chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Headache, Night sweats, Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US009014, is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604932) on 18 Jan 2016. This report refers to a 41-year-old female patient. Historical condition included nasal allergies. The patient was allergic to cephalexin. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported) into the right arm on 16 Oct 2015. On 19 Oct 2015, the patient experienced headache. On 21 Oct 2015, the patient experienced welts that were itchy, red and swollen on forearms, face, back and knee. Further the patient had night sweats on 21 Oct 2015 and 22 Oct 2015. The patient's headache went away and came back on 24 Oct 2015. The patient's welts were finally going down on 26 Oct 2015. Final outcome of events was recovered. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US011297 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605026) on 18 Jan 2016. This report refers to a 36 year old female patient. Her medical history included pregnancy. She had no current conditions. Her concomitant medications were FLINSTONES vitamins, allergy shots and RHINOCORT Aqua. She was vaccinated with FLUVIRIN (batch number: 15735P) intramuscularly in the right arm on 02 Oct 2015. On the same day after vaccination, she experienced pain in her shoulder. She thought that the immunization was given too high above deltoid muscle. She was recommended to follow up with her primary care physician for possible further testing. The outcome of the events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Odynophagia, Pharyngeal oedema, Pyrexia
Clinical narrative: Case number PHHY2015US171215, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 605857) website on 29 Dec 2015. This report refers to a 69-year-old female patient. Past medication included penicillin. Current illness was none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 26 Oct 2015. On the same day after vaccination the patient experienced, throat swelling, very painful to swallow, fever, chills and headache. Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 75.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Pruritus, Rash generalised
Clinical narrative: Case number PHHY2015US173009, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 605922) website on 29 Dec 2015. This report refers to a 75-year-old male patient. Medical history and current illness was none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and varicella zoster vaccine (manufacturer and batch number: not reported) on 21 Sep 2015. On 29 Sep 2015 seven days after vaccination, the patient experienced rash on body excluding head, face and bottom of feet. The rash rapidly increased in severity and the patient visited dermatologist on 01 Oct 2015 and was prescribed steroid cream for itching. Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported. Seriousness of the event was upgraded based on information available in the source document.
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Discomfort, Swelling
Clinical narrative: Case number PHHY2016US009196, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 605940) on 18 Jan 2016. This report refers to a 64 years old male patient. Medical history and concomitant medications were not reported. The patient was in good health at the time of vaccination. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly into left arm on 25 Oct 2015. On the same day the patient was also vaccinated with PREVNAR 13 (batch number: M13067, other manufacturer) intramuscularly into left arm and ZOSTAVAX (batch number: L002422, other manufacturer) subcutaneously into left arm. On 26 Oct 2015 the patient experienced 4.5 inches of swelling and discomfort while sleeping. The swelling had started to go down on 28 Oct 2015. The patient did not take anything for the swelling. Final outcome of the events was not reported. The case was assessed as non-serious. Causality of the events was not reported.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Condition aggravated, Cough, Dyspnoea, Erythema
Clinical narrative: Case number PHHY2015US172900, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 606305) website on 29 Dec 2015. This report refers to a 73 years old female patient. Past medical history included as problems with cholesterol medication and stopped taking them at the time when blood pressure elevated. Current condition included as little wheezing. Concomitant medication included as levothyroxine (manufacturer unknown), lisinopril (manufacturer unknown), allopurinol (manufacturer unknown), carvedilol (manufacturer unknown), furosemide (manufacturer unknown) and Vitamin D. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 Sep 2015. On 25 Sep 2015, the patient experienced chills, hard coughing, loud wheezing, throat tightness, short of breath, very difficult breathing and skin red lumpy, skin was very itchy at shot sight for 03 weeks, still itchy for another week (unspecified) and the patient was sleeping sitting up. The outcome of very itchy at shot sight and wheezing was reported as condition unchanged and final outcome of the events was reported as complete recovery and for wheezing it was condition unchanged. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Seriousness assessment of the events throat tightness, cough, erythema, wheezing and dyspnea was upgraded to medically significant based on the information available in the source document.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Insomnia, Skin swelling, Throat tightness, Wheezing
Clinical narrative: Case number PHHY2015US172900, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 606305) website on 29 Dec 2015. This report refers to a 73 years old female patient. Past medical history included as problems with cholesterol medication and stopped taking them at the time when blood pressure elevated. Current condition included as little wheezing. Concomitant medication included as levothyroxine (manufacturer unknown), lisinopril (manufacturer unknown), allopurinol (manufacturer unknown), carvedilol (manufacturer unknown), furosemide (manufacturer unknown) and Vitamin D. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 Sep 2015. On 25 Sep 2015, the patient experienced chills, hard coughing, loud wheezing, throat tightness, short of breath, very difficult breathing and skin red lumpy, skin was very itchy at shot sight for 03 weeks, still itchy for another week (unspecified) and the patient was sleeping sitting up. The outcome of very itchy at shot sight and wheezing was reported as condition unchanged and final outcome of the events was reported as complete recovery and for wheezing it was condition unchanged. The seriousness of the events was reported as non-serious. The causality of the events was not reported. Seriousness assessment of the events throat tightness, cough, erythema, wheezing and dyspnea was upgraded to medically significant based on the information available in the source document.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2015US173396 is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS, reference number: 603110) on 29 Dec 2015. This report refers to a 48 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 24 Oct 2015. On 27 Oct 2015, the patient developed Bell's palsy. On an unknown date, nuclear magnetic resonance imaging and unspecified laboratory tests were performed (results were not given). The patient was taken to an emergency room. Outcome of the event was unknown. Event was reported as non-serious. Seriousness assessment of the event was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2016US010657, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606346) on 18 Jan 2016. This report refers to a 62 years old female patient. Past medical history was not reported. Current conditions included hypertension, asthma/allergy component and wheezing. Concomitant medications included triamterene and hydrochlorothiazide (manufacturer unknown) 75-50 mg daily, montelukast (manufacturer unknown) 10 mg daily, PROVENTIL (manufacturer unknown) 90 mcg inhaler 2 puffs every 4 hours as needed for wheezing and valsartan (manufacturer unknown) 160 mg daily. She was vaccinated with FLUVIRIN (batch number: 157022) intramuscularly and ZOSTAVAX (batch number: L028281) subcutaneously; both into the right arm on 24 Oct 2015. After vaccination, on 29 Oct 2015, she experienced swelling of upper right arm and localized swelling on back of right arm between injection sites, warmth, erythema in circle on back of right arm about 4 inches in diameter and itching. The outcome of the events was reported as unknown. The events were assessed as non serious and causality was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Chills, Computerised tomogram normal, Diarrhoea, Dysstasia
Clinical narrative: Case number PHHY2015US172838, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606377) website on 29 Dec 2015. This report refers to a 65 years old female patient. Past medical history and current condition was not reported. Concomitant medications included lisinopril (manufacturer unknown), buspirone (manufacturer unknown), simvastatin (manufacturer unknown), zolpidem (manufacturer unknown), fluoxetine (manufacturer unknown) and cyclobenzaprine (manufacturer unknown). She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into the right arm on 30 Oct 2015. After vaccination, she experienced sudden watery diarrhea which worsened over time, it became impossible to stand or walk, she had shakes, chills, severe shivering over entire body. Laboratory data included blood drawn twice which showed white blood cell count increased indicating possible virus or infection and a computerized tomography scan in which nothing was found. She received treatment with 3 intravenous bags. Emergency room doctor indicated that the flu shot could have been the cause. The outcome of the events was reported as unknown. These events were assessed as non serious. Causality of the events was reported as suspected. The seriousness assessment of the events diarrhea and asthenia were upgraded (medically significant) based on the information available in the source document.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor, White blood cell count increased
Clinical narrative: Case number PHHY2015US172838, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606377) website on 29 Dec 2015. This report refers to a 65 years old female patient. Past medical history and current condition was not reported. Concomitant medications included lisinopril (manufacturer unknown), buspirone (manufacturer unknown), simvastatin (manufacturer unknown), zolpidem (manufacturer unknown), fluoxetine (manufacturer unknown) and cyclobenzaprine (manufacturer unknown). She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into the right arm on 30 Oct 2015. After vaccination, she experienced sudden watery diarrhea which worsened over time, it became impossible to stand or walk, she had shakes, chills, severe shivering over entire body. Laboratory data included blood drawn twice which showed white blood cell count increased indicating possible virus or infection and a computerized tomography scan in which nothing was found. She received treatment with 3 intravenous bags. Emergency room doctor indicated that the flu shot could have been the cause. The outcome of the events was reported as unknown. These events were assessed as non serious. Causality of the events was reported as suspected. The seriousness assessment of the events diarrhea and asthenia were upgraded (medically significant) based on the information available in the source document.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Middle insomnia, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US009241, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 606385) website on 18 Jan 2016. This report refers to a 46 year old female patient. Medical history was not reported. Concomitant medication included XANAX. The patient was vaccinated with FLUVIRIN (batch number: 66521 0118 10) intramuscularly into left arm on 20 Oct 2015. On 21 Oct 2015, the day after injection the patient experienced shoulder pain and muscle weakness. Three days after the vaccination the patient had joint and muscle pain all over body that lasted for 48 hours. It was reported that the pain woke up the patient at night the first 3 nights. Further, 12 days later the patient still had arm pain and have difficultly lifting arm, deep pain inside the arm and joint pain. The patient was transferred to the emergency room, on an unknown date. The final outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Case number PHHY2016US009241, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 606385) website on 18 Jan 2016. This report refers to a 46 year old female patient. Medical history was not reported. Concomitant medication included XANAX. The patient was vaccinated with FLUVIRIN (batch number: 66521 0118 10) intramuscularly into left arm on 20 Oct 2015. On 21 Oct 2015, the day after injection the patient experienced shoulder pain and muscle weakness. Three days after the vaccination the patient had joint and muscle pain all over body that lasted for 48 hours. It was reported that the pain woke up the patient at night the first 3 nights. Further, 12 days later the patient still had arm pain and have difficultly lifting arm, deep pain inside the arm and joint pain. The patient was transferred to the emergency room, on an unknown date. The final outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Burning sensation, Erythema, Induration, Pruritus, Swelling
Clinical narrative: Case number PHHY2016US010276, is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 606439) on 18 Jan 2016. This report refers to a 61-year-old female patient. The patient had no medical history and current illness. Concomitant medication included Levothyroxine 125. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly and ZOSTAVAX (batch number: not reported) on 22 Oct 2015. On 23 Oct 2015, the patient experienced swelling, redness, burning, hardness and itching. Final outcome of events was recovered. Events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2016US010277, is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 606452) on 18 Jan 216. This report refers to a 55-year-old female patient. Current illness included "Ca" (as reported). The patient was on concomitant medication (details unspecified). The patient was vaccinated with FLUVIRIN (batch number: 15732P) intramuscularly into the right arm on 21 Oct 2015. On the same day after vaccination, the patient's arm was hurting, trouble with movement and the patient keeps up at night. Final outcome of events was not recovered. Events were reported s non-serious. Causality was not reported.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US173075, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 606531) website on 29 Dec 2015. This report refers to a 32 years old female patient. Past medical history was not reported. Concomitant medication included as phentermine (manufacture unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 21 Oct 2015. On 24 Oct 2015, the patient experienced severe hives all over. The patient visited to the emergency room. The patient treated with intravenous fluids, prednisone (manufacture unknown), BENADRYL, ZYRTEC and ZANTAC to control severe hives. The outcome of the event was reported as complete recovery. The seriousness of the event was reported as non-serious. The causality of the event was not reported. Seriousness assessment of urticaria was upgraded to medically significant based on the information available in the source document.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Erythema, Heart rate increased, Pain, Peripheral swelling
Clinical narrative: Case number PHHY2016US009188 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606900) on 18 Jan 2016. This report refers to a 68 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158005) and PNEUMOVAX (other manufacturer, batch number: L026033) both into left arm on 22 Oct 2015. On 23 Oct 2015, the patient experienced fever, fast heartbeat, swelling from shoulder down arm, redness, extreme pain and weakness. The outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2016US009188 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606900) on 18 Jan 2016. This report refers to a 68 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158005) and PNEUMOVAX (other manufacturer, batch number: L026033) both into left arm on 22 Oct 2015. On 23 Oct 2015, the patient experienced fever, fast heartbeat, swelling from shoulder down arm, redness, extreme pain and weakness. The outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Musculoskeletal discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHHY2016US010486, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 607172) website on 18 Jan 2016. This report refers to an 85-year-old male patient. Medical history was not reported. Concomitant medication included meloxicam, MICARDIS, IMDUR, levothyroxine, hydralazine, B12, folic acid, B Complex-Vitamin B12, Multivitamin, latanoprost, adult low dose Aspirin, tamsulosin ER, TRUSOPT, amlodipine, omeprazole. The patient was vaccinated with fifteenth dose of FLUVIRIN (batch number: 157925) intramuscularly into left arm on 09 Oct 2015. After vaccination on 10 Oct 2015, the patient complaint of pain in left arm, felt like there was something inside the muscle, fatigue and tenderness at vaccination site. The patient visited the emergency room on an unknown date. The final outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious and causality not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pruritus
Clinical narrative: Case number PHHY2016US010381, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 607387) on 18 Jan 2016. This report refers to a 23 years old polymedicated female patient. Medical history was not reported. Current illnesses were none. The patient was vaccinated with FLUVIRIN (batch number: 1517401) intramuscularly into left arm on 02 Nov 2015. On the same day after vaccination the patient experienced blisters and itching to the arm. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2016US011507, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 607711) on 18 Jan 2016. This report refers to a 46 years old female patient. Past medical history was not reported. Current condition included asthma. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 157102) and PNEUMOVAX (other manufacturer) (batch number: 2017406); both into the left arm intramuscularly on 04 Nov 2015. After vaccination, on the same day, her arm became very sore, hot to touch and red from the shoulder down to the elbow. Outcome of the events was reported as unknown. The events were assessed as non serious and causality was not reported.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Chest pain, Chills, Confusional state
Clinical narrative: Case number PHHY2015US173517, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 607713) website on 29 Dec 2015. This report refers to a 71-year-old female patient. Past medical history was not reported. Current condition included diabetes. Concomitant medications included clonazepam (manufacturer unknown), valsartan (manufacturer unknown) and citalopram (manufacturer unknown). She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 29 Oct 2015. On 01 Nov 2015, she experienced fever, headache, nausea, swelling and soreness at site, weakness, extreme fatigue, exhaustion, confusion, muscle aches, chest aches and pain, chills, difficulty breathing, back and neck stiffness and pain. The outcome of the events was unknown. Seriousness of the events was not reported and causality of the events was not reported. The events dyspnoea and chest pain was upgraded to medically significant based on the information available in the source document.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2015US173517, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 607713) website on 29 Dec 2015. This report refers to a 71-year-old female patient. Past medical history was not reported. Current condition included diabetes. Concomitant medications included clonazepam (manufacturer unknown), valsartan (manufacturer unknown) and citalopram (manufacturer unknown). She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 29 Oct 2015. On 01 Nov 2015, she experienced fever, headache, nausea, swelling and soreness at site, weakness, extreme fatigue, exhaustion, confusion, muscle aches, chest aches and pain, chills, difficulty breathing, back and neck stiffness and pain. The outcome of the events was unknown. Seriousness of the events was not reported and causality of the events was not reported. The events dyspnoea and chest pain was upgraded to medically significant based on the information available in the source document.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Neck pain, Pyrexia
Clinical narrative: Case number PHHY2015US173517, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 607713) website on 29 Dec 2015. This report refers to a 71-year-old female patient. Past medical history was not reported. Current condition included diabetes. Concomitant medications included clonazepam (manufacturer unknown), valsartan (manufacturer unknown) and citalopram (manufacturer unknown). She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 29 Oct 2015. On 01 Nov 2015, she experienced fever, headache, nausea, swelling and soreness at site, weakness, extreme fatigue, exhaustion, confusion, muscle aches, chest aches and pain, chills, difficulty breathing, back and neck stiffness and pain. The outcome of the events was unknown. Seriousness of the events was not reported and causality of the events was not reported. The events dyspnoea and chest pain was upgraded to medically significant based on the information available in the source document.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Chest pain, Dyspnoea, Vomiting
Clinical narrative: Case number PHHY2015US171169, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 607825) website on 29 Dec 2015. This report refers to a 16-year-old female patient. Medical history was not reported. Concomitant medications included Fluoxetine, PROVENTIL, fluticasone and ondansetron hydrochloride. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and GARDASIL (batch number: not reported) on 31 Oct 2015. On 01 Nov 2015, the patient experienced vomiting, shortness of breath, chest pain and the patient was admitted to the hospital. Prior being admitted to the hospital, the patient self-administered EPIPEN to herself. The patient was stable and was recovering from the events after receiving an unspecified treatment in the hospital. The reporter considered the events to be life threatening and medically significant. Causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Case number PHHY2015US172369, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 607884) website on 29 Dec 2015. This report refers to an adult female patient. Current condition included fibromyalgia. Vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) pretty much every year. Concomitant medication included simvastatin, BENADRYL, Calcium, CENTRUM SILVER and Vitamin D. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in Oct 2013. In Jan 2014, approximately three months later (91 days after receiving vaccine), the patient experienced the Flu/Influenza. The patient reported that she got the senior dose one shot but noted it was stronger than the quadrivalent vaccine. Also the patient stated that, she was told the trivalent vaccine was stronger and better for seniors so that was what she was referring to when she noted senior dose. The patient stated that she cannot recall that her physician was aware that she got the Flu. Final outcome of the event was recovered. Events were reported as non-serious. The reporter considered the influenza to be related to Influenza vaccine. Seriousness of the events was upgraded based on information available in the source document.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Erythema, Paraesthesia
Clinical narrative: Case number PHHY2015US172402, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 608154) website on 29 Dec 2015. This report refers to a 45 years old female patient. Medical history and concurrent illness were none. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm on 07 Nov 2015. On the same day after vaccination the patient presented with difficulty breathing, red face, tingling on face moved through her body and weak feeling. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "difficulty breathing" was upgraded based on information in the source document.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Case number PHHY2016US011753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608191) website on 18 Jan 2016. This report refers to a 59-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1516601) intramuscularly in left arm on 03 Nov 2015. On 04 Nov 2015, she experienced muscle aches, soreness on both shoulders and neck. She reported on 08 Nov 2015 that she was improving. Also stated that, she was not sure whether she slept wrong or hurt herself in another way. The final 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.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Limb discomfort, Pain in extremity
Clinical narrative: Case number PHHY2016US011293, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS ID: 608549) website on 18 Jan 2016. This report refers to a 47-year-old female patient. Historical condition was not reported. Current conditions included cold. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1518101) intramuscularly on 22 Oct 2015 and she felt that shot was given too high on arm. On same day after vaccination, the patient experienced sore arm, pain in elbow and arm feels tight, no redness, swelling or drainage. The patient was experiencing the pain and arm was still sore as of 09 Nov 2015. The final outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious and causality not reported.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Exposure during pregnancy, Injection site pain, Injection site pruritus, Mobility decreased
Clinical narrative: Case number PHHY2015US173122, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 608590) website on 29 Dec 2015. This report refers to a 33 years old pregnant female patient. Past medical history was not reported. Current history included as cold with nasal and chest congestion. Concomitant medication included as levothyroxine (manufacture unknown), progesterone (manufacture unknown) and Prenatal vitamin. The eight weeks female pregnant patient was vaccinated with seasonal influenza vaccine (unknown manufacturer and batch number: not reported) into left arm, on 06 Nov 2015. On 07 Nov 2015, the patient experienced hives beginning on buttocks and spreading to elbows, intense burning and itching at site. On 08 Nov 2015, she had hives spread to forearms backs of thighs, knees, and calves. On 09 Nov 2015, the patient had hives spread to wrists, neck, below left eye, behind ears, ankles, top of right foot, knuckles of both hands causing redness, swelling, and difficulty bending digits. On 09 Nov 2015, the patient visited to the obstetrics (OB), who recommended 50 mg of BENADRYL at bedtime. It was stated that, BENADRYL had lessened the burning/itching sensation for several yore after being taken but the swollen welts remain and itching is never completely relieved and returns at full force a few hours after BENADRYL is administered. The outcome of intense burning and itching at site was reported as condition improving and events of swollen welts, itching was reported as condition unchanged and rest of events outcome reported as unknown. The seriousness of the event was reported as non serious. The causality of the event was not reported. The seriousness assessment of urticaria was upgraded to medically significant based on the information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: Case number PHHY2015US173122, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 608590) website on 29 Dec 2015. This report refers to a 33 years old pregnant female patient. Past medical history was not reported. Current history included as cold with nasal and chest congestion. Concomitant medication included as levothyroxine (manufacture unknown), progesterone (manufacture unknown) and Prenatal vitamin. The eight weeks female pregnant patient was vaccinated with seasonal influenza vaccine (unknown manufacturer and batch number: not reported) into left arm, on 06 Nov 2015. On 07 Nov 2015, the patient experienced hives beginning on buttocks and spreading to elbows, intense burning and itching at site. On 08 Nov 2015, she had hives spread to forearms backs of thighs, knees, and calves. On 09 Nov 2015, the patient had hives spread to wrists, neck, below left eye, behind ears, ankles, top of right foot, knuckles of both hands causing redness, swelling, and difficulty bending digits. On 09 Nov 2015, the patient visited to the obstetrics (OB), who recommended 50 mg of BENADRYL at bedtime. It was stated that, BENADRYL had lessened the burning/itching sensation for several yore after being taken but the swollen welts remain and itching is never completely relieved and returns at full force a few hours after BENADRYL is administered. The outcome of intense burning and itching at site was reported as condition improving and events of swollen welts, itching was reported as condition unchanged and rest of events outcome reported as unknown. The seriousness of the event was reported as non serious. The causality of the event was not reported. The seriousness assessment of urticaria was upgraded to medically significant based on the information available in the source document.
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Case number PHHY2016US011618, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608601) website on 18 Jan 2016. This report refers to a 55-year-old female patient. Medical history was not reported. Concomitant medication included Aspirin. The patient was vaccinated with FLUVIRIN (batch number: 15752P) into left arm intramuscularly 21 Oct 2015. On 05 Nov 2015 the patient returned to the pharmacy and reported a bruise 2 inch diameter as a result of the flu shot. The outcome of the events was unknown. Seriousness was reported as non-serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Administration site pain, Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHHY2016US011610 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608728) website on 18 Jan 2016. This report refers to a 61 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN on 06 Oct 2015. On the same day after vaccination, the patient experienced pain at administration site. On 07 Oct 2015 24 hours after vaccination, the patient experienced pain and stiffness in left arm. The patient had limited range of motion without pain in the left arm and in the shoulder. Outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Fatigue, Myalgia, Posture abnormal
Clinical narrative: Case number PHHY2016US011636 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 608819) website on 18 Jan 2016. This report refers to a 51 year old female patient. Medical history included migraines and concurrent condition included hypothyroidism. Concomitant medication included SYNTHYROID. The patient was vaccinated with FLUVIRIN (batch number: not reported) into left arm intramuscularly on 09 Nov 2015. On 10 Nov 2015 the patient was unable to hold head up and experienced excessive fatigue, severe muscle soreness, and very uncomfortable. Outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Case number PHHY2016US011535, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 608956) website on 18 Jan 2016. This report refers to a 44 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number not reported) intramuscularly into right arm on 06 Oct 2015. On the same day, the patient experienced pain in arm where vaccine was given, shoulder pain during certain motions and numbness radiating into fingers. The final 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.
Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Feeling abnormal, Lethargy, Nasal congestion, Pain
Clinical narrative: Case number PHHY2016US006951 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 609015) on 18 Jan 2016. This report refers to a 71 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 174272) intramuscularly in the left arm on 03 Nov 2015. On the same day, she felt bad, lethargic and achy. At 2:00 am she woke up and had trouble breathing and her nose was completely stuffy. She had all respiratory symptoms. The final outcome of events was reported as condition unchanged. The seriousness of the events was not reported, but the event trouble breathing was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Respiratory symptom
Clinical narrative: Case number PHHY2016US006951 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 609015) on 18 Jan 2016. This report refers to a 71 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 174272) intramuscularly in the left arm on 03 Nov 2015. On the same day, she felt bad, lethargic and achy. At 2:00 am she woke up and had trouble breathing and her nose was completely stuffy. She had all respiratory symptoms. The final outcome of events was reported as condition unchanged. The seriousness of the events was not reported, but the event trouble breathing was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 20.0
Sex: F
Vaccine: FLUC3
Symptoms: Flushing, Oral mucosal blistering, Oropharyngeal blistering, Pyrexia, Urticaria
Clinical narrative: Case number PHHY2016US027040, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 609763) on 29 Feb 2016. This report refers to a 20 years old female patient. Medical history included Tourette's syndrome, anorexia, anemia and "pecans". The patient's current illness and concomitant medications were none. The patient was vaccinated with FLUCELVAX (batch number: 173253) intramuscularly into left arm on 10 Nov 2015. Following day the patient experienced fever along with hives. Two days after vaccination the patient experienced flushing blisters in mouth and throat. The patient went to emergency room and placed on oral steroids. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "hives" was upgraded based on information in the source document.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pruritus, Pruritus, Rash, Urticaria, Vaccination site rash
Clinical narrative: Case number PHHY2016US027675, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 610823) website on 29 Feb 2016. This report refers to a 44 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174277) intramuscularly into left arm on 10 Nov 2015. On same day after vaccination, the patient experienced rash, itching and whelps across arm at vaccination site, within 02 hours it was on bilateral upper extremity and chest, within 06 hours across abdomen, back, chest and arms and within 12 hours across all as listed above and onto hips, neck and face. The patient visited emergency room on an unknown date. The final outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the events "rash generalised, pruritus generalized and urticaria" was upgraded based on information available in the source document.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Vaccination site reaction
Clinical narrative: Case number PHHY2016US027675, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 610823) website on 29 Feb 2016. This report refers to a 44 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174277) intramuscularly into left arm on 10 Nov 2015. On same day after vaccination, the patient experienced rash, itching and whelps across arm at vaccination site, within 02 hours it was on bilateral upper extremity and chest, within 06 hours across abdomen, back, chest and arms and within 12 hours across all as listed above and onto hips, neck and face. The patient visited emergency room on an unknown date. The final outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the events "rash generalised, pruritus generalized and urticaria" was upgraded based on information available in the source document.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash erythematous, Rash generalised, Swelling face
Clinical narrative: Case number PHHY2016US022577, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 610871) website on 19 Feb 2016. This report refers to a 07 years old male patient. Past medical history was not reported. Concurrent condition included allergic to pollen. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 10 Nov 2015. On 11 Nov 2015, the patient experienced rash and itching on arms, face and back. He also experienced red spots all over and his face was swollen. The patient visited an emergency room and he was treated with BENADRYL. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality was not reported. Seriousness of the event rash erythematous, pruritus, swelling face was upgraded based on the available information in the source documents.
Age: 19.0
Sex: F
Vaccine: FLUC3, HEP
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Case number PHHY2016US027850 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 613728) on 29 Feb 2016. This report refers to a 19 year old female patient. The patient had no known allergies (NKA). She denied illness at the time of vaccination and her concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 174274) in the left arm and ENGERIX B (other manufacturer, batch number: 42SR3) in the right arm; both vaccines administered intramuscularly on 11 Nov 2015. On 14 Nov 2015, the patient experienced fine generalized red rash over face, arms and trunk. She took self-treatment with BENADRYL. The events outcome was reported as complete recovery. The events were reported as non-serious, but the events were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 60.0
Sex: M
Vaccine: FLUC3
Symptoms: Eye swelling, Mouth swelling, Urticaria
Clinical narrative: Case number PHHY2016US028670 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 614753) on 29 Feb 2016. This report refers to a 60 year old male patient. His current conditions included diabetes, hyperlipidemia and hypertension. His concomitant medications were ranitidine, CRESTOR, glimepiride, valsartan, metformin and gabapentin. He was vaccinated with FLUCELVAX (batch number: 173988) intramuscularly in the right arm on 31 Oct 2015. On 01 Nov 2015, the patient woke up with hives from head to toe and swelling of the eyes and mouth. He went to emergency room, visited doctor and was given prednisone. No laboratory tests were done. The events outcome was reported as complete recovery. The events were reported as non-serious, but were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 72.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram abdomen normal, Computerised tomogram normal, Computerised tomogram pelvis
Clinical narrative: Case number PHHY2016US023697, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 616040) on 19 Feb 2016. This report refers to a 72 years old female patient. Medical history included associated decreased sodium and fever which abated after 2 weeks. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174084) intramuscularly on 02 Nov 2015. On 04 Nov 2015 the patient developed febrile illness (temperature between 100 and greater than or equal to 104 degrees F) which required hospitalization for 13 days. The patient had no response to broad antibiotics. The patient underwent blood culture test, legionella test, chest x-ray, mycoplasma test, urine analysis, rickettsia test, HIDA (hepatobiliary scan), computerized tomogram of abdomen/pelvis and the results of the tests were negative. Outcome of the events was unknown. The causality of the events was not reported.