chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain of skin
Clinical narrative: Case PHHY2013US117367 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (reference number: 483892) on 15 Oct 2013: This report refers to a 29-year-old polymedicated female patient. Her concurrent conditions included asthma and seasonal allergies. Her past vaccination history included DTP at the age of 2 and experienced unable to walk. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) and DTaP both intramuscularly on left arm on 09 Sep 2012. On 13 Sep 2012, she woke up with acute pain at the injection site which was radiating from the shoulder to elbow. It was extremely painful to use her arm or even touch it. Her left arm, where the injection site took place, was nearly immobilized by the pain. She went to an urgent care facility and was prescribed hi-dose naproxen and to use a cold compress. After 24 hours the pain lessened, but was still severe. She returned to primary care doctor, who prescribed antibiotics in case of infection, which were not effective. Over time the pain gradually subsided, but still have daily pain (to a much lesser degree) at the injection site 4 months later. Final outcome of the events was reported as not recovered as of 10 Feb 2013. Seriousness, outcome and causality of the event were not reported. Following an internal review on 30 Oct 2013, of the data received on 15 Oct 2013, it was found that the events were wrongly assessed as non-serious. Hence it was upgraded to serious.
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Influenza like illness
Clinical narrative: Case number PHHY2013US116904 is an initial report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 483898) on 15 OCT 2013. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 08 NOV 2012. On 10 NOV 2012, he had flu like symptoms with aching joints, weakness, muscle aches and mile headache. It was reported that he felt like ha had aged 10 years. He went back to clinic, told doctor that he felt tired and was given no treatment. It was reported that on 10 FEB 2013, the symptoms still persisted. The final outcome was reported as condition unchanged.
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Case number PHHY2013US116904 is an initial report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 483898) on 15 OCT 2013. This report refers to an 80-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 08 NOV 2012. On 10 NOV 2012, he had flu like symptoms with aching joints, weakness, muscle aches and mile headache. It was reported that he felt like ha had aged 10 years. He went back to clinic, told doctor that he felt tired and was given no treatment. It was reported that on 10 FEB 2013, the symptoms still persisted. The final outcome was reported as condition unchanged.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Pharyngeal oedema
Clinical narrative: Case number PHHY2013US116908 is an initial report received from Vaccine Adverse Event Reporting System (VAERS referencing number: 484026) on 15 OCT 2013. This report refers to a 32-year-old female patient. Her medical history and current conditions were not reported. She received a seasonal influenza vaccine in the past and developed fever following vaccination. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) 3 dose on right arm on 12 JAN 2013. On the same day of vaccination (12  JAN 2013), she developed throat swelling, hoarse voice and constant coughing (couldn't hold conversation). She called her family member who was a nurse and she suggest4ed BENADRYL. Outcome of the event was reported as recovered. Seriousness and causality were not reported.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, FLUX, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Irritability
Clinical narrative: Case number PHHY2013US116939 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 484692) website on 15 OCT 2013. This case refers to a 2-year-old male patient. His medical history included obesity. Concomitant medications included TYLENOL. He was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) intramuscularly in left thigh, PENTACEL (other manufacturer, batch number: not reported) intramuscularly right thigh; MMR (other manufacturer, batch number: not reported) intramuscularly in left thigh and VARCEL (other manufacturer, batch number: not reported) intramuscular in left thigh on 13 FEB 2013. On 15 February 2013, after the vaccinations, he developed erythema (of 3 inches diameter) fluid filled vesicles (of 1 inch diameter within erythema) and edema of left thigh.  It was also reported that child was fussy. The patient visited to emergency room due to events. The outcome of events was reported as condition unchanged as of 16 FEB 2013. The seriousness and causality of events was not reported.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2013US1169410 is an initial report received from Vaccine Adverse Event Reporting System (VAERS reference number: 484695) on 15 OCT 2013. This report refers to a 40-year-old female patient. Her current conditions includes allergy to PAXIL, Wellbutrin and VICODIN. Concomitant medications include acyclovir, L-lysine and citalopram. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on to left arm on 06 FEB 2013. She developed excruciating shoulder pain at the joint and deltoid muscle on the very next day of vaccination (07 FEB 2013). The paint was much, much more than regular shot pain. She was unable to lift arm       above shoulder and was unable to use left arm much. Outcome of the events were reported as not recovered as of 17 FEB 2013. Seriousness and causality were not reported.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Case number PHHY2013US116944 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484698) website on 15 OCT 2013. This report refers to 44-year-old female patient. Her medical history included oromandibular dystonia. Her concomitant medications included Wellbutrin, Klonopin, Rhodiola, fish oil and vitamins. She was vaccinated with seasonal influenza v vaccine (unknown manufacturer, batch number not reported), in the right arm on 09 OCT 2012. She experienced chronic, fluctuating, but ongoing right upper arm pain since date of vaccination in right arm, manifesting as deep intermittent aching and intermittent shooting  /twinging pain radiating down upper arm and sometimes into shoulder area. She also experienced persistent soreness to touch in and around the site of vaccination. She experienced difficulty/pain with some arm movements and uses of muscles. She felt pain/difficulty sleeping on right side and getting comfortable in general. She did not seek any treatment yet. The event outcome was condition unchanged as of 17 FEB 2013. The seriousness and causality was not reported. No additional information was available.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2013US116944 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484698) website on 15 OCT 2013. This report refers to 44-year-old female patient. Her medical history included oromandibular dystonia. Her concomitant medications included Wellbutrin, Klonopin, Rhodiola, fish oil and vitamins. She was vaccinated with seasonal influenza v vaccine (unknown manufacturer, batch number not reported), in the right arm on 09 OCT 2012. She experienced chronic, fluctuating, but ongoing right upper arm pain since date of vaccination in right arm, manifesting as deep intermittent aching and intermittent shooting  /twinging pain radiating down upper arm and sometimes into shoulder area. She also experienced persistent soreness to touch in and around the site of vaccination. She experienced difficulty/pain with some arm movements and uses of muscles. She felt pain/difficulty sleeping on right side and getting comfortable in general. She did not seek any treatment yet. The event outcome was condition unchanged as of 17 FEB 2013. The seriousness and causality was not reported. No additional information was available.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Case number PHHYY2013US116949 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 484745) website on 15 OCT 2013. This case refers to 2-year-old male patient. He was vaccinated with influenza vaccine (unknown manufacturer, batch number, not reported, so conservatively coded as Seasonal influenza vaccine (INN) on 16 FEB 2013. On 17 FEB 2013, after the vaccination, the patient was tired, had sore and fever. The outcome of events was reported as condition unchanged as of 18 FEB 2013. The seriousness and causality of events was not reported.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy skin, Skin lesion, Wound
Clinical narrative: Case number PHHY2013US116955 is an initial spontaneous report from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 484810) website on 15 Oct 2013. This case refers to 65-year-old male patient. He was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unspecified date in 2008. On an unspecified date, after the vaccination, the patient had a wound and lesion on her arm. He had biopsy of lesion. The outcome of events was reported as complete recovery. The seriousness and causality of event was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Bedridden, Discomfort, Hypoaesthesia, Insomnia, Pain in extremity
Clinical narrative: Case number PHHY2013US116958, is an initial report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 484917) on 15 Oct 2013. This report refers to a 61-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) and ZOSTAVAX (other manufacturer, batch number: not reported) intramuscularly on 27 Jan 2013. On the next day, she experienced numbness in both hands as if LANACANE was applied. A sharp pain in her right arm began shortly afterwards. The pain got progressively worse and traveled to a sharp pain in the area between her shoulder blades. It got so bad that she went to the emergency room. She was prescribed gabapentin. They confirmed that it was a reaction to the vaccine. She was bedridden for the next 7 days as the pain moved to outside of her legs and around her rib cage. She could not sleep as she could not get comfortable. She was taking many hot whirlpool baths. She started relief after taking gabapentin. The event outcome was condition unchanged as of 20 Feb 2013. No further information about seriousness and causality was reported.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: Case number PHHY2013US116962 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 484999) website on 15 Oct 2013. This case refers to 45-year-old male patient. He was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) in left arm on 14 Jan 2013. On 04 Feb 2013, after the vaccination, the patient's shoulder was numb, also felt hard to lift left arm and dull pain. He also had weakness. The patient visited emergency room for the events. The outcome of events was reported as condition unchanged as of 20 Feb 2013. The seriousness and causality of events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Headache
Clinical narrative: Case number PHHY2013US116965 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 485240) website on 15 Oct 2013. This case refers to 67-year-old female patient. Concomitant medications included trimetrin, vitamin D and vitamin B-12 complex. She was vaccinated with influenza vaccine (unknown manufacture, batch number: not reported, so conservatively coded as Seasonal Influenza Vaccine INN) on 18 Oct 2012. On 18 Feb 2013, after the vaccination, the patient developed chills, stomach ache, vomiting, diarrhea, headache and overall weakness. The outcome of event was reported as complete recovery. The seriousness and causality of events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2013US116965 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 485240) website on 15 Oct 2013. This case refers to 67-year-old female patient. Concomitant medications included trimetrin, vitamin D and vitamin B-12 complex. She was vaccinated with influenza vaccine (unknown manufacture, batch number: not reported, so conservatively coded as Seasonal Influenza Vaccine INN) on 18 Oct 2012. On 18 Feb 2013, after the vaccination, the patient developed chills, stomach ache, vomiting, diarrhea, headache and overall weakness. The outcome of event was reported as complete recovery. The seriousness and causality of events was not reported.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Food aversion, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHHY2013US117373 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (reference number: 485534) on 15 Oct 2013: This report refers to a 24-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on right arm on 10 Dec 2012. On 17 Dec 2012, she experienced short term diarrhea, long term red itchy bumps on top of hands which looks like rash. She also had aversion to milk now (did not have any issue with it prior to vaccination). Outcome of the events was reported as not recovered as of 25 Feb 2013. Seriousness, outcome and causality of the event were not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Headache, Nausea, Pyrexia, Vomiting, Wrong drug administered
Clinical narrative: Case number PHHY2013US116888, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 485714) website on 15 Oct 2013. This report refers to an adult male patient. His medical history and concomitant medications was not reported. He was wrongly vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unspecified date in Nov 1976. Twenty minutes after the vaccination, he complained of nausea, vomiting and had a fever that resulted in a three day hospital admission. He denied any muscle weakness, tingling, loss of sensation or paralysis. He was unable to locate or obtain these 1976 records. He was vaccinated with the influenza vaccine in 1985 and experienced headache, nausea, vomiting (see case PHHY2013US120739). The event outcome was completely recovered. The seriousness was hospitalization. The causality was not reported. No additional information was available.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: Case number PHHY2013US116888, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 485714) website on 15 Oct 2013. This report refers to an adult male patient. His medical history and concomitant medications was not reported. He was wrongly vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unspecified date in Nov 1976. Twenty minutes after the vaccination, he complained of nausea, vomiting and had a fever that resulted in a three day hospital admission. He denied any muscle weakness, tingling, loss of sensation or paralysis. He was unable to locate or obtain these 1976 records. He was vaccinated with the influenza vaccine in 1985 and experienced headache, nausea, vomiting (see case PHHY2013US120739). The event outcome was completely recovered. The seriousness was hospitalization. The causality was not reported. No additional information was available.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Feeling of body temperature change, Gastroenteritis, Headache, Migraine, Nausea
Clinical narrative: Case number PHHY2013US116888, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 485714) website on 15 Oct 2013. This report refers to an adult male patient. His medical history and concomitant medications was not reported. He was wrongly vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unspecified date in Nov 1976. Twenty minutes after the vaccination, he complained of nausea, vomiting and had a fever that resulted in a three day hospital admission. He denied any muscle weakness, tingling, loss of sensation or paralysis. He was unable to locate or obtain these 1976 records. He was vaccinated with the influenza vaccine in 1985 and experienced headache, nausea, vomiting (see case PHHY2013US120739). The event outcome was completely recovered. The seriousness was hospitalization. The causality was not reported. No additional information was available.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, Tendonitis, Vomiting
Clinical narrative: Case number PHHY2013US116888, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 485714) website on 15 Oct 2013. This report refers to an adult male patient. His medical history and concomitant medications was not reported. He was wrongly vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unspecified date in Nov 1976. Twenty minutes after the vaccination, he complained of nausea, vomiting and had a fever that resulted in a three day hospital admission. He denied any muscle weakness, tingling, loss of sensation or paralysis. He was unable to locate or obtain these 1976 records. He was vaccinated with the influenza vaccine in 1985 and experienced headache, nausea, vomiting (see case PHHY2013US120739). The event outcome was completely recovered. The seriousness was hospitalization. The causality was not reported. No additional information was available.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PNC, RVX
Symptoms: Body temperature increased, Rhinorrhoea, Sneezing, Urticaria
Clinical narrative: Case number PHHY2013US117724 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (reference number: 4859378) on 15 Oct 2013: This report refers to a 1-year-old female infant. Her medical history was not reported. Concomitant medications included BENADRYL and TYLENOL. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 08 Feb 2012. On the same date, she was also vaccinated with DTAP IPV HIB vaccine (manufacturer unknown and batch number unknown), PREVNAR (other manufacturer and batch number unknown) and rotavirus vaccine (manufacturer and batch number unknown). On 20 Feb 2012, she experienced runny nose and sneezing. On 11 Feb 2012, she had a temperature of 100.2. On 14 Feb 2012, she had hives all over body. The physician prescribed her BENADRYL for reaction. Final outcome of the events was reported as recovered as of 02 Mar 2013. Seriousness and causality was not reported for the events.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2013US117727 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 486083) on 15 Oct 2013: This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly on an unknown date. After an unspecified time interval after vaccination she experienced anaphylaxis. No further information about outcome, seriousness and causality was reported.
Age: 21.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2013US117377 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 486407) website on 15 Oct 2013. This report refers to a 21-year-old male patient. His medical history included Crohn's disease. He was vaccinated with Seasonal influenza vaccine (manufacturer and batch number unknown) subcutaneously into left arm and pneumococcal vaccine (manufacturer and batch number unknown) subcutaneously into right arm on 01 Mar 2013. On the same day, after vaccination, he had extreme pain at injection site with slight redness. pain reached peak two hours after onset and decreased in intensity 24 hours after onset. pain disappeared 48 hours after onset. Outcome of the events was reported as recovered. No seriousness and causality was reported for the event.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Fatigue, Headache, Migraine, Nausea
Clinical narrative: Case number PHHY2013US116988, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 487273) website on 15 Oct 2013. This report refers to 23-year-old female patient. Her medical history included celiac sprue and hypothyroidism. Her concomitant medications included ADDERALL XR, levothyroxine, PAMPRIN and BENADRYL. On 18 Mar 2013, the patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown). On 19 Mar 2013, at 06:00 pm, she experienced extreme exhaustion/fatigue with severe body ache and neck pain. At 08:00 pm, she experienced headache and migraine like symptoms impacting ability to function. She also experienced abdominal pain and nausea. She tried to sleep from 07:30 to 07:45 pm, but could not achieve it. Warm compress in combination with noise and light restriction helped with severe neck pain, but nausea and vomiting continued for at least 8 hours. At 01:00 am, she took an adult dose of diphenhydramine hydrochloride to help with muscle aches and headache. It was immediately followed by vomiting. She had been unable to eat or drink without vomiting. At the time of reporting, the events were still ongoing. The event outcome was condition unchanged as of 20 Mar 2013. The seriousness and causality was not reported. No additional information was available.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain, Vomiting
Clinical narrative: Case number PHHY2013US116988, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 487273) website on 15 Oct 2013. This report refers to 23-year-old female patient. Her medical history included celiac sprue and hypothyroidism. Her concomitant medications included ADDERALL XR, levothyroxine, PAMPRIN and BENADRYL. On 18 Mar 2013, the patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown). On 19 Mar 2013, at 06:00 pm, she experienced extreme exhaustion/fatigue with severe body ache and neck pain. At 08:00 pm, she experienced headache and migraine like symptoms impacting ability to function. She also experienced abdominal pain and nausea. She tried to sleep from 07:30 to 07:45 pm, but could not achieve it. Warm compress in combination with noise and light restriction helped with severe neck pain, but nausea and vomiting continued for at least 8 hours. At 01:00 am, she took an adult dose of diphenhydramine hydrochloride to help with muscle aches and headache. It was immediately followed by vomiting. She had been unable to eat or drink without vomiting. At the time of reporting, the events were still ongoing. The event outcome was condition unchanged as of 20 Mar 2013. The seriousness and causality was not reported. No additional information was available.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Case number PHHY2013US117525 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 488092) on 15 Oct 2013: This report refers to a 51-year-old female patient. Her medical history included allergy to sulfa drugs. Her concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) along with ZOSTAVAX (other manufacturer, batch number: unknown) in to the arm on an unknown date in Sep 2012. On an unknown date after vaccination, in Sep 2012, the patient developed an injection site reaction which was described as swelling, erythema, a walnut-sized pus-filled blister/ rash, and inflammation from shoulder to elbow with warmth. She was hospitalized for two days and was sent to ICU  (intensive care unit). The patient was treated with vancomycin and unspecified pain medications. The event outcome was unknown. No further information about seriousness and causality was reported.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site warmth, Intensive care
Clinical narrative: Case number PHHY2013US117525 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 488092) on 15 Oct 2013: This report refers to a 51-year-old female patient. Her medical history included allergy to sulfa drugs. Her concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) along with ZOSTAVAX (other manufacturer, batch number: unknown) in to the arm on an unknown date in Sep 2012. On an unknown date after vaccination, in Sep 2012, the patient developed an injection site reaction which was described as swelling, erythema, a walnut-sized pus-filled blister/ rash, and inflammation from shoulder to elbow with warmth. She was hospitalized for two days and was sent to ICU  (intensive care unit). The patient was treated with vancomycin and unspecified pain medications. The event outcome was unknown. No further information about seriousness and causality was reported.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Ear pain, Fatigue, Headache, Pain
Clinical narrative: Case number PHHY2013US116741 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 488156) website on 15 Oct 2013. This report refers to a 66-year-old female patient. Her medical history included allergic to Penicillin and codeine. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly into left arm on 02 Jan 2013. On 01 Feb 2013, she experienced body aches, headache, earache, chills and minor fever. She stated that her body aches were so bad that she was totally bent over like a 100 year old. These symptoms were recovered after 24 hours, but she was exhausted. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US116741 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 488156) website on 15 Oct 2013. This report refers to a 66-year-old female patient. Her medical history included allergic to Penicillin and codeine. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly into left arm on 02 Jan 2013. On 01 Feb 2013, she experienced body aches, headache, earache, chills and minor fever. She stated that her body aches were so bad that she was totally bent over like a 100 year old. These symptoms were recovered after 24 hours, but she was exhausted. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Case number PHHY2013US117449 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 489159) website on 15 Oct 2013. This case refers to 47-year-old female patient. Concomitant medications included lisinopril, gemfibrozil, ranitidine, CELEXA and ibuprofen. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on 14 Jan 2013. On 14 Jan 2013, after the vaccination, the patient developed itching on arms, leg and torso, hives. She developed itchy throat all within approximately 45 minutes to 1 hour and had taken an antihistamine. The outcome of events was reported as recovered. The seriousness and causality of events was not reported.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2013US117536 is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS reference number: 489718) on 15 Oct 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: not reported) and ZOSTAVAX (batch number: not reported) on an unknown date of Sep 2012. On an unknown date of Sep 2012, she had fever of 100 plus, redness and nausea. Her arm was sore and she could not raise arm. The outcome of the event was unknown.
Age: 59.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Rash, Skin lesion, Swelling
Clinical narrative: Case number PHHY2013US116936 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system (VAERS reference number: 489750) on 15 Oct 2013. This report refers to a 59-year-old male patient. His current condition included unspecified cancer (malignant neoplasm) which started on an unknown date in 2007 and he recovered in Jul 2012. He did not have any drug reactions or allergies. His concomitant medications were atenolol, CRESTOR and fenofibrate. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date (around the same time as ZOSTAVAX, but not on same date). He also received ZOSTAVAX (other manufacturer, batch number: not reported) on an unknown date in Oct 2009 (reported as three and half months ago from events). In 2009, couple of days after vaccination he broke out with sores all over his arms, buttocks, head, and back. He also developed a couple of unspecified lumps on his back. He was prescribed an unspecified medication as two weekly treatments of 6 pills taken simultaneously a week apart on the same day of the week. He stated that these pills did eliminate the lumps but did not eliminate the sores. He also consulted dermatologist and had a diagnotic biopsy test to see if his reaction was caused by mite bites. The test for mites came back negative. He was prescribed triamcinolone acetonide cream USP 1% to treat his rash. The outcome was reported as recovering.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Neuralgic amyotrophy
Clinical narrative: Case number PHHY2013US117462 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 490189) on 15 Oct 2013: This report refers to a 50-year-old male patient. His medical history included obstructive sleep apnea. His concomitant medications included PRISTIQ 100 mg daily and NUVIGIL 250 mg daily prn. He was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly in to left arm on 18 Feb 2013. On 01 Apr 2013, he experienced left brachial plexus neuritis and was diagnosed with neuralgic amyotrophy by a neurologist. Final outcome of the event was reported as condition unchanged as on 26 Apr 2013. No further information about seriousness and causality was reported.
Age: 34.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Erythema, Injection site reaction, Scab, Swelling, Vaccination site discolouration
Clinical narrative: Case number PHHY2013US116796 is an initial report received via vaccine adverse event reporting system (VAERS reference number: 490259) on 15 Oct 2013. This report refers to a 34-year-old male patient. His medical history included lactose intolerance and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intradermally in arm and Tdap vaccine (other manufacturer, batch number: not reported) in arm on 18 Feb 2013. On 19 Feb 2013, red bump started and later a yellow crust formed at vaccination spots about an inch large. It was unusual reaction which was for about two months and the events were ongoing. It was reported that there was a possible exposure to unclean or infected office and was trying to figure out the cause of the reaction and solve it. The outcome of the events was reported as condition unchanged.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117308 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490361) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, PPV23, Td combination vaccines, HepA and HepB. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccine, was extremely low. This report refers to a 65-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Three days after vaccination, the patient experienced Guillain-Barre syndrome (GBS) and was hospitalized. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. No further information was provided.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117304 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490362) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, PPV23, Td combination vaccines, HepA and HepB. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. this report refers to a 65-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. 14 days after vaccination, the patient experienced Guillain-Barre syndrome (GBS) and was hospitalized. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. No further information was provided.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117311 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490363) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, PNEUMOVAX 23, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This report refers to an 87-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. 18 days after vaccination, the patient experienced Guillain-Barre syndrome (GBS) and was hospitalized. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. No further information was provided.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117313 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset to GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS hd been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This report refers to a 76-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date: 35 days after vaccination, the patient experienced Guillain-Barre Syndrome (GBS) and was hospitalized. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. No further information was provided.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117548 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490367) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. This case refers to a 65-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that 14 days after vaccination, the patient had onset of Guillain Barre syndrome and was hospitalized. The outcome of event was not reported. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. No further information was provided.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117552 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490371) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. This report refers to a 66-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that 36 days after vaccination, the patient had onset of Guillain Barre syndrome and was hospitalized. The outcome of the event was not reported. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. No further information was provided.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117324 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490372) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. This case refers to 59-year-old male patient. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, 24 days after the vaccination, the patient was diagnosed with Guillain Barre syndrome and was hospitalized. The outcome of event was not reported. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. No further information was provided.