chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US010877, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603166) website on 18 Jan 2016. This report refers to a 47-years-old female patient. Past medical history was not reported. Concomitant medications included trazodone (manufacturer unknown). She was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly in right arm on 02 Oct 2015. On the same day, she experienced pain in right deltoid after vaccine. On an unknown date, she experienced shoulder pain. The outcome of the events unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Asthenia, Dehydration, Diarrhoea, Dizziness
Clinical narrative: Case number PHHY2015US174312, is an initial spontaneous report received from a nurse (also patient) via Vaccine Adverse Events Reporting System (VAERS reference number: 603190) on 29 Dec 2015. This report refers to a 52-year-old female patient. Historical conditions included arthralgia, arthritis (on a steroid burst), back pain and obesity. Concomitant medication included MOBIC, LYRICA, CYMBALTA, ULTRAM, prednisone, omeprazole and tizanidine. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2015. On 17 Oct 2015, the patient developed moderate continuous frontal headache all afternoon and the patient felt feverish. Later in the day the patient experienced generalized aching in legs and aching in neck. In the evening the patient developed abdominal feeling of impending diarrhea and had a loose stool before bedtime. On 18 Oct 2015 by 05:00 AM, the patient experienced hourly or less episodes of moderate diarrhea. The patient was unable to eat and drink. Further, the patient slept all day except to get up to have diarrhea. The patient was not in pain but was so sleepy. The patient felt cold and used heated blankets. The patient did not have fever or shaking, chills throughout any of this day on 18 Oct 2015. However on 18 Oct 2015, the patient was dizzy and felt so weak from the continuous diarrhea episodes. The patient's last episode was at 08:00 PM on 18 Oct 2015. On 19 Oct 2015, the patient awoke feeling just a slight headache and slight dehydration. The patient had one soft loose BM on 19 Oct 2015 but stated that that this will not be diarrhea. The patient was drinking coffee and fluids and feels stronger with totally resolving symptoms. The patient did not need any treatment for the events. Final outcome of events was recovered. Events were reported as non-serious. Causality was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Feeding disorder, Fluid intake reduced, Headache, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2015US174312, is an initial spontaneous report received from a nurse (also patient) via Vaccine Adverse Events Reporting System (VAERS reference number: 603190) on 29 Dec 2015. This report refers to a 52-year-old female patient. Historical conditions included arthralgia, arthritis (on a steroid burst), back pain and obesity. Concomitant medication included MOBIC, LYRICA, CYMBALTA, ULTRAM, prednisone, omeprazole and tizanidine. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2015. On 17 Oct 2015, the patient developed moderate continuous frontal headache all afternoon and the patient felt feverish. Later in the day the patient experienced generalized aching in legs and aching in neck. In the evening the patient developed abdominal feeling of impending diarrhea and had a loose stool before bedtime. On 18 Oct 2015 by 05:00 AM, the patient experienced hourly or less episodes of moderate diarrhea. The patient was unable to eat and drink. Further, the patient slept all day except to get up to have diarrhea. The patient was not in pain but was so sleepy. The patient felt cold and used heated blankets. The patient did not have fever or shaking, chills throughout any of this day on 18 Oct 2015. However on 18 Oct 2015, the patient was dizzy and felt so weak from the continuous diarrhea episodes. The patient's last episode was at 08:00 PM on 18 Oct 2015. On 19 Oct 2015, the patient awoke feeling just a slight headache and slight dehydration. The patient had one soft loose BM on 19 Oct 2015 but stated that that this will not be diarrhea. The patient was drinking coffee and fluids and feels stronger with totally resolving symptoms. The patient did not need any treatment for the events. Final outcome of events was recovered. Events were reported as non-serious. Causality was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Somnolence
Clinical narrative: Case number PHHY2015US174312, is an initial spontaneous report received from a nurse (also patient) via Vaccine Adverse Events Reporting System (VAERS reference number: 603190) on 29 Dec 2015. This report refers to a 52-year-old female patient. Historical conditions included arthralgia, arthritis (on a steroid burst), back pain and obesity. Concomitant medication included MOBIC, LYRICA, CYMBALTA, ULTRAM, prednisone, omeprazole and tizanidine. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2015. On 17 Oct 2015, the patient developed moderate continuous frontal headache all afternoon and the patient felt feverish. Later in the day the patient experienced generalized aching in legs and aching in neck. In the evening the patient developed abdominal feeling of impending diarrhea and had a loose stool before bedtime. On 18 Oct 2015 by 05:00 AM, the patient experienced hourly or less episodes of moderate diarrhea. The patient was unable to eat and drink. Further, the patient slept all day except to get up to have diarrhea. The patient was not in pain but was so sleepy. The patient felt cold and used heated blankets. The patient did not have fever or shaking, chills throughout any of this day on 18 Oct 2015. However on 18 Oct 2015, the patient was dizzy and felt so weak from the continuous diarrhea episodes. The patient's last episode was at 08:00 PM on 18 Oct 2015. On 19 Oct 2015, the patient awoke feeling just a slight headache and slight dehydration. The patient had one soft loose BM on 19 Oct 2015 but stated that that this will not be diarrhea. The patient was drinking coffee and fluids and feels stronger with totally resolving symptoms. The patient did not need any treatment for the events. Final outcome of events was recovered. Events were reported as non-serious. Causality was not reported.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US173627 is an initial spontaneous report received via Adverse Events Reporting System (VAERS reference number: 603239) on 29 Dec 2015. This report refers to a 78 year old female patient. Her medical history and current conditions were not reported. Her concomitant medications were sertraline, quinapril, hydrochlorothiazide, diltiazem, anastrozole, calcium tablets and vitamin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 14 Oct 2015. On the same day after vaccination, the events started with sore arm and she was just feeling bad. At about 7 pm, her shoulders and neck began to ache. She had extreme chills and then severe headache. She took TYLENOL and went to bed at 9:00 pm. When she awoke a little later, the symptoms were gone. She was very tired on 15 Oct 2015 and 16 Oct 2015. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2015US173627 is an initial spontaneous report received via Adverse Events Reporting System (VAERS reference number: 603239) on 29 Dec 2015. This report refers to a 78 year old female patient. Her medical history and current conditions were not reported. Her concomitant medications were sertraline, quinapril, hydrochlorothiazide, diltiazem, anastrozole, calcium tablets and vitamin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 14 Oct 2015. On the same day after vaccination, the events started with sore arm and she was just feeling bad. At about 7 pm, her shoulders and neck began to ache. She had extreme chills and then severe headache. She took TYLENOL and went to bed at 9:00 pm. When she awoke a little later, the symptoms were gone. She was very tired on 15 Oct 2015 and 16 Oct 2015. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 40.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Case number PHHY2016US010416 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 603310) website on 18 Jan 2016. This report refers to a 40 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly in the right deltoid. On 16 Oct 2015, the patient experienced redness and hot to touch at the site of vaccination (right deltoid). It was reported that, vaccination site measured 7 centimeter x 3 centimeter. The patient was taken to an emergency room and he refused to apply ice. Outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Headache, Injection site warmth, Lacrimation increased, Pain
Clinical narrative: Case number PHHY2016US010699, in an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 603371) website on 18 Jan 2016. This report refers to a 58-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly into left arm on 12 Oct 2015. After vaccination on 15 Oct 2015, the patient experienced redness/ redness measured 10cm x 3cm, headache, water eyes and nose, pain and site was warm to touch. The patient visited the emergency room on an unknown date. The final outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported.
Age: 58.0
Sex: F
Vaccine: FLUC3
Symptoms: Rhinorrhoea
Clinical narrative: Case number PHHY2016US010699, in an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 603371) website on 18 Jan 2016. This report refers to a 58-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly into left arm on 12 Oct 2015. After vaccination on 15 Oct 2015, the patient experienced redness/ redness measured 10cm x 3cm, headache, water eyes and nose, pain and site was warm to touch. The patient visited the emergency room on an unknown date. The final outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported.
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2016US010446, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603372) website on 18 Jan 2015. This report refers to a 48 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) into left arm intramuscular on 14 Oct 2015. ON 16 Oct 2015 injection site was warm to touch and redness. Redness was measured 7.5 cm x 4.5 cm. The patient went to emergency room. The outcome of the events was unknown. The seriousness of the event was reported as non serious and causality was not reported.
Age: 72.0
Sex: F
Vaccine: FLUC3
Symptoms: Ecchymosis, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Tenderness
Clinical narrative: Case number PHHY2016US006714, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603564) website on 18 Jan 2015. This report refers to a 72 years old female patient. Historical conditions included epilepsy, breast cancer and thyroid nodule. Concurrent condition included and hypertension. Concomitant medications included lamotrigine (manufacture unknown), anastrozole (manufacture unknown), HCTZ, atorvastatin (manufacture unknown), losartan (manufacture unknown), levetiracetam (manufacture unknown), ibuprofen (manufacture unknown), amlodipine (manufacture unknown). The patient was vaccinated with FLUCELVAX (batch number: 173989) intramuscularly into left arm on 07 Oct 2015. On 09 Oct 2015, patient developed stiffness in the anterior, posterior deltoid and supraspinatus muscles. The patient's arm was very tender, painful and she was unable to lift her arm. The patient had large ecchymosis of anterior deltoid, softer muscles when she was seen on 19 Oct 2015. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality was not reported.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Muscle spasms, Pain
Clinical narrative: Case number PHHY2015US173662, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 603566) on 29 Dec 2015. This report refers to a 50 years female patient. Medical history was not reported. Concomitant medications were none. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly on 08 Oct 2015. Post vaccination the patient experienced injection site muscle pain and spasm for two weeks. Further the patient experienced decrease range of motion because of pain. The patient went to emergency room due to these events. The patient was treated with MEDROL dose pack, ibuprofen and physical therapy. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Case number PHHY2015US173996 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 603757) on 29 Dec 2015. This report refers to a 43 year old female patient. Her medical history included minor sciatica in right leg. She had no current conditions. Her concomitant medications were multivitamin and Vitamin D3. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left shoulder on 08 Oct 2015. The nurse stated that she was having a problem with the syringe plunger while the needle was already in the let shoulder on 02 Oct 2015. The nurse stated that she was having a problem with the syringe plunger while the needle was already in the left shoulder of the patient. After few seconds, she finally was able to get the vaccine injected. Immediately after vaccination, she felt a numbing pain in her left shoulder. A few hours after vaccination, she could not lift her arm above the shoulder level. It was reported that her whole shoulder was very painful, especially the shoulder joints. On 11 Oct 2015, she went to doctor at immediate care (emergency room) because her left arm started getting numb, lame and tingly. The shoulder was still sore. She was prescribed 3 to 4 ADVIL three times per day and was referred to a neurologist. On 21 Oct 2015, she still had severe pain in her shoulder and limited range of motion. It seemed to be getting worse, rather than becoming better. She had to physical therapy treatments which did not help. She would have an appointment on 26 Oct 2015 and hope to get a magnetic resonance imaging (MRI) of her shoulder and get referred to an orthopedic surgeon. The final outcome of events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, Syringe issue
Clinical narrative: Case number PHHY2015US173996 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 603757) on 29 Dec 2015. This report refers to a 43 year old female patient. Her medical history included minor sciatica in right leg. She had no current conditions. Her concomitant medications were multivitamin and Vitamin D3. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left shoulder on 08 Oct 2015. The nurse stated that she was having a problem with the syringe plunger while the needle was already in the let shoulder on 02 Oct 2015. The nurse stated that she was having a problem with the syringe plunger while the needle was already in the left shoulder of the patient. After few seconds, she finally was able to get the vaccine injected. Immediately after vaccination, she felt a numbing pain in her left shoulder. A few hours after vaccination, she could not lift her arm above the shoulder level. It was reported that her whole shoulder was very painful, especially the shoulder joints. On 11 Oct 2015, she went to doctor at immediate care (emergency room) because her left arm started getting numb, lame and tingly. The shoulder was still sore. She was prescribed 3 to 4 ADVIL three times per day and was referred to a neurologist. On 21 Oct 2015, she still had severe pain in her shoulder and limited range of motion. It seemed to be getting worse, rather than becoming better. She had to physical therapy treatments which did not help. She would have an appointment on 26 Oct 2015 and hope to get a magnetic resonance imaging (MRI) of her shoulder and get referred to an orthopedic surgeon. The final outcome of events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain
Clinical narrative: Case number PHHY2015US173614, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604034) on 29 Dec 2015. This report refers to a 58 years old female patient. Medical history was none. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscular on 26 Sep 2015. On 05 Oct 2015 the patient experienced pain. Further, the patient had loss of motion in arm shoulder which seems to be getting worse. It was reported that ibuprofen helps to control it. The case was  assessed as non-serious. Outcome and causality of the events was not reported.
Age: 70.0
Sex: M
Vaccine: FLUC3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Case number PHHY2015US173615, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604040) on 29 Dec 2015. This report refers to a 70 years old polymedicated male patient. Concurrent condition included pressure in left chest. Historical drug included Penicillin. The patient was vaccinated with FLUCELVAX (batch number: 174084) intramuscularly into right arm on 15 Oct 2015. On 17 Oct 2015 the patient experienced swelling, erythema and itching. The patient seen at primary case physician office and treated with MEDROL dose pak. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2016US010382, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604058) on 18 Jan 2016. This report refers to a 46 years old male patient. Medical history and current illness were unknown. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173989) intramuscularly into left arm on 08 Oct 2015. On the same day after vaccination the patient developed inhibited range of motion with shoulder pain as the vaccine was given too high on the shoulder. Outcome of the events of the events was not recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Case number PHHY2015US173629, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 604068) website on 29 Dec 2015. This report refers to a 62-year-old male patient. The patient had no medical history and current illness. Concomitant medication included LIPITOR, SYNTHROID, potassium, carbomyazepine, omeprazole and losartan. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 12 Oct 2015. On the same day after vaccination, the patient experienced pain at injection. Further, the aching pain has continued down the whole arm and it was very painful and the patient reduction in mobility in the arm and the patient wakes the up at night. Final outcome of the events was not reported. Events were reported as non-serious. Causality was not reported.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event
Clinical narrative: Case number PHHY2016US010383, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604132) on 18 Jan 2016. This report refers to a 17 years old female patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) intramuscularly into left arm on an unknown date. No adverse event was reported following this medication error.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Ear congestion
Clinical narrative: Case number PHHY2015US173693 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604174) on 29 Dec 2015. This report refers to a 41 year old female patient. The patient had no medical history or current conditions. Her concomitant medications were multivitamin chews, fish oil, biotin, CLA, Garcinia and probiotic. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2015. On 20 Oct 2015, she experienced left ear fullness and dizziness. The outcome of the events was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Case number PHHY2015US173825 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604207) on 29 Dec 2015. This report refers to a 26 year old female patient. Her current conditions included birth control, allergy to trees and nuts, seasonal allergy and environmental allergy. Her concomitant medications were Women's multivitamin, JUNEL birth control daily, ADVAIR twice daily and Albuterol inhaler as required. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm and PNEUMOVAX 23 (other manufacturer, batch number: not reported) in the right arm; both vaccines administered on 21 Oct 2015. On the same date, she experienced pain in the right arm limiting movement and strength. She stated that any use of the upper bicep or shoulder created intense pain leading to lack of sleep and lack of ability to complete daily routines requiring arm. The onset of pain occurred few hours after receiving the shot and by evening it intensified. The pain was unbearable throughout the night. In the morning, the pain was still present and limited mobility was evident. No laboratory tests were done. The final outcome of events was reported as unknown. The events were reported as non-serious. The causality of the events was not reported. Following an internal review of the data received on 29 Dec 2015, it was identified that the event verbatim "intense pain leading to lack of sleep" was erroneously coded as sleep disturbed and hence it was recoded as sleep loss.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Laboratory test normal, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Case number PHHY2015US173937, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 604603) website on 29 Dec 2015. This report refers to a 49 years old female patient. Past medical history included as autoimmune and many allergies. Patient prior vaccination history included as severe shoulder pain, unable to fully move arm, pain radiating up neck and down arm, tingling sensation into pointer finger and thumb, unable to fully dress self, use bathroom, reach for items, complete normal work and home tasks and also vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm, intramuscularly on 22 Oct 2015. On 23 Oct 2015, the patient experienced severe shoulder pain, unable to fully move arm, pain radiating up neck and down arm, tingling sensation into pointer finger and thumb, unable to fully dress self, use bathroom, reach for items, complete normal work and home tasks. 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: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2015US173937, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 604603) website on 29 Dec 2015. This report refers to a 49 years old female patient. Past medical history included as autoimmune and many allergies. Patient prior vaccination history included as severe shoulder pain, unable to fully move arm, pain radiating up neck and down arm, tingling sensation into pointer finger and thumb, unable to fully dress self, use bathroom, reach for items, complete normal work and home tasks and also vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm, intramuscularly on 22 Oct 2015. On 23 Oct 2015, the patient experienced severe shoulder pain, unable to fully move arm, pain radiating up neck and down arm, tingling sensation into pointer finger and thumb, unable to fully dress self, use bathroom, reach for items, complete normal work and home tasks. 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: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US173782, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 604643) website on 29 Dec 2015. This report refers to a 3-year-old female patient. The patient had no medical history and current illness. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into the right leg on 23 Oct 2015. On 24 Oct 2015, the patient's right leg around injection site displayed redness, swelling, warm to the touch and tender. By the next morning, the red area had spread considerably covering about one fourth of the thigh. By the evening of 25 Oct 2015, it stopped spreading and by 26 Oct 2015 it was not any worse and started to resolve. Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Case number PHHY2015US173716, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604764) on 29 Dec 2015. This report refers to a 55 years old female patient. Concurrent condition included hypothyroidism. Concomitant medication included NATURE THROID (thyroid). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 23 Oct 2015. On the same day after vaccination the patient developed severe lower back spasms and slight fever. The patient went to emergency room due to these events. Outcome of the events was reported as not recovered. The case was assessed as non-serious. Causality of the events was not reported.
Sex: M
Vaccine: FLUX, FLUX, FLUX(H1N1)
Symptoms: Exposure during pregnancy
Clinical narrative: Baby Case. Case number PHHY2015US173584, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 604878) website on 29 Dec 2015. This report refers to a male neonate patient of an unknown age. Past medical history and concomitant medications were not reported. The mother of the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) (reported as H1N1 vaccine) on an unknown date in 2009 (for mother case, see case: PHHY2015US173585). On an unknown date, the patient experienced acid reflux. The mother of the patient strongly felt that is was caused by the flu vaccine. The final outcome, seriousness and causality of the event was not reported.
Sex: M
Vaccine: FLUX, FLUX, FLUX(H1N1)
Symptoms: Foetal exposure during pregnancy, Gastrooesophageal reflux disease
Clinical narrative: Baby Case. Case number PHHY2015US173584, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 604878) website on 29 Dec 2015. This report refers to a male neonate patient of an unknown age. Past medical history and concomitant medications were not reported. The mother of the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) (reported as H1N1 vaccine) on an unknown date in 2009 (for mother case, see case: PHHY2015US173585). On an unknown date, the patient experienced acid reflux. The mother of the patient strongly felt that is was caused by the flu vaccine. The final outcome, seriousness and causality of the event was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2015US173783, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 605027) website on 29 Dec 2015. This report refers to a 43-year-old female patient. Historical condition included celiac disease. The patient had no current illness. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Sep 2015. On 25 Sep 2015, the patient experienced pain in shoulder. The patient had the pain particularly upon raising arm above head, stretching arm behind back and other shoulder rotations. This had persisted for one month. Final outcome of the events was not recovered. Events were reported as non-serious. Causality was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal discomfort, Musculoskeletal pain, Paraesthesia
Clinical narrative: Case number PHHY2015US173796, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 605059) website on 29 Dec 2015. This report refers to a 37-year-old female patient. Medical history and current illness was none. Concomitant medication was none. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported, site of vaccination: not reported) on 22 Sep 2015. On 28 Sep 2015, the patient developed severe intermittent shoulder pain and was unable to fully lift arm that lasted for 7 to 10 days and it exacerbated by certain motions. The shoulder pain had lessoned but the discomfort was always present and it exacerbated by multiple routine motions. The patient's hand/lower arm occasionally feels tingly and asleep and this had persisted for the last few weeks. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported.
Age: 0.67
Sex: F
Vaccine: FLUX, HEP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Case number PHHY2015US173797, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 605511) website on 29 Dec 2015. This report refers to an 8-month-old female patient. Current illness was none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the leg along with hepatitis B vaccine (manufacturer and batch number: not reported) into the leg on 23 Oct 2015. On 24 Oct 2015, the patient experienced vomiting and diarrhea. Final outcome of the events was not reported. Events were reported as non-serious. Causality was not reported.
Age: 63.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Burning sensation, Erythema, Pain
Clinical narrative: Case number PHHY2015US173798 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605513) on 29 Dec 2015. This report refers to a 63 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal polyvalent vaccine (other manufacturer, batch number: not reported); both vaccines administered on 25 Oct 2015. On the same day after vaccination, he had pain/burning sensation, soreness and redness. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Case number PHHY2015US173814 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 605617) on 29 Dec 2015. This report refers to a 42 year old female patient. Her current condition included rheumatoid arthritis and concomitant medications were CIMZIA 400 mg injections every 4 weeks, Trazodone, MIRAPEX and ibuprofen. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal polyvalent vaccine (other manufacturer, batch number: not reported); both vaccines administered in the left arm on 26 Oct 2015. On the same day after vaccination, she had swelling, redness measuring 2 inches x 3 inches and it was hot and painful to touch. She also had slight fever. The events outcome was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Blood test, Chills, Decreased appetite
Clinical narrative: Case number PHHY2015US173819 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605643) on 29 Dec 2015. This report refers to a 54 year old male patient. He had no pre-existing conditions or no illness at the time of vaccination. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Oct 2015. On 23 Oct 2015, he experienced fever, chills, sweats, weakness, muscle ache, joint ache, poor sleep, loss of appetite and bad headache. On 26 Oct 2015, blood work was done and results were not reported. The events outcome was not reported. The events were reported as non-serious. The reporter stated that the events occurred from an influenza vaccine.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Hyperhidrosis, Myalgia, Poor quality sleep, Pyrexia
Clinical narrative: Case number PHHY2015US173819 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 605643) on 29 Dec 2015. This report refers to a 54 year old male patient. He had no pre-existing conditions or no illness at the time of vaccination. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Oct 2015. On 23 Oct 2015, he experienced fever, chills, sweats, weakness, muscle ache, joint ache, poor sleep, loss of appetite and bad headache. On 26 Oct 2015, blood work was done and results were not reported. The events outcome was not reported. The events were reported as non-serious. The reporter stated that the events occurred from an influenza vaccine.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal pain, Neck pain, Vertigo, Vomiting
Clinical narrative: Case number PHHY2015US174290, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 605811) website on 29 Dec 2015. This report refers to a 78 year old male patient. Historical condition was not reported. Current condition included asthma. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Oct 2015. On 23 Oct 2015, the patient developed vertigo, vomiting, headache, shoulder pain and neck pain. Outcome of the events was reported as complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2015US173821, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 605865) on 29 Dec 2015. This report refers to a 63 years old female patient. The patient had no medical history and no current illness. Concomitant medications included SYNTHROID, PREMARIN and PRAVACHOL. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 05 Oct 2015. On the same day after vaccination the patient experienced pain at the injection site and pain in down arm. Further the patient experienced extreme pain in the shoulder joint and was unable to lift arm or use it. It was reported that the pain continued in the arm and shoulder joint. Not getting any better so far. Final outcome of the events was reported as not recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Musculoskeletal pain, Nodule, Pain in extremity, Pruritus
Clinical narrative: Case number PHHY2016US009117, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 605921) website on 18 Jan 2016. This report refers to a 64 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174273) intramuscularly in left arm on 09 Oct 2015. On 10 Oct 2015, the patient experienced large red spot oval shape, knot, hot to touch, itchy, achy pain from shoulder down to hand. The patient still had pain two weeks later and still had red spot. The final outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious and causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: Skin warm
Clinical narrative: Case number PHHY2016US009117, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 605921) website on 18 Jan 2016. This report refers to a 64 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174273) intramuscularly in left arm on 09 Oct 2015. On 10 Oct 2015, the patient experienced large red spot oval shape, knot, hot to touch, itchy, achy pain from shoulder down to hand. The patient still had pain two weeks later and still had red spot. The final outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious and causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Case number PHHY2015US173764, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606072) website on 29 Dec 2015. This report refers to a 40 years old female patient. Past medical history included as seasonal allergies, diabetes, epilepsy, and hypothyroid. Concomitant medications included as KEPPRA, SYNTHROID, Multi Vitamin and LANTUS. Patient prior vaccination history included as allergic reaction and also she vaccinated with Pneumo vaccine (manufacturer and batch number: not reported) on an unknown date. The patient was vaccinated with seasonal influenza (manufacturer and batch number: not reported) into left arm on 05 Sep 2015. On 12 Sep 2015, the patient experienced extreme soreness in the upper arm that did not go away after the first few days after vaccination. It was stated that, pain has continued in the upper arm and there has been a loss of motion in the shoulder. The outcome of the events was reported as unknown. The seriousness of the events was reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Contusion, Swelling
Clinical narrative: Case number PHHY2015US173733, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606108) on 29 Dec 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on an unknown date. After vaccination, she experienced swelling and bruising. The outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Contusion, Immediate post-injection reaction, Injection site pain, Swelling
Clinical narrative: Case number PHHY2015US173733, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606108) on 29 Dec 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on an unknown date. After vaccination, she experienced swelling and bruising. The outcome, seriousness and causality of the events were not reported.
Age: 73.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Contusion, Swelling
Clinical narrative: Case number PHHY2015US173727, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606108) on 29 Dec 2015. This report refers to a 73 years old female patient. Past vaccination history included seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on an unknown date and she experienced swelling and bruising. Concomitant medication included levothyroxine (manufacturer unknown) 0.025 mg. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into left arm on 20 Oct 2014. Immediately after vaccination, she experienced pain at injection site. Pain was at shoulder and also more often between shoulder and elbow of left arm. Pain continued intermittently to the time of this report. The outcome of the events was reported as condition unchanged. The events were assessed as non serious and causality was not reported.
Age: 73.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Contusion, Immediate post-injection reaction, Injection site pain, Swelling
Clinical narrative: Case number PHHY2015US173727, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606108) on 29 Dec 2015. This report refers to a 73 years old female patient. Past vaccination history included seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on an unknown date and she experienced swelling and bruising. Concomitant medication included levothyroxine (manufacturer unknown) 0.025 mg. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) into left arm on 20 Oct 2014. Immediately after vaccination, she experienced pain at injection site. Pain was at shoulder and also more often between shoulder and elbow of left arm. Pain continued intermittently to the time of this report. The outcome of the events was reported as condition unchanged. The events were assessed as non serious and causality was not reported.
Age: 69.0
Sex: M
Vaccine: FLUC3
Symptoms: Confusional state, Discomfort, Dizziness, Gait disturbance, Nausea
Clinical narrative: Case number PHHY2016US007509, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 606174) on 18 Jan 2016. This report refers to a 69 years old male patient. Medical history was not reported. Current illness was none. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173839) on 15 Oct 2015 at 01:30 PM. On the same day at about 03:30 PM the patient was extremely dizzy and was unable to walk safely. Further the patient had nausea and mental confusion. Extreme discomfort continued throughout next day. Events recovered finally in the morning of 17 Oct 2015. The case was assessed as non-serious. Causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Dermatitis, Discomfort, Rash erythematous
Clinical narrative: Case number PHHY2016US007515, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS, reference number: 606278) on 18 Jan 2016. This report refers to a 61 years old female patient. Medical history and current illness were none. Concomitant medications included propranolol and tacrolimus ointment. The patient was vaccinated with FLUCELVAX (batch number: 174084) intramuscularly into left arm on 28 Oct 2015. On 29 Oct 2015 the patient noticed a discomfort in the area below her right shoulder blade while driving home from work. After arriving home, the patient discovered a red rash in that area. Subsequently the patient called pharmacy and then went to an urgent care center where the patient was diagnosed with a non-specific dermatitis. The patient applied CORTAID to the rash at bedtime. The rash had slightly subsided as of 30 Oct 2015 AM. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.