chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US028770, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 615269) website on 29 Feb 2016. This report refers to 7 year old female patient. Medical history was not reported. Concurrent condition included allergic to penicillin. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 19 Nov 2015. On the same day after vaccination, the patient experienced hives on chest, upper back, upper arms, and face, red and itchy and later it was subsided when the patient treated with Children's BENADRYL (7.5 ml). Hives occurred again the following three nights, subsided with BENADRYL or ALLEGRA at doses of 5 ml each time. Outcome of the events was reported as condition improving. Seriousness of the events was reported as no serious and causality of the events was not reported. Seriousness of the events urticaria, erythema and pruritus was upgraded based on the available information in the source document.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2016US028707, is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 615306) on 29 Feb 2016. This report refers to a 58 year old male patient. He had no medical history or current conditions. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 157603) intramuscularly in the left arm on 13 Dec 2015. On 15 Dec 2015, the patient woke up and had hives all over and itching. The hives went down by 16 Dec 2015, but itching was still present. He went to emergency room, visited doctor on 16 Dec 2015 and was told that he had a reaction to the vaccine. He was given a steroid shot. The outcome of hives all over was reported as condition improving and that of itching was reported as unknown. The events were reported as non-serious, but were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US026980, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS,  reference number: 615627) on 29 Feb 2016. This report refers to a 39 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157103) into right arm and BOOSTRIX (batch  number: KP95K,  other  manufacturer)  into left arm on 16 Nov 2015. On 12 Dec 2015 the patient went to emergency room and diagnosed with Guillain-Barre syndrome. The patient was hospitalized for 17 days (dates not specified). Outcome of the events was unknown. The case was assessed as serious (life threatening and hospitalization). Causality of the event was not reported. Seriousness assessment of "Guillain-Barre syndrome" was upgraded based on the NVS-IMS list
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2016US030004, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 616327) website on 29 Feb 2016. This report refers to a 58 years old male patient. Medical history was not reported. Concomitant medications included Levothyroxine and testosterone (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 174277) intramuscularly in to right arm on 22 Oct 2015. On same day after vaccination, the patient experienced extreme pain at vaccination site upon injection and had a pain at vaccination 24/7. The outcome of the event was reported as condition unchanged. The seriousness of the event was reported as serious (permanent disability) and causality not reported.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Eyelid oedema, Headache, Lip swelling, Vomiting
Clinical narrative: Case number PHHY2016US027800, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 616351) website on 29 Feb 2016. This report refers to 39 year old female patient. The patient had no known drug allergy. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158425) and ADACEL (other manufacturer, batch number: U5257AA) both received on the right arm on 14 Dec 2015. On the same day after vaccination, the patient experienced vomiting, headache, slight swelling of lips and eyelids. The patient was presented to an emergency room. The patient was treated with PHENERGAN 25 mg intramuscular QD at 11.10 and was well tolerated. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality of the events was not reported. Seriousness of the events lip swelling and eyelid edema and vomiting was upgraded based on the available information in the source document. Batch review report reference number (1012993) received from quality assurance department on 03 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (158425) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up information received from Quality Assurance (QA) department on 07 Mar 2016: Added QA reference number (1012993) only. Follow up information received from Quality Assurance (QA) department on 03 Apr 2016: QA summary added to the case.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Presyncope, Syncope
Clinical narrative: Case number PHHY2016US023698, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 616408) on 19 Feb 2016. This report refers to 15 years old male patient. The patient had no medical history and no current illness. Concomitant medications were unknown. The patient was vaccinated with FLUVIRIN (batch number: 158301) intramuscularly into left arm on 24 Dec 2015. On the same day after vaccination the patient exhibited a vagal response to the flu vaccine, whereby he felt woozy, and briefly fainted, but quickly regained consciousness. The patient was walked to a chair, elevated his legs, and was given water and cookies. No medications were warranted. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "syncope" was upgraded based on information in the source document.
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Case number PHHY2016US029374, is an initial spontaneous report received from  Vaccine Adverse Event Reporting System (VAERS ID: 616438) website on 29 Feb 2016. This report refers to a 34 years old female patient. Historical condition was not reported. Current conditions included allergy latex/penicillin. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 30 Nov 2015. On 03 Dec 2015 after vaccination, the patient's throat swelled. The patient went to emergency room and was hospitalized on an unknown date for 02 days. The final outcome of the event was reported as complete recovery and causality not reported.
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2016US031464, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617474) on 08 Mar 2016. This report refers to a female patient of an unknown age. Medical history was not reported. Concurrent conditions were none. Concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 1518101) intramuscularly on 30 Dec 2015. On the same day after vaccination the patient swooned and fainted. Laboratory tests were none needed. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the event was not reported. Seriousness assessment of "faint" was upgraded based on information in the source document.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest X-ray, Chills, Diarrhoea, Dizziness, Electrocardiogram
Clinical narrative: Case number PHHY2016US033300, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 617879) website on 08 Mar 2016. This report refers to a 58 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) into left arm and pneumococcal vaccine polyvalent (manufacturer unknown, batch number: 487117) into right arm both received on 05 Jan 2016. On same day after vaccination, the patient experienced dizziness, diarrhea repeatedly violently, vomiting repeatedly violently, headache, chills and fever with body temperature 101.2. The patient had EKG (electrocardiogram) and chest X-ray (results unspecified). The patient was treated with ZOFRAN and TYLENOL. The patient visited the emergency room on an unknown date. Outcome of the events diarrhea and vomiting was reported as continued on 3rd day, recovering (condition improving) and for other events it was reported as unknown. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the events diarrhoea and vomiting was upgraded based on the available information in the source document. Batch review report reference number (1013310) received from quality assurance department on 15 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1516501) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up received from quality assurance department (QA reference number: 1013310) on 15 Mar 2016: Updated QA number only. Follow up received from quality assurance (QA) department on 15 Apr 2016: Added batch summary report.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2016US033300, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 617879) website on 08 Mar 2016. This report refers to a 58 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) into left arm and pneumococcal vaccine polyvalent (manufacturer unknown, batch number: 487117) into right arm both received on 05 Jan 2016. On same day after vaccination, the patient experienced dizziness, diarrhea repeatedly violently, vomiting repeatedly violently, headache, chills and fever with body temperature 101.2. The patient had EKG (electrocardiogram) and chest X-ray (results unspecified). The patient was treated with ZOFRAN and TYLENOL. The patient visited the emergency room on an unknown date. Outcome of the events diarrhea and vomiting was reported as continued on 3rd day, recovering (condition improving) and for other events it was reported as unknown. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the events diarrhoea and vomiting was upgraded based on the available information in the source document. Batch review report reference number (1013310) received from quality assurance department on 15 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1516501) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up received from quality assurance department (QA reference number: 1013310) on 15 Mar 2016: Updated QA number only. Follow up received from quality assurance (QA) department on 15 Apr 2016: Added batch summary report.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: Case number PHEH2015US019982, is a spontaneous report initially received from a consumer who is also a nurse on 06 Oct 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. Concurrent condition included allergy to latex. She was vaccinated with FLUVIRIN (batch number and expiry date: not reported) intramuscularly on 01 Oct 2015 and experienced severe allergic reaction to vaccine because she was allergic to latex. Shortly after vaccination, she experienced tightness in the throat. She received treatment with BENADRYL injection for tightness in the throat and observed for 10 minutes. Later in the day, the patient went to the emergency department for tightness in the throat. She did not have hives or shortness of breath. The patient was not admitted and was discharged with a prescription for MEDROL dose pak and BENADRYL. On 05 Oct 2015, patient was seen for checkup and the symptoms resolved. The outcome of the event tightness in the throat was reported as complete recovery on 05 Oct 2015 while it was not reported for severe allergic reaction to vaccine. The seriousness of the events was not reported. The causality of the event tightness in the throat was reported as suspected while it was not reported for the event severe allergic reaction to vaccine. Seriousness assessment of the event hypersensitivity was upgraded based on information available in the source document. Follow up information received from a nurse on 06 Jan 2016: Added patient initials, treatment medication, event tightness in the throat and its outcome, seriousness and causality were updated. Non significant FU received from the Vaccine Adverse Event Reporting System (VAERS reference number: 617904) website on 15 Mar 2016: Added VAERS ID.
Age: 32.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHHY2016US035268 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 618330) on 15 Mar 2016. This report refers to a 32 year old male patient. He had no medical history, current conditions or concomitant medications. He was vaccinated with FLUVIRIN (batch number: 15751P) intramuscularly in the left arm and VARIVAX (other manufacturer, batch number: K011082) subcutaneously in the right arm; both vaccines administered on 28 Dec 2015. On 08 Jan 2016, the patient felt feverish and noticed several red raised bumps on back. Over the next two days, red itchy bumps appeared on face, head, torso, arms and legs. It was reported that they were approximately 20 in number. No laboratory data were reported. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the event red itchy bumps on face, head, torso, arms and legs were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Case number PHHY2016US041425 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 619565) on 29 Mar 2016. This report refers to a 25 year old female patient. Her medical history, current conditions and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1516501) at a dose of 0.5 ml on 08 Nov 2015. On the same date after vaccination, the patient experienced swelling of arm and face after receiving FLUVIRIN. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event swelling of face was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Headache, Heart rate increased, Pain in extremity
Clinical narrative: Case number PHHY2016US041496, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 620474) website on 29 Mar 2016. This report refers to a 51 years old female patient. Past vaccination history included administration of seasonal influenza vaccine (manufacture unknown) and experienced chest tightness, dizziness and headache (see case number: PHHY2016US041584). Current conditions included medication allergies and seasonal allergies. Concomitant medications included iron, Vit B and Vit D. The patient was vaccinated with FLUVIRIN (batch number: 157802) in the left arm on 04 Nov 2015. Within minutes after the vaccination, the patient had tightness in chest, dizziness, headache and rapid pulse. On 05 Nov 2015, she had dizziness and rapid pulse which lasted 26 hours. Her upper arm was swollen and lasted 2 weeks, pain in arm lasted several weeks; chest tight and headache continued. The patient was given a round of prednisone then methylprednisolone and it helped some. The patient used XOPENEX inhaler which did not help and she continued to have mild chest tightness. The final outcome of the event was reported as unknown. Seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the events chest discomfort, heart rate increased and dizziness were upgraded based on the information available in the source documents.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Case number PHHY2016US041496, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 620474) website on 29 Mar 2016. This report refers to a 51 years old female patient. Past vaccination history included administration of seasonal influenza vaccine (manufacture unknown) and experienced chest tightness, dizziness and headache (see case number: PHHY2016US041584). Current conditions included medication allergies and seasonal allergies. Concomitant medications included iron, Vit B and Vit D. The patient was vaccinated with FLUVIRIN (batch number: 157802) in the left arm on 04 Nov 2015. Within minutes after the vaccination, the patient had tightness in chest, dizziness, headache and rapid pulse. On 05 Nov 2015, she had dizziness and rapid pulse which lasted 26 hours. Her upper arm was swollen and lasted 2 weeks, pain in arm lasted several weeks; chest tight and headache continued. The patient was given a round of prednisone then methylprednisolone and it helped some. The patient used XOPENEX inhaler which did not help and she continued to have mild chest tightness. The final outcome of the event was reported as unknown. Seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the events chest discomfort, heart rate increased and dizziness were upgraded based on the information available in the source documents.
Age: 20.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Case number PHHY2016US041436 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 621129) on 29 Mar 2016. This report refers to a 20 year old male patient. His medical history was not reported. His current conditions include dehydration. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1517001) and BOOSTRIX (other manufacturer, batch number: XZ444); both vaccines administered intramuscularly in the left arm on 09 Nov 2015. On the same date approximately within half an hour to 45 minutes after vaccination, the patient experienced syncope and vomiting which was dry to mucous. The patient was rehydrated. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event syncope was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Back pain, CSF protein increased, Computerised tomogram head, Facial paralysis, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US041679, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621577) website on 29 Mar 2016. This report refers to a 56-years-old male patient. Past medical history was not reported. Current conditions included type 1 diabetes, hypertension and hyperlipidemia. Concomitant medications included lisinopril (manufacturer unknown), amlodipine (manufacturer unknown), NOVOLOG and insulin (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 1516101) intramuscularly in arm on 24 Nov 2015. On 26 Dec 2015, the patient experienced back pain and lower back pain progressively worsened. On 29 Dec 2015, leg weakness started. On 31 Dec 2015, right (R) fingers got numb and on 02 Jan 2016, numbness started in left fingers. On 04 Jan 2016, left mouth drooped and 05 Jan 2016, the patient was diagnosed with Guillain-Barre. The patient was treated with IVIG (intravenous immunoglobulin) since 05 Jan 2016 at approximately 6pm for 5 days. Laboratory data included spinal fluid protein was 115 (units and normal range unspecified) and results of nerve conduction studies, magnetic resonance imaging of brain, cervical spine and computer tomography (CT) scan of brain was not provided. On an unknown date, the patient visited the emergency room and was hospitalized for 7 days. Outcome of the events was reported as condition unchanged. Causality of the events was not reported. The quality assurance department reported that, batch review report (reference number: 1013976) received from quality assurance department on 24 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 1516101, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report received from quality assurance department (QA number: 1013976) on 27 Apr 2016: Updated QA reference number only. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1013976) on 24 Apr 2016: Updated batch review report (conclusion added).
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Nerve conduction studies, Nuclear magnetic resonance imaging brain
Clinical narrative: Case number PHHY2016US041679, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621577) website on 29 Mar 2016. This report refers to a 56-years-old male patient. Past medical history was not reported. Current conditions included type 1 diabetes, hypertension and hyperlipidemia. Concomitant medications included lisinopril (manufacturer unknown), amlodipine (manufacturer unknown), NOVOLOG and insulin (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 1516101) intramuscularly in arm on 24 Nov 2015. On 26 Dec 2015, the patient experienced back pain and lower back pain progressively worsened. On 29 Dec 2015, leg weakness started. On 31 Dec 2015, right (R) fingers got numb and on 02 Jan 2016, numbness started in left fingers. On 04 Jan 2016, left mouth drooped and 05 Jan 2016, the patient was diagnosed with Guillain-Barre. The patient was treated with IVIG (intravenous immunoglobulin) since 05 Jan 2016 at approximately 6pm for 5 days. Laboratory data included spinal fluid protein was 115 (units and normal range unspecified) and results of nerve conduction studies, magnetic resonance imaging of brain, cervical spine and computer tomography (CT) scan of brain was not provided. On an unknown date, the patient visited the emergency room and was hospitalized for 7 days. Outcome of the events was reported as condition unchanged. Causality of the events was not reported. The quality assurance department reported that, batch review report (reference number: 1013976) received from quality assurance department on 24 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 1516101, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report received from quality assurance department (QA number: 1013976) on 27 Apr 2016: Updated QA reference number only. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1013976) on 24 Apr 2016: Updated batch review report (conclusion added).
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal
Clinical narrative: Case number PHHY2016US041679, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621577) website on 29 Mar 2016. This report refers to a 56-years-old male patient. Past medical history was not reported. Current conditions included type 1 diabetes, hypertension and hyperlipidemia. Concomitant medications included lisinopril (manufacturer unknown), amlodipine (manufacturer unknown), NOVOLOG and insulin (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 1516101) intramuscularly in arm on 24 Nov 2015. On 26 Dec 2015, the patient experienced back pain and lower back pain progressively worsened. On 29 Dec 2015, leg weakness started. On 31 Dec 2015, right (R) fingers got numb and on 02 Jan 2016, numbness started in left fingers. On 04 Jan 2016, left mouth drooped and 05 Jan 2016, the patient was diagnosed with Guillain-Barre. The patient was treated with IVIG (intravenous immunoglobulin) since 05 Jan 2016 at approximately 6pm for 5 days. Laboratory data included spinal fluid protein was 115 (units and normal range unspecified) and results of nerve conduction studies, magnetic resonance imaging of brain, cervical spine and computer tomography (CT) scan of brain was not provided. On an unknown date, the patient visited the emergency room and was hospitalized for 7 days. Outcome of the events was reported as condition unchanged. Causality of the events was not reported. The quality assurance department reported that, batch review report (reference number: 1013976) received from quality assurance department on 24 Apr 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 1516101, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up report received from quality assurance department (QA number: 1013976) on 27 Apr 2016: Updated QA reference number only. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1013976) on 24 Apr 2016: Updated batch review report (conclusion added).
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Pain, Sleep disorder
Clinical narrative: Case number PHHY2016US041395, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622000) website on 29 Mar 2016. This report refers to a 51 years old female patient. Medical history was not reported. Concomitant medication included ZOMIG Nasal spray. The patient received FLUVIRIN (batch number: 1514701) intramuscular left arm on 06 Jan 2016. Patient stated no pain upon injections. Tenderness noted about an hour after vaccination. Within a couple days, (08 Jan 2016) pain was increasingly sore and shoulder was not moving freely. Pain was keeping patient awake and she saw primary care physician on 20 Jan 2016 with chief complaint being left shoulder pain with motion. Chart notes stated that pain was primarily in just distal to acromion with rotation and extension limited. X ray showed normal joint with amorphous calcification superior to the humeral head which could be hydroxyapatite deposition/calcific tendinitis. Patient saw an orthopedist on 26 Jan 2016 and pain was significantly better after she was treated with MEDROL DOSEPAK. She was currently doing physical therapy to improve range of movement. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the events injected limb mobility decreased and pain were upgraded based on the information available in the source documents.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness, X-ray limb normal
Clinical narrative: Case number PHHY2016US041395, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622000) website on 29 Mar 2016. This report refers to a 51 years old female patient. Medical history was not reported. Concomitant medication included ZOMIG Nasal spray. The patient received FLUVIRIN (batch number: 1514701) intramuscular left arm on 06 Jan 2016. Patient stated no pain upon injections. Tenderness noted about an hour after vaccination. Within a couple days, (08 Jan 2016) pain was increasingly sore and shoulder was not moving freely. Pain was keeping patient awake and she saw primary care physician on 20 Jan 2016 with chief complaint being left shoulder pain with motion. Chart notes stated that pain was primarily in just distal to acromion with rotation and extension limited. X ray showed normal joint with amorphous calcification superior to the humeral head which could be hydroxyapatite deposition/calcific tendinitis. Patient saw an orthopedist on 26 Jan 2016 and pain was significantly better after she was treated with MEDROL DOSEPAK. She was currently doing physical therapy to improve range of movement. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the events injected limb mobility decreased and pain were upgraded based on the information available in the source documents.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2016US041396 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 622244) on 29 Mar 2016. This report refers to a 50 year old female patient. Her current condition included latex allergy and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 157802) intramuscularly on 07 Feb 2016. On 09 Feb 2016, the patient experienced redness, pain and swelling at injection site. The patient was counseled to take BENADRYL and ibuprofen and to see if the symptoms decrease. If the symptoms did not decrease in 2+ days, the patient was asked to check with primary care physician (PCP) for possible cellulitis. The events outcome was unknown. The events were reported as non-serious, but were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 68.0
Sex: M
Vaccine: FLUC3
Symptoms: Aphasia, Dyspnoea, Grip strength decreased, Guillain-Barre syndrome, Pain in extremity
Clinical narrative: Case number PHHY2016US041449, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622347) website on 29 Mar 2016. This report refers to a 68 years old male patient. Historical conditions included Hepatitis C, liver and prostate cancers and high blood pressure. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 174269) on 19 Oct 2015 in the left arm. On 23 Oct 2015, he experienced tingling pains in hands and arms. Days later same tingling was experienced in legs and feet. He had difficulty breathing, could not talk or grab/hold on to anything and diagnosed with Guillain Barre Syndrome. The patient went to emergency room. The seriousness of the events was reported as serious (existing hospitalization prolonged and life threatening). Outcome and causality of the events were not reported.
Age: 68.0
Sex: M
Vaccine: FLUC3
Symptoms: Paraesthesia
Clinical narrative: Case number PHHY2016US041449, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622347) website on 29 Mar 2016. This report refers to a 68 years old male patient. Historical conditions included Hepatitis C, liver and prostate cancers and high blood pressure. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 174269) on 19 Oct 2015 in the left arm. On 23 Oct 2015, he experienced tingling pains in hands and arms. Days later same tingling was experienced in legs and feet. He had difficulty breathing, could not talk or grab/hold on to anything and diagnosed with Guillain Barre Syndrome. The patient went to emergency room. The seriousness of the events was reported as serious (existing hospitalization prolonged and life threatening). Outcome and causality of the events were not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Guillain-Barre syndrome, Hypoaesthesia, Nausea
Clinical narrative: Case number PHHY2016US058549, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622861) website on 27 Apr 2016. This report refers to 28 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517801) intramuscularly in the left arm on 17 Dec 2015. Since 18 Jan 2016, the patient started to experience numbness to feet that traveled to arms, nausea, weakness and back pain. On an unknown date the patient was hospitalized with diagnosis of Guillain Barre Syndrome. The final outcome of the events was reported as unknown. The seriousness of the events was reported as (hospitalization, life threatening). Causality of the events was not reported. Batch review report (reference number (1014492) received from quality assurance department on 02 Jun 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1517801) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from Quality Assurance (QA) department on 04 May 2016: QA reference number (1014492) added. Follow up information received from Quality Assurance (QA) department on 02 Jun 2016: Batch summary added.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TDAP
Symptoms: Injection site rash, Rash, Rash erythematous, Vaccination site induration, Vaccination site pain
Clinical narrative: Case number PHHY2016US058094, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 623024) website on 27 Apr 2016. This report refers to a 53 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515071) on left arm, PNEUMOVAX (other manufacture, batch number: L017265) on left arm, ENGERIX-B (other manufacture, batch number: 5G943) on right arm and ADACEL (other manufacture, batch number: U5264AA) on right arm all vaccination received on 27 Jan 2016. On the same day after vaccination, by night area of vaccination was warm to touch and hard feeling and it was painful. The next day it was the same. By Friday (29 Jan 2016) the patient experienced rash on arm and it looked as if rash started at injection site and spread down and around upper and lower arm and also, had rash on stomach, back and chest. Rash appeared to be red, raised areas. The patient started taking BENADRYL every 4 to 6 hours on Friday until Sunday before rash improved. The final outcome of the events was reported as complete recovery. The seriousness was reported as non serious and causality was not reported. The seriousness of the events rash generalized and rash erythematous were upgraded based on information available in the source document.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TDAP
Symptoms: Vaccination site warmth
Clinical narrative: Case number PHHY2016US058094, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 623024) website on 27 Apr 2016. This report refers to a 53 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515071) on left arm, PNEUMOVAX (other manufacture, batch number: L017265) on left arm, ENGERIX-B (other manufacture, batch number: 5G943) on right arm and ADACEL (other manufacture, batch number: U5264AA) on right arm all vaccination received on 27 Jan 2016. On the same day after vaccination, by night area of vaccination was warm to touch and hard feeling and it was painful. The next day it was the same. By Friday (29 Jan 2016) the patient experienced rash on arm and it looked as if rash started at injection site and spread down and around upper and lower arm and also, had rash on stomach, back and chest. Rash appeared to be red, raised areas. The patient started taking BENADRYL every 4 to 6 hours on Friday until Sunday before rash improved. The final outcome of the events was reported as complete recovery. The seriousness was reported as non serious and causality was not reported. The seriousness of the events rash generalized and rash erythematous were upgraded based on information available in the source document.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Case number PHHY2016US069455 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 629459) on 17 May 2016. This report refers to a 36 year old female patient. Medical history was not reported. She had no current conditions and her concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157603) intramuscularly on 12 Jan 2016. She had no problem after vaccination when she was in the store. When she left for home, while driving she started to feel faint. She pulled over on side of road and had fainting spell. She stated that there were no other problems. Following the events the patient visited emergency room and followed up with primary care provider (PCP) within 24 hours. The outcome of the events was reported as complete recovery. The events were reported as non-serious, but the event was upgraded as medically significant based on the information available in the source document. The causality of the event was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Eyelid oedema, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHHY2016US069631, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 631036) website on 17 May 2016. This report refers to a 67 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001) into left arm, intramuscularly, PREVNAR 13 vaccine (other manufacture, batch number: M35760) into left arm, intramuscularly and ZOSTAVAX vaccine (other manufacturer, batch number: L034724) into left arm, subcutaneously on 16 Mar 2016. Approximately on 24 Mar 2016, the patient experienced red, itchy spots on face and cheeks and right eyelid was puffy. It was reported that, patient is following up with primary care physician (PCP). 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. Seriousness assessment of eyelid oedema was upgraded to serious (medically significant) based on the information available in the source document.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza B virus test positive, Vaccination failure
Clinical narrative: Case number PHEH2016US009056 is a spontaneous report initially received from a pharmacist on 11 Apr 2016. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) 0.5 ml intramuscularly in Sep 2015. On 11 Apr 2016, the patient tested positive for flu B (vaccination failure). Outcome of the events was not reported. Seriousness of the events was reported as non serious. Causality was not reported. Seriousness of the events Influenza B virus test positive and vaccination failure was upgraded based on the available information in the source document. Since the batch number was not reported, a batch specific review could not be performed. Based on few FLUVIRIN 2015/2016 batches summary report, it was concluded that FLUVIRIN 2015/2016 manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN 2015/2016 vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non significant follow up report from Vaccine Adverse Event Reporting System (VAERS, reference nr. 631531) received on 17 May 2016: updated VAERS reference number only. Follow up information received from Quality Assurance (QA) department on 15 Apr 2016: Added QA reference number (1014179). Follow up information received from Quality Assurance (QA) department on 24 May 2016: Added expanded QA summary report.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US092933, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 632316) website on 06 Jul 2016. This report refers to a 43-year-old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (lot number: 15725P) in left arm intramuscularly on 09 Nov 2015. On 17 Dec 2015 the patient experienced Guillain-Barre Syndrome. The patient was taken to an emergency room. On an unknown date, the patient was admitted in the hospital and she was admitted for 7 days in the hospital. Outcome of the event was reported as complete recovery. Causality of the event was not reported.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Case number PHHY2016US092741, is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS reference number: 632319) website on 06 Jul 2016. This report refers to a 42 years old female patient. Past medical history included herniated disc in lower back. Concomitant medications included OXYCONTIN and PERCOCET. The patient was vaccinated with first dose of FLUVIRIN (batch number: not reported (earlier reported as invalid batch number 1578001) intramuscularly in arm on 19 Oct 2015. On an unknown date, the patient was hospitalized. On 18 Jan 2016, the patient was diagnosed with Guillain Barre in the hospital. The patient was treated with intravenous immunoglobulin (manufacturer unknown). The outcome of the event was reported as condition unchanged. The seriousness of the event was reported as serious (life threatening). The causality of the event was not reported. Follow up report received from quality assurance department on 25 Aug 2016: Updated suspect drug batch number information (deleted invalid batch number from product tab and narrative).
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Central nervous system lesion, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal, Paralysis
Clinical narrative: Case number PHHY2016US092878, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 632612) on 06 Jul 2016. This report refers to a 54 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) on 10 Jan 2013. After vaccination, on 22 Apr 2013, he was paralyzed from the waist down and was diagnosed with Transverse Myelitis. Laboratory data included nuclear magnetic resonance imaging (MRI) which showed lesion on spinal cord. Subsequent nuclear magnetic resonance imaging and multiple blood tests were performed (results unspecified). He was hospitalized on an unknown date and the hospitalization was prolonged for 7 days (details unspecified). The outcome of the events was reported as condition unchanged. The events were assessed as serious (disability) and causality was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Plasmapheresis
Clinical narrative: Case number PHHY2016US092878, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 632612) on 06 Jul 2016. This report refers to a 54 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) on 10 Jan 2013. After vaccination, on 22 Apr 2013, he was paralyzed from the waist down and was diagnosed with Transverse Myelitis. Laboratory data included nuclear magnetic resonance imaging (MRI) which showed lesion on spinal cord. Subsequent nuclear magnetic resonance imaging and multiple blood tests were performed (results unspecified). He was hospitalized on an unknown date and the hospitalization was prolonged for 7 days (details unspecified). The outcome of the events was reported as condition unchanged. The events were assessed as serious (disability) and causality was not reported.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test negative, Foaming at mouth, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHHY2016US092913, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 633994) on 06 Jul 2016. This report refers to a 16 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with first dose of FLUVIRIN (batch number: 158302) into the right arm intramuscularly on 17 Dec 2015. After vaccination, on 31 Dec 2015, he started feeling tingling and numbness in the feet and it progressed over the next several weeks and months to numbness in the legs and groin area. He saw chiropractors, acupuncturists, and neurologists as symptoms progressed and was diagnosed by a neurologist as Guillain Barre Syndrome (GBS). At one point, he developed foamy mucous in the mouth. Laboratory data was not known at the time of this report. The patient's mother informed that doctors performed several tests to rule out Lyme's disease and other possibilities. The outcome of the events was reported as complete recovery on an unknown date. The events were reported as non serious and causality was not reported. The seriousness assessment of the event Guillain-Barre Syndrome (medically significant) was upgraded based on the Novartis Important Medical Events list.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal, Plasmapheresis, Sensory loss
Clinical narrative: Case number PHHY2016US092805, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 634461) on 06 Jul 2016. This report refers to a 35 years old female patient. Past medical history included rheumatoid arthritis. Current condition included parotitis swollen gland. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 145301) into the arm on 20 Jan 2015. After vaccination, on 01 Feb 2015, she experienced Guillain-Barre syndrome and loss of sensation all over body. She was hospitalized on an unknown date and the events caused prolonged hospitalization (details unspecified). Laboratory data included lumbar puncture performed on an unknown date (results unspecified). She received plasma treatment and therapy for the events. The outcome of the events was unknown. The events were assessed as serious (life threatening, disability) and causality was not reported.