromyalgia. The patient vaccination history included influenza vaccine and the patient experienced swollen blistered arm/fevers. Please refer this case: (PHHY2017US022564). Current conditions included Rheumatoid arthritis, asthma and Chronic obstructive pulmonary disease (COPD). Concomitant medication was not reported. The patient was vaccinated with third dose of seasonal influenza virus vaccine (manufacturer unknown, batch number not reported) into left arm and second dose of pneumococcal vaccine, polyvalent (manufacturer unknown, batch number not reported) into left arm on 17 Nov 2016. On 18 Nov 2016 the patient woke up with severe pain in her left arm, the felt very ill and very cold. The patient checked her temperature and it read 100.9. The patient took her medications which included 1 LORTAB 7.5 mg, ibuprofen 800 mg and 1 OXYCONTIN 20 mg. After a couple of hours her fever started to spike and it went up to 102.9, the patient fever continued fluctuating between 102.9 to 100.9 and back up. The patient took her pain medication as directed along with her ibuprofen but that did not even touch the pain even taking an extra LORTAB still it did nothing to alleviate the excruciating pain in her arm. The patient continued to have had fever and severe excruciating pain in her left arm (where the shots were given), on through until this morning (on an unspecified date) at which time, (so far anyway), the patient had not yet ran a fever but her arm was still sore with a blistered type of look, red and swollen. The patient wanted to say though that looking at my arm today the redness is worse than in the beginning. The patient had slight cough. The patient was treated with COMBIVENT inhaler, DYMISTA, OXYCONTIN. Outcome of the events were unknown and seriousness was reported as non serious and causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX, PPV
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2017US020750, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 667208) on 23 Jan 2017. This report refers to a 57-year-old female patient. Historical conditions included Hepatitis C and fibromyalgia. The patient vaccination history included influenza vaccine and the patient experienced swollen blistered arm/fevers. Please refer this case: (PHHY2017US022564). Current conditions included Rheumatoid arthritis, asthma and Chronic obstructive pulmonary disease (COPD). Concomitant medication was not reported. The patient was vaccinated with third dose of seasonal influenza virus vaccine (manufacturer unknown, batch number not reported) into left arm and second dose of pneumococcal vaccine, polyvalent (manufacturer unknown, batch number not reported) into left arm on 17 Nov 2016. On 18 Nov 2016 the patient woke up with severe pain in her left arm, the felt very ill and very cold. The patient checked her temperature and it read 100.9. The patient took her medications which included 1 LORTAB 7.5 mg, ibuprofen 800 mg and 1 OXYCONTIN 20 mg. After a couple of hours her fever started to spike and it went up to 102.9, the patient fever continued fluctuating between 102.9 to 100.9 and back up. The patient took her pain medication as directed along with her ibuprofen but that did not even touch the pain even taking an extra LORTAB still it did nothing to alleviate the excruciating pain in her arm. The patient continued to have had fever and severe excruciating pain in her left arm (where the shots were given), on through until this morning (on an unspecified date) at which time, (so far anyway), the patient had not yet ran a fever but her arm was still sore with a blistered type of look, red and swollen. The patient wanted to say though that looking at my arm today the redness is worse than in the beginning. The patient had slight cough. The patient was treated with COMBIVENT inhaler, DYMISTA, OXYCONTIN. Outcome of the events were unknown and seriousness was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Hot flush, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Case number PHHY2017US020008, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667228) website on 23 Jan 2017. This report refers to a 33 years old male patient. Past medical history and concomitant medications were reported as none. He was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch  number not reported) on 17 Nov 2016. After vaccination, on same day at 22:30 hours, he experienced nausea and sweats. At 23:30 hours, he experienced vomiting, fever and diarrhea. On an unknown date, he experienced heat flashes. It was reported that he would visit the doctors on 21 Nov 2016. He visited the emergency room. The outcome of the events was condition unchanged. The seriousness and causality of the event were not reported.
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2017US020008, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667228) website on 23 Jan 2017. This report refers to a 33 years old male patient. Past medical history and concomitant medications were reported as none. He was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch  number not reported) on 17 Nov 2016. After vaccination, on same day at 22:30 hours, he experienced nausea and sweats. At 23:30 hours, he experienced vomiting, fever and diarrhea. On an unknown date, he experienced heat flashes. It was reported that he would visit the doctors on 21 Nov 2016. He visited the emergency room. The outcome of the events was condition unchanged. The seriousness and causality of the event were not reported.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Induration, Pain, Pruritus, Rash generalised
Clinical narrative: Case number PHHY2017US014397, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 667231) on 23 Jan 2017. This report refers to a 51 years old male patient. Historical condition was not reported. Current condition included various allergies (not to eggs). Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 18 Nov 2016. On same day after vaccination, the patient started with pain, redness, swelling quite a bit and hard feeling, progressed to become crazy itchy while also painful, from there it became body rash. After a couple of days the patient was taking BENADRYL. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event rash generalized was upgraded to medically significant based on the information available in the source document.