chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2017US020784, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 657336) on 23 Jan 2017. This report refers to a 27-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with DTAP into unspecified arm intramuscularly on 14 Sep 2016 instead of Seasonal Influenza virus vaccine INN (manufacturer unknown, batch number: not reported). No adverse event was reported following this medication error.
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2017US020110, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 657428) website on 23 Jan 2017. This report refers to a 63 years old female patient. Medical history was not reported. Current illness was reported as none. Concomitant medication was not reported. She was vaccinated with INFANRIX (other manufacturer, batch number: not reported) intramuscularly into the arm on 14 Sep 2016 instead of seasonal influenza vaccine. No adverse event was reported following this maladministration.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache, Palpitations
Clinical narrative: Case number PHHY2016US164376 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 658033) website on 21 Nov 2016. This report refers to 42 year old female patient. Historical condition included seasonal allergy (unspecified). Concomitant medication included Lithium, WELLBUTRIN, SEROQUEL, XYZAL, FLONASE. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) on 05 Oct 2016. On 06 Oct 2016, the patient experienced dizziness, severe headache, heart palpitations/racing heart, lightheaded and patient was feeling faint. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. Seriousness assessment of the event dizziness was upgraded (medically significant) based on information available in the source document. The causality of the events was not reported.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Grip strength decreased, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Case number PHHY2016US165664, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS Reference number: 658181) website on 21 Nov 2016. This report refers to a 46 years old male 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 30 Sep 2016. On the same day after vaccination, the patient experienced decreased grip strength in left arm starting the following morning. Later in the day on 01 Oct 2016, patient developed decreased right arm grip strength. Patient was hospitalized and on 02 Oct 2016, patient noticed weakness in left quadriceps. Patient was ultimately diagnosed and treated for Guillain-Barre Syndrome that was thought likely secondary to the influenza vaccine. The outcome of the events was reported as condition unchanged.  The causality of the events was not reported.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Case number PHHY2016US164197, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 658216) website on 21 Nov 2016. This report refers to a 55-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 05 Oct 2016. On the same day after vaccination, the patient experienced fever of 102.5 F, chills and shivering. It was reported that, the fever increased to 104.3 F at 2:30 AM and reduced to 101.1 F by 6:00 AM and remained until 3:00 PM. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. Causality of the events was not reported. The seriousness of the events fever and chills was upgraded to medically significant based on the information provided in the source document.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, MEN
Symptoms: Vaccination site cellulitis
Clinical narrative: Case number PHHY2016US163863 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 658330) on 21 Nov 2016. This report refers to 12 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinate with seasonal influenza vaccine (manufacturer unknown) intramuscular into left arm, HPV vaccine (other manufacturer) intramuscular into right arm, Meningococcal vaccine (other manufacturer) intramuscular into left arm on 07 Oct 2016. On 10 Oct 2016 the patient experienced cellulitis at site of vaccination. On an unknown date, the patient went to visit emergency room/doctor. The outcome of the event was condition unchanged. The seriousness and causality of the event was not reported. Seriousness assessment of the events Vaccination site cellulitis was upgraded based on information available in the source document.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Urticaria
Clinical narrative: Case number PHHY2016US165591, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 658463) website on 21 Nov 2016. This report refers to a 44 years old female patient. Past medical history was not reported. Current conditions included as allergic to BACTRIM, high blood pressure, bipolar disorder, high cholesterol and anxiety. Concomitant medications included as simvastatin, SEROQUEL, LAMICTAL, hydrochlorothiazide, clonazepam, Vitamin C and melatonin. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 01 Nov 2015. On the same day after vaccination, the patient experienced rapid heartbeat, feeling faint, mild hives and feeling out of breath. Patient called physician and was directed to go the emergency room for side effects. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was not reported. The causality of the events was not reported. Seriousness assessment of events (dizziness, dyspnoea) was upgraded to serious (medically significant) based on the information available in the source document.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Case number PHHY2017US019241, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 658634) through pharmaceutical company (Pfizer, reference number 2016444890) website on 23 Jan 2017. This report refers to an unknown age of 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. On an unknown date, following the vaccination, the patient experienced flu like symptoms. The outcome of the events was reported as unknown. The seriousness and causality of the event were not reported.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: Case number PHHY2016US163686, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 658738) website on 21 Nov 2016. This report refers to a 02-years-old male patient (reported as 2 and half years old). Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date, the patient experienced fever, congestion, vomiting and diarrhea. It would last for a few days and he would feel better. The final outcome, seriousness and causality of the events were not reported.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Chills, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: Case number PHHY2017US019263 is an initial spontaneous report received from consumer via vaccine adverse event reporting system (VAERS reference number: 658819) website on 23 Jan 2017. This report refers to unknown demographics patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal Influenza virus vaccine INN (manufacturer unknown, batch number not reported) and PNEUMOVAX (other manufacturer) on 20 Sep 2016. On an unspecified date in Sep 2016, after the vaccination with PNEUMOVAX 23, the patient experienced joint pain, fatigue, chills without fever, pyrexia and muscle weakness. No product quality complaint was involved. At the time of reporting, the outcome of arthralgia, fatigue, chills, pyrexia and muscle weakness was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. The outcome the events was unknown, seriousness of events was non serious and causality of the events was not reported.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2016US164984 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 659001) website on 21 Nov 2016. This report refers to a 06 year old male patient. Current condition included upper respiratory virus. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) into left arm on 11 Oct 2016. On 12 Oct 2016, the patient experienced redness, heat, swelling at around injection site and diagnosed with cellulitis. The patient visited emergency room/doctor (date not reported). The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. Seriousness assessment of the events vaccination site cellulitis was upgraded based on information available in the source document. The causality of the events was not reported.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Case number PHHY2016US164933, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 659037) website on 21 Nov 2016. This report refers to a 50-years-old male patient. Past medical history was not reported. Current condition included diabetic type 2. Concomitant medications included metformin, glipizide and INVOKANA. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) in left arm on 05 Oct 2016. On 06 Oct 2016, 12 hours after vaccination, the left side of face of patient went numb and the patient concerned that it might be stroke, so he visited the urgent care (emergency room). The patient was diagnosed with Bell's Palsy. The patient was treated with prednisone and Valacyclovir. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. Causality of the events was not reported. The seriousness of the event facial paralysis (medically significant) was upgraded based on the Novartis Important Medical Events list.
Age: 11.0
Sex: M
Vaccine: FLUX, HEPA, HPVX
Symptoms: Asthenia, Cold sweat, Dizziness, Syncope, Tremor
Clinical narrative: Case number PHHY2016US165716, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 659104) website on 21 Nov 2016. This report refers to a 11-years-old male patient. Past medical history was not reported. Current conditions included attention deficit hyperactivity disorder (ADHD). Concomitant medications included CONCERTA, Multivitamin and PERIACTIN. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) in right arm on 13 Oct 2016. The patient was also vaccinated with Hep A vaccine (manufacturer unknown and batch number: not reported) in right arm and HPV (manufacturer unknown and batch number: not reported) in left arm, both on 13 Oct 2016. On the same day after vaccination, within minutes of the HPV vaccination, the patient became dizzy, before he could move from sitting in a chair to lying on the exam table, he fainted. The patient was caught by the nurse and did not fall. The patient seemed to be mild shaking as well. He was then picked up by the nurse and laid on the exam table. The patient requested something to drink and was given some Sprite and a cool rag for his forehead. The patient's skin was clammy and he was weak. After a few minutes he was able to sit up and drink the Sprite. He sat in the exam room for approximately 30 minutes until he felt strong enough to walk. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was not reported. Causality of the events was not reported. Seriousness assessment of events (dizziness, syncope) was upgraded (medically significant) as per information available in source document.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Dizziness, Headache, Mobility decreased, Muscle spasms
Clinical narrative: Case number PHHY2016US165629, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 659414) website on 21 Nov 2016. This report refers to a 59 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on 13 Oct 2016. On the same day after vaccination, the patient experienced pounding headache, nausea, loss of appetite, weakness in extremities, lightheaded and faint, cervical and thoracic spine muscles very tight and spasms, and limited mobility. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. Seriousness assessment of the event syncope and dizziness was upgraded based on the information available in the source document. The causality of the events was not reported.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle tightness, Muscular weakness, Nausea, Syncope
Clinical narrative: Case number PHHY2016US165629, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 659414) website on 21 Nov 2016. This report refers to a 59 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on 13 Oct 2016. On the same day after vaccination, the patient experienced pounding headache, nausea, loss of appetite, weakness in extremities, lightheaded and faint, cervical and thoracic spine muscles very tight and spasms, and limited mobility. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. Seriousness assessment of the event syncope and dizziness was upgraded based on the information available in the source document. The causality of the events was not reported.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Lymphadenopathy, Rash generalised, Rash pruritic
Clinical narrative: Case number PHHY2016US164958, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 659421) website on 21 Nov 2016. This report refers to a 60 years old male patient. Past medical history was not reported. Concomitant medications included as Aspirin, bupropion, fexofenadine, fluticasone propionate Nasal Spray, Lisinopril, pantoprazole and NITROSTAT. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm, intramuscularly on 13 Oct 2016. On the same day after vaccination, the patient experienced very itchy rash all over body, especially on left side (same side that shot was given on) and large swollen gland under left armpit (same arm that shot was given in). The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of rash pruritic, rash generalized was upgraded to serious (medically significant) based on the information available in the source document.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Contusion, Erythema, Headache, Injection site pain, Nausea
Clinical narrative: Case number PHHY2017US019920, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 659447) website on 23 Jan 2017. This report refers to a 37 years old female patient. Historical condition included lupus. Current condition was reported as none. Concomitant medications included IMITREX, PREMARIN and NEXIUM. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) intramuscularly into the left arm on 13 Oct 2016. After vaccination, on the same day, she experienced pain at injection site which turned into her arm being covered in large red hot painful welts that did not itch, but feel bruised. On an unknown date, she was nauseous and had a bad headache. She was waiting to see her doctor on Monday. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity, Skin warm, Urticaria
Clinical narrative: Case number PHHY2017US019920, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 659447) website on 23 Jan 2017. This report refers to a 37 years old female patient. Historical condition included lupus. Current condition was reported as none. Concomitant medications included IMITREX, PREMARIN and NEXIUM. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) intramuscularly into the left arm on 13 Oct 2016. After vaccination, on the same day, she experienced pain at injection site which turned into her arm being covered in large red hot painful welts that did not itch, but feel bruised. On an unknown date, she was nauseous and had a bad headache. She was waiting to see her doctor on Monday. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness
Clinical narrative: Case number PHHY2017US020815, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 659460) website on 23 Jan 2017. This report refers to a 34 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) into left arm, intramuscularly on 26 Sep 2016. On 29 Sep 2016, the patient experienced full arm weakness in arm of injection. It was reported that, no medical help or treatment sought yet. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, MMR
Symptoms: Blood sodium decreased, Decreased appetite, Diarrhoea, Injection site rash, Lethargy
Clinical narrative: Case number PHHY2017US020464, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 659490) website on 23 Jan 2017. This report refers to a 04 years old male patient. Past medical history was not reported. Current condition included peanut and tree nut allergy. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly on 06 Oct 2016. On an unspecified date, the patient also received vaccination with DTAP (manufacturer unknown, batch number: not reported) and measles vaccine, mumps vaccine, rubella vaccine (unknown manufacturer, batch number: not reported) both intramuscularly on 06 Oct 2016. On 08 Oct 2016 after vaccination the patient experienced lethargy, vomiting, diarrhea, fever, loss of appetite, unusual rash at injection site measuring approximately 8 inches by 4 inch. Blood work was done at doctors and shows that sodium level was low and rest of results were still pending. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Case number PHHY2017US020464, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 659490) website on 23 Jan 2017. This report refers to a 04 years old male patient. Past medical history was not reported. Current condition included peanut and tree nut allergy. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly on 06 Oct 2016. On an unspecified date, the patient also received vaccination with DTAP (manufacturer unknown, batch number: not reported) and measles vaccine, mumps vaccine, rubella vaccine (unknown manufacturer, batch number: not reported) both intramuscularly on 06 Oct 2016. On 08 Oct 2016 after vaccination the patient experienced lethargy, vomiting, diarrhea, fever, loss of appetite, unusual rash at injection site measuring approximately 8 inches by 4 inch. Blood work was done at doctors and shows that sodium level was low and rest of results were still pending. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Initial insomnia, Malaise, Nasal congestion, Pruritus, Rash
Clinical narrative: Case number PHHY2017US020422, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 659497) on 23 Jan 2017. This report refers to a 46 years old female patient. Medical history was not reported. Medical history was not reported. Concomitant medication included FLONASE. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 11 Oct 2016. On 12 Oct 2016 after vaccination, the patient experienced nasal congestion, rash on torso/back, itchiness on torso/back, malaise, difficultly falling asleep. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2017US021339, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 659506) on 23 Jan 2017. This report refers to a 61 years old female patient. Medical history and concomitant medication were reported as none. The patient was vaccinated with second dose of seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) into left arm and varicella zoster vaccine (manufacturer unknown, batch number: not reported) into right arm on 13 Oct 2016. On 16 Oct 2016 after vaccination, the patient experienced bright red, swollen area, warm to touch around vaccination area, about two and half in diameter, lighter pink area, slightly swollen radiating from vaccination area about 05 inches from vaccination site to arm area above elbow, extremely itchy directly around vaccination site. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Case number PHHY2017US020867, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 659511) website on 23 Jan 2017. This report refers to a 58-year-old male patient. Historical condition was not reported. Current conditions included slight sinusitis and allergy to penicillin and its relatives. Concomitant medication included Lisinopril, Levothyroxine and Famotidine. The patient was vaccinated with Seasonal Influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into left arm on 11 Oct 2016. On 13 Oct 2016, the patient developed initial pain at injection location stopped on this day, but later in the evening, the patient began experiencing intense pain in the shoulder/collarbone region on the side of the injection. The patient could barely lift arm, could not lay or stand comfortably. Pain had lessened slightly, but increased throughout the day. The patient was still suffering from pain. Outcome of the events were condition unchanged and seriousness of the events were reported as non-serious. Causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2017US011120 is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 659537) on 23 Jan 2017. This report refers to a female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown start date. Two weeks after vaccination, the patient experienced Bell's palsy. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. The event was reported as non-serious but was upgraded as medically significant based on NVS-IME list. The causality of the event was not reported.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Chills, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: Case number PHHY2017US020233 is an initial spontaneous report received from other healthcare professional via vaccine adverse event reported system (Vaers number: 659644) website on 23 Jan 2017. This report refers to a 25 year old female patient. Current condition included mild seasonal allergies. Medical history included hay fever. Concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown, batch number not reported) intramuscular into left arm on 01 Oct 2011. On 03 Oct 2011, patient experienced extreme concentrated stomach pain which lasted for about 1.5 hours. This stomach pain had recurred often and sporadically to present day, on next day 04 Oct 2011 patient experienced hay fever, chills, sweats and general flu like symptoms, which last for 5 days. The patient visited emergency room/doctor (date not reported). The outcome of the events was condition unchanged, seriousness of the events was non serious and causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: Case number PHHY2017US020532 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 659844) website on 23 Jan 2017. This report refers to an adult female patient of unspecified age. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on an unspecified date in 2016. After vaccination on an unspecified date in 2016, patient arm became swollen after receiving the flu vaccine. It was reported that patient was unaware of the brand name. The outcome, seriousness and causality of the event were not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Emotional distress, Injection site swelling, Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Case number PHHY2017US020577 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 659877) website on 23 Jan 2017. This report refers to a 49 year old female patient. Historical condition was not reported. Current condition included gastrooesophageal reflux disease. Concomitant medications included PRILOSEC. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) intramuscularly into left arm on 12 Oct 2016. On the same day after vaccination, patient was very swollen at the injection site. It was reported that on an unspecified date in Oct 2016 (reported as 48 hours) after the flu shot injection patient had a large welted up hive that extended across her bicep, the raised hive was hot and itchy and the arm of the patient was so sore that she could hardly move it. It was also reported that on an unspecified date in Oct 2016, the lymph nodes in her armpit were also swollen and had a difficult time controlling her emotions on the fourth and fifth days following the shot. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Skin warm, Urticaria
Clinical narrative: Case number PHHY2017US020577 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 659877) website on 23 Jan 2017. This report refers to a 49 year old female patient. Historical condition was not reported. Current condition included gastrooesophageal reflux disease. Concomitant medications included PRILOSEC. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) intramuscularly into left arm on 12 Oct 2016. On the same day after vaccination, patient was very swollen at the injection site. It was reported that on an unspecified date in Oct 2016 (reported as 48 hours) after the flu shot injection patient had a large welted up hive that extended across her bicep, the raised hive was hot and itchy and the arm of the patient was so sore that she could hardly move it. It was also reported that on an unspecified date in Oct 2016, the lymph nodes in her armpit were also swollen and had a difficult time controlling her emotions on the fourth and fifth days following the shot. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2017US011372, is an initial spontaneous report received from a consumer via call center representative via Vaccine Adverse Events Reporting System (VAERS reference number: 659892) on 23 Jan 2017. This report refers to a male patient of an unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced Guillain-Barre syndrome. The outcome of the event was reported as unknown. The seriousness of the event was reported as non serious and causality was not reported. Seriousness assessment of the event Guillain-Barre syndrome was upgraded based on the Novartis Important Medical Events list.
Age: 0.7
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Body temperature increased, Nasal congestion, Rhinorrhoea, Viral upper respiratory tract infection
Clinical narrative: Case number PHHY2017US019924, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 660028) website on 23 Jan 2017. This report refers to a 08 months old male patient. 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) on 14 Oct 2016. The patient was also vaccinated with Hepatitis A vaccine (batch number: not reported) on 14 Oct 2016. On 15 Oct 2016 after vaccination the patient experienced cold like symptoms after receiving flu vaccine and experienced elevated temperature and stuffy runny nose. The outcome of the event was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Case PHHY2017US021682  is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 660029) website on 23 Jan 2017. This report refers to a 32 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown, batch number not reported) intramuscular into left arm on 13 Oct 2016. Vaccine was not given in correct location, supposed to be administered in deltoid, was given much lower in arm in back of arm. No adverse event was reported following this medication error (drug administered at inappropriate site).
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Case number PHHY2017US010220, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 660343) through social media website on 23 Jan 2017. This report refers to a patient of an unknown age and gender. Past vaccination history included patient vaccinated with pneumonia vaccine and influenza virus vaccine unknown INN (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) and had near lethal flu (refer the case ID: PHHY2017US010236) due to influenza virus vaccine. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, following the vaccination, the patient experienced near lethal flu. It was a potential vaccination failure. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported. Seriousness assessment of the event influenza was upgraded (life threatening) based on the information available in the source document. Seriousness assessment of the event vaccination failure was upgraded (medically significant) based on the information available in the source document.
Age: 27.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Dyspnoea, Injection site rash
Clinical narrative: Case number PHHY2017US012223, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660391) website on 23 Jan 2017. This report refers to a 27 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 left arm on 12 Oct 2016. The patient also vaccinated with VARIVAX vaccine (other manufacturer, batch number: L045953) into right arm, subcutaneously on 12 Oct 2016. On the same day after vaccination, the patient experienced difficulty breathing. It was reported that, 911 was called and 01 dose of intramuscularly diphenhydramine 50 mg administered. Patient was breathing and talking entire time until Emergency medical services (E.M.S.) arrived. On 12 Oct 2016, the patient had rash was present on arm DF injection. The patient visited the emergency room. 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 event dyspnoea was upgraded to serious (medically significant) based on the information available in the source document.
Age: 1.3
Sex: M
Vaccine: DTPHIB, FLUX, MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: Case number PHHY2017US020522, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 660485) on 23 Jan 2017. This report refers to a 01 year and 03 months old male patient. Medical history was reported as none. Concomitant medication included Polymyxin B-Trimethoprim. The patient was vaccinated with second dose of seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported), MMR vaccine (other manufacturer), batch number: not reported) and third dose of TETRAMUNE (other manufacturer, batch number: not reported) all intramuscularly on 18 Oct 2016, when the patient was 1 year and 03 months old. On same day after vaccination, the patient experienced scattered hives and fever. The patient was treated with BENADRYL and TYLENOL. The outcome of the events was reported as complete recovery. The seriousness of the events scattered hives and fever was reported as non serious and not reported for medication error. The causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Case number PHHY2017US020159, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS660494) website on 23 Jan 2017. This report refers to a 48-year-old female patient. Historical condition included fibromyalgia. Concomitant medication was not reported. The patient received first dose of INN (manufacturer unknown, batch number not reported) into right arm on 14 Oct 2016. On 15 Oct 2016, the patient developed experienced pain and swelling of lymph nodes in right arm pit and swelling and pain at injection site (right arm). The patient was treated with ibuprofen 800mg; FLEXERIL 10 mg; TRAMADOL 30mg; Amitriptyline 10 mg. Outcome of the events was unknown. Seriousness of the events were reported as non serious. Causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2017US020126, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660516) website on 23 Jan 2017. This report refers to a 41 years old female patient. Historical conditions included lupus and anxiety. Current conditions included allergy to pineapple, allergy to erythromycin and penicillin. Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) intramuscularly into the left arm on 17 Oct 2016. After vaccination, around 23:00 hours, she started getting fever and felt very sore everywhere. She took two TYLENOL and went to bed. She woke in the night to find that the injection site was swollen to golf ball size. By morning, it was hot, red, and the size of a softball. She also had a migraine. The knot was now the size of a grapefruit and it hurt. She called the clinic and was told that a reaction was normal. She felt that it was not normal. The skin was stretched so think that it was almost translucent. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: Case number PHHY2017US020126, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660516) website on 23 Jan 2017. This report refers to a 41 years old female patient. Historical conditions included lupus and anxiety. Current conditions included allergy to pineapple, allergy to erythromycin and penicillin. Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) intramuscularly into the left arm on 17 Oct 2016. After vaccination, around 23:00 hours, she started getting fever and felt very sore everywhere. She took two TYLENOL and went to bed. She woke in the night to find that the injection site was swollen to golf ball size. By morning, it was hot, red, and the size of a softball. She also had a migraine. The knot was now the size of a grapefruit and it hurt. She called the clinic and was told that a reaction was normal. She felt that it was not normal. The skin was stretched so think that it was almost translucent. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Case number PHHY2017US020766, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660533) website on 23 Jan 2017. This report refers to a 53 years old female patient. Vaccination history included she was vaccinated with pandemic H1N1 influenza vaccine (batch number: not reported) an unknown date and experienced pain and weakness (see case: PHHY2017US020801). Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) into the left arm on 07 Dec 2015. After vaccination, on the same day, she experienced pain at injection site in arm, pain that lasted for months, range of motion limited, moving arm was painful. She experienced pain and weakness in arm that received injection. She went back to same doctor for follow up and told him that she believed that flu shot injection was improperly administered by nurse (details unspecified). He ordered an X-ray done which was inconclusive about the cause of pain. The outcome of the events was complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray normal
Clinical narrative: Case number PHHY2017US020766, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660533) website on 23 Jan 2017. This report refers to a 53 years old female patient. Vaccination history included she was vaccinated with pandemic H1N1 influenza vaccine (batch number: not reported) an unknown date and experienced pain and weakness (see case: PHHY2017US020801). Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) into the left arm on 07 Dec 2015. After vaccination, on the same day, she experienced pain at injection site in arm, pain that lasted for months, range of motion limited, moving arm was painful. She experienced pain and weakness in arm that received injection. She went back to same doctor for follow up and told him that she believed that flu shot injection was improperly administered by nurse (details unspecified). He ordered an X-ray done which was inconclusive about the cause of pain. The outcome of the events was complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Angioedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2017US012344, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660581) website on 23 Jan 2017. This report refers to a 70 years old female patient. Past medical history included as depression. Current condition included as hypertension. Concomitant medications included as lisinopril, trazodone and citalopram. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm, intramuscularly on 17 Oct 2016. The patient also vaccinated with first dose of PNEUMOVAX (other manufacture, batch number: not reported) into left arm, intramuscularly on 17 Oct 2016. On 18 Oct 2016, the patient experienced swollen, sore and warm extremity where both immunizations were given, soreness continue migrating distally, along with angioedema. 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. The seriousness assessment of angioedema was upgraded serious (medically significant) based on the Novartis Important Medical Event list.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site rash, Swelling face
Clinical narrative: Case number PHHY2017US011418 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 660588) website on 23 Jan 2017. This report refers to 59 year old female patient. Medical history was not reported. Past drugs included CECLOR and sulfadiazine. Concomitant medication included Albuterol inhaler, Lisinopril. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number not reported) intramuscular on 19 Oct 2016. On 20 Oct 2016, the patient experienced injection site rash with localized facial swelling. The outcome of the events was reported as complete recovery. The seriousness of the events was not reported. The causality of the events was not reported. Seriousness assessment of the event vaccination site rash and swelling face was upgraded to (medically significant) based on information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Swelling face, Urticaria
Clinical narrative: Case number PHHY2017US011358 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS Reference number: 660613) on 23 Jan 2017. This report refers to a 33 year old female patient. She had no medical history and current illness. It was reported that she tried to conceive but was not pregnant at the time of reporting. She informed the same to the pharmacist before the administration of flu shot. Concomitant medication included daily prenatal vitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 19 Oct 2016. On 20 Oct 2016, the patient woke up with hives and had one hive on wrist. She had welt like swelling on both sides of face and neck. She had no lab tests and called pharmacy just to confirm if it was normal. She was told to take antihistamines as directed until hives went away. The outcome of the events was reported as unknown. The events were reported as non-serious but were upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.