chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Electroencephalogram, Fatigue, Gait inability
Clinical narrative: Case number PHHY2016US175962, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 643660) on 21 Dec 2016. This report refers to a 54 years old female patient. Historical condition included herpes. Current conditions included environmental allergies and asthma. Concomitant medications included CENTRUM SILVER Vitamin, ZOVIRAX, Albuterol and QVAR. The patient was vaccinated with third dose of FLUVIRIN (batch number: 1515801) intramuscularly in to left arm on 26 Oct 2015. On 28 Oct 2015, the patient experienced tingling in fingers and feet. On 14 Nov 2015, it was reported that, the patient was taken to her bed and on 19 Nov 2015, she was unable to walk more than 2-3 steps. The patient was hospitalized for 33 days. On an unknown date, the patient was diagnosed with Guillain-Barre Syndrome and was treated with intravenous immunoglobulin treatment. On an unknown date, the patient's heart rate rose to 160 beats per minute. The patient had loss of movement and sensation in most of Dec 2015, the patient went to rehabilitation until end of Jan 2016 with weakness, balance issues and fatigue. The laboratory data revealed that, the patient had electroencephalogram (EEGS) and tested for movement, strength, sensation and balance (unspecified result). The outcome of the event fatigue was reported as condition unchanged, for event balance issues and weakness it was reported as condition improving (ongoing, but improved) and for the other events is was not reported. The seriousness of the events was reported as serious (life threatening, hospitalization and medically significant) and causality was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Heart rate increased, Hypokinesia, Immunoglobulin therapy, Paraesthesia
Clinical narrative: Case number PHHY2016US175962, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 643660) on 21 Dec 2016. This report refers to a 54 years old female patient. Historical condition included herpes. Current conditions included environmental allergies and asthma. Concomitant medications included CENTRUM SILVER Vitamin, ZOVIRAX, Albuterol and QVAR. The patient was vaccinated with third dose of FLUVIRIN (batch number: 1515801) intramuscularly in to left arm on 26 Oct 2015. On 28 Oct 2015, the patient experienced tingling in fingers and feet. On 14 Nov 2015, it was reported that, the patient was taken to her bed and on 19 Nov 2015, she was unable to walk more than 2-3 steps. The patient was hospitalized for 33 days. On an unknown date, the patient was diagnosed with Guillain-Barre Syndrome and was treated with intravenous immunoglobulin treatment. On an unknown date, the patient's heart rate rose to 160 beats per minute. The patient had loss of movement and sensation in most of Dec 2015, the patient went to rehabilitation until end of Jan 2016 with weakness, balance issues and fatigue. The laboratory data revealed that, the patient had electroencephalogram (EEGS) and tested for movement, strength, sensation and balance (unspecified result). The outcome of the event fatigue was reported as condition unchanged, for event balance issues and weakness it was reported as condition improving (ongoing, but improved) and for the other events is was not reported. The seriousness of the events was reported as serious (life threatening, hospitalization and medically significant) and causality was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory loss
Clinical narrative: Case number PHHY2016US175962, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 643660) on 21 Dec 2016. This report refers to a 54 years old female patient. Historical condition included herpes. Current conditions included environmental allergies and asthma. Concomitant medications included CENTRUM SILVER Vitamin, ZOVIRAX, Albuterol and QVAR. The patient was vaccinated with third dose of FLUVIRIN (batch number: 1515801) intramuscularly in to left arm on 26 Oct 2015. On 28 Oct 2015, the patient experienced tingling in fingers and feet. On 14 Nov 2015, it was reported that, the patient was taken to her bed and on 19 Nov 2015, she was unable to walk more than 2-3 steps. The patient was hospitalized for 33 days. On an unknown date, the patient was diagnosed with Guillain-Barre Syndrome and was treated with intravenous immunoglobulin treatment. On an unknown date, the patient's heart rate rose to 160 beats per minute. The patient had loss of movement and sensation in most of Dec 2015, the patient went to rehabilitation until end of Jan 2016 with weakness, balance issues and fatigue. The laboratory data revealed that, the patient had electroencephalogram (EEGS) and tested for movement, strength, sensation and balance (unspecified result). The outcome of the event fatigue was reported as condition unchanged, for event balance issues and weakness it was reported as condition improving (ongoing, but improved) and for the other events is was not reported. The seriousness of the events was reported as serious (life threatening, hospitalization and medically significant) and causality was not reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2016US175530 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 644605) website on 21 Dec 2016. This report refers to a 59 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517701) intramuscular into left arm on 13 Oct 2015. On the same day patient had left deltoid muscle pain and no relief. The outcome of the event was condition unchanged. The seriousness of the event was reported as permanent disability. The causality of the event was not reported.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Asthenia, Guillain-Barre syndrome, Tremor
Clinical narrative: Case number PHHY2016US175475, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 648673) website on 21 Dec 2016. This report refers to a 78 years old female patient. Past medical history was not reported. Current conditions included arthritis and heart issue. Concomitant medication included blood pressure pill (unspecified). She was vaccinated with FLUVIRIN (batch number: 1516201) into the left arm, intramuscularly on 05 Oct 2015. On 27 Oct 2015, she experienced total body weakness and shaking, she could not speak and was taken to the hospital. She was diagnosed with Guillain Barre Syndrome. She visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (disability). The causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Pyrexia, Throat irritation
Clinical narrative: Case number PHHY2016US176268 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 650210) on 21 Dec 2016. This report refers to a 29 year old female patient. Medical history was not reported. Concomitant medications included dicyclomine and venlafaxine. The patient was vaccinated with FLUVIRIN (batch number: 1618701) intramuscularly on 18 Aug 2016. After 10 minutes of sitting, the patient stated that her throat felt tight and itchy. At that time patient's breathing was assessed and the staff recommended epinephrine, however the patient refused it as she could still breathe. She was then given oral diphenhydramine 50 mg with water at 4:51 PM so that they would reassess the need for epinephrine. She was monitored regularly. Her was blood pressure was 114/80 mmHg. The patient stated that she felt nervous about getting the vaccine when the shot was given. She felt better after taking the treatment. She left for home around 5:25 PM by walk. On 19 Aug 2016, the patient came to store and reported fever, chills and diarrhea. On 20 Aug 2016, she reported headache for 3 days. The outcome of the events was reported as complete recovery. The events were reported as non-serious, but the event throat tightness was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Case number PHHY2016US176268 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 650210) on 21 Dec 2016. This report refers to a 29 year old female patient. Medical history was not reported. Concomitant medications included dicyclomine and venlafaxine. The patient was vaccinated with FLUVIRIN (batch number: 1618701) intramuscularly on 18 Aug 2016. After 10 minutes of sitting, the patient stated that her throat felt tight and itchy. At that time patient's breathing was assessed and the staff recommended epinephrine, however the patient refused it as she could still breathe. She was then given oral diphenhydramine 50 mg with water at 4:51 PM so that they would reassess the need for epinephrine. She was monitored regularly. Her was blood pressure was 114/80 mmHg. The patient stated that she felt nervous about getting the vaccine when the shot was given. She felt better after taking the treatment. She left for home around 5:25 PM by walk. On 19 Aug 2016, the patient came to store and reported fever, chills and diarrhea. On 20 Aug 2016, she reported headache for 3 days. The outcome of the events was reported as complete recovery. The events were reported as non-serious, but the event throat tightness was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US165705, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 651218) website on 21 Nov 2016. This report refers to a 44 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1618801) intramuscularly in left arm on 06 Sep 2016. On the same day in four hours after vaccination the patient experienced hives from head to toe. The patient did not have any change in medications at visit and she was eating same diet. On 07 Sep 2016 at 5:30 post morning the symptoms were present. The patient received treatment with BENADRYL. The patient was instructed to take famotidine (manufacture unknown) 150 mg twice daily and ALLEGRA 180 mg twice daily on 07 Sep 2016. The outcome of the event hives from head to toe was reported as condition unchanged. The seriousness and causality of the event were not reported. The seriousness of urticaria was upgraded to medically significant based on the information provided in the source document.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2016US177968, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 651673) website on 21 Dec 2016. This report refers to a 20 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 168802) into the left arm, intramuscularly on 11 Sep 2016. On the same day after vaccination, the patient fainted moments after injecting FLUVIRIN and she recovered with stable vitals less than 02 minutes later. Emergency Medical Technician (EMT) personnel was dispatched as a precaution and found her to be normal and able to drive herself home. The outcome of event was reported as complete recovery on the same day. The seriousness and causality of the event were not reported. Seriousness assessment of syncope was upgraded to serious (medically significant) based on the information available in the source document.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Case number PHHY2016US176041, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 653823) on 21 Dec 2016. This report refers to a 68 years old male patient. Historical condition was not reported. Current condition included high blood pressure. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1618901) intramuscularly into the right arm on 15 Sep 2016. On the same day, one and half hour after vaccination, the patient experienced severe shakes. The patient went to emergency room, had extremely high fever. On an unknown date, the patient was hospitalized for 01 day due to the events. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as serious (hospitalization and medically significant) and causality was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pruritus generalised, Rash, Urticaria
Clinical narrative: Case number PHHY2016US176853, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 656083) website on 21 Dec 2016. This report refers to a 40 years old female patient. Past medical history was not reported. Historical drug included CLARITIN to manage recurrent hives. Current condition included as allergic to codeine and unknown or generalized allergies (unspecified). Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1619901) into right arm, intramuscularly on 27 Sep 2016. On 27 Sep 2016 at 14:00 pm, she experienced generalized hives more  predominant to face and neck, feeling itchiness to body, rash and hives spread to her abdomen and back. Her blood pressure was 140/82 (unit unspecified), temperature 98.2 (unit unspecified) and respiration was easy and non labored. On 27 Sep 2016 at 14:10 pm, she took BENADRYL at a dose of 50 mg, intramuscularly given into left deltoid. On 27 Sep 2016 at 14:30 pm, the redness subsided and she was released with supervision of a friend. Her blood pressure was 120/72. She was alert and awake and was instructed to follow up with physician if allergy was to flare up. She took a follow up next day and reported to work. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was not reported. The causality of the events was not reported. Seriousness assessment of the event hypersensitivity was upgraded (medically significant) based on the information available in the source document.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Case number PHHY2016US178041 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 656085) on 21 Dec 2016. This report refers to a 46 year old female patient. She had no history of allergies and her history of generalized allergy was unknown. She had no current illness. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619901) intramuscularly into left arm on 27 Sep 2016. On the same day at 09:33 AM, the patient experienced hives and itchiness on her arms, face, lower back and legs. Her blood pressure was 120/70, pulse was 98 and body temperature was 96.4 (units and normal values were not reported). Her respirations were easy and non-labored. At 09:35 AM, rash spread rapidly and she treated with BENADRYL 50 mg intramuscularly into the right deltoid. The patient was monitored and observed continuously. At 10:05 AM, redness, itching and hives subsided and the patient was released with the supervision of a friend. She was alert and awake. She was instructed to follow up with physician and call 911 (emergency number) if allergy was to flare up with any respiratory issues. The patient was followed up the next day and it was stated that she reported to work. The final outcome of the events was reported as complete recovery. The events were reported as non-serious, but the event urticaria was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Case number PHHY2016US179067, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 656616) website on 21 Dec 2016. This report refers to a 58-year-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620401) intramuscularly in left arm on 29 Sep 2016. On 30 Sep 2016, after vaccination the patient experienced an allergic reaction as hives all over the body, itching and rash. The patient went to emergency room on 30 Sep 2016 and 02 Oct 2016. The patient was treated with oral prednisone (manufacture unknown), diphenhydramine (manufacture unknown), and famotidine (manufacture unknown). The outcome of the events was reported as condition unchanged. The seriousness of the events were not reported. The seriousness hypersensitivity was upgraded (medically significant) based on the information available in the source document. The causality of the events was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Burning sensation, Feeling hot, Pruritus, Rash generalised, Urticaria
Clinical narrative: Case number PHHY2016US176920, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 659628) website on 21 Dec 2016. This report refers to a 45-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1620401) intramuscularly in right arm on 05 Oct 2016. The patient also vaccinated with BOOSTRIX (batch number: F7YE3) intramuscularly in left arm on 05 Oct 2016. On 07 Oct 2016 after vaccination the patient experienced hives, itching, burning, warm sensation, rashes all over her body except her face. The outcome of events was reported as condition unchanged. The seriousness of the events was not reported. The seriousness assessment of the event rash generalized was upgraded (medically significant) based on the information available in the source document. The causality of the events were not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US178156, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 659729) website on 21 Dec 2016. This report refers to a 64 years old female patient. Past medical history was not reported. Current condition included as Hashimoto's disease. Concomitant medication included as TAZTIA. She was vaccinated with FLUVIRIN (batch number: 1618701) into the left arm, intramuscularly on 09 Oct 2016. On the same day after vaccination, she experienced full body hives starting day after immunization. She self treated with over the counter (OTC) diphenhydramine. It was reported that the symptoms started within 07 hours after immunization. The outcome of event was reported as complete recovery on an unknown date. The seriousness of the event was not reported. The causality of the event was not reported. Seriousness assessment of urticaria was upgraded to serious (medically significant) based on the information available in the source document.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Dysphagia, Ear pain, Eyelid ptosis, Facial paralysis
Clinical narrative: Case number PHHY2017US027698, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660101) website on 21 Feb 2017. This report refers to a 23 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 169221) intramuscularly into the left arm on 28 Sep 2016. After vaccination, on 29 Sep 2016, the patient experienced some pain behind her ear. Patient progressively developed more symptoms as the day/days went on. Patient had sore throat, difficulty swallowing and a bad earache on 29 Sep 2016. Patient then later developed numbness on half of her face, her eye drooped and she had loss the sense of taste on 29 Sep 2016. The physician stated patient developed Bell's Palsy and believed it should resolve in time. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of facial paralysis was upgraded to serious (medically significant) based on the Novartis Important Medical Event list.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Oropharyngeal pain
Clinical narrative: Case number PHHY2017US027698, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660101) website on 21 Feb 2017. This report refers to a 23 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 169221) intramuscularly into the left arm on 28 Sep 2016. After vaccination, on 29 Sep 2016, the patient experienced some pain behind her ear. Patient progressively developed more symptoms as the day/days went on. Patient had sore throat, difficulty swallowing and a bad earache on 29 Sep 2016. Patient then later developed numbness on half of her face, her eye drooped and she had loss the sense of taste on 29 Sep 2016. The physician stated patient developed Bell's Palsy and believed it should resolve in time. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of facial paralysis was upgraded to serious (medically significant) based on the Novartis Important Medical Event list.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2017US028652, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 660458) website on 21 Feb 2017. This report refers to a 61 years old male patient. Past medical history was not reported. Current conditions included as cirrhosis, smoker and hepatic encephalopathy. Concomitant medication was not reported. The patient was vaccinated with first dose of FLUVIRIN (batch number: 169304) into left arm, intramuscularly on 13 Oct 2016. On the same day after vaccination, the patient experienced Bells Palsy. The patient visited the emergency room. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported. The seriousness assessment of facial paralysis was upgraded serious (medically significant) based on the Novartis Important Medical Event list.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Dysgeusia, Feeling abnormal, Heart rate increased, Hypertension
Clinical narrative: Case number PHHY2017US010527, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 660622) website on 23 Jan 2017. This report refers to a 34 years old female patient. Medical history and concomitant medication were not reported. It was reported that patient had no prior reactions to any vaccines, including prior flu vaccines. The patient was vaccinated with FLUVIRIN (batch number: 169024) intramuscularly into left arm on 20 Oct 2016. On the same day after vaccination, approximately 30 minutes, the patient experienced metallic taste in mouth and complained of tongue and limbs feeling strange. Following the events the patient visited emergency room/urgent care. The vital signs examined on an unknown date showed tachycardia (102 to 108 BPM (beats per minute)) (normal range and units not reported), mildly hypertensive (138/90) (normal range and units not reported) and the blood glucose was 100 (normal, normal range and units not reported). The final outcome of the events was reported as complete recovery on an unknown date. Seriousness and causality of the events were not reported. Seriousness assessment of the event hypertension (medically significant) was upgraded based on the information available in the source document.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Tachycardia
Clinical narrative: Case number PHHY2017US010527, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 660622) website on 23 Jan 2017. This report refers to a 34 years old female patient. Medical history and concomitant medication were not reported. It was reported that patient had no prior reactions to any vaccines, including prior flu vaccines. The patient was vaccinated with FLUVIRIN (batch number: 169024) intramuscularly into left arm on 20 Oct 2016. On the same day after vaccination, approximately 30 minutes, the patient experienced metallic taste in mouth and complained of tongue and limbs feeling strange. Following the events the patient visited emergency room/urgent care. The vital signs examined on an unknown date showed tachycardia (102 to 108 BPM (beats per minute)) (normal range and units not reported), mildly hypertensive (138/90) (normal range and units not reported) and the blood glucose was 100 (normal, normal range and units not reported). The final outcome of the events was reported as complete recovery on an unknown date. Seriousness and causality of the events were not reported. Seriousness assessment of the event hypertension (medically significant) was upgraded based on the information available in the source document.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2017US029578, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 660854) website on 21 Feb 2017. This report refers to an 18 years old female patient. Past medical history was not reported. Current condition included allergy to penicillin. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 168805) intramuscularly in left arm on 21 Oct 2016. On the same day after vaccination the patient fainted while signing at counter. It was reported that an ambulance came and assessed patient however she did not go to hospital for further treatment. The outcome of the event was reported as complete recovery on an unspecified date. The seriousness and causality of the event were not reported. The seriousness assessment of the event syncope was upgraded (medically significant) based on the information available in the source document.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain, X-ray limb
Clinical narrative: Case number PHHY2017US021213, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 660998) on 23 Jan 2017. This report refers to a 65 years old female patient. Medical history was reported as none. Concomitant medication included LEXAPRO, ACIPHEX, zolpidem, Multivitamin. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 21 Oct 2016. On same day after vaccination, the patient experienced extreme pain in right shoulder, unable to move arm without excruciating pain, pain was a 10 on a 1-10 scale. The patient performed the shoulder X ray (result unspecified) on 22 Oct 2016. The patient went to emergency room on an unknown date. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events pain and musculoskeletal pain was upgraded based on information available in the source document.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Lip pruritus, Lip swelling, Swelling face
Clinical narrative: Case number PHHY2017US029579 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661125) website on 21 Feb 2017. This report refers to a 57 year old female patient. Medical history and current illness were reported as none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619701) intramuscularly into the left arm on 27 Sep 2016. On the same day after vaccination (reported as approximately 2 hours after vaccination), the flu shot site of the patient was swollen and reported as subsided with massage of the area. On an unknown date (reported as several hours after that), the lip of the patient started to itch and was followed by swelling of right cheek and bottom lip. Following the events patient visited emergency room and received treatment with steroid dose pack. The outcome of the event vaccination site swelling was reported as complete recovery on 27 Sep 2016 and for the other events was reported as complete recovery on an unknown date. The events were assessed as non serious by the reporter and causality was not reported. Seriousness of the events lip pruritus, lip swelling and swelling face (medically significant) was upgraded based on the information available in the source document.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis, Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHHY2017US014565, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 661143) on 23 Jan 2017. This report refers to a 24 years old female patient. Medical history was not reported. Vaccination history included administration of seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on an unknown date in 2015 and experienced bell's palsy when she was 23 years old (see case: PHHY2017US014590). Concomitant medication was not reported. The patient was vaccinated with first dose of FLUVIRIN (batch number: 169001) into left arm on 28 Sep 2016. On same day after vaccination, the patient experienced facial numbness and tingling that persisted and the patient was diagnosed with bell's palsy on an unknown date in 2016. The patient was treated with steroids. The patient visited emergency room on an unknown date. The outcome of the events was reported as recovered after taper dose of steroids, the events lasted acutely for 03 days and gone by one month (complete recovery). The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events paraesthesia and hypoaesthesia was upgraded to medically significant based on the information available in the source document and seriousness assessment of the event facial paralysis was upgraded based on the Novartis Important Medical Event List.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2017US028695, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 661571) on 21 Feb 2017. This report refers to a 43 years old female patient. Historical conditions included major depression, polycystic ovary syndrome and ADD adult (attention deficit disorder), no history of herpes simplex viruses. Concomitant medications included ZOLOFT and ADDERALL. The patient was vaccinated with FLUVIRIN (batch number: 168521) intramuscularly into the arm on 22 Sep 2016. On 08 Oct 2016, 15 days after vaccination the patient was diagnosed with Bell's Palsy. The patient went to emergency room on an unknown date. No prodromal virus infections, no other Immunization were reported. The outcome of the event was reported as unknown. The seriousness of the event was reported as non serious and causality was not reported. The seriousness assessment of the event facial paralysis was upgraded (medically significant) based on the Novartis Important Medical Event list.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Vaccination site cellulitis
Clinical narrative: Case number PHHY2017US027903, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference  number: 661665) website on 21 Feb 2017. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620401) intramuscularly in left arm on 17 Oct 2016. The patient was also vaccinated with ZOSTAVAX (batch number: M018453) subcutaneously in left arm on 17 Oct 2016. On 18 Oct 2016 after vaccination the patient experienced swelling softball size on muscle on arm and pain, redness and warm at injection site reaction ZOSTAVAX on back of left tricep. The patient received treatment for cellulitis post reaction (unspecified medication). The outcome of the event was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of the event vaccination site cellulitis was upgraded (medically significant) based on the information available in the source document.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2017US029853, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661882) website on 21 Feb 2017. This report refers to a 10 years old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1620501) intramuscularly on 09 Oct 2016. On the same day, she was nervous about getting a shot and right after vaccine was administered she fainted. 911 was called and as per her parents request, she was transported to hospital despite normal vitals. She 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. The seriousness assessment of the event syncope was upgraded (medically significant) based on the information available in the source document.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray
Clinical narrative: Case number PHHY2017US026740, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 661931) website on 21 Feb 2017. This report refers to a 64 years old female patient. Historical condition was not reported. Current condition included diabetes. Concomitant medications included metformin ER 500 mg and simvastatin 20 mg. She was vaccinated with first dose of FLUVIRIN (batch number: 1615101) on 03 Dec 2015. After vaccination, on 07 Dec 2015, she experienced extreme upper right arm pain at site of injection and shoulder and lessened range of motion which continued as of this report. She was treated with PENNSAID, FLECTOR PATCH and cortisone shot. The X ray was performed on an unknown date (results unspecified). The outcome of the events was reported as condition unchanged. The events were assessed as serious (disability) and causality was not reported.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Nausea, Pain, Throat irritation, Tongue discomfort
Clinical narrative: Case number PHHY2017US029646, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 661972) website on 21 Feb 2017. This report refers to a 40 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1618621) intramuscularly in left arm on 10 Oct 2016. On 12 Oct 2016 after vaccination, the patient started to develop tongue burning, throat felt raw, trouble breathing, body aches and nausea. Symptoms were progressing. The patient notified pharmacy on 24 Oct 2016. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported. The seriousness assessment of the event pain was upgraded (medically significant) based on the information available in the source document.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Headache, Nausea, Pruritus
Clinical narrative: Case number PHHY2017US029910, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 662084) website on 21 Feb 2017. This report refers to a 65 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with first dose of FLUVIRIN (batch number: 1619901) into right arm, intramuscularly on 24 Oct 2016. On the same day after vaccination, the patient experienced rash over entire body, itchy, headache, nausea, tired and weak. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of rash generalized, pruritus was upgraded to serious (medically significant) based on the information available in the source document.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2017US029910, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 662084) website on 21 Feb 2017. This report refers to a 65 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with first dose of FLUVIRIN (batch number: 1619901) into right arm, intramuscularly on 24 Oct 2016. On the same day after vaccination, the patient experienced rash over entire body, itchy, headache, nausea, tired and weak. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of rash generalized, pruritus was upgraded to serious (medically significant) based on the information available in the source document.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2017US030058 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 664047) website on 21 Feb 2017. This report refers to 42 year male patient. Medical history and concomitant medication was not reported. The patient was vaccinated FLUVIRIN (batch number: 168723) intramuscular left arm on 24 Oct 2016. On the same day, patient fainted 3 to 4 minutes after receiving vaccine; patient came immediately and refused any treatment. The outcome of the event was complete recovery and seriousness of the event was non serious and causality of the event was not reported. Seriousness assessment of the event syncope was upgraded to (medically significant) based on information available in the source document.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Case number PHHY2017US010376 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 664084) on 23 Jan 2017. This report refers to a 73 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) intramuscularly into the right arm on 03 Oct 2016. The patient visited her oncologist and was found to have profound thrombocytopenia. She usually had a platelet count of 300,000-400,000 (units not reported) but it dropped to 1000 (units not reported) with symptomatic petechiae. This occurred two weeks post flu shot (on 16 Oct 2016) and there were no changes in the medication during this time. The patient was sent to emergency room and was hospitalized for 3 days. At the time of admission, her platelet count was 1000. She was treated with dexamethasone 40 mg intravenously. On 01 Nov 2016, her platelet count was 335,000 (units not reported). The final outcome of the events was reported as complete recovery. The events were reported as life threatening. The causality of the events was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site cellulitis
Clinical narrative: Case number PHHY2017US029389, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 664230) on 21 Feb 2017. This report refers to a 28 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 16H704) intramuscularly on 02 Nov 2016. On an unknown date in Nov 2016 after vaccination, the patient experienced cellulitis at vaccination site. The patient went to emergency room on an unknown date. The outcome of the event was reported as unknown. The seriousness of the event was reported as non serious and causality was not reported. Seriousness assessment of the event vaccination site cellulitis was upgraded based on information available in the source document.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Case number PHHY2017US029867, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 664591) website on 21 Feb 2017. This report refers to a 67 years old female patient. Medical history and current illness were reported as none. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 166001) and PNEUMOVAX (other manufacturer, batch number: M038216) subcutaneously; both vaccines into the left arm on 27 Oct 2016. On the evening of vaccination, she experienced swelling, redness, hard core at the site. By Friday noon, 28 Oct 2016, pain was worse, she could not lift significant weight (over 10 lb). Friday evening through Sunday morning (28 Oct 2016 to 30 Oct 2016) she had chills and fever. The symptoms looked similar to cellulitis extended from shoulder to elbow. The outcome of chills and fever was reported as complete recovery on 30 Oct 2016 while it was reported as complete recovery on an unknown date for other events. The seriousness and causality of the event were not reported. The seriousness assessment of the events vaccination site cellulitis was upgraded (medically significant) based on the information available in the source document.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Weight bearing difficulty
Clinical narrative: Case number PHHY2017US029867, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 664591) website on 21 Feb 2017. This report refers to a 67 years old female patient. Medical history and current illness were reported as none. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 166001) and PNEUMOVAX (other manufacturer, batch number: M038216) subcutaneously; both vaccines into the left arm on 27 Oct 2016. On the evening of vaccination, she experienced swelling, redness, hard core at the site. By Friday noon, 28 Oct 2016, pain was worse, she could not lift significant weight (over 10 lb). Friday evening through Sunday morning (28 Oct 2016 to 30 Oct 2016) she had chills and fever. The symptoms looked similar to cellulitis extended from shoulder to elbow. The outcome of chills and fever was reported as complete recovery on 30 Oct 2016 while it was reported as complete recovery on an unknown date for other events. The seriousness and causality of the event were not reported. The seriousness assessment of the events vaccination site cellulitis was upgraded (medically significant) based on the information available in the source document.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2017US029963, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 664875) website on 21 Feb 2017. This case also contains QA reference number: 1020262. This report refers to a 14 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 169403) into right arm, intramuscularly on 02 Nov 2016. On 04 Nov 2016, the patient experienced cellulitis at injection site. Patient was performed unknown tests, diagnosis made from primary care physician (PCP). The patient visited emergency room. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event were not reported. The seriousness assessment of vaccination site cellulitis was upgraded to serious (medically significant) based on the information available in the source document. Non significant follow up report from the QA department (QA reference number: 1020262) received on 15 Mar 2017: Updated QA reference number only. Follow up received on 10-Apr-2017: Batch review report reference number (1020262) received from quality assurance department on 10 April 2017: Based on the document review, it was stated that the concerned FLUVIRIN 2016/2017 (NVD) batch number (169403) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Updated expiry date as 30 Jun 2017 and release date as 15 Sep 2016.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blindness, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Case number PHHY2017US026896, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 665368) website on 21 Feb 2017. This report refers to a 41 years old female patient. Past medical history was not reported. Current condition included penicillin allergy. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly into left arm on 31 Aug 2015. The patient was also vaccinated with ADACEL (batch number: U5241AA) intramuscularly into right arm on 31 Aug 2015. On 12 Sep 2015 after 02 weeks of vaccination, the patient experienced numbness in extremities, severe pain and loss of vision. On an unspecified date after 03 weeks of vaccination the patient had lumbar puncture and diagnosed with Guillain-Barre syndrome. On an unspecified date the patient was hospitalized for 07 days. The patient received treatment with IVIG (intravenous immunoglobulin). The outcome of the events was reported as condition unchanged. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain
Clinical narrative: Case number PHHY2017US026896, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 665368) website on 21 Feb 2017. This report refers to a 41 years old female patient. Past medical history was not reported. Current condition included penicillin allergy. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly into left arm on 31 Aug 2015. The patient was also vaccinated with ADACEL (batch number: U5241AA) intramuscularly into right arm on 31 Aug 2015. On 12 Sep 2015 after 02 weeks of vaccination, the patient experienced numbness in extremities, severe pain and loss of vision. On an unspecified date after 03 weeks of vaccination the patient had lumbar puncture and diagnosed with Guillain-Barre syndrome. On an unspecified date the patient was hospitalized for 07 days. The patient received treatment with IVIG (intravenous immunoglobulin). The outcome of the events was reported as condition unchanged. The causality of the events was not reported.