chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2016US060991, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 625750) on 27 Apr 2016. This report refers to a 03 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a FLUCELVAX (batch number: 174087A) intramuscularly in left leg on 04 Dec 2015. No adverse event was reported following the administration error. The case was reported as non-serious. Following an internal review of 03 Mar 2017, based on the information received on 27 Apr 2016, the below correction was done. The event inappropriate schedule of vaccine administered was amended to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Scar
Clinical narrative: Information has been received on 24-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her husband. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-MAR-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient developed severe and painful itching on her stomach and back. The patient presented to her primary care physician and was diagnosed with shingles. Thereafter, the patient developed painful blisters which resulted in severe scarring over large portions of her body. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Persistent and severe strain of herpes zoster/shingles and severe scarring over large portions of her body were considered to be disabling. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLUX, PPV, VARCEL
Symptoms: Allergy to vaccine, Blood glucose increased
Clinical narrative: Case number PHHY2016US160835, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 644747) website on 21 Nov 2016. This report refers to a 16 years old male patient. Prior vaccination history included as patient vaccinated with unspecified vaccine (no brand name) and had burning skin, welts. Past medical history was not reported. Historical medication included as HUMALOG on sliding scale, patient body was rejecting HUMALOG that was, burning of the skin and huge welts at the injection sites which lasted 8 to 10 hours. Current condition included as allergic reaction to antibiotics (allergy to cillin antibiotics) and diabetes. Concomitant medication included as LANTUS for diabetes. It was reported that, reporter heard about TOUJEO which comes is 300 unit pens. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unspecified date. The patient also vaccinated with pneumococcal vaccine (other manufacture, batch number: not reported) (reported as pneumo/pneumonia shot) and vaccinated with Varicella vaccine (other manufacture, batch number: not reported) (reported as chicken pox vaccine), both on an unspecified date. On an unknown date, following the vaccination, the patient seems to be allergic to many things, including, the pneumonia shot, flu shot and chicken pox vaccine. The laboratory data included as, sugar level which was 85 currently and it was 200 in the past. The patient glycosylated haemoglobin (A1C) was decreased from 14 to 10. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Discomfort
Clinical narrative: Case number PHHY2016US164195, is an initial spontaneous report received from a consumer via other manufacturer via the Vaccine Adverse Event Reporting System (VAERS reference number: 646056) website on 21 Nov 2016. This report refers to a patient of unspecified age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with INN (unknown manufacturer, batch number: not reported) on an unspecified date. On an unspecified date after vaccination, the patient felt uncomfortable. The outcome of event felt uncomfortable was reported as condition unchanged. The seriousness and causality for the event felt uncomfortable were not reported.
Age: 94.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Gait disturbance, Insomnia, Malaise, Pain in extremity
Clinical narrative: Case number PHHY2016US163836, is an initial spontaneous report received from a consumer via other pharmaceutical company (Pfizer, Pfizer reference number: 2015406514) through Vaccine Adverse Event Reporting System (VAERS) web site (VAERS reference number: 646832) on 21 Nov 2016. This report refers to a 94 year old female patient. Historical condition was not reported. Current conditions included chronic bronchitis (this was first diagnosed about 5 years ago (date unspecified) and thyroid disorder NOS (medical history also included blood pressure (unspecified whether high or low)). Concomitant medication included LEVOXYL, an unspecified drug (once a day (QD)) for stomach and an unspecified drug (low dose, QD) for blood pressure. The patient received seasonal influenza virus vaccine INN (manufacturer unknown, batch number was not reported) in her left arm from 21 Oct 2015 (at 11 AM). The patient was also vaccinated with PREVNAR 13 in her left arm from 21 Oct 2015 (at 11 AM). The patient had no illness at the time of vaccination. On 21 Oct 2015 (few hours after vaccination), the patient experienced sickness, weakness, she could hardly sleep and her arm was sore. On an unspecified date, the patient experienced difficulty in walking (when sitting could hardly get up and go). The patient had received flu shots (unspecified), pneumonia shots (unspecified) and the shingles shot (unspecified) before and never had any bad reactions in the past. The outcome of the event she could hardly sleep was unknown, while the outcome of the events difficulty in walking (when sitting could hardly get up and go), weakness and sickness was condition unchanged and the outcome of the event her arm was sore was complete recovery. The seriousness and causality assessment of the events were not reported.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema, Oedema peripheral
Clinical narrative: Case number PHHY2016US181096, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 648219) website on 21 Dec 2016. This report refers to a 68 years old male patient. Past medical history was not reported. Concomitant medications included gabapentin, lisinopril, cetirizine, metformin, insulin glargine and clotrimazole. The patient was vaccinated with FLUCELVAX (batch number: 174271) left arm on 06 Oct 2016. On 07 Oct 2016, the patient experienced erythema, edema and edema of arm. It was reported that, reactions occurred 7 days after immunization was given and was seen in clinic. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site inflammation, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2016US180153, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 649085) on 21 Dec 2016. This report refers to a 77 year old female patient. The patient had no reported medical history or current conditions. Her concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185285) and PREVNAR 13 (other manufacturer, batch number: M73332); both vaccines administered into right arm on an unknown date. On an unknown date after vaccination, the patient experienced pain in right deltoid, swelling, inflammation, rash and warmth down to elbow. No known lab data were reported. The outcome of the events was unknown. The events were reported as non-serious. The causality of the events were not reported.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Case number PHHY2016US180520 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 651648) on 21 Dec 2016. This report refers to a 48 year old female patient. Her medical history included gynecological condition and foot problems. Current illness was not reported. Lab data was unknown. Concomitant medication included Norethindrone, diclofenac, misoprostol and ibuprofen. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185886) intramuscularly into right arm on 31 Aug 2016. On 1 Sep 2016, the patient experienced fever and sharp abdominal pain. Following the events patient was brought to the attention of primary care. The outcome of the events was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: ANTH, FLUC4, TYP
Symptoms: Feeling abnormal, Feeling cold, Flushing
Clinical narrative: Case number PHHY2016US181995, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 651822) website on 21 Dec 2016. This report refers to a 35 years old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with first dose of FLUCELVAX QUADRIVALENT (batch number: not reported) into left arm intramuscularly on 10 Sep 2016. The patient was also vaccinated with BIOTHRAX (manufacturer unknown, batch number: FAV482A) into left arm and TYPHIM VI (manufacturer unknown, batch number: M0102-1) into right arm intramuscularly on 10 Sep 2016. It was reported that, 30 to 45 minutes after immunization, the patient was not feeling good, was feeling cold and skin flushing. The patient blood pressure (BP) was reported as 116/83 and pulse was 83 on an unknown date. It was reported that the patient was taken to emergency room/urgent care and was ambulatory alert and oriented. The outcome of the events was reported as unknown. The seriousness of the events was reported as non-serious and causality was not reported. The Quality Assurance department confirmed that the initially reported batch number WT53906 was not valid for FLUCELVAX QUADRIVALENT.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US180772, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 651859) on 21 Dec 2016. This report refers to a 62 years old female patient. Historical condition and concomitant medication was reported as unknown. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185284) intramuscularly into arm on 24 Aug 2016. On same day after vaccination, the patient experienced severe shoulder pain and difficult to perform daily activities. The outcome of the event was reported as condition unchanged. The seriousness of the event was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Case number PHHY2016US180679, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 652035) website on 21 Dec 2016. This report refers to a 52-years-old male patient. Past medical history was not reported. Historical drug included FLEXERIL. Concomitant medications ATIVAN, SPIRIVA, PROVENTIL HF, NEXIUM, ADVAIR diskus, polyethylene glycol, ibuprofen, hydrocodone-acetaminophen and sulfasalazine. It was decided by both the patient and the provider to receive flu shot and PNEUMOVAX. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number 1619901) intramuscularly in left arm on 29 Aug 2016. The patient was also vaccinated with PNEUMOVAX (batch number: L014420) intramuscularly in left arm on 29 Aug 2016. it was reported that the patient was advised to have one injection in each arm however the patient repeatedly refused and insisted on both in left arm. On an unspecified date after vaccination the patient experienced fever and arm edema. On 01 Sep 2016, the patient was seen for fever and arm edema. The patient received treatment with KEFLEX after phone call to nurse. The patient was fine now. The outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Case number PHHY2016US180825, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 653354) website on 21 Dec 2016. This report refers to a 55 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) into left arm on 25 Aug 2016. On 26 Aug 2016, the patient experienced itching of arm, swelling slight, warmth and reddish. 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 quality assurance department has confirmed recovery on an unknown date. The seriousness and causality of the events were not reported. The quality assurance department has confirmed that the initially reported batch number: CS979 was not valid for FLUCELVAX QUADRIVALENT.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Lethargy, Myalgia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Case number PHHY2016US181558, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 653469) website on 21 Dec 2016. This report refers to a 53-years-old male patient. Past medical history included anxiety and acne. Current condition included Gastrooesophageal reflux disease (GERD). Concomitant medication included TRUVADA, MINOCIN and PROTONIX. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619601) in left arm on 09 Sep 2016. On 10 Sep 2016 after vaccination, the patient experienced intense muscle aches, sore throat, runny nose and lethargy. The outcomes of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Vaccination site joint pain
Clinical narrative: Case number PHHY2016US181216, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 653608) on 21 Dec 2016. This report refers to a 34 years old female patient. Medical history and current illness was reported as no. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1618801) intramuscularly into left arm on 12 Sep 2016. On 13 Sep 2016 after vaccination, the patient experienced joint pain at vaccination site. The outcome of the event was reported as unknown. The seriousness of the event was reported as non serious and causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Hypoaesthesia, Injection site pain
Clinical narrative: Case number PHHY2016US180569, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 653836) on 21 Dec 2016. This report refers to a 43 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168702) intramuscularly into left arm on 15 Sep 2016. After vaccination, on 16 Sep 2016, the patient woke up with stabbing pain in the upper arm on the injection arm and her hand on the same arm felt numb. As the time progressed, the hand was less numb but her lower arm and elbow still felt weird. It was reported that the patient did not need to go the physician or hospital as of the day, but if the patient still experiences the problem the next day she might go as a precaution. 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: 56.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Dyspnoea, Peripheral swelling, Swelling
Clinical narrative: Case number PHHY2016US179029, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 653947) website on 21 Dec 2016. This report refers to a 56 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) into right arm, intramuscularly on 16 Sep 2016. The patient was also vaccinated with PNEUMOVAX vaccine (batch number: 6027795) into left arm, intramuscularly on 16 Sep 2016. On the same day after vaccination, the patient experienced left arm was swollen as well as his chest on the same side and had some difficulty breathing. The patient said that his breathing was better but he was still swollen. The patient was give two 25mg oral diphenhydramine caps and sat on the bench in front of the pharmacy. Reporter called patient at 5:00PM Sat. The patient said his breathing was better but he was still swollen. Reporter advised him to seek medical attention if the swelling did not go down. 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. The quality assurance department had confirmed that the initially reported batch number: WT53206 was not vailed for FLUCELVAX QUADRIVALENT.
Age: 78.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Case number PHHY2016US181741, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 654266) website on 21 Dec 2016. This report refers to a 78-years-old female patient. Past medical history included irregular heartbeat. Current condition included allergy to FOSAMAX, BONIVA, CIPRO, EVISTA, FORTEO. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) intramuscularly in left arm on 19 Sep 2016. The patient was also vaccinated with PNEUMOVAX (batch number: L036437) intramuscularly in right arm on 19 Sep 2016. On the same day after vaccination the patient experienced fever, swelling of right arm, heat to right arm and pain to right arm. The outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2016US181723, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 654300) on 21 Dec 2016. This report refers to a 44 years old male patient. Historical condition was not reported. Current conditions included diabetes, hyperlipidemia and allergy to penicillin (hives). Concomitant medication included JANUMET XR, INVOKANA and atorvastatin. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185284) into left arm intramuscularly on 12 Sep 2016. After vaccination on 14 Sep 2016, the patient experienced left shoulder swelling and stiffness with limited range of motion. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non-serious and causality was not reported.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2016US181812, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 654314) website on 21 Dec 2016. This report refers to a 26 years old female patient. Past medical history was not reported. Current conditions included as allergies (respiratory) and environmental allergies. Concomitant medications included as ZYRTEC and diphenhydramine. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 185286) into right arm on 09 Sep 2016. On the same day after vaccination the patient injection burning then next morning on 10 Sep 2016, patient body temperature 99 degrees Fahrenheit, right arm red swollen and hot to touch has continued. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Vertigo
Clinical narrative: Case number PHHY2016US182012, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 654334) website on 21 Dec 2016. This report refers to a 53 years old female patient. Past medical history was not reported. Current condition included as sulfa. Concomitant medications included as losartan, amlodipine, pantoprazole and terbinafine. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185325A) into left arm, intramuscularly on 16 Sep 2016. On the same day after vaccination, the patient experienced vertigo that came on between 30 to 60 minutes post injection and lasted for approximately 30 hours. The outcome of the event was reported as complete recovery on an unknown date. The seriousness and causality of the event were not reported.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Case number PHHY2016US181818, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 654630) website on 21 Dec 2016. This report refers to a 66-years-old female patient. Past medical history and concomitant were not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) Intramuscularly in arm on 21 Sep 2016. On the same day after vaccination, the patient experienced dizziness. The outcome of the event was reported as condition unchanged. The seriousness causality of the event were not reported.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2016US180140, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 654736) on 21 Dec 2016. This report refers to a 43 years old female patient. Historical condition was not reported. Current conditions included allergy to penicillin, sulfa, erythromycin and DEMEROL. Concomitant medications included LEXAPRO and benazepril. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1618621) intramuscularly into left arm on 13 Sep 2016. On same day after vaccination, the patient's vaccination site became red, hot to touch, swollen and very itchy. The treatment medication included BENADRYL tablet 25 mg 01 DF, orally (PO). The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US181748, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 654764) on 21 Dec 2016. This report refers to a 58 years old male patient. Medical history was not reported. Concomitant medication included tamsulosin 0.4 mg. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 169001) intramuscularly into left arm on 21 Sep 2016. On 22 Sep 2016 after vaccination, the patient experienced light-headedness, dizziness and soreness in shoulder. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Arthralgia, Chills, Dizziness, Muscular weakness, Nausea
Clinical narrative: Case number PHHY2016US181632, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system website (VAERS: 654896) website on 21 Nov 2016. This report refers to a 59-year-old female patient. Historical condition was not reported. Current condition included asthma. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVLANT (lot number: 186685) and PNEUMOVAX (batch number: M018766) into left arm intramuscularly on 19 Sep 2016. On 20 Sep 2016 the patient experienced dizziness, nausea, sore throat, fever chills, severe joint pain and muscle weakness. The patient self-treated with ibuprofen and acetaminophen. Reported symptoms were ceased on 22 Sep 2016 afternoon. Seriousness of the events were reported as non serious and causality was not reported.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Case number PHHY2016US181632, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system website (VAERS: 654896) website on 21 Nov 2016. This report refers to a 59-year-old female patient. Historical condition was not reported. Current condition included asthma. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVLANT (lot number: 186685) and PNEUMOVAX (batch number: M018766) into left arm intramuscularly on 19 Sep 2016. On 20 Sep 2016 the patient experienced dizziness, nausea, sore throat, fever chills, severe joint pain and muscle weakness. The patient self-treated with ibuprofen and acetaminophen. Reported symptoms were ceased on 22 Sep 2016 afternoon. Seriousness of the events were reported as non serious and causality was not reported.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Influenza A virus test negative, Influenza B virus test, Influenza like illness, Influenza virus test negative
Clinical narrative: Case number PHHY2016US181800, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655495) on 21 Dec 2016. This report refers to a 25 years old female patient. Past medical history was not reported. Concomitant medications included TRI SPRINTEC and Multi Vitamin. She was vaccinated FLUCELVAX QUADRIVALENT (batch number: 185284) intramuscularly into the left arm on 18 Sep 2016. After vaccination, on 24 Sep 2016, she experienced flu like symptoms, low grade fever, body aches, chills, night sweats. The symptoms only occurred at night. She was tested for rapid flu test for Influenza A or B virus on 27 Sep 2016 which showed negative results. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: Case number PHHY2016US181800, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655495) on 21 Dec 2016. This report refers to a 25 years old female patient. Past medical history was not reported. Concomitant medications included TRI SPRINTEC and Multi Vitamin. She was vaccinated FLUCELVAX QUADRIVALENT (batch number: 185284) intramuscularly into the left arm on 18 Sep 2016. After vaccination, on 24 Sep 2016, she experienced flu like symptoms, low grade fever, body aches, chills, night sweats. The symptoms only occurred at night. She was tested for rapid flu test for Influenza A or B virus on 27 Sep 2016 which showed negative results. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 68.0
Sex: M
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Pain, Pruritus, Swelling
Clinical narrative: Case number PHHY2016US181746, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 655556) website on 21 Dec 2016. This report refers to a 68 years old male patient. Historical condition included peripheral vascular disease (PVD). Current conditions included hypertension and obesity. Concomitant medication was not reported. The patient was vaccinated FLUCELVAX QUADRIVALENT (batch number: 1619901) into left arm intramuscularly on 20 Sep 2016. After vaccination on 21 Sep 2016, the patient experienced pruritus followed by swelling and pain which resulted in limited range of motion. It was reported that conservative management with heat and cold packs and non-steroidal anti-inflammatory drug (NSAIDS) as needed (PRN) were taken by the patient. 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: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Case number PHHY2016US182051, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655618) website on 21 Dec 2016. This report refers to a 26-years-old female patient. Past medical history and concomitant were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) on 24 Sep 2016. On an unspecified date, the patient experienced area where shot was given was hot and swelling of upper arm and headache and nausea. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Case number PHHY2016US179560, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 656099) website on 21 Dec 2016. This report refers to a 39 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 169005) intramuscularly into the arm on 22 Sep 2016. On the same day after vaccination, the patient experienced urticarial rash and throat swelling sensations. The patient visited the emergency room. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Vaccination site discolouration, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Case number PHHY2016US181831, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 656476) on 21 Dec 2016. This report refers to a 07 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) on 29 Sep 2016. On same day after vaccination, the patient experienced vaccination site reaction, large red spot on leg, hot to the touch and white ring around the red spot. 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: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2016US181788, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 656510) on 21 Dec 2016. This report refers to a 52 years old female patient. Past vaccination included unspecified reaction to an unknown vaccine. Concomitant medications were not reported. She was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) intramuscularly on 28 Sep 2016. After vaccination, on 29 Sep 2016, she noted that her arm was somewhat painful at injection site and warm around injection site. It was reported that she had a better reaction than previous vaccine she received. No treatment was requested at the time of this report. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Muscular weakness, Pyrexia
Clinical narrative: Case number PHHY2016US181828, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 656519) website on 21 Dec 2016. This report refers to a 56 years old female patient. Past medical history was not reported. Concomitant medication included as Daily Multivitamin. The patient was vaccinate with FLUCELVAX QUADRIVALENT (batch number: not reported) into right arm, intramuscularly on 01 Oct 2016. On the same day after vaccination, the patient experienced whole body muscle weakness, low-grade fever, headache and fatigue. It was reported that, patient when to bed and slept, drank fluids. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Feeling hot, Flushing, Hyperhidrosis, Presyncope
Clinical narrative: Case number PHHY2016US179461 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 656552) website on 21 Dec 2016. This report refers to 39 year old female patient. Medical history and concomitant medications was not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 168802), intramuscular into left arm on 02 Oct 2016. On the same day patient felt warm at 5:51PM and rather sit on cool floor, then felt clammy, sweaty, flushed face, so she laid down at 5:53PM. She was coherent entire time of near syncope stating this was routine reaction post shots and doctor was aware. The salt and orange juice was provided to her. She refused further medical treatment. She returned to felt much better and normal self she stated at 6:09PM and stood up at 6:15PM with no problems or concerns. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Erythema, Induration, Injection site induration, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2016US180719, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 656682) website on 21 Dec 2016. This report refers to a 25 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185286) into right arm (right deltoid), intramuscularly on 22 Sep 2016. On 23 Sep 2016, the patient experienced 04 hours diarrhea and redness today vaccinated yesterday, feels stiff and firm approximately 2 cm of induration on right deltoid, with axillary tenderness. It was reported that, patient had mild reaction (unspecified). The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Tenderness
Clinical narrative: Case number PHHY2016US180719, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 656682) website on 21 Dec 2016. This report refers to a 25 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185286) into right arm (right deltoid), intramuscularly on 22 Sep 2016. On 23 Sep 2016, the patient experienced 04 hours diarrhea and redness today vaccinated yesterday, feels stiff and firm approximately 2 cm of induration on right deltoid, with axillary tenderness. It was reported that, patient had mild reaction (unspecified). The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Balance disorder, Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Case number PHHY2016US179536 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 656700) website on 21 Dec 2016. This report refers to 48 year male patient. Medical history included hypertension diagnosed 3 month ago and historical condition hay fever. Concomitant medication included Lisinopril with HCTZ. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185888) intramuscular into left arm on 29 Sep 2016. On the same day, after 30 minutes injection, patient started felt dizzy, lightheaded, sweating, N+V (nausea, vomiting) multiple times. Felt S/S all day long and next day only has lightheadedness, dizzy, off balance. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Case number PHHY2016US181779, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657070) on 21 Dec 2016. This report refers to a 33 years old female patient. Historical condition was not reported. Current condition included latex allergy. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619021) intramuscularly in to left arm on 03 Oct 2016. On the same day after vaccination, the patient experienced red, warm area around the vaccination site, area measures 01 inch by 3.5 inches, soreness around and above the vaccination site extending into the upper shoulder and no pain or soreness below the vaccination site. 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: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscular weakness
Clinical narrative: Case number PHHY2018US179692 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 657294) website on 21 Dec 2016. This report refers to 52 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated FLUCELVAX QUADRIVALENT (batch number: 168705) intramuscular on 04 Sep 2016. On the same day felt weakness between her elbow and the fingers of her left arm. The outcome of the event was reported as not reported. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2016US181773, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657319) on 21 Dec 2016. This report refers to a 03 years old female patient. Medical history and current illness was reported as none. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619301) intramuscularly in to left leg on 03 Oct 2016, when she was 03 years old (only indicated for 04 years and older). No adverse event was reported following this administration error. The seriousness of the event was reported as non serious.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US182227, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657475) on 21 Dec 2016. This report refers to a 38 years old female patient. Medical history was reported as no. Concomitant medication included ALLEGRA 180 mg. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1619801) intramuscularly into left arm on 09 Sep 2016. On the same day after vaccination, the patient began to experience pain and it was reported as, currently 04 weeks from administration of vaccination and symptoms continue to include arm and shoulder pain, the patient requiring ibuprofen for some relief and had very limited range of motion without increased pain. On 27 Sep 2016, the patient consulted doctor but no treatment or follow up was advised. The outcome of the event arm and shoulder pain was reported as condition unchanged and for other event it was not reported. The seriousness of the event was reported as non serious and causality was not reported.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain
Clinical narrative: Case number PHHY2016US181592, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 657621) website on 21 Dec 2016. This report refers to a 30 years old female patient. Past medical history included as Chiari malformation. Procedure included as brain surgery 1 year before. Concomitant medications was not reported. It was reported that, patient was healthy at time of shot. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185284) into left arm on 08 Aug 2016. On the same day after vaccination, the patient experienced sharp pain in shoulder, been going for 01 month and 1/2. Patient received pain patches about 01 month after shot. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 44.0
Sex: F
Vaccine: FLUC4, HEPAB, IPV, MMR, PPV, TDAP
Symptoms: Headache, Migraine, Pain, Pyrexia
Clinical narrative: Case number PHHY2016US181760, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 657634) on 21 Dec 2016. This report refers to a 44 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1618501), TWINRIX (other manufacturer, batch number: DX7D3) intramuscularly into the right arm, IPOL (other manufacturer, batch number: M1120), intramuscularly into the left arm, MMR II (other manufacturer, batch number: L041456), subcutaneously into the left arm, PNEUMOVAX (other manufacturer, batch number: L014420) intramuscularly into the left arm and ADACEL (other manufacturer, batch number: U5468AA) intramuscularly into the right arm: on 30 Sep 2016. After vaccination, on the same day, she started feeling adverse reactions after work hours including headaches, migraines, fever and body aches. She went to the clinic on 02 Oct 2016. She also visited the emergency room. 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: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2016US181225, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 657659) website on 21 Dec 2016. This report refers to a 50 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: I85784) intramuscularly in left arm on 23 Sep 2016. On an unknown date, the patient experienced arm numbness and went to emergency room (ER) for treatment. The outcome of the event was reported as condition unchanged. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Nervous system disorder, Tenderness, X-ray abnormal
Clinical narrative: Case number PHHY2016US179088, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 657820) on 21 Dec 2016. This report refers to a 61 year old female patient. She had no medical history and current condition. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) on 19 Sep 2016. On the same day, the patient developed tenderness in arm and neck for 3 weeks. Following the events she visited emergency room. She had an x-ray test and her physician believed that she had a nerve issue. The outcome of the events was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Paraesthesia
Clinical narrative: Case number PHHY2016US182226, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 657979) on 21 Dec 2016. This report refers to a 56 years old female patient. Medical history was reported as no. It was reported that, not sure what medications and vaccines patient has received before or after. The patient was vaccinated with first dose of FLUCELVAX QUADRIVALENT (batch number: 168704) intramuscularly into left arm on 27 Sep 2016. On 07 Oct 2016 (09 days later) after vaccination, the patient experienced numbness and tingling on the arm flu shot was given and could not lift her arm. 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: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscle spasms, Pain in extremity, Rash
Clinical narrative: Case number PHHY2016US182011, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system website (657983) on 21 Dec 2016. This report refers to a 36-year-old female patient. Historical conditions included epilepsy, anxiety, depression and heart valve deficiency. Past medications included BACTRIM, penicillin, doxycycline and CORICIDIN. Current conditions included hypothyroidism, allergies, type 2 diabetes and hypertension. The patient was polymedicated. The patient was vaccinated with FLUCELVAX QUADRIVALENT dose 3 (batch number: 1618701) into right arm intramuscularly 04 Oct 2016. On 05 Oct 2016 the patient experienced rash on face and pain/cramping in legs began day after vaccine was administered. Outcome of the events was unknown. Seriousness of the event was reported as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Diarrhoea, Inflammation, Myalgia, Pain
Clinical narrative: Case number PHHY2016US181840, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 658019) on 21 Dec 2016. This report refers to a 30 years old female patient. Past medical history and current condition were not reported. Concomitant medications included SINGULAIR, cyproheptadine and NUVARING. She was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) and PNEUMOVAX (other manufacturer, batch number: M033086); both vaccines intramuscularly into the right arm on 05 Oct 2016. After vaccination, on the same day, she experienced muscle pain, diarrhea, chills, body aches, fever and post injection inflammatory reaction. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.