chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cough, Nausea, Tachycardia, Throat irritation
Clinical narrative: Case number PHHY2017US009797, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 660633) website on 23 Jan 2017. This report refers to a 46 years old male patient. Past medical history was not reported. His current conditions included hypertension and hyperlipidemia. Concomitant medication was not reported. He was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on 30 Sep 2016. Within several hours of vaccination, he began with itching sensation in his throat, coughing and nausea. He reported to the medical group clinic and was found to be tachycardic and it was presumed to be an early anaphylaxis. He was given epinephrine 0.3 mg intramuscularly with significant improvement. He was transported to an emergency room and he was primarily observed to be stable and discharged home on oral steroids. Outcome of the events was reported as complete recovery on an unknown date. The events were assessed as serious (life threatening) and causality was not reported.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Case number PHHY2017US021539, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 660656) on 23 Jan 2017. This report refers to a 50 years old female patient. Historical condition included Hashimoto's. Current conditions included rosacea and Meniere's disease. Concomitant medication included HCTZ, SYNTHROID, doxycycline, WELLBUTRIN and potassium. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 20 Oct 2016. On same day after vaccination, the patient experienced sneezing, runny nose, was achy, headache, extreme soreness and stiffness of arm. The patient took 50 mg BENADRYL. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Sneezing
Clinical narrative: Case number PHHY2017US021539, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 660656) on 23 Jan 2017. This report refers to a 50 years old female patient. Historical condition included Hashimoto's. Current conditions included rosacea and Meniere's disease. Concomitant medication included HCTZ, SYNTHROID, doxycycline, WELLBUTRIN and potassium. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 20 Oct 2016. On same day after vaccination, the patient experienced sneezing, runny nose, was achy, headache, extreme soreness and stiffness of arm. The patient took 50 mg BENADRYL. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV, TD
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Case number PHHY2017US021757 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 660880) website on 23 Jan 2017. This report refers to 51 year old female patient. Medical history was not reported, current condition included diabetes and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown, batch number not reported), pneumococcal vaccine and diphtheria vaccine, tetanus vaccine on 20 Oct 2016. On 21 Oct 2016, the patient experienced redness and swelling at injection site. Patient had some pain and discomfort; pain subsided but redness was moving to the right side of left arm to muscle area and swelling was still present. The outcome of the event vaccination site pain was recovered (reported as subsided) and other events was condition unchanged, seriousness of the events was non serious and causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema, Respiratory tract oedema
Clinical narrative: Case number PHHY2017US012775, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660898) website on 23 Jan 2017. This report refers to a 62 years old female patient. Past medical history was not reported. Concomitant medications included as ZETIA and Krill oil. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into right arm, intramuscularly on 19 Oct 2016. On the same day after vaccination, the patient experienced swelling of airway in throat and chest. The patient received CLARITIN due to the events. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported. The seriousness assessment of respiratory tract oedema was upgraded serious (medically significant) based on the Novartis Important Medical Event list. The seriousness assessment of pharyngeal oedema was upgraded to serious (medically significant) based on the information available in the source document.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2017US013703, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 660903) website on 23 Jan 2017. This report refers to a 45 years old female patient. Past medical history was not reported. Current condition included soreness around injection site. The patient's vaccination history included that received flu shot for 20 years without incident. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 21 Oct 2016. On 22 Oct 2016 after vaccination, the patient experienced hives all over body. The patient received treatment with BENADRYL but the hives have not gone away yet. The outcome of the event was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of the event urticaria was upgraded (medically significant) based on the information available in the source document.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2017US021830 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 660939) website on 23 Jan 2017. This report refers to 70 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown, batch number not reported) and pneumococcal vaccine on 18 Oct 2016. On 19 Oct 2016, patient experienced extreme soreness, swelling, red inflammation down the arm. Patient visited emergency room/doctor (date not reported). The outcome of the events was complete recovery on an unknown date. The seriousness of the events was non serious and causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Influenza, Vaccination failure
Clinical narrative: Case number PHHY2017US012676, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660964) website on 23 Jan 2017. This report refers to an unknown age (aged between 15 and 44 years old) of pregnant female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with influenza virus vaccine unknown INN (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient had suspected vaccination failure. The outcome of pregnancy was lost to follow up as the case is lost to follow up due to reporter anonymity. The outcome, seriousness and causality of the event was not reported. The seriousness assessment of the event influenza was upgraded to serious (medically significant) based on the information available in the source document.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Case number PHHY2017US020880, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 660975) website on 23 Jan 2017. This report refers to a 43 years old female patient. Historical condition included stroke. Current conditions included LAMICTAL, DEPAKOTE, SINGULAIR, FLUORINEF, and vitamin. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) into the left arm on 21 Sep 2016. After vaccination, on the same day, she experienced pain at injection site and since injection she experienced increased pain, weakness and range of motion. She visited the emergency room on an unknown date. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Case number PHHY2017US020451, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 660996) website on 23 Jan 2017. This report refers to a female patient of unspecified age. Past medical history and concomitant medications were reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in 1990. On an unspecified date after vaccination the patient experienced reaction to influenza vaccine. The outcome, seriousness and causality of the event were not reported.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain, X-ray limb
Clinical narrative: Case number PHHY2017US021213, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS Reference number: 660998) on 23 Jan 2017. This report refers to a 65 years old female patient. Medical history was reported as none. Concomitant medication included LEXAPRO, ACIPHEX, zolpidem, Multivitamin. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 21 Oct 2016. On same day after vaccination, the patient experienced extreme pain in right shoulder, unable to move arm without excruciating pain, pain was a 10 on a 1-10 scale. The patient performed the shoulder X ray (result unspecified) on 22 Oct 2016. The patient went to emergency room on an unknown date. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events pain and musculoskeletal pain was upgraded based on information available in the source document.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2017US014590, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 661143) on 23 Jan 2017. This report refers to a 23 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on unknown date in 2015. On an unknown date after vaccination, the patient developed Bell's palsy. The outcome, seriousness and causality of the event was not reported. Seriousness assessment of the event facial paralysis was upgraded based on the Novartis Important Medical Event List.
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2017US020889, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 661191) website 23 Jan 2017. This report refers to a 30-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with Seasonal Influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into left arm on 13 Oct 2016. On the same day of vaccination the patient experienced hand hurts and also swollen. The patient went to an emergency room. Outcome of the events were reported as condition unchanged. Seriousness of the events were reported as non serious and causality was not reported.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Pruritus generalised, Syncope, Urticaria
Clinical narrative: Case number PHHY2017US009841, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661230) website on 23 Jan 2017. This report refers to a 24 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) on 21 Oct 2016. After vaccination, on 22 Oct 2016, he experienced global itching, developed hives, noted lightheadedness and subsequent orthostatic syncope. The outcome of the events was reported as condition unchanged. The events were assessed as serious (life threatening) and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2017US009971, is an initial spontaneous report received from a consumer (patient's daughter) via Vaccine Adverse Events Reporting System (VAERS reference number: 661263) on 23 Jan 2017. This report refers to a female patient of an unknown age. Medical history was not reported. The patient illness at the time of vaccination, pre-existing, physician diagnosed allergies, birth defects, medical conditions was not provided and any other vaccinations within four weeks of vaccinations was reported as none. The patient concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on an unknown date ten years ago. On an unknown date after vaccination, the patient experienced Guillain-Barre syndrome. On an unknown date, the patient was hospitalized which resulted in prolonged hospitalization and she spent time in nursing home. The patient corrective treatment and laboratory tests were not reported. The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as serious (hospitalization and medically significant). The causality of the event was reported as directly related to a vaccine by the physician of the patient.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: Case number PHHY2017US020772, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 661336) website on 23 Jan 2017. This report refers to a 65 years old male patient. Past medical history was not reported. Current conditions included as heart disease and diabetes. Concomitant medications included as ALTACE, JENTADUETO, AVODART, TOPROL XL, rosuvastatin and Aspirin. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 01 Oct 2016. On the same day after vaccination, the patient experienced extremely sore arm at the point of the shot and above and below area of the shot. After a couple of days, patient suffered with joint pain in the shoulder area where the shot was administered, that had not yet gone away. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis, Fatigue, Headache, Nausea
Clinical narrative: Case number PHHY2017US014020 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 661337) website on 23 Jan 2017. This report refers to 48 year old female patient. Medical history was not reported. Concomitant medication included as metformin, LEVEMIR insulin, multivitamin, omega fish oil, Co Q10. Current condition included diabetes. The patient was vaccinated with Seasonal influenza virus vaccine (manufacturer unknown) intramuscular on left arm on 12 Oct 2016. On the same day, the patient experienced nausea, fatigue and headache. On 20 Oct 2016, the patient was diagnosed with Bell's palsy. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported. Seriousness assessment of the event nausea was upgraded to (medically significant) based on information available in the source document. Seriousness assessment of event facial paralysis (medically significant) was upgraded based on NVS IME list.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Inflammation, Influenza, Rash
Clinical narrative: Case number PHHY2017US011385, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 661343) website on 23 Jan 2017. This report refers to a 54 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 20 Oct 2016. On the same day after vaccination, the patient experienced flu symptoms and reactions as redness, rash and inflammation on left arm. The outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported. The seriousness assessment of the event influenza was upgraded (medically significant) based on the information available in the source document.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Musculoskeletal pain
Clinical narrative: Case number PHHY2017US021267, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661354) website on 23 Jan 2017. This report refers to a 60 years old female patient. Past medical history and concomitant medication were reported as none. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) intramuscularly into the left arm on 24 Oct 2016. After vaccination, on 25 Oct 2016, she experienced severe shoulder pain lasting through the night, without sleep. She took 500 mg TYLENOL around 05:00 am and it helped until wore off. She took ADVIL at 11:00 am to ease the pain. It was reported that she was not fully recovered as of 12:49 pm on 25 Oct 2016. Final outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphagia, Lip swelling, Lymphadenopathy, Oropharyngeal pain, Swollen tongue
Clinical narrative: Case number PHHY2017US012550 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 661797) on 23 Jan 2017. This report refers to a 42 year old male patient. The patient had no medical history or current conditions. The patient's concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 26 Oct 2016. On 27 Oct 2016, the patient experienced sore throat, swollen tongue, burning sensation on tongue, swollen lips, swollen glands and difficulty swallowing. The patient had no breathing problems. He took 2 BENADRYL and 1 ZYRTEC as per on call doctor's instructions. The events outcome was reported as complete recovery. The events were reported as non-serious, but the events swollen tongue, sore throat, burning sensation on tongue, swollen lips and difficulty swallowing were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Tongue discomfort
Clinical narrative: Case number PHHY2017US012550 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 661797) on 23 Jan 2017. This report refers to a 42 year old male patient. The patient had no medical history or current conditions. The patient's concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 26 Oct 2016. On 27 Oct 2016, the patient experienced sore throat, swollen tongue, burning sensation on tongue, swollen lips, swollen glands and difficulty swallowing. The patient had no breathing problems. He took 2 BENADRYL and 1 ZYRTEC as per on call doctor's instructions. The events outcome was reported as complete recovery. The events were reported as non-serious, but the events swollen tongue, sore throat, burning sensation on tongue, swollen lips and difficulty swallowing were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX, MNQ, PPV
Symptoms: Chills, Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Case number PHHY2017US019618, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 661859) website on 23 Jan 2017. This report refers to a 61 years old female patient. Past medical history was not reported. The patient's vaccination history included pneumococcal vaccine and influenza vaccine. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in left arm on 19 Oct 2016. The patient was also vaccinated with MENVEO (unknown manufacturer, batch number: not reported) and pneumococcal vaccine (unknown manufacturer, batch number: not reported) both in right arm on 19 Oct 2016. On the same day after vaccination the patient experienced chills and fever. The patient received MENVEO at the age of 61 years, which led to inappropriate age at vaccine administration. The reporter stated that, because she has had a flu vaccine and pneumonia vaccine in the past, she only believes the side effects are related to the Meningitis vaccine. The patient had not notified her physician of the events, but was encouraged to do so. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: Case number PHHY2017US019814 is an initial spontaneous report received from a physician via other company (Pfizer) via Vaccine Adverse Event Reporting System (VAERS reference number: 662078) website on 23 Jan 2017. This report refers to a 68 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with influenza virus vaccine INN (unknown whether seasonal and pandemic, manufacturer and batch number: not reported) on an unknown date. After vaccination, on an unspecified date, the patient experienced adverse reaction (unspecified). The outcome, seriousness and causality of the event were not reported.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Urticaria
Clinical narrative: Case number PHHY2017US012664 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 662098) website on 23 Jan 2017. This report refers to 45 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine (manufacturer unknown, batch number not reported) into left arm on 27 Oct 2016. On the same day, the patient developed lips swelling and a hive. The outcome of the events was reported as unknown. The seriousness and causality of the events was not reported. Seriousness of the events lip swelling and urticarial was upgraded to (medically significant) based on information available in the source document.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Axillary pain, Body temperature fluctuation, Chills, Discomfort
Clinical narrative: Case number PHHY2017US020906 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 662106) website on 23 Jan 2017. This report refers to 66 year old female patient. Medical history was not reported. Concomitant medication included as SYNTHROID, Vitamin D3, B complex, Baby aspirin (All taken in the morning before the injection was given). The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown) on 24 Oct 2016. On the same day, 4 hours after receiving the PNEUMOVAX 23, the patient arm in which the vaccine was given began to throb with pain, not only at the site of the injection but, under the arm. Patient experienced chills and fever. The muscles and joints in her legs began to ache. Patient had discomfort she received treatment with TYLENOL but had not effect. On 25 Oct 2016, (time: 02:00 AM) temperature spiked to 101.5. Patient had chills and such intense muscle and joint pain in her legs and pain in her arm she could not sleep. On the same day, her temperature fluctuated between 98.6 and 101.8. Finally, around (7:00 PM) her fever broke and the muscle/joint pain subsided. Her arm continued to be sore on 26 Oct 2016 but as of today 27 Oct 2016 the pain was minor. She never had such a harsh reaction to a vaccine before. The outcome of the events was reported as complete recovery on an unknown date, seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: Case number PHHY2017US020906 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 662106) website on 23 Jan 2017. This report refers to 66 year old female patient. Medical history was not reported. Concomitant medication included as SYNTHROID, Vitamin D3, B complex, Baby aspirin (All taken in the morning before the injection was given). The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown) on 24 Oct 2016. On the same day, 4 hours after receiving the PNEUMOVAX 23, the patient arm in which the vaccine was given began to throb with pain, not only at the site of the injection but, under the arm. Patient experienced chills and fever. The muscles and joints in her legs began to ache. Patient had discomfort she received treatment with TYLENOL but had not effect. On 25 Oct 2016, (time: 02:00 AM) temperature spiked to 101.5. Patient had chills and such intense muscle and joint pain in her legs and pain in her arm she could not sleep. On the same day, her temperature fluctuated between 98.6 and 101.8. Finally, around (7:00 PM) her fever broke and the muscle/joint pain subsided. Her arm continued to be sore on 26 Oct 2016 but as of today 27 Oct 2016 the pain was minor. She never had such a harsh reaction to a vaccine before. The outcome of the events was reported as complete recovery on an unknown date, seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2017US020906 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 662106) website on 23 Jan 2017. This report refers to 66 year old female patient. Medical history was not reported. Concomitant medication included as SYNTHROID, Vitamin D3, B complex, Baby aspirin (All taken in the morning before the injection was given). The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown) on 24 Oct 2016. On the same day, 4 hours after receiving the PNEUMOVAX 23, the patient arm in which the vaccine was given began to throb with pain, not only at the site of the injection but, under the arm. Patient experienced chills and fever. The muscles and joints in her legs began to ache. Patient had discomfort she received treatment with TYLENOL but had not effect. On 25 Oct 2016, (time: 02:00 AM) temperature spiked to 101.5. Patient had chills and such intense muscle and joint pain in her legs and pain in her arm she could not sleep. On the same day, her temperature fluctuated between 98.6 and 101.8. Finally, around (7:00 PM) her fever broke and the muscle/joint pain subsided. Her arm continued to be sore on 26 Oct 2016 but as of today 27 Oct 2016 the pain was minor. She never had such a harsh reaction to a vaccine before. The outcome of the events was reported as complete recovery on an unknown date, seriousness of the events was reported as non serious and causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Drug administered to patient of inappropriate age
Clinical narrative: Case number PHHY2017US020489, is an initial spontaneous report received from a medical assistant via Vaccine Adverse Events Reporting System (VAERS reference number: 662145) on 23 Jan 2017. This report refers to a neonate female patient. Medical history was not reported. Concomitant medication was not reported. The neonate patient was vaccinated with first dose of seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 07 Mar 2016 (drug administered to patient of inappropriate age). On an unknown date in 2016 after vaccination, the patient experienced diarrhea. The outcome, seriousness and causality of the event was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Eyelid oedema, Eyelid pain, Hot flush, Rash
Clinical narrative: Case number PHHY2017US013891, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 662421) on 23 Jan 2017. This report refers to a 30-year-old female patient. Historical condition included weeds and grasses (details not specified), spinal stenosis, degenerative disc disease, migraines, fibromyalgia, interstitial cystitis and endometriosis. The patient had no reported current condition. This poly-medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm on 21 Oct 2016. The patient reported that her face had been growing increasingly hot and flushed since the vaccine on 21 Oct 2016. She also stated that this was not abnormal for her to feel a little under the weather after receiving her annual flu shot. When she went out into the sun on 23 Oct 2016, her face felt like it was on fire and when she blinked, her eyelashes was terribly painful when touching together. When she got back inside and looked in the mirror she had a rash from the top of her chest, up neck, on her chin and cheeks, up to the bottom of her eyes. Right side of her eye was swollen above and below on the eyelid. She went to urgent care and was asked to come back if it gets worse or did not get better. She is still having pain when she blinks, but the swelling had gone down. She is still having the rash on her neck and chin. The outcome of the other events was not reported. The events were reported as non-serious. The causality of the events was not reported. Seriousness assessment of the events rash, eye swelling, eyelid oedema and eye pain was upgraded medically significant based on the information available in the source document.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2017US012695, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS Reference number: 662468) on 23 Jan 2017. This report refers to a 50-year-old male patient. Medical history included hypercholesterolemia. The patient had no reported current condition. Concomitant medications included simvastatin, omeprazole, ZOLOFT, trazodone and Multivitamin. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) administered intramuscularly into left arm on 14 Oct 2016. On the same day, the patient developed urticaria on trunk, upper arms, lower extremities and groin area which lasted approximately 10 days. No lab data was reported. The patient fully recovered from the event on an unknown date. The event was reported as non-serious. The causality of the event was not reported. Seriousness assessment of the event urticaria was upgraded medically significant based on the information available in the source document.
Age: 0.25
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain lower, Allergy test, Asthenia, Headache, Myalgia
Clinical narrative: Case number PHHY2017US020211, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 662503) website on 23 Jan 2017. This report refers to a 4-month-old male patient. Historical condition was not reported. Current conditions included asthma and allergies. Concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus Vaccine INN (manufacturer unknown, batch number not reported) on 25 Oct 2016. On 27 Oct 2016, the patient developed experienced racing heart, lower abdominal pain, weakness, muscle aches, nausea, and headache. He was tested for allergies both scratch testing and intradermal the same day and on 27 Oct 2016 was administered his first allergy shot. Outcome of the events were condition unchanged. Seriousness of the events were reported as non serious and causality was not reported.
Age: 0.25
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Palpitations
Clinical narrative: Case number PHHY2017US020211, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 662503) website on 23 Jan 2017. This report refers to a 4-month-old male patient. Historical condition was not reported. Current conditions included asthma and allergies. Concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus Vaccine INN (manufacturer unknown, batch number not reported) on 25 Oct 2016. On 27 Oct 2016, the patient developed experienced racing heart, lower abdominal pain, weakness, muscle aches, nausea, and headache. He was tested for allergies both scratch testing and intradermal the same day and on 27 Oct 2016 was administered his first allergy shot. Outcome of the events were condition unchanged. Seriousness of the events were reported as non serious and causality was not reported.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Case number PHHY2017US012641 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 662688) on 23 Jan 2017. This report refers to a 2 year old male patient (inappropriate age). Medical history was not reported. He had no current illness. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the right arm 28 Oct 2016. On 29 Oct 2016, the patient developed hives on his wrist, feet, torso, and arms everywhere except his face. He also complained of severe leg pains. Following the events the patient visited emergency room of the hospital on 29 Oct 2016 (5 PM) and was prescribed BENADRYL so that the hives would go away. It was reported that the patient still had hives at the time of reporting. The final outcome of the events 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 document. The causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Oral pruritus
Clinical narrative: Case number PHHY2017US020974, is an initial spontaneous report received from a health care professional via Vaccine adverse Event reporting system (VAERS: 663410) website on 23 Jan 2017. This report refers to a 38-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with second dose seasonal influenza vaccine (manufacture unknown, batch number not reported) into right arm intramuscularly on 12 Aug 2015. On the same day of vaccination the patient experienced mouth itching, increasing spasmodic coughing. The patient immediately took BENADRYL and symptoms subsided. Outcome of the events were complete recovery on an unknown date. Seriousness of the events were reported as non serious and causality was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Case number PHHY2017US021429, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 663649) website on 23 Jan 2017. Past medical history and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) on 15 Oct 2016. After vaccination, on the same day he had flu like symptoms. Laboratory data and corrective treatment were not reported. The outcome of the event was reported as complete recovery on 16 Oct 2016. The seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2017US012761 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 663810) on 23 Jan 2017. This report refers to a 60 year old female patient. She had no medical history, current illness and concomitant medication. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 19 Oct 2016. On same day, the patient developed hives all over her body. The outcome of the event was reported as unknown. The event was reported as non-serious, but was upgraded as medically significant based on the information available in the source document. The causality of the event was not reported.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Decreased appetite, Insomnia
Clinical narrative: Case number PHHY2017US022365, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663824) website on 23 Jan 2017. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) into arm and a single dose of PREVNAR 13 (other manufacturer, batch number: not reported) into arm; both vaccines on an unknown date. It was reported that the flu shot was given on an another arm. After vaccination, since an unknown date, the patient lost her appetite (she did not eat from 01:00 hours in the afternoon until 19:00 hours of the day after) and it was hard to sleep for her. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2017US020480, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663857) website on 23 Jan 2017. This report refers to a 37 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) into the left arm on 12 Oct 2016. After vaccination, on the same day, she experienced sore arm and shoulders and she could not lift arm. She visited the emergency room on an unknown date. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2017US020575, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 663864) website on 23 Jan 2017. This report refers to a 69 years old female patient. Past medical history and concomitant modifications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 11 Oct 2016. On 12 Oct 2016 after vaccination the patient experienced severe shoulder and arm pain, fingers going numb and tingling and shooting pain. The outcome of the events was reported as condition unchanged. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Contusion, Headache, Influenza like illness, Neck pain
Clinical narrative: Case number PHHY2017US019973, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663867) website on 23 Jan 2017. This report refers to a 69 years old female patient. Past medical history and concomitant medications were reported as none. She was vaccinated with first dose of seasonal influenza vaccine INN (manufacturer unknown, batch  number not reported) and first dose of Pneumo (unknown manufacturer, batch number: not reported); intramuscularly into the left arm on 31 Oct 2016. After vaccination, on the same day, she experienced uncontrolled shivering and fever. on 01 Nov 2016, she experienced leg aches, severe head and neck ache, welt and bruise on arm. On an unknown date, she had general flu like symptoms which lasted for 24 hours. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Case number PHHY2017US019973, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663867) website on 23 Jan 2017. This report refers to a 69 years old female patient. Past medical history and concomitant medications were reported as none. She was vaccinated with first dose of seasonal influenza vaccine INN (manufacturer unknown, batch  number not reported) and first dose of Pneumo (unknown manufacturer, batch number: not reported); intramuscularly into the left arm on 31 Oct 2016. After vaccination, on the same day, she experienced uncontrolled shivering and fever. on 01 Nov 2016, she experienced leg aches, severe head and neck ache, welt and bruise on arm. On an unknown date, she had general flu like symptoms which lasted for 24 hours. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Case number PHHY2017US019260, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 663869) website on 23 Jan 2017. This report refers to a 75 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly in left arm on 06 Oct 2016. On the same day after vaccination the patient experienced pain in shoulder started immediately following injection and had not gone away. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Feeling hot, Headache, Malaise, Pyrexia
Clinical narrative: Case number PHHY2017US019834 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 663874) website on 23 Jan 2017. This report refers to a 54 year old female patient. Historical condition was not reported. Current condition included asthma, hypothyroid and rheumatoid arthritis (RA). Concomitant medications included omeprazole, PLAQUENIL, ASMANEX and INCRUSE. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on 01 Sep 2016. On the same day after vaccination, patient felt unwell, weak very hot and headache. It was reported that patient had fever of over 101 (results, normal range and units not specified). Patient received TYLENOL for treatment. The outcome of the events feeling hot, asthemia, malaise, headache and pyrexia 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: 52.0
Sex: U
Vaccine: FLUX, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHHY2017US020157 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 663968) website on 23 Jan 2017. This report refers to 52 year old patient of unknown gender. Medical history and concomitant medication was not reported. The patient prior vaccination history included BOOSTRIX vaccine in 2015 (date not reported). The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown, batch number not reported) on 09 Aug 2016. Patient was screened alongside family for recommended adult vaccines when receiving his seasonal influenza vaccine. Patient did not recall the last time he had a Tdap and the pharmacist recommended that he receive a dose of ADACEL along with his seasonal influenza vaccine. Pharmacist reviewed patient's full medication history for all stores within the pharmacy chain after administering ADACEL (to see if he had received Hepatitis B vaccine series) and discovered that he had received BOOSTRIX previously in 2015 at another store within the chain. The dose was administered at incorrect interval/2nd dose of pertussis containing vaccine was not indicated. No adverse event was reported following this medication error (inappropriate schedule of drug administration).
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Case number PHHY2017US009658, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 664057) on 23 Jan 2017. This report refers to a 47 year old male patient. The patient had no reported medical history and current conditions. Concomitant medications included Multivitamin and amitriptyline. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) on 11 Nov 2016. On the same day, the patient had high fever of 104, body aches and chills. The patient fully recovered from the events on an unknown date. The events were reported as non-serious. The causality of the events was not reported. Seriousness assessment of the event pyrexia was upgraded medically significant based on the information available in the source document.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea, Vomiting
Clinical narrative: Case number PHHY2017US014332, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 664131) website on 23 Jan 2017. This report refers to a 30 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly in left deltoid on 04 Nov 2016 at 07:30. On the same day after vaccination at 08:00, the patient felt tightness in chest, short of breath and had one episode of vomiting. The patient was given EPIPEN injection and brought to emergency room for evaluation. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported. The seriousness assessment of the events chest discomfort and dyspnoea was upgraded (medically significant) based on the information available in the source document.