chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Dyskinesia, Presyncope
Clinical narrative: Case number PHHY2015US002906, is an initial spontaneous report received from a nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 553109) website on 06 JAN 2015. This report refers to male patient of unknown age. The patient had no medical history and concomitant medications. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported), along with the third dose of GARDASIL (batch number: not reported) intramuscularly on an unknown date. On an unknown date in SEP 2014, the patient started to faint, but the patient did not loose his consciousness. Further the patient body began to jerk. On an unknown date, the patient underwent blood pressure test (results were not provided). The patient had sought for medical attention on an unknown date. The outcome of the events was recovered. The events were reported as non-serious. Causality was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthma, Foetal exposure during pregnancy, Food allergy, Swelling, Urticaria
Clinical narrative: Baby case: Case number PHHY2015US001693, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553322) website on 06 JAN 2015. This report refers to a male patient of unknown age born to the parent specified in (see case: PHHY2015US001694). The mother's medical history and concomitant medication was not reported. The mother during her pregnancy received seasonal influenza vaccine INN (manufacturer and batch number unknown) in OCT 2010. On an unknown date the mother gave birth to this child. Within 10  months after birth the child developed an egg allergy with symptoms of hives, swelling and vomiting. He also developed multiple food allergies and had asthma. The patient's mother stated there was no family history of food allergies or asthma and believed her son's allergies and asthma are reactions to her having received the flu vaccine during her pregnancy. Lab tests was unknown. The reporter stated she later had another child, and did not have the flu vaccine during that pregnancy and her daughter has none of the allergies or asthma like her first son. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: Baby case: Case number PHHY2015US001693, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553322) website on 06 JAN 2015. This report refers to a male patient of unknown age born to the parent specified in (see case: PHHY2015US001694). The mother's medical history and concomitant medication was not reported. The mother during her pregnancy received seasonal influenza vaccine INN (manufacturer and batch number unknown) in OCT 2010. On an unknown date the mother gave birth to this child. Within 10  months after birth the child developed an egg allergy with symptoms of hives, swelling and vomiting. He also developed multiple food allergies and had asthma. The patient's mother stated there was no family history of food allergies or asthma and believed her son's allergies and asthma are reactions to her having received the flu vaccine during her pregnancy. Lab tests was unknown. The reporter stated she later had another child, and did not have the flu vaccine during that pregnancy and her daughter has none of the allergies or asthma like her first son. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Baby case: Case number PHHY2015US001693, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553322) website on 06 JAN 2015. This report refers to a male patient of unknown age born to the parent specified in (see case: PHHY2015US001694). The mother's medical history and concomitant medication was not reported. The mother during her pregnancy received seasonal influenza vaccine INN (manufacturer and batch number unknown) in OCT 2010. On an unknown date the mother gave birth to this child. Within 10  months after birth the child developed an egg allergy with symptoms of hives, swelling and vomiting. He also developed multiple food allergies and had asthma. The patient's mother stated there was no family history of food allergies or asthma and believed her son's allergies and asthma are reactions to her having received the flu vaccine during her pregnancy. Lab tests was unknown. The reporter stated she later had another child, and did not have the flu vaccine during that pregnancy and her daughter has none of the allergies or asthma like her first son. Final outcome of the events was unknown. Causality assessment was not reported. Events were reported as non-serious.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Case number PHHY2015US104731, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559108) on 25 Aug 2015. This report refers to a 1-year-old male patient. Historical conditions were none. Current conditions included right otitis media. The patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) along with MMR vaccine (unknown manufacturer, batch number: not reported), pneumococcal vaccine polyvalent (unknown manufacturer, batch number: not reported) and varicella vaccine (unknown manufacturer, batch number: not reported) on 09 Dec 2014. On 19 Dec 2014, the patient experienced fever and generalized measles type rash. Final outcome of the event was not reported. The events were reported as non-serious and causality was not reported. Seriousness of the event rash morbilliform was upgraded based on information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site inflammation, Injection site swelling, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Case number PHHY2015US105224, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559791) website on 25 Aug 2015. This report refers to a 33 year old female patient. Medical history was not reported. Concomitant medication included birth control pill. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 22 Oct 2014. On the same day post vaccination the patient experienced pain in arm, shoulder and connective tendons. Inflammation and swelling at injection site and muscle pain grew progressively worse over four weeks. Eventually patient could not lie on her side or move arm or use it to bear weight. The patient went to the emergency room and contacted a doctor. Patient recovered after a course of physical therapy. Final outcome of the events was recovered. Events were reported as non-serious. Causality assessment was not reported. Seriousness of the events 'Inflammation and swelling at injection site' was upgraded based on information available in source document. No further information was provided.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Tendon pain, Weight bearing difficulty
Clinical narrative: Case number PHHY2015US105224, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559791) website on 25 Aug 2015. This report refers to a 33 year old female patient. Medical history was not reported. Concomitant medication included birth control pill. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 22 Oct 2014. On the same day post vaccination the patient experienced pain in arm, shoulder and connective tendons. Inflammation and swelling at injection site and muscle pain grew progressively worse over four weeks. Eventually patient could not lie on her side or move arm or use it to bear weight. The patient went to the emergency room and contacted a doctor. Patient recovered after a course of physical therapy. Final outcome of the events was recovered. Events were reported as non-serious. Causality assessment was not reported. Seriousness of the events 'Inflammation and swelling at injection site' was upgraded based on information available in source document. No further information was provided.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Asthenia, Dizziness, Dysphonia, Headache
Clinical narrative: Case number PHHY2015US105441, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559797) on 25 Aug 2015. This report refers to an 87-year old female patient. Past medical history included heart problems, cholesterol and the patient was gluten sensitive. Past medications included codeine, aspirin and morphine. This polymedicated patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 29 Sep 2014. On 01 Oct 2014, the patient experienced fainting, headache, runny nose, stiff neck, intense muscle aches, hoarseness, paleness, weakness, dizziness, behavior changes, extreme shoulder and leg pains, soreness and redness of injection site. Final outcome of the events was not recovered. The events were reported as non-serious and causality was not reported. Seriousness of the event syncope was upgraded based on the information available in the source document.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Case number PHHY2015US105441, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559797) on 25 Aug 2015. This report refers to an 87-year old female patient. Past medical history included heart problems, cholesterol and the patient was gluten sensitive. Past medications included codeine, aspirin and morphine. This polymedicated patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 29 Sep 2014. On 01 Oct 2014, the patient experienced fainting, headache, runny nose, stiff neck, intense muscle aches, hoarseness, paleness, weakness, dizziness, behavior changes, extreme shoulder and leg pains, soreness and redness of injection site. Final outcome of the events was not recovered. The events were reported as non-serious and causality was not reported. Seriousness of the event syncope was upgraded based on the information available in the source document.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pallor, Rhinorrhoea, Syncope
Clinical narrative: Case number PHHY2015US105441, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559797) on 25 Aug 2015. This report refers to an 87-year old female patient. Past medical history included heart problems, cholesterol and the patient was gluten sensitive. Past medications included codeine, aspirin and morphine. This polymedicated patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 29 Sep 2014. On 01 Oct 2014, the patient experienced fainting, headache, runny nose, stiff neck, intense muscle aches, hoarseness, paleness, weakness, dizziness, behavior changes, extreme shoulder and leg pains, soreness and redness of injection site. Final outcome of the events was not recovered. The events were reported as non-serious and causality was not reported. Seriousness of the event syncope was upgraded based on the information available in the source document.
Age: 47.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Injection site cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Case number PHHY2015US105759, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560016) website on 25 Aug 2015. This report refers to a 47 year old male patient. Medical history included Diabetes Type I and hypothyroidism. Concomitant medication included insulin, levothyroxine, NEXIUM, lisinopril, CRESTOR, SINGULAIR, ALLEGRA, Multivitamin, Fish Oil and vitamin B. the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscular into left arm on 04 Dec 2014. On the same day the patient was vaccinated with pneumococcal vaccine (other manufacturer, batch number: unknown) intramuscular into left arm. On the same day his left arm at injection site was red, warm to touch, inflamed and very painful as well as fever and chills. Within 3 days, the redness, swelling and heat had spread to below the elbow however the fever and chills went away. The patient had spoken with the doctors office on 06 Dec 2014 and was told it was just a reaction and he should be fine however by 07 Dec 2014 it was worse, then on 08 Dec 2014 spoke directly to the doctor who wanted to see him right away, he was then told he had cellulitis at the site and placed on KEFLEX. After approximately one and half weeks the arm was returning to normal. The patient went to the emergency room. Final outcome of the events was recovered. Events were reported as non-serious. Causality assessment was not reported. Seriousness of the event 'cellulitis at site and symptoms' was upgraded based on information available in source document. No further information was provided.
Age: 47.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site warmth, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Case number PHHY2015US105759, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560016) website on 25 Aug 2015. This report refers to a 47 year old male patient. Medical history included Diabetes Type I and hypothyroidism. Concomitant medication included insulin, levothyroxine, NEXIUM, lisinopril, CRESTOR, SINGULAIR, ALLEGRA, Multivitamin, Fish Oil and vitamin B. the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscular into left arm on 04 Dec 2014. On the same day the patient was vaccinated with pneumococcal vaccine (other manufacturer, batch number: unknown) intramuscular into left arm. On the same day his left arm at injection site was red, warm to touch, inflamed and very painful as well as fever and chills. Within 3 days, the redness, swelling and heat had spread to below the elbow however the fever and chills went away. The patient had spoken with the doctors office on 06 Dec 2014 and was told it was just a reaction and he should be fine however by 07 Dec 2014 it was worse, then on 08 Dec 2014 spoke directly to the doctor who wanted to see him right away, he was then told he had cellulitis at the site and placed on KEFLEX. After approximately one and half weeks the arm was returning to normal. The patient went to the emergency room. Final outcome of the events was recovered. Events were reported as non-serious. Causality assessment was not reported. Seriousness of the event 'cellulitis at site and symptoms' was upgraded based on information available in source document. No further information was provided.
Age: 47.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Case number PHHY2015US105759, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560016) website on 25 Aug 2015. This report refers to a 47 year old male patient. Medical history included Diabetes Type I and hypothyroidism. Concomitant medication included insulin, levothyroxine, NEXIUM, lisinopril, CRESTOR, SINGULAIR, ALLEGRA, Multivitamin, Fish Oil and vitamin B. the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscular into left arm on 04 Dec 2014. On the same day the patient was vaccinated with pneumococcal vaccine (other manufacturer, batch number: unknown) intramuscular into left arm. On the same day his left arm at injection site was red, warm to touch, inflamed and very painful as well as fever and chills. Within 3 days, the redness, swelling and heat had spread to below the elbow however the fever and chills went away. The patient had spoken with the doctors office on 06 Dec 2014 and was told it was just a reaction and he should be fine however by 07 Dec 2014 it was worse, then on 08 Dec 2014 spoke directly to the doctor who wanted to see him right away, he was then told he had cellulitis at the site and placed on KEFLEX. After approximately one and half weeks the arm was returning to normal. The patient went to the emergency room. Final outcome of the events was recovered. Events were reported as non-serious. Causality assessment was not reported. Seriousness of the event 'cellulitis at site and symptoms' was upgraded based on information available in source document. No further information was provided.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2015US048009, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 562026) website on 21 Apr 2015. This report refers to a patient of unknown age and gender. Historical conditions and concomitant medications were none. On an unspecified date, years ago, the patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number unknown). On an unspecified date, the patient developed a Guillain-Barre-like reaction. Outcome of the event was not reported. Case was assessed as non-serious. Seriousness assessment of Guillain-Barre-like reaction was upgraded based on the NVS-IMS list.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLUX, HEPAB, IPV, MEN, TDAP
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Case number PHHY2015US047477, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 563316) website on 21 Apr 2015. This report refers to an 18-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown), adenovirus types 4 and 7, live, oral vaccine (other manufacturer, batch number: unknown), TWINRIX (other manufacturer, batch number: unknown), IPOL (other manufacturer, batch number: unknown), MENOMUNE (other manufacturer, batch number: unknown) and BOOSTRIX (other manufacturer, batch number: unknown) on 18 Dec 2014. On an unknown date 1 month after the vaccinations, he presented with acute disseminated encephalomyelitis (ADEM). The final outcome of the event was not recovered. The event was reported as non serious. Causality of the event was not reported. Seriousness of ADEM was upgraded based on NVS-IME list.
Age: 1.5
Sex: F
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: Case number PHHY2015US047496, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 563468) website on 21 Apr 2015. This report refers to a 1.5-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on to her left gluteus on 18 Dec 2014. On 23 Dec 2014, she had short seizures while playing. The final outcome of the event was not recovered. The event was reported as non serious. Causality of the event was not reported. Seriousness of seizure was upgraded based on available information in the source document.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure fluctuation, Blood test, Cardiac stress test, Cough, Dizziness
Clinical narrative: Case number PHHY2015US047544, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 564267) website on 21 Apr 2015. This report refers to a 40-year-old male patient. Medical history included post-traumatic stress disorder (PTSD) and several muscle skeletal issues. Concomitant medications included meloxicam. He had no sickness at the time of vaccination. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 02 Nov 2012. On the same day, after vaccination, the patient experienced cough. As the day progressed the patient started getting stiff, cramp like feelings at the injection site and upper back. On 03 Nov 2012, the patient was admitted to hospital emergency room with cramping in legs, dizzy, difficulty breathing, radiating pain all over, blood pressure all over the place and high pulse rate. The patient had undergone blood work, electrocardiogram (EKG), stress test, nuclear stress test, ultrasound, X-ray with upper GI, magnetic resonance imaging (MRI) thoracic and cervical spine (results not reported). Outcome of the events were reported as not recovered. Causality of the events was not reported. Seriousness of the event dyspnea was upgraded based on information available in the source document.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Electrocardiogram, Heart rate increased, Injection site reaction, Muscle spasms
Clinical narrative: Case number PHHY2015US047544, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 564267) website on 21 Apr 2015. This report refers to a 40-year-old male patient. Medical history included post-traumatic stress disorder (PTSD) and several muscle skeletal issues. Concomitant medications included meloxicam. He had no sickness at the time of vaccination. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 02 Nov 2012. On the same day, after vaccination, the patient experienced cough. As the day progressed the patient started getting stiff, cramp like feelings at the injection site and upper back. On 03 Nov 2012, the patient was admitted to hospital emergency room with cramping in legs, dizzy, difficulty breathing, radiating pain all over, blood pressure all over the place and high pulse rate. The patient had undergone blood work, electrocardiogram (EKG), stress test, nuclear stress test, ultrasound, X-ray with upper GI, magnetic resonance imaging (MRI) thoracic and cervical spine (results not reported). Outcome of the events were reported as not recovered. Causality of the events was not reported. Seriousness of the event dyspnea was upgraded based on information available in the source document.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic, Pain, Scan myocardial perfusion
Clinical narrative: Case number PHHY2015US047544, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 564267) website on 21 Apr 2015. This report refers to a 40-year-old male patient. Medical history included post-traumatic stress disorder (PTSD) and several muscle skeletal issues. Concomitant medications included meloxicam. He had no sickness at the time of vaccination. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 02 Nov 2012. On the same day, after vaccination, the patient experienced cough. As the day progressed the patient started getting stiff, cramp like feelings at the injection site and upper back. On 03 Nov 2012, the patient was admitted to hospital emergency room with cramping in legs, dizzy, difficulty breathing, radiating pain all over, blood pressure all over the place and high pulse rate. The patient had undergone blood work, electrocardiogram (EKG), stress test, nuclear stress test, ultrasound, X-ray with upper GI, magnetic resonance imaging (MRI) thoracic and cervical spine (results not reported). Outcome of the events were reported as not recovered. Causality of the events was not reported. Seriousness of the event dyspnea was upgraded based on information available in the source document.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Ultrasound scan, X-ray gastrointestinal tract
Clinical narrative: Case number PHHY2015US047544, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 564267) website on 21 Apr 2015. This report refers to a 40-year-old male patient. Medical history included post-traumatic stress disorder (PTSD) and several muscle skeletal issues. Concomitant medications included meloxicam. He had no sickness at the time of vaccination. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 02 Nov 2012. On the same day, after vaccination, the patient experienced cough. As the day progressed the patient started getting stiff, cramp like feelings at the injection site and upper back. On 03 Nov 2012, the patient was admitted to hospital emergency room with cramping in legs, dizzy, difficulty breathing, radiating pain all over, blood pressure all over the place and high pulse rate. The patient had undergone blood work, electrocardiogram (EKG), stress test, nuclear stress test, ultrasound, X-ray with upper GI, magnetic resonance imaging (MRI) thoracic and cervical spine (results not reported). Outcome of the events were reported as not recovered. Causality of the events was not reported. Seriousness of the event dyspnea was upgraded based on information available in the source document.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Hypersensitivity, Somnolence, Throat tightness
Clinical narrative: Case number PHHY2015US047497 is an initial spontaneous report received from the consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 564438) website on 21 Apr 2015. This report refers to a 29-year-old female patient. Her current condition included allergy to amoxicillin. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 20 Jan 2015. On the same day, she experienced mild throat tightening, cough and breathing difficulty. She thought it was an allergic reaction as she ate both squid and peanuts, but she never had allergies to those items and had eaten them since with zero reaction. The events lasted for 3 to 4 hours. She took BENADRYL 50 mg liquid after about 1.5 hours of symptoms. However it did not help, instead made her extremely drowsy and she slept off. She woke up the next day and was completely fine. Outcome of the events were reported as complete recovery. The events were reported as non serious, but the event hypersensitivity was upgraded as medically significant based on the information available in the source documents. Causality of the events was not reported.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Rash erythematous, Rash generalised, Swelling face
Clinical narrative: Case number PHHY2015US047845, is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 565581) website on 21 Apr 2015. This report refers to a 06-year-old male patient. Medical history was not reported. Concomitant medication included CONCERTA. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 02 Oct 2014. On 03 Oct 2014 after the vaccination, he had generalized erythematous body rash, facial swelling and redness which regressed within 24 hours. He was treated with BENADRYL. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of generalized erythematous body rash, facial swelling was upgraded based on available information in the source document.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Platelet count decreased
Clinical narrative: Case number PHHY2015US048038, is an initial spontaneous report received from the consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 565730) website on 21 Apr 2015. This report refers to a 43-year-old male patient. Current condition included immune thrombocytopenic purpura since 2007. Concomitant medication included prednisone. His vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: unknown) in 2008, 2009, 2010 and 2011 respectively and experienced drop in platelet count after each dose (see cases: PHHY2015US047960, PHHY2015US048035, PHHY2015US048036 and PHHY2015US048037). He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in 2012. At an unspecified time after vaccination, the patient experienced drop in platelet count for 6 months. It was reported that "all of these years, his platelet count was above 50000". Outcome of the event was reported as recovered. Seriousness of the event was reported as non serious. Causality of the event was not reported. Seriousness assessment of drop in platelet count was upgraded based on information in the source document.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Platelet count decreased
Clinical narrative: Case number PHHY2015US047980, is an initial spontaneous report received from the consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 565730) website on 21 Apr 2015. This report refers to a 39-year-old male patient. Current condition included immune thrombocytopenic purpura since 2007. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in 2008. At an unspecified time after vaccination, the patient experienced drop in platelet count for 6 months. It was reported that "all of these years, his platelet count was above 50000". Outcome of the event was reported as recovered. Seriousness of the event was reported as non serious. Causality of the event was not reported. Seriousness assessment of drop in platelet count was upgraded based on information in the source document. The patient again received seasonal influenza vaccine (manufacturer and batch number: unknown) in 2009, 2010, 2011 and 2012 respectively and experienced drop in platelet count after each dose (see cases: PHHY2015US048035, PHHY2015US048036, PHHY2015US048037 and PHHY2015US048038).
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Formication, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US047997, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 567901) website on 21 Apr 2015. This report refers to a 43 year old female patient. Past drug history included sulfa drugs, tetracycline and CECLOR. The patient's current conditions included seasonal allergies and allergy induced asthma. Concomitant medication included prenatal vitamins and Vitamin D. The patient had no illness at the time of vaccination. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into the left arm 09 Oct 2014. On the same date after vaccination, the patient felt like there were bugs crawling in her arm where the vaccine was given. Over the next couple of days, the spot where vaccine was given was red hot, swollen and very itchy. Four days after vaccination, she started having itching and rash on upper abdomen. The rash had spread to extremities. She was diagnosed with allergic urticaria. The patient was treated with oral steroids. The reaction allergic urticaria lasted about six weeks. The reaction went away and then came back in the first week of Jan 2015. The event allergic urticaria lasted again for another six weeks. She was again treated with two rounds of oral steroids. She saw another allergist who diagnosed her with allergic urticaria. The final outcome of the events was reported as unknown. Seriousness of the events was reported as non serious. Seriousness assessment of "allergic urticaria" was upgraded based on available information in the source document. Causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Case number PHHY2015US047997, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 567901) website on 21 Apr 2015. This report refers to a 43 year old female patient. Past drug history included sulfa drugs, tetracycline and CECLOR. The patient's current conditions included seasonal allergies and allergy induced asthma. Concomitant medication included prenatal vitamins and Vitamin D. The patient had no illness at the time of vaccination. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into the left arm 09 Oct 2014. On the same date after vaccination, the patient felt like there were bugs crawling in her arm where the vaccine was given. Over the next couple of days, the spot where vaccine was given was red hot, swollen and very itchy. Four days after vaccination, she started having itching and rash on upper abdomen. The rash had spread to extremities. She was diagnosed with allergic urticaria. The patient was treated with oral steroids. The reaction allergic urticaria lasted about six weeks. The reaction went away and then came back in the first week of Jan 2015. The event allergic urticaria lasted again for another six weeks. She was again treated with two rounds of oral steroids. She saw another allergist who diagnosed her with allergic urticaria. The final outcome of the events was reported as unknown. Seriousness of the events was reported as non serious. Seriousness assessment of "allergic urticaria" was upgraded based on available information in the source document. Causality of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Arthritis infective, Guillain-Barre syndrome, Streptococcal infection
Clinical narrative: Case number PHHY2015US069811, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 570377) website on 09 Jun 2015. This report refers to a male patient of unknown age. Medical history and concomitant medication were not reported. He was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. After vaccination, he experienced Guillain-Barre syndrome (GBS). Final outcome, seriousness and causality of the event were not reported. Seriousness assessment of the event GBS was upgraded based on the Novartis Important Medical Events (NVS-IME) list. it was further reported that on 06 Nov 2012, he received FLUVIRIN (batch number: 1206001) and developed infectious right shoulder arthropathy and Streptococcus pyogenes infection (see case number: PHHY2015US069763).
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2015US073190, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 574413) website on 15 Jun 2015. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced Guillain Barre Syndrome. Final outcome, seriousness and causality were not reported. Seriousness of the event Guillain Barre Syndrome was upgraded based on Novartis Important Medical Events list. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 Feb 2015 and experienced Guillain Barre Syndrome (see case: PHHY2015US073183).
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Case number PHHY2015US138595, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 582481) website on 20 Oct 2015. This report refers to a 31 year old male patient. Medical history included dialysis on an unknown date. No concomitant medication was reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Dec 2002. On 01 Jan 2003, the patient paralyzed from the neck down which was later diagnosed as Guillain-Barre syndrome. The patient was hospitalized. Outcome of the event was condition unchanged. Events were reported as serious (permanent disability and hospitalization). Causality was not reported.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypoaesthesia, Lacrimation increased, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US138577, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 585446) website on 20 Oct 2015. This report refers to a 22 year old female patient. Historical condition and concomitant medication were none. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 11 Oct 2013. On 14 Oct 2013, the patient experienced numbness on left side of face, headache, watery eyes and dropping left side of mouth. The patient went to a doctor's office where Bell's palsy was diagnosed. Outcome of the event was condition unchanged. Events were reported as non-serious. Seriousness assessment of the event Bell's palsy was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2015US142514, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 586324) on 23 Oct 2015. This report refers to a 65-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 23 Jan 2012. On 25 Jan 2012, the patient experienced anaphylaxis. The outcome of the event was recovered. The event was reported as non-serious and causality was not reported. Seriousness of the event was upgraded based on Novartis Important Medical Events list.
Age: 37.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Case number PHHY2015US146969 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 590844) on 02 Nov 2015. This report refers to a 37 year old male patient. Past medical history was not reported. Current condition included hospital admission to medicine department for suspected cellulitis and potential deep vein thrombosis (DVT). Concomitant medications included acetaminophen, amlodipine, clindamycin, enoxaparin and insulin aspart. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal polyvalent vaccine (other manufacturer, batch number: not reported); both vaccines administered intramuscularly in the right arm on 16 Dec 2014 and the vaccine was administered following hospital admission. On 16 Dec 2014, in 24 hours the patient was febrile with a body temperature of 102.9 degrees. His right arm was tender, warm and erythematous around the injection site. Fever abated over the following day. The final outcome of events was unknown. The events were reported as serious. The causality of the events was not reported.
Age: 37.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Case number PHHY2015US146969 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 590844) on 02 Nov 2015. This report refers to a 37 year old male patient. Past medical history was not reported. Current condition included hospital admission to medicine department for suspected cellulitis and potential deep vein thrombosis (DVT). Concomitant medications included acetaminophen, amlodipine, clindamycin, enoxaparin and insulin aspart. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal polyvalent vaccine (other manufacturer, batch number: not reported); both vaccines administered intramuscularly in the right arm on 16 Dec 2014 and the vaccine was administered following hospital admission. On 16 Dec 2014, in 24 hours the patient was febrile with a body temperature of 102.9 degrees. His right arm was tender, warm and erythematous around the injection site. Fever abated over the following day. The final outcome of events was unknown. The events were reported as serious. The causality of the events was not reported.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Injection site pain, Wheezing
Clinical narrative: Case number PHHY2015US147021 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 594808) on 02 Nov 2015. This report refers to a 69 year old female patient. She had no medical history and was healthy. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 09 Sep 2015. On the same day after vaccination, she experienced wheezing, coughing and she was feeling like her breathing was obstructed. She also had sore arm at the injection site. She took BENADRYL at 5:00 pm and the symptoms went next morning. The final outcome of events was reported as complete recovery. The events were reported as non-serious, but the events wheezing, coughing and breathing obstruction were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2015US148467 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 594823) on 02 Nov 2015. This report refers to a 49 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 09 Sep 2015. On 10 Sep 2015, she experienced shortness of breath and rapid heart rate. On 11 Sep 2015 at 7:00 am, the area where she received injection was red, swollen, hot and tender to touch. She stopped at doctor's office and was prescribed antibiotic. The events outcome was reported as complete recovery. The events were reported as non-serious, but the events shortness of breath and rapid heart rate were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth
Clinical narrative: Case number PHHY2015US148467 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 594823) on 02 Nov 2015. This report refers to a 49 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 09 Sep 2015. On 10 Sep 2015, she experienced shortness of breath and rapid heart rate. On 11 Sep 2015 at 7:00 am, the area where she received injection was red, swollen, hot and tender to touch. She stopped at doctor's office and was prescribed antibiotic. The events outcome was reported as complete recovery. The events were reported as non-serious, but the events shortness of breath and rapid heart rate were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Eye swelling, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US155031 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 596256) on 24 Nov 2015. This report refers to a 53 year old male patient. His current condition included allergy to VIOXX and an injury that required stitches. His concomitant medications included lisinopril/hydrochlorothiazide 20 mg tablet, naproxen, SPECTRAVITE multivitamin and amoxicillin used for 10 days for an injury that required stitches. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 17 Sep 2015. On the same day after vaccination, he had swollen fingers and itchy hands with hives which was increasing on the first day. He was given prednisone 20 mg along with BENADRYL every 6 hours on 17 Sep 2015. On 18 Sep 2015, the second day after vaccination, he had itchy hands and feet and larger hives. He had swollen eyes, larger hives and itchy hands and feet on the third day, 19 Sep 2015. He went back to health department on the third day and his prednisone dose was increased to 60 mg and he continued taking BENADRYL. He was instructed to go to hospital if breathing problems arise. The outcome of the event was reported as condition unchanged. The events were reported as non-serious, but the event swollen eye was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphagia, Eye swelling, Peripheral swelling, Pharyngeal oedema, Pruritus
Clinical narrative: Case number PHHY2015US154253, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596280) on 24 Nov 2015. This report refers to a 79 years old female patient. Past medical history and concomitant medication were not reported. The patient vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number, expiry date: not reported) on 18 Sep 2015. On the same day after vaccination, the patient experienced slightly swollen arm, itchy, moved to soft spots in both legs the next two days, slightly swollen arm, swelling and itchiness moved down arm, next 2 days moved to soft spots in legs and buttocks, 4th day woke up with swollen eyes and cheeks and by the evening swelling and itchiness moved to chin. The patient woke up at 2:30 am with hugely swollen chin/throat and tongue and could not swallow or talk. The patient went to the emergency room. The seriousness of the events were reported as non serious. The outcome of the events were reported complete recovery. The causality of the events were not reported. The seriousness assessment of the event pharyngeal oedema, peripheral swelling, dysphagia, aphasia, swollen tongue, eye swelling, swelling face and pruritus was upgraded based on the information available in the source documents.