chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Case number PHHY2016US165864, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 654876) on 21 Nov 2016. This report refers to a 70 years old female patient. Medical history and concomitant medication was not reported. It was reported that the patient take no medications but only the annual flu shot. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 21 Sep 2016. On 22 Sep 2016, the patient experienced severe headache on top of head. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Adverse drug reaction, Drug hypersensitivity
Clinical narrative: Case number PHEH2016US018551, is an initial spontaneous report received from a consumer (patient wife) on 13 Jul 2016. This report refers to a 67 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient had drug reactions/allergies. The outcome of event was not reported. The causality of event was not reported. The seriousness of the event was reported as non serious. No further follow-up attempts were required. Follow up report received from a consumer (patient wife), via Vaccine Adverse Event Reporting System (VAERS reference number: 654892) on 21 Nov 2016: Suspect drug coding changed from unknown influenza vaccine to seasonal influenza vaccine and added VAERS reference number.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Back pain, Pain in extremity
Clinical narrative: Case number PHHY2016US170460, is an initial report received from Vaccine Adverse Events Reporting System (VAERS reference number: 654908) on 21 Nov 2016. This report refers to an 83 years old male patient. Historical condition was not reported. Current condition included yearly physical examination. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and second dose of pneumococcal vaccine (manufacturer unknown and batch number: not reported) on 31 Aug 2016. On same day after vaccination, the patient had no symptoms for two minutes, after that he had severe lower back pain and minor pain to left leg for 10 minutes. It was reported that, for pain the patient had numerous needles to back and then the pain subsided. The outcome of the events was reported as complete recovery. The seriousness and outcome of the events were not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Case number PHHY2016US170629, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 655042) website on 21 Nov 2016. This report refers to a 63 years old female patient. Past medical history was not reported. Current condition included as hypothyroidism. Concomitant medication included as levothyroxine. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 19 Sep 2016. On 20 Sep 2016, the patient experienced mild fever, sore throat and coughing from flu shot. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Constant sharp pain in shoulder and numbness to wrist.
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Case number PHHY2016US172240 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 655067) website on 21 Nov 2016. This report refers to 63 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) on 23 Sep 2016. On 24 Sep 2016 the patient experienced intense itching of head an upper torso. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2016US171882, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655069) website on 21 Nov 2016. This report refers to a 25-years-old female patient. Past medical history was not reported. Current condition included seasonal allergy (especially hay) and latex allergy. Concomitant medications included LUVOX, ROBAXIN, AMETHIA, ranitidine, PROTONIX, montelukast, and ibuprofen. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in left arm on 22 Sep 2016. On the same day after vaccination, the patient experienced a large red circle grew around the injection site, swelled and then became hot and itchy and continued to grow over next days. The largest diameter the patient had so far was 04 inches. The patient was treated with BENADRYL at home because no access to weekend healthcare. The outcome of the events were reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US172559, is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 655070) website on 21 Nov 2016. This report refers to a 07-years-old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 24 Sep 2016. On the same day after vaccination, the patient experienced hives covering the left armpit. The outcome of the event was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2016U014752, is an initial spontaneous report received from a consumer (patients husband) via Vaccine Adverse Event Reporting System (VAERS reference number: 655165) website on 23 Jan 2017. This report refers to an 81 years old female patient. Past medical history was not reported. Patient pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported and illness at time of vaccination was reported as none. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 14 Sep 2016. On 14 Sep 2016, same day following the vaccination, the patient experienced hives on face. On 15 Sep 2016, one day following the vaccination, the patient experienced itchy hives. It was also reported that, the patient did not had a previous reaction to flu vaccines. Corrective treatment includes as ALLEGRA. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PNC13, TDAP, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Case number PHHY2016US173582, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 655366) website on 21 Nov 2016. This report refers to a 66 years old female patient. Past medical history was not reported. Current condition included as diabetes, hypertension and neuropathic pain. Concomitant medications included as atorvastatin, tramadol, valsartan, hydrochlorothiazide, esomeprazole, escitalopram, gabapentin, montelukast, hydrocodone/APAP, methocarbamol, zolpidem and ferrous sulfate. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 21 Sep 2016. The patient also vaccinated with PREVNAR 13 vaccine (batch number: M73332) into right arm intramuscularly, Tdap vaccine (other manufacture, batch number: not reported) intramuscularly and ZOSTAVAX vaccine (other manufacturer, batch number M001745) into left arm, subcutaneously on 21 Sep 2016. On 25 Sep 2016, the patient experienced Rash and itching encompassing most of upper left arm. The patient was treated with oral diphenhydramine and ranitidine. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US165532, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655418) website on 21 Nov 2016. This report refers to a 34-years-old female patient. Past medical history was not reported. Current condition included allergy to mold, cats, dogs, dust mites, tree pollen, grasses and gluten. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in right arm on 26 Sep 2016. On the same day after vaccination, the patient experienced itchy skin and hives. The outcome of events itchy skin and hives was condition unchanged. The seriousness and causality of the event itchy skin and hives were not reported.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Case number PHHY2016US168636 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 655525) website on 21 Nov 2016. This report refers to female patient of an unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) and PREVNAR 13 on 08 Sep 2016. On 10 Sep 2016 the patient experienced injection site started itching and turned red. She put cold rags on it and took BENADRYL which did not do anything. She had been using BENADRYL for several days. Reporter had not seen a reaction like this before. She had no fever, and did not feel bad. The area was not swollen, just red and itches and burns. It was the size of a small orange and started at the top of her arm down to a little below the injection site. The outcome of events was unknown. The seriousness and causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Case number PHHY2016US165623, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655579) website on 21 Nov 2016. This report refers to a 57-years-old female patient of an unspecified age. 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) in 2014. On an unspecified date in 2014, the patient experienced swelling. The outcome, seriousness and causality of event swelling were not reported.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2016US166199, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655653) on 21 Nov 2016. This report refers to a 61 years old female patient. Historical condition was not reported. Current conditions included hypertension, asthma, allergies include penicillin and sulfa. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) intradermally on an unknown date in Sep 2016. On the next day after vaccination, the patient noticed feeling of mild pain/swelling if she touched it and rash in the area vaccine was administered. The outcome, seriousness and causality of the events were not reported.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling abnormal, Nausea, Pain, Pain in extremity
Clinical narrative: Case number PHHY2016US170624, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655665) website on 21 Nov 2016. This report refers to a 55-years-old female patient. Past medical history and concomitant medications were not reported. Current condition included auto immune illness and chronic fatigue syndrome. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on 26 Sep 2016. On 27 Sep 2016, the patient reported arm throbbed badly over an hour, felt weird like somewhat dizzy, nauseous and achy. The patient drank fluids and did not drive for the rest of the day. At 5:00 PM the patient started getting better. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events was not reported.
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Case number PHHY2016US174269, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655679) website on 21 Nov 2016. This report refers to a 35 years old male patient. Past medical history was not reported. Concomitant medications included ranitidine, DICLEGIS, TUMS, Multivitamins, and SENNA-S. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) in right arm along with TDAP (manufacturer unknown and batch number: not reported) in left arm, both intramuscularly on 26 Sep 2016. On 27 Sep 2016 at 9:00 AM, the patient experienced headache and nausea and uncontrolled chills and fever (102.3, units unspecified) started at noon. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Rash erythematous
Clinical narrative: Case number PHHY2016US174842, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 655746) on 21 Nov 2016. This report refers to a 31 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into his arm on 27 Sep 2016. On the same day two hours after the flu shot, the patient experienced red spots in the forearm of the vaccinated arm. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US167386, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655866) website on 21 Nov 2016. This report refers to a 36-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) in right arm on 27 Sep 2016. On the same day after vaccination the patient broke out in hives. The outcome of event was reported as complete recovery on an unspecified date. The seriousness and causality of the event were not reported.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Case number PHHY2017US016074 is an initial spontaneous report received from consumer via other company (Pfizer) via Vaccine Adverse Event Reporting System (VAERS reference number: 656011) website on 23 Jan 2017. This report refers to a 75 years old female patient. Historical condition not reported. Current conditions included high blood pressure (since 2012), osteopenia for last ten years, codeine allergies and penicillin allergy (onset date unknown for both). Concomitant medications included Valsartan/HCTZ and raloxifene. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into left arm on 01 Sep 2015. On the same day after vaccination the patient experienced vaccination site pain and warmth. It was also reported that laboratory investigations were reported none and patient received treatment with TYLENOL. The outcome of the event was reported as complete recovery on an unknown date. The events were assessed as non serious by the reporter and causality of the events were not reported.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHHY2016US173203, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656234) on 21 Nov 2016. This report refers to a 75 years old male patient. Medical history and current condition was reported as no. Concomitant medications included ELIQUIS, diltiazem and flecainide. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on 29 Sep 2016. On 30 Sep 2016 after vaccination, the patient experienced slight pain at vaccination site with pain in hand. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported.
Age: 81.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Rash pruritic
Clinical narrative: Case number PHHY2016US164569, is an initial spontaneous report received from a consumer (patient) via vaccine adverse event reporting system (VAERS (VAERS reference number: 656310) web site on 21 Nov 2016. This report refers to an 81 year old female patient. Historical condition was not reported. Historical drug included high blood pressure medication (unspecified) in 2004 (the patient received two high blood pressure medications (unspecified) and had bad reactions (unspecified). In 2010, the patient underwent cataract surgery in both eyes. Current conditions included osteoporosis (was diagnosed with two years ago), gastrooesophageal reflux disease (GERD) (since 2004), allergy to sulfa (since 2004), high cholesterol (since 2004), irritable bowel (since 2004), Barrett's esophagus (since 2004), hiatal hernia (since 2004), diverticulosis (since 2004), gastritis erosive (since 2004), blood pressure increased and eye disorder. It was also reported that, the patient had received influenza vaccine (unspecified), one injection every year since 2004 (no adverse event was specified). Concomitant medication included calcium carbonate, CALTRATE, omeprazole capsule, Preservision soft capsule, vitamin B capsule, Lipitor tablet, CENTRUM SIVLER tablet and biotin capsules (was started ages before the report and was ongoing as of this report as supplementation therapy at a dose of 1000 ug, daily (QD), orally). The patient was vaccinated with INN (manufacturer, batch number: 656310) in left arm from 09 Sep 2016. The patient was also vaccinated with PREVNAR 13 from 09 Sep 2016 (at 10:30 hrs) in right arm at a dose of 0.5 ml, intramuscularly. On 24 Sep 2016 (at 13:00), the rash worsened and grew to 4 inches in length. The outcome of the event was condition deteriorated (not recovered). The seriousness and causality assessment of the event were not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Case number PHHY2016US167419, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 656324) on 21 Nov 2016. This report refers to a 48 years old female patient. Medical history and current condition were reported as none. Concomitant medication included simvastatin. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 01 Oct 2013. On the same day, approximately 12 hours after the flu shot, the patient experienced itching on torso area, behind knees, in armpits and groin area. She had hundreds of hives/rash for a week which finally went away on 07 Oct 2013. The next morning she went to clinic and the front desk staff told her she had probably done something else that caused it. She mentioned that she has not done anything differently. The patient was treated with BENADRYL, (2 tsp., every 6 hours). The outcome of the events was reported as complete recovery. The seriousness and causality of the events was not reported.
Sex: M
Vaccine: DTAP, FLUX, MMRV
Symptoms: Vomiting
Clinical narrative: Case number PHHY2016US17952, is an initial spontaneous report received from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 656375) website on 21 Nov 2016. This report refers to a 04-years-old male patient. Past medical history was not reported. Current condition included developmental delay. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 15 Sep 2016. The patient also vaccinated with DAPTACEL (batch number: not reported) and PROQUAD (batch number: not reported) on 15 Sep 2016. On the same day after vaccination during a visit to the physician's office, the patient experienced brief episode of vomiting. At the time of the report, the outcome of the event vomiting was unknown. The seriousness and causality of the event vomiting were not reported.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Case number PHHY2016US167244 is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 656493) website on 21 Nov 2016. This report refers to 67 year old female patient. Historical condition included allergy to codeine and naproxen, unknown medical condition. Concomitant medication included as patient received annual influenza vaccine at her doctor office within the last four weeks but date/immunization information was unknown. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) on an unspecified date. On an unknown date, the patient stated she had felt dizzy after a previous influenza immunization three years prior but had successfully been vaccinated for influenza twice since then, so thought the previous reaction was a fluke. The outcome of the event was reported as complete recovery on an unknown date. The Seriousness and causality of the event was not reported.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Injection site pain, Malaise
Clinical narrative: Case number PHHY2016US166144, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656654) website on 21 Nov 2016. This report refers to a 60-years-old female patient (reported as 60.5-years-old). 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 an unspecified date. On an unspecified date, the patient experienced headache, malaise, and injection site aching. The outcome, seriousness and causality of events headache, malaise, and injection site aching were not reported.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Case number PHHY2016US166144, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656654) website on 21 Nov 2016. This report refers to a 60-years-old female patient (reported as 60.5-years-old). 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 an unspecified date. On an unspecified date, the patient experienced headache, malaise, and injection site aching. The outcome, seriousness and causality of events headache, malaise, and injection site aching were not reported.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2016US172676, is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 656681) on 21 Nov 2016. This report refers to a 75 year old female patient. Her current conditions included high blood pressure and type II diabetes. She had no reported concomitant medications. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 07 Sep 2016. On the same day after vaccination, the patient experienced tenderness, redness and swelling in the left arm at the injection site. She also had mild fever that lasted for 5 days. The events outcome was reported as complete recovery. The seriousness and causality of the events was not reported.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2017US014655, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 656733) website on 23 Jan 2017. This report refers to a 66 year 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) on 30 Sep 2016. On 01 Oct 2016 after vaccination, the patient experienced redness approximately 2 inches diameter around injection area. The outcome of the event was reported as condition unchanged. The seriousness and causality of the events were not reported.
Sex: M
Vaccine: FLUA3
Symptoms: Pruritus, Rash
Clinical narrative: Case number PHHY2016US181975, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656886) website on 21 Dec 2016. This report refers to a 69 years old male patient. Medical history was not reported. Concomitant medications included propranolol. The patient was vaccinated with FLUAD (batch number: 165703) intramuscularly into left arm on 30 Sep 2016. After vaccination on 02 Oct 2016, the patient experienced itching and rash which did not resolved. The patient visited emergency room for the treatment on an unknown date (reported as today) and was given prescription for itching and rash. The outcome of the events was reported as unknown. The seriousness of the events was reported as non-serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Myalgia
Clinical narrative: Case number PHHY2016US173222, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656897) website on 21 Nov 2016. This report refers to a 35 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on 02 Oct 2016. On 03 Oct 2016, the patient experienced muscle pain and tiredness. 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: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Rash pruritic
Clinical narrative: Case number PHHY2016US172581, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 656975) website on 21 Nov 2016. This report refers to a 70 years old female patient. Past medical history were not reported. Current condition included allergic to pollens, dust, food and latex. Concomitant medications included Vitamins and high blood pressure medications. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 29 Sep 2016. On 30 Sep 2016, the patient experienced rash, that was both painful and itchy. It was reported that the rash was felt as though it were in the muscle and 5 cm in diameter, at the site and spread inward toward the armpit (left arm) and lasted 3 days. The patient was treated with cortisone cream (reported as that of minimal benefit) and oral antihistamines. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Vaccination site swelling
Clinical narrative: Case number PHHY2017US014683 is an initial spontaneous report received from pharmacist via Vaccine Adverse Event Reporting System (VAERS number: 657091) website on 23 Jan 2017. This report refers to 67 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown); PREVNAR 13 (other manufacturer, batch number: N05077) intramuscular into left arm on 28 Sep 2016. On the same day, patient's arm bubbled up where at the point of vaccination with outcome of recovered. The action taken in response to the event for PREVNAR 13 and influenza vaccine was not applicable. Therapeutic measures were taken as a result of patient's arm blew up like it swelled up really bad. The outcome of the event was reported as complete recovery on 28 Sep 2016, seriousness of the event was reported as non serious. The causality of the events was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2016US172503 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 657106) on 21 Nov 2016. This report refers to a 42 year old female patient. She had no medical history or current conditions. Her concomitant medications included ENPRESSE. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 29 Sep 2016. On the same day after vaccination, she had ache started at the injection point. During night the ache spread to her shoulder. By the morning on 30 Sep 2016, the ache was down left side of back around left shoulder and down the left arm. Aching existed on 04 Oct 2016. The events outcome was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 64.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Case number PHHY2016US168194, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 657174) website on 21 Nov 2016. This report refers to a 64 years old male patient. Past medical history was not reported. Current conditions included as drug hypersensitivity, allergy to cephalosporins, codeine and morphine derivatives meperidine, Naloxone, penicillin, Propoxyphene, Methadone, opium and alkaloids. Concomitant medications included as atorvastatin, bupropion hydrochloride, mirtazapine, escitalopram and diazepam. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 16 Aug 2016. The patient also vaccinated with ZOSTAVAX vaccine (other manufacturer, batch number: not reported) subcutaneously on 16 Aug 2016. It was reported that, the patient was also vaccinated with an unspecified flu vaccine (manufacturer unknown) at the same time he received ZOSTAVAX. On an date in Aug 2016, the patient developed a red, hard lump at the injection site. The patient received ZOSTAVAX in the opposite arm as the flu vaccine. The outcome of the events was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2016US172758 is an initial spontaneous report received from a pharmacist via company representative and via Vaccine Adverse Events Reporting System (VAERS reference number: 657346) on 21 Nov 2016. This report refers to a 65 year old male patient. No pertinent medical history, drug reactions, allergies or current diseases were reported. His current condition included unspecified prophylaxis. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PNEUMOVAX 23 (other manufacturer, batch number: not reported); both vaccines administered in the same arm on unknown dates. On an unknown date, the patient experienced injection site redness that spread down to the elbow. The patient was prescribed unspecified antibiotics and the symptoms went. The event outcome was reported as complete recovery. The seriousness and causality of the event was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Case number PHHY2016US173388, is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 657394) website on 21 Nov 2016. This report refers to a 65-years-old female patient. Past medical history included missing thyroid and slight hay fever. Current condition included allergies (unspecified details). Concomitant medication levothyroxine. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 22 Sep 2016. On 27 Sep 2016 after vaccination, the patient experienced headache. The patient received treatment with ALEVE and continued along with sweats, nausea, vomiting and diarrhea. The patient slept through the night after vomiting and awoke free of all symptoms. The outcome of the event was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Case number PHHY2016US182036, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 657399) website on 21 Dec 2016. This report refers to a 67 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: 165863) intramuscularly into arm on 30 Sep 2016. On the same day after vaccination, the patient experienced sore arm and unresolved red spot on arm. On 30 Sep 2016, it was also reported that the patient experienced red arm lingered for one week. 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: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US173212, is an initial spontaneous report received Vaccine Adverse Events Reporting System (VAERS reference number: 657468) on 21 Nov 2016. This report refers to a 30 years old female patient. Historical condition included eczema. Current condition included latex allergy. Concomitant medications included CLARITIN, ZYRTEC and Mini-pill. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) intramuscularly into left arm on 30 Sep 2016. On same day after vaccination, the patient experienced itching arms and legs, hives on legs. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Malaise, Nausea
Clinical narrative: Case number PHHY2016US173298, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657746) on 21 Nov 2016. This report refers to a 48 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. After vaccination on an unknown date, the patient experienced illness, weakness and nausea. The outcome, seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, VARCEL
Symptoms: Back pain, Chills, Dizziness, Erythema, Headache
Clinical narrative: Case number PHHY2016US174093, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657798) on 21 Nov 2016. This report refers to a 60 years old female patient. Historical condition included heart murmurs. Vaccination history included administration of unknown vaccine and adverse reaction was reported as none. Current conditions included rheumatoid arthritis, osteoporosis, scoliosis and degenerative bone disease in the spine. Concomitant medication included HUMIRA, leflunomide, prednisone, NEXIUM, metoprolol, anastrozole, bupropion, clonazepam, ranitidine and atorvastatin. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported), pneumococcal vaccine polyvalent (manufacturer unknown and batch number: not reported) and varicella zoster vaccine (manufacturer unknown and batch number: not reported) on 04 Oct 2016. On same day after vaccination, the patient experienced fever, chills, sweats, pain in the back and legs, a red strip down shoulder to arm pit, very light headed and headache. The nurse at the doctor's office said it was a co-incidence, the patient must have the flu. The outcome of the events was not reported. The seriousness of the events was reported as non serious and causality not reported.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, VARCEL
Symptoms: Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2016US174093, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657798) on 21 Nov 2016. This report refers to a 60 years old female patient. Historical condition included heart murmurs. Vaccination history included administration of unknown vaccine and adverse reaction was reported as none. Current conditions included rheumatoid arthritis, osteoporosis, scoliosis and degenerative bone disease in the spine. Concomitant medication included HUMIRA, leflunomide, prednisone, NEXIUM, metoprolol, anastrozole, bupropion, clonazepam, ranitidine and atorvastatin. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported), pneumococcal vaccine polyvalent (manufacturer unknown and batch number: not reported) and varicella zoster vaccine (manufacturer unknown and batch number: not reported) on 04 Oct 2016. On same day after vaccination, the patient experienced fever, chills, sweats, pain in the back and legs, a red strip down shoulder to arm pit, very light headed and headache. The nurse at the doctor's office said it was a co-incidence, the patient must have the flu. The outcome of the events was not reported. The seriousness of the events was reported as non serious and causality not reported.
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Case number PHHY2016US170654, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 657861) on 21 Nov 2016. This report refers to a 07 years old male patient. Historical condition was not reported. Current condition included ADHD (Attention deficit hyperactivity disorder). Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in to left arm on 06 Oct 2016. On 07 Oct 2016, the patient experienced fever and pain at vaccination site. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Case number PHHY2017US019163, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 657889) website on 23 Jan 2017. This report refers to a female patient of unspecified age. Past medical history was not reported. Current condition included allergic to egg. The concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in 1978. On an unspecified date in 1978 after vaccination the patient experienced a reaction to the flu vaccine. Lab data and corrective treatment were not reported. The outcome, seriousness and outcome of the event was not reported.
Sex: M
Vaccine: FLUX, FLUX, PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2016US172030, is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 657903) website on 21 Nov 2016. This report refers to a male patient of unspecified age. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in right arm on an unspecified date. On an unspecified date after vaccination the patient experienced slight soreness and heat at (injection site) there. The outcome, seriousness and causality of the events were not reported.
Sex: M
Vaccine: FLUX, FLUX, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: Case number PHHY2016US172030, is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 657903) website on 21 Nov 2016. This report refers to a male patient of unspecified age. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in right arm on an unspecified date. On an unspecified date after vaccination the patient experienced slight soreness and heat at (injection site) there. The outcome, seriousness and causality of the events were not reported.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary pain, Erythema, Local swelling, Rash
Clinical narrative: Case number PHHY2016US172704, is an initial spontaneous report received from Vaccine Adverse Events Reporting System website (VAERS website: 658008) on 21 Nov 2016. This report refers to a 7-year-old male patient. Historical condition was not reported. Current condition included allergic to amoxicillin. Concomitant medication was not reported. The patient received Influenza virus vaccine seasonal INN, lot number: B5592CP) intramuscularly into right arm on 05 Oct 2016. On 06 Oct 2016 the patient experienced red, painful, and swollen rash like area in the armpit of the right arm. The patient was treated with BENARDYL for the treatment red, painful, and swollen rash like area in the armpit of the right arm and going down. The outcome of the events were reported as complete recovery on an unknown date. Seriousness of the events were reported as non serious and causality was not reported. Following an internal review done on 03 Feb 2017, it was identified that, the reported batch number does not belong to any of the Novartis legacy vaccine as confirmed by QA. Hence the case was deactivated.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2016US172717, is an initial spontaneous report received from via Vaccine Adverse Event Reporting System (VAERS reference number: 658009) website on 21 Nov 2016. This report refers to a 57-years-old female patient. Past medical history included restless leg syndrome. Current condition included high blood pressure, high cholesterol, gastrooesophageal reflux disease, glaucoma and osteoarthritis, depression. Concomitant medication included PROTONIX, CRESTOR, TOPROL, XALATAN, ZOLOFT, gabapentin, baby aspirin and eye vitamin (unspecified details). The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in left arm on 06 Oct 2016. On the same day after vaccination, large raised red spot over injection area. The outcome of event was reported as condition unchanged. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Case number PHHY2016US172812 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 658015) website on 21 Nov 2016. This report refers to 42 year old female patient. Medical history included osteoarthritis and Raynaud's disease. Current condition included cold allergy symptoms. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) on 05 Oct 2016. On 07 Oct 2016 the patient experienced dizziness, fatigue, headache and low fever. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: Case number PHHY2016US171370, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 658028) on 21 Nov 2016. This report refers to an 87 year old male patient. Medical history was not reported. It was mentioned that he never had reaction with flu vaccine in past. Concomitant medication included PLAVIX, ramipril, aspirin, ALTACE, LIPITOR, levothyroxine, AMBIEN, metoprolol, pantoprazole and daily vitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Oct 2016. On the same day, his arm where vaccine shot was given turned bright red to the size of a half dollar. Six days later, he still had red spot but it was now getting lighter. The outcome of the event was reported as condition improving. The seriousness and causality of the event was not reported.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Pain, Pyrexia
Clinical narrative: Case number PHHY2016US169019, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 658085) website on 21 Nov 2016. This report refers to a 71 years old female patient. Past medical history was not reported. Current condition included as high blood pressure, hypothyroid and state 03 kidney disease. Concomitant medications included as atorvastatin, carvedilol, gabapentin, levothyroxine, losartan, prednisone, CENTRUM SILVER, Calcium with Vitamin D3. The patient was vaccinated with INN (manufacturer and batch number: not reported) into left arm, intramuscularly on 29 Sep 2016. On 29 Sep 2016, the patient experienced pain, fever, chills and cough. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy
Clinical narrative: Case number PHHY2016US168823, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 658096) on 21 Nov 2016. This report refers to a 40 years old female patient. Historical condition included iron deficiency anemia. Past medication included sulfa. Concomitant medications included EVOXAC, CLARITIN-D 12 hour. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly into right arm on 02 Oct 2016. On 04 Oct 2016 after vaccination, the patient experienced lymphadenopathy on left cervical node. It was reported that, the patient had a pending diagnosis of Sjogren's syndrome. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.