chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Paraesthesia oral, Rhinorrhoea
Clinical narrative: Case number PHHY2015US172479 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604660) on 29 Dec 2015. This report refers to a 69 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 30 Sep 2015. On 01 Oct 2015, he had a slight shortness of breath (SOB), cough, runny nose and tingly lips. The outcome of the events was reported as complete recovery. The events were reported as non-serious, but the event SOB was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: Case number PHHY2015US170598, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 604979) website on 29 Dec 2015. This report refers to a 57 years old female patient. Concurrent conditions included Graves' disease, Hashimoto's disease and multi nodular toxic goiter. Concomitant medications included Methimazole, ESTRADIOL, naltrexone and progesterone. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Oct 2015. On the same day after vaccination the patient presented with fast and irregular heartbeat. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Mobility decreased, Pain, Sensory disturbance
Clinical narrative: Case number PHHY2015US172739, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 605329) website on 29 Dec 2015. This report refers to a 56 years old female patient. Vaccination history included vaccinated with seasonal influenza vaccine (manufacturer unknown) and experienced normal soreness. Past medical history included silent reflux and current conditions included seasonal allergy, asthma and sleep apnea. Concomitant medications included sertraline (manufacturer unknown), pravastatin (manufacturer unknown), SYMBICORT, esomeprazole (manufacturer unknown), montelukast (manufacturer unknown), ALLERGRA, DYSMISTA, levocetirizine (manufacturer unknown), women's Multivitamins, VIACTIV with Vitamin D, fish oil (manufacturer unknown), ZANTAC 150, biotin (manufacturer unknown), TYLENOL Arthritis and allergy shots. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) intramuscularly into the left upper arm on 07 Oct 2015. After vaccination, flu shot injection felt different than previous years; felt an unusual fluid flow. On 08 Oct 2015, the following morning, she experienced usual soreness but as the day progressed soreness became pain and she also noticed limited motion of left arm. She increased activity to keep shoulder and arm moving. Pain worsened at night and made turning over very difficult, it hurt worse when used under pressure such as lifting or supporting weight. Her left arm hurt when it lifted level to shoulders and when rotated from side to side. 12 days after vaccination, she still experienced pain in her left arm. She consulted with her family physician on 19 Oct 2015. Pain subsided some after medication wears off but always came back. She received treatment with TYLENOL, ice packs, ICY HOT, ibuprofen (manufacturer unknown) and a heating pad for pain relief with little or no improvement. The pain did not go away. The final outcome of the events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Nausea, Neck pain, Vertigo
Clinical narrative: Case number PHHY2015US173566 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605445) on 29 Dec 2015. This report refers to a 27 year old male patient. His current condition included depression. His concomitant medications included doxepin 150 mg per day, bupropion 300 mg per day and Amphetamine salts 30 mg per day. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 27 Oct 2015. On the same day after vaccination, he had neck ache and headache. On 28 Oct 2015, he had throbbing headache, nausea and vertigo. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Headache, Myalgia, Piloerection
Clinical narrative: Case number PHHY2015US172834 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605492) on 29 Dec 2015. This report refers to a 34 year old female patient. She had no known drug allergies (NKDA) or birth defects. Her medical history included PCDS (not further specified). Her current conditions were Hashimoto's thyroiditis and mild upper respiratory tract infection (URI) with no fever from 13 Oct 2015 to 21 Oct 2015. Her concomitant medications included Vitamin D, SYNTHROID and Omega 3 (fish oil). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 22 Oct 2015. It was reported that the symptoms developed acutely within 1 to 1.5 hours and this was the first time the patient was experiencing these symptoms after the flu shot. On 22 Oct 2015, approximately 7 hours after vaccination, the patient developed the following symptoms in the specified order: she had whole body chills with goose bumps, whole body myalgia, severe headache and severe sleepiness. Her body temperature of 100.4 degree F. She slept 12 hours straight and when she woke up from her sleep, her temperature reduced to 96.5 degree F. Her chills and myalgia went and she had mild residual headache and sleepiness. All her symptoms went after 48 hours. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Somnolence
Clinical narrative: Case number PHHY2015US172834 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605492) on 29 Dec 2015. This report refers to a 34 year old female patient. She had no known drug allergies (NKDA) or birth defects. Her medical history included PCDS (not further specified). Her current conditions were Hashimoto's thyroiditis and mild upper respiratory tract infection (URI) with no fever from 13 Oct 2015 to 21 Oct 2015. Her concomitant medications included Vitamin D, SYNTHROID and Omega 3 (fish oil). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 22 Oct 2015. It was reported that the symptoms developed acutely within 1 to 1.5 hours and this was the first time the patient was experiencing these symptoms after the flu shot. On 22 Oct 2015, approximately 7 hours after vaccination, the patient developed the following symptoms in the specified order: she had whole body chills with goose bumps, whole body myalgia, severe headache and severe sleepiness. Her body temperature of 100.4 degree F. She slept 12 hours straight and when she woke up from her sleep, her temperature reduced to 96.5 degree F. Her chills and myalgia went and she had mild residual headache and sleepiness. All her symptoms went after 48 hours. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash generalised, Urticaria
Clinical narrative: Case number PHHY2015US172526 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605642) on 29 Dec 2015. This report refers to a 6 year old male patient. Current condition included allergy to tree and nuts. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 27 Oct 2015. On the same day after vaccination, he experienced severe hives and rash from head to toe. He had rash on the back of thigh and buttocks, itching all over and low grade fever with a body temperature of 99. He went to emergency room. The outcome of the events was reported as complete recovery. The events were reported as non-serious, but the events hives and rash from head to toe and itching all over was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: Case number PHHY2015US171170, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 605864) website on 29 Dec 2015. This report refers to a 38 years old female patient. Medical history and concurrent illness were none. Concomitant medication included PRILOSEC. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch  number: not reported) on 21 Oct 2015. On the same day after vaccination the patient experienced huge bruise at the injection site. Further the patient also bled quite a bit. It was reported that the patient never had a bruise in 10 years of getting the flu shot. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Case number PHHY2015US170639, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 605868) website on 29 Dec 2015. This report refers to a 52 years female patient. Medical history and concurrent illness were none. Concomitant medications included ALEVE, PROTONIX, DYAZIDE and TOPAMAX. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 21 Oct 2015. On the same day after vaccination the patient experienced joint pain in left hip and muscle pain in both legs. The patient took ALEVE and by 11:30 PM that patient started chilling and rigoring. These continued for approximately 4 hours of severe rigors. The patient's body temperature reached 102.6 degrees, muscle and joint pain became more severe. The patient was awake for most of the night with the rigors and increasing fever. During this time it was noted that the patient's pulse and respiration rate were increased. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory rate increased
Clinical narrative: Case number PHHY2015US170639, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 605868) website on 29 Dec 2015. This report refers to a 52 years female patient. Medical history and concurrent illness were none. Concomitant medications included ALEVE, PROTONIX, DYAZIDE and TOPAMAX. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 21 Oct 2015. On the same day after vaccination the patient experienced joint pain in left hip and muscle pain in both legs. The patient took ALEVE and by 11:30 PM that patient started chilling and rigoring. These continued for approximately 4 hours of severe rigors. The patient's body temperature reached 102.6 degrees, muscle and joint pain became more severe. The patient was awake for most of the night with the rigors and increasing fever. During this time it was noted that the patient's pulse and respiration rate were increased. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US173011, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 605989) website on 29 Dec 2015. This report refers to a 3-year-old male patient. The patient had no medical history and current illness. Concomitant medication was none. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left leg on 28 Oct 2015. On the same day after vaccination, the patient experienced giant hives on legs left arm, and neck. The patient was treated with BENADRYL was and calamine lotion topically. Final outcome of the event was not recovered. Event was reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Contusion, Insomnia, Lethargy, Pain
Clinical narrative: Case number PHHY2015US173834, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 605990) website on 29 Dec 2015. This report refers to a 45-years-old female patient. Past medical history included severe back pain and malaise and septra and AUGMENTIN as historical drugs. Concomitant medications included buspirone (manufacturer unknown), zolpidem (manufacturer unknown), ibuprofen (manufacturer unknown), BENADRYL, cyclobenzaprine (manufacturer unknown), Metaxalone (manufacturer unknown), NUVARING, montelukast (manufacturer unknown), and GABA. Vaccination history included administration of unknown influenza vaccine on an unknown date. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 23 Oct 2015. On 23 Oct 2015, she experienced increasing lethargy, bad back pain, pain in spine increased to worsen, did not sleep due to excruciating pain and feel like back has been bruised as if had experienced a car accident. The patient stated that, she did not experienced such pain ever before and was not relieved by pain medications, stretching or sleep, it lasted for 5 days. She was treated with pain medications (unspecified). The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Spinal pain
Clinical narrative: Case number PHHY2015US173834, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 605990) website on 29 Dec 2015. This report refers to a 45-years-old female patient. Past medical history included severe back pain and malaise and septra and AUGMENTIN as historical drugs. Concomitant medications included buspirone (manufacturer unknown), zolpidem (manufacturer unknown), ibuprofen (manufacturer unknown), BENADRYL, cyclobenzaprine (manufacturer unknown), Metaxalone (manufacturer unknown), NUVARING, montelukast (manufacturer unknown), and GABA. Vaccination history included administration of unknown influenza vaccine on an unknown date. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 23 Oct 2015. On 23 Oct 2015, she experienced increasing lethargy, bad back pain, pain in spine increased to worsen, did not sleep due to excruciating pain and feel like back has been bruised as if had experienced a car accident. The patient stated that, she did not experienced such pain ever before and was not relieved by pain medications, stretching or sleep, it lasted for 5 days. She was treated with pain medications (unspecified). The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Case number PHHY2015US173894, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606183) website on 29 Dec 2015. This report refers to a 53-years-old female patient. Past medical history was not reported. Concomitant medications included Ibuprofen (manufacturer unknown). She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 07 Oct 2015. On 19 Oct 2015, she experienced pain in shoulder. She stated that it was similar to the day of/after she received the shot. The outcome of the event was reported as condition unchanged. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Erythema, Headache, Muscle spasms, Peripheral swelling
Clinical narrative: Case number PHHY2015US173838, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606317) on 29 Dec 2015. This report refers to a 52 years old female patient. Past medical history and concomitant medications were not reported. Current condition included seasonal spring allergies. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on 26 Oct 2015. On the same day after vaccination, she experienced arm redness, it became hot and extremely swollen, by midnight her muscles were cramping, joints hurt to move for the next three days and she had a severe headache for three days. Her arm was red and swollen as of the day of this report. Final outcome of the events was reported as condition unchanged. The events were assessed as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Skin warm
Clinical narrative: Case number PHHY2015US173838, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606317) on 29 Dec 2015. This report refers to a 52 years old female patient. Past medical history and concomitant medications were not reported. Current condition included seasonal spring allergies. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on 26 Oct 2015. On the same day after vaccination, she experienced arm redness, it became hot and extremely swollen, by midnight her muscles were cramping, joints hurt to move for the next three days and she had a severe headache for three days. Her arm was red and swollen as of the day of this report. Final outcome of the events was reported as condition unchanged. The events were assessed as non serious and causality was not reported.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Induration, Injection site discomfort, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Case number PHHY2015US172836, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606319) website on 29 Dec 2015. This report refers to a 09 years old male patient. Historical condition was not reported. Current condition included allergic to amoxicillin. Concomitant medications included sodium fluoride (manufacture unknown), Multi Vitamin. The patient was vaccinated with ninth dose of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into right leg on 28 Oct 2015. On the same day after vaccination, the patient experienced raised pink swelling with hard knot underneath 1/2 inch away from injection site with some discomfort reported. On 29 Oct 2015, patient experienced painful at 6:30 AM upon awakening. The patient was administered ibuprofen (manufacture unknown) chewable 200 mg along with food at 6:45 AM. Local pain, swelling and hard area under swelling continued and lymph nodes in groin were swollen and hard at 3:00 PM. The patient was again administered 200 mg ibuprofen with food at 4:30 PM, situation continued at 6:30 AM on 30 Oct 2015. Swollen, pink, warm area measured 2 1/2 inches across and 1  1/2 inches down at 6:45 AM. Administered 200 mg ibuprofen with food at 6:50 AM. Increased pain in groin lymph nodes 31 Oct 2015 at 7:30 AM. The patient was administered 200 mg ibuprofen with food at 7:45 AM. The final outcome of the events were reported as condition unchanged. The seriousness was reported as non-serious and causality was not reported.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Local swelling, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Case number PHHY2015US172836, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606319) website on 29 Dec 2015. This report refers to a 09 years old male patient. Historical condition was not reported. Current condition included allergic to amoxicillin. Concomitant medications included sodium fluoride (manufacture unknown), Multi Vitamin. The patient was vaccinated with ninth dose of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into right leg on 28 Oct 2015. On the same day after vaccination, the patient experienced raised pink swelling with hard knot underneath 1/2 inch away from injection site with some discomfort reported. On 29 Oct 2015, patient experienced painful at 6:30 AM upon awakening. The patient was administered ibuprofen (manufacture unknown) chewable 200 mg along with food at 6:45 AM. Local pain, swelling and hard area under swelling continued and lymph nodes in groin were swollen and hard at 3:00 PM. The patient was again administered 200 mg ibuprofen with food at 4:30 PM, situation continued at 6:30 AM on 30 Oct 2015. Swollen, pink, warm area measured 2 1/2 inches across and 1  1/2 inches down at 6:45 AM. Administered 200 mg ibuprofen with food at 6:50 AM. Increased pain in groin lymph nodes 31 Oct 2015 at 7:30 AM. The patient was administered 200 mg ibuprofen with food at 7:45 AM. The final outcome of the events were reported as condition unchanged. The seriousness was reported as non-serious and causality was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US173895, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606321) website on 29 Dec 2015. This report refers to a 61-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 18 Sep 2015. On 18 Sep 2015, she experienced shoulder pain and limited range of motion that continued to worse after administration of flu shot. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Dizziness, Insomnia, Nausea, Pain in extremity
Clinical narrative: Case number PHHY2015US173697, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 606328:) website on 29 Dec 2015. This report refers to a 36-year-old male patient. Historical condition was not reported. Current conditions included hereditary spherocytosis and tree nuts. Concomitant medication included ZYRTEC and daily supplemental vitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into right arm and first dose of pneumococcal vaccine polyvalent (manufacturer unknown, batch number: not reported) intramuscularly in to left arm both on 30 Oct 2015. On same day after vaccination in afternoon, the patient experienced dizziness, nausea, arm soreness and he was treated with 01 ibuprofen; in night the patient experienced chills, insomnia and was treated with 6 layers of clothing and up heat to 76. On Saturday morning, the patient was treated with bland diet for nausea, dizziness and arm soreness; on Saturday afternoon, the patient experienced fever with body temperature 99.9 and fever, chills was treated with rest, rice and layered clothing. The outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2015US173697, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 606328:) website on 29 Dec 2015. This report refers to a 36-year-old male patient. Historical condition was not reported. Current conditions included hereditary spherocytosis and tree nuts. Concomitant medication included ZYRTEC and daily supplemental vitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into right arm and first dose of pneumococcal vaccine polyvalent (manufacturer unknown, batch number: not reported) intramuscularly in to left arm both on 30 Oct 2015. On same day after vaccination in afternoon, the patient experienced dizziness, nausea, arm soreness and he was treated with 01 ibuprofen; in night the patient experienced chills, insomnia and was treated with 6 layers of clothing and up heat to 76. On Saturday morning, the patient was treated with bland diet for nausea, dizziness and arm soreness; on Saturday afternoon, the patient experienced fever with body temperature 99.9 and fever, chills was treated with rest, rice and layered clothing. The outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspepsia, Fatigue, Pain, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US173255, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606347) website on 29 Dec 2015. This report refers to a 68 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in left arm on 30 Oct 2015. On the same day 4 hours after vaccination, he experienced severe heartburn followed by vomiting, aches, feverish feeling and fatigued. These events continued through the night and abated in the morning. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Case number PHHY2015US172624, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 606362) website on 29 Dec 2015. This report refers to a 36 years old female patient (breastfeeding). Past medical history was not reported. Concomitant medication included as prednisone (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm, intramuscularly on 30 Oct 2015. On 31 Oct 2015, the patient experienced vertigo-like symptoms, dizziness and nausea. Outcome of the events was not reported. Seriousness of the events was reported as non-serious. The causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Influenza, Malaise
Clinical narrative: Case number PHHY2015US173428, is an initial spontaneous received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 606388) on 29 Dec 2015. This report refers to a 38 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 21 Oct 2015. On 22 Oct 2015, the patient experienced flu symptoms, fever, aches, sore throat, headache, terrible cough, malaise and tiredness. The patient was taken to an emergency room. Outcome of the events was reported as condition unchanged. Events were reported as non-serious. Causality was not reported.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Case number PHHY2015US173428, is an initial spontaneous received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 606388) on 29 Dec 2015. This report refers to a 38 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 21 Oct 2015. On 22 Oct 2015, the patient experienced flu symptoms, fever, aches, sore throat, headache, terrible cough, malaise and tiredness. The patient was taken to an emergency room. Outcome of the events was reported as condition unchanged. Events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Oropharyngeal pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Case number PHHY2015US172978, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 606418) website on 29 Dec 2015. This report refers to a 29 years old female patient. Past medical history included as airborne allergies, hay fever and also received treatment of BACTRIM (manufacturer unknown), WELLBUTRIN (manufacturer unknown). Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 31 Oct 2015. On 01 Nov 2015, the patient experienced low fever with body temperature 99 degrees (unit unspecified), sore throat, swollen throat and aching muscles. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US172833, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606458) website on 29 Dec 2015. This report refers to a 04 years old female patient. Past medical history was not reported. Current condition included DiGeorge Syndrome and runny nose. Concomitant medications included PREVACID, carnitine (manufacturer unknown), probiotics (manufacturer unknown), Multivitamins. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in right leg along with DTAP vaccine (other manufacturer and batch number: not reported) in right leg on 28 Oct 2015. On 30 Oct 2015, she broke out on hives all over body and it was very itchy. She was treated with ZYRTEC. She calmed down after a dose of ZYRTEC, but the hives come back after the meds wear off. Patient never had hives before. She was taken to the emergency room. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The events urticaria and pruritus were upgraded based on the information available in the source document.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram, Diplopia, Electrocardiogram normal, Nuclear magnetic resonance imaging normal, Visual impairment
Clinical narrative: Case number PHHY2015US173129, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606515) website on 29 Dec 2015. This report refers to a 46 years old female patient. Past medical history was not reported. Concomitant medications included DECADRON. Current condition included breast cancer and spread to brain in Aug 2015. She was vaccinated with tenth dose of seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in right arm on 29 Oct 2015. On the same day after vaccination, she experienced double vision and right (unspecified) became crooked and turned inward and vision worsened. The physician thought it was brain tumors growing, but the tumors were not growing. Laboratory test included magnetic resonance imaging (MRI), computed tomography scan (CT scan) and electrocardiogram (EKG) with good results. She was taken to the emergency room and treated with steroids (unspecified). It was also reported that she was treated with chemotherapy for brain cancer. The outcome of the events was not reported. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Rash generalised, Urticaria
Clinical narrative: Case number PHHY2015US172743, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606594) website on 29 Dec 2015. This report refers to a 63 years old female patient. Historical condition included psoriasis. Concomitant medication was reported as COSENTYX. The patient received several seasonal flu shots over the last several years and had absolutely no problem. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number: not reported) on 20 Oct 2015. On the same day after vaccination (roughly 12 hours after injection) patient experienced full body rash and hives. Outcome of the events was reported as condition unchanged. The seriousness was reported as non serious and causality was not reported. Seriousness of the event generalized rash and generalized urticaria was upgraded based on information available in source document.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US172815 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 606636) on 29 Dec 2015. This report refers to a 63 year old female patient. Her vaccination history included administration of a shingles vaccine (manufacturer and batch number: not reported) at the age of 60 following and the vaccine was administered by an allergist. Her historical drug included neomycin. Her current condition included latex allergy. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the arm on 24 Oct 2015. On 25 Oct 2015, she experienced hives that started on the trunk of her body and it moved to her arms and legs. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the event hives was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Eye irritation, Eye pain, Eye swelling, Eyelid oedema, Lacrimation increased
Clinical narrative: Case number PHHY2015US172826, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606682) website on 29 Dec 2015. This report refers to a 52 years old female patient. Concurrent conditions included high blood pressure and allergies to mold and dust. Concomitant medications included etodolac and citalopram. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 02 Nov 2015. On the same day after vaccination the patient's eyes became very irritated and eventually became very swollen, shut and also watery. The patient still had swollen eyes and they are red and hurt, following morning. Final outcome of the events was reported as not recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "eyes irritation" and "swollen eyes" was upgraded based on information in the source document.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia
Clinical narrative: Case number PHHY2015US172826, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606682) website on 29 Dec 2015. This report refers to a 52 years old female patient. Concurrent conditions included high blood pressure and allergies to mold and dust. Concomitant medications included etodolac and citalopram. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 02 Nov 2015. On the same day after vaccination the patient's eyes became very irritated and eventually became very swollen, shut and also watery. The patient still had swollen eyes and they are red and hurt, following morning. Final outcome of the events was reported as not recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "eyes irritation" and "swollen eyes" was upgraded based on information in the source document.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Eye pruritus, Pruritus, Pyrexia, Rash
Clinical narrative: Case number PHHY2015US172827 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606851) website on 29 Dec 2015. This report refers to a 54 years old male patient. Concurrent conditions included arthritis, sciatica, bursitis, Chiari syndrome, diabetes type II, arthritis, migraine, vertigo and allergic to penicillin. Concomitant medications included LANTUS, aspirin, LEXAPRO, lovastatin, lisinopril and metformin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 30 Oct 2015. On the same day after vaccination the patient developed rash across upper chest. In the evening the rash spread and continued the next day with itchy eyes and skin accompanied with low grade fever of 100 degrees. The patient was treated with antihistamine from 01 Nov 2015 to 03 Nov 2015. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "itchy eyes" was upgraded based on information in the source document.
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Malaise
Clinical narrative: Case number PHHY2015US173516, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 607088) on 29 Dec 2015. This report refers to a 47 years old female patient. Past vaccination included flu vaccine given two years ago and she got sick. Current condition included seasonal allergies. Concomitant medication included ZYRTEC. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into the right arm on 02 Nov 2015. The nurse who gave the flu vaccine was not wearing gloves. She did not let her hands dry after applying the hand sanitizer and did not wash her after giving the injection. On 03 Nov 2015, she experienced diarrhea, abdominal cramping, body aches, mild soreness on the right arm, nausea, vomiting and temperature 99 degrees, could not keep anything down. She was diagnosed with gastrointestinal virus. At 14:00 hours, she developed a fever of 102 degrees. After 45 minutes was able to sip on water and ate couple of soda crackers. At 19:00 hours she had body aches and fever 101 degrees. She experienced last episode of diarrhea at approximately 18:30 hours. The next day, she was feeling a little bit better not completely better. She was treated with ZOFRAN and TYLENOL, MOTRIN for fever. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the events viral infection, gastrointestinal infection, diarrhea, abdominal pain, pain and pain in extremity was upgraded (medically significant) based on the information available in the source document.
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain, Diarrhoea, Gastrointestinal viral infection, Inadequate aseptic technique in use of product, Nausea
Clinical narrative: Case number PHHY2015US173516, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 607088) on 29 Dec 2015. This report refers to a 47 years old female patient. Past vaccination included flu vaccine given two years ago and she got sick. Current condition included seasonal allergies. Concomitant medication included ZYRTEC. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into the right arm on 02 Nov 2015. The nurse who gave the flu vaccine was not wearing gloves. She did not let her hands dry after applying the hand sanitizer and did not wash her after giving the injection. On 03 Nov 2015, she experienced diarrhea, abdominal cramping, body aches, mild soreness on the right arm, nausea, vomiting and temperature 99 degrees, could not keep anything down. She was diagnosed with gastrointestinal virus. At 14:00 hours, she developed a fever of 102 degrees. After 45 minutes was able to sip on water and ate couple of soda crackers. At 19:00 hours she had body aches and fever 101 degrees. She experienced last episode of diarrhea at approximately 18:30 hours. The next day, she was feeling a little bit better not completely better. She was treated with ZOFRAN and TYLENOL, MOTRIN for fever. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the events viral infection, gastrointestinal infection, diarrhea, abdominal pain, pain and pain in extremity was upgraded (medically significant) based on the information available in the source document.
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US173516, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 607088) on 29 Dec 2015. This report refers to a 47 years old female patient. Past vaccination included flu vaccine given two years ago and she got sick. Current condition included seasonal allergies. Concomitant medication included ZYRTEC. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into the right arm on 02 Nov 2015. The nurse who gave the flu vaccine was not wearing gloves. She did not let her hands dry after applying the hand sanitizer and did not wash her after giving the injection. On 03 Nov 2015, she experienced diarrhea, abdominal cramping, body aches, mild soreness on the right arm, nausea, vomiting and temperature 99 degrees, could not keep anything down. She was diagnosed with gastrointestinal virus. At 14:00 hours, she developed a fever of 102 degrees. After 45 minutes was able to sip on water and ate couple of soda crackers. At 19:00 hours she had body aches and fever 101 degrees. She experienced last episode of diarrhea at approximately 18:30 hours. The next day, she was feeling a little bit better not completely better. She was treated with ZOFRAN and TYLENOL, MOTRIN for fever. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the events viral infection, gastrointestinal infection, diarrhea, abdominal pain, pain and pain in extremity was upgraded (medically significant) based on the information available in the source document.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Headache, Muscle twitching, Pyrexia
Clinical narrative: Case number PHHY2015US173044, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 607419) on 29 Dec 2015. This report refers to a 62 years old female patient. Past medical history and current condition were reported as none. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on 30 Oct 2015. A few hours after vaccination, she experienced mild headache. The next day, on 31 Oct 2015, headache got worse with fever, dizziness, fatigue, twitching on the side of her face. She received treatment with MOTRIN 400 mg every six hours. As of 04 Nov 2015, symptoms were present. The final outcome of the events was not reported. The seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Dizziness, Gait disturbance, Injection site joint pain, Joint swelling
Clinical narrative: Case number PHHY2015US173450, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 607576) website on 29 Dec 2015. This report refers to a 42 years old female patient. Past medical history included herpes simplex virus 2 (HSV2). Current condition included high blood pressure and depression. Concomitant medications included bupropion (manufacturer unknown) as antidepressant and metoprolol (manufacturer unknown) for blood pressure. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm on 29 Oct 2015. On the same day after vaccination, the patient felt sick at stomach and light headed all day. On 30 Oct 2015, left knee was swollen, had trouble walking, hives developed on hands, arms and shoulders, felt itchy on arms, face and head. On 31 Oct 2015, right wrist had a knot and without full mobility. On an unknown date, the patient had joint pain in injection shoulder and left knee, could not lift arm and knees felt very painful and swollen. The patient was treated with CLARITIN and PEPCID AC for hives and itching on 02 Nov 2015. The patient visited the emergency room. The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Nodule, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US173450, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 607576) website on 29 Dec 2015. This report refers to a 42 years old female patient. Past medical history included herpes simplex virus 2 (HSV2). Current condition included high blood pressure and depression. Concomitant medications included bupropion (manufacturer unknown) as antidepressant and metoprolol (manufacturer unknown) for blood pressure. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm on 29 Oct 2015. On the same day after vaccination, the patient felt sick at stomach and light headed all day. On 30 Oct 2015, left knee was swollen, had trouble walking, hives developed on hands, arms and shoulders, felt itchy on arms, face and head. On 31 Oct 2015, right wrist had a knot and without full mobility. On an unknown date, the patient had joint pain in injection shoulder and left knee, could not lift arm and knees felt very painful and swollen. The patient was treated with CLARITIN and PEPCID AC for hives and itching on 02 Nov 2015. The patient visited the emergency room. The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.