chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain upper, Constipation, Diarrhoea
Clinical narrative: Case number PHHY2016US039626, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622708) website on 18 MAR 2016. This report refers to a 26 year old female patient. Medical history was none. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 05 NOV 2015. On the same day after vaccination the patient experienced intense stomach cramping with alternating constipation and diarrhea. These events got worse in the next few days. Further stated that the events reappeared several weeks later, causing a visit to emergency room. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: Case number PHHY2016US039727 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 622710) on 18 Mar 2016. This report refers to a 41 year old female patient. She had no medical history. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) in the past and the injections were not pleasant as she had injection site soreness (see related case number: PHHY2016US039764). She had no current conditions. Her concomitant medications were citalopram hydrobromide 10mg tablet, omeprazole delayed release (DR) 40mg capsule and ADVIL over the counter (OTC) as needed. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the arm on 24 Sep 2015 in the morning. On the same day after vaccination, she had stabbing, shooting extreme pain felt deep within her shoulder immediately at the time of injection that travelled from her arm to her fingertips which tingled. The arm pain continued to get worse. She used heat thinking that it was some sort of muscle soreness and she gave it some time to be sure it was not just the soreness associated with the injection site, but the pain was deep within the shoulder. On 04 Oct 2015, she notified her doctor. She went to emergency room. She was advised to ice the area off and on and to let the doctor know the results after 2 weeks. After 2 weeks, there was no improvement and hence the doctor was called back. She was advised to another round of ice for another 2 weeks and to visit office if there was no improvement. On 02 Nov 2015, she had an appointment with the doctor and she was prescribed diclofenac sodium 75 mg tablet. The tablet was taken as prescribed and she had some improvement while she was on this medication. It was reported that once the medication was completed, the pain came back. The doctor was notified of this event on 23 Nov 2015 and she was prescribed another round of diclofenac sodium 75 mg tablet. It was reported that there was improvement again while on the tablet, but the pain came back after completion of medication. The doctor was notified of this and she was referred to a shoulder specialist. She had an appointment with the shoulder specialist on 04 Jan 2016. X-rays were taken (results not reported) and cortisone shot was administered. She had immediate relief from the shot for 2 weeks and the pain came back on the third week. On 25 Jan 2016, follow up visit with shoulder specialist was done. At the time of follow up visit, the pain was back. She was prescribed methylprednisone 4 mg dose pak to take if needed and to follow up with the shoulder specialist soon and was prescribed physical therapy for future treatment. The events outcome was reported as condition unchanged. 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: 41.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2016US039727 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 622710) on 18 Mar 2016. This report refers to a 41 year old female patient. She had no medical history. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) in the past and the injections were not pleasant as she had injection site soreness (see related case number: PHHY2016US039764). She had no current conditions. Her concomitant medications were citalopram hydrobromide 10mg tablet, omeprazole delayed release (DR) 40mg capsule and ADVIL over the counter (OTC) as needed. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the arm on 24 Sep 2015 in the morning. On the same day after vaccination, she had stabbing, shooting extreme pain felt deep within her shoulder immediately at the time of injection that travelled from her arm to her fingertips which tingled. The arm pain continued to get worse. She used heat thinking that it was some sort of muscle soreness and she gave it some time to be sure it was not just the soreness associated with the injection site, but the pain was deep within the shoulder. On 04 Oct 2015, she notified her doctor. She went to emergency room. She was advised to ice the area off and on and to let the doctor know the results after 2 weeks. After 2 weeks, there was no improvement and hence the doctor was called back. She was advised to another round of ice for another 2 weeks and to visit office if there was no improvement. On 02 Nov 2015, she had an appointment with the doctor and she was prescribed diclofenac sodium 75 mg tablet. The tablet was taken as prescribed and she had some improvement while she was on this medication. It was reported that once the medication was completed, the pain came back. The doctor was notified of this event on 23 Nov 2015 and she was prescribed another round of diclofenac sodium 75 mg tablet. It was reported that there was improvement again while on the tablet, but the pain came back after completion of medication. The doctor was notified of this and she was referred to a shoulder specialist. She had an appointment with the shoulder specialist on 04 Jan 2016. X-rays were taken (results not reported) and cortisone shot was administered. She had immediate relief from the shot for 2 weeks and the pain came back on the third week. On 25 Jan 2016, follow up visit with shoulder specialist was done. At the time of follow up visit, the pain was back. She was prescribed methylprednisone 4 mg dose pak to take if needed and to follow up with the shoulder specialist soon and was prescribed physical therapy for future treatment. The events outcome was reported as condition unchanged. 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: 41.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: X-ray limb
Clinical narrative: Case number PHHY2016US039727 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 622710) on 18 Mar 2016. This report refers to a 41 year old female patient. She had no medical history. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) in the past and the injections were not pleasant as she had injection site soreness (see related case number: PHHY2016US039764). She had no current conditions. Her concomitant medications were citalopram hydrobromide 10mg tablet, omeprazole delayed release (DR) 40mg capsule and ADVIL over the counter (OTC) as needed. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the arm on 24 Sep 2015 in the morning. On the same day after vaccination, she had stabbing, shooting extreme pain felt deep within her shoulder immediately at the time of injection that travelled from her arm to her fingertips which tingled. The arm pain continued to get worse. She used heat thinking that it was some sort of muscle soreness and she gave it some time to be sure it was not just the soreness associated with the injection site, but the pain was deep within the shoulder. On 04 Oct 2015, she notified her doctor. She went to emergency room. She was advised to ice the area off and on and to let the doctor know the results after 2 weeks. After 2 weeks, there was no improvement and hence the doctor was called back. She was advised to another round of ice for another 2 weeks and to visit office if there was no improvement. On 02 Nov 2015, she had an appointment with the doctor and she was prescribed diclofenac sodium 75 mg tablet. The tablet was taken as prescribed and she had some improvement while she was on this medication. It was reported that once the medication was completed, the pain came back. The doctor was notified of this event on 23 Nov 2015 and she was prescribed another round of diclofenac sodium 75 mg tablet. It was reported that there was improvement again while on the tablet, but the pain came back after completion of medication. The doctor was notified of this and she was referred to a shoulder specialist. She had an appointment with the shoulder specialist on 04 Jan 2016. X-rays were taken (results not reported) and cortisone shot was administered. She had immediate relief from the shot for 2 weeks and the pain came back on the third week. On 25 Jan 2016, follow up visit with shoulder specialist was done. At the time of follow up visit, the pain was back. She was prescribed methylprednisone 4 mg dose pak to take if needed and to follow up with the shoulder specialist soon and was prescribed physical therapy for future treatment. The events outcome was reported as condition unchanged. 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: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Case number PHHY2016US039311, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622712) website on 18 MAR 2016. This report refers to a 55-years-old female patient. Past medical history included neuropathy in feet, toxic mold exposure/diagnosis 2007 to 2012, memory loss and hormone replacement therapy. Concomitant medications included A-Liporic acid (manufacturer unknown), Vitamin D (manufacturer unknown), AMPK (manufacturer unknown) and magnesium (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 28 OCT 2015. On 29 OCT 2015, he experienced sore left arm that last few days and went away. She reported that, it started again in the month of November with several pain when slept or shoulder and certain movements. The patient also stated that, numbness, weakness in both hands during the day and when slept, her hands were numb during night regardless of side on which she slept. The patient stated that, she was unsure that it was because of neuropathy or from flu shot. Laboratory data included magnetic resonance imaging (MRI) of neck (reported as 2 weeks ago) (results unspecified) and nerve test was scheduled next week. The outcome of the events was not reported. The seriousness of the  events was reported as non serious. The causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: Case number PHHY2016US039311, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622712) website on 18 MAR 2016. This report refers to a 55-years-old female patient. Past medical history included neuropathy in feet, toxic mold exposure/diagnosis 2007 to 2012, memory loss and hormone replacement therapy. Concomitant medications included A-Liporic acid (manufacturer unknown), Vitamin D (manufacturer unknown), AMPK (manufacturer unknown) and magnesium (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 28 OCT 2015. On 29 OCT 2015, he experienced sore left arm that last few days and went away. She reported that, it started again in the month of November with several pain when slept or shoulder and certain movements. The patient also stated that, numbness, weakness in both hands during the day and when slept, her hands were numb during night regardless of side on which she slept. The patient stated that, she was unsure that it was because of neuropathy or from flu shot. Laboratory data included magnetic resonance imaging (MRI) of neck (reported as 2 weeks ago) (results unspecified) and nerve test was scheduled next week. The outcome of the events was not reported. The seriousness of the  events was reported as non serious. The causality of the events was not reported.
Age: 77.0
Sex: F
Vaccine: FLUX, UNK, FLUX
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Myalgia, Sleep disorder
Clinical narrative: Case number PHHY2016US039956, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622715) website on 18 MAR 2016. This report refers to a 77-years-old female patient. Past medical history was not reported. Concomitant medications included levothyroxine (manufacturer unknown) 75 mcg, Aspirin 81 mg X2 and estradiol (manufacturer unknown) 0.5 mg. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in left arm along with an unknown vaccine (manufacturer unknown and batch number: not reported), both on 101 OCT 2014. On an unknown date, the patient experienced periodic but persistent severe arm pain in left arm in area of flu shot. Periodic muscle ache, moderate weakness and reduced range of motion in upper arm, often the pain wakes me up from sleep if the patient rest on left arm. Because the patient has this problem earlier when received a flu shot for the past three or four years. The outcome of the events was not reported. The seriousness of the events mobility decreased, sleep disorder, asthenia, myalgia and vaccination site pain was reported as no serious and not reported for the event pain. The causality of the events was not reported.
Age: 77.0
Sex: F
Vaccine: FLUX, UNK, FLUX
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased, Myalgia, Sleep disorder
Clinical narrative: Case number PHHY2016US039956, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622715) website on 18 MAR 2016. This report refers to a 77-years-old female patient. Past medical history was not reported. Concomitant medications included levothyroxine (manufacturer unknown) 75 mcg, Aspirin 81 mg X2 and estradiol (manufacturer unknown) 0.5 mg. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) in left arm along with an unknown vaccine (manufacturer unknown and batch number: not reported), both on 101 OCT 2014. On an unknown date, the patient experienced periodic but persistent severe arm pain in left arm in area of flu shot. Periodic muscle ache, moderate weakness and reduced range of motion in upper arm, often the pain wakes me up from sleep if the patient rest on left arm. Because the patient has this problem earlier when received a flu shot for the past three or four years. The outcome of the events was not reported. The seriousness of the events mobility decreased, sleep disorder, asthenia, myalgia and vaccination site pain was reported as no serious and not reported for the event pain. The causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US040798 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622720) on 18 MAR 2016. This report refers to a 44 year old female patient. Medical history was not reported. Current condition included eye allergy. Her concomitant medications included anti-allergy and anti-conception drug. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 05 OCT 2015. On 07 OCT 2015, the patient developed strong arm and shoulder pain. The outcome of the events was reported as condition unchanged. Events were reported as non-serious. Causality of the events was not reported.
Age: 38.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Dyspnoea, Pruritus, Swelling face, Urticaria
Clinical narrative: Case number PHHY2016US053584, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622911) website on 18 Apr 2016. This report refers to a 38 years old male patient. Medical history was not reported. Historical drug included muscle relaxer SOMA. Concurrent condition included possible chest cold. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 12 Feb 2016. On 13 Feb 2016 the patient woke up to severe itching located at hands and feet. Further the patient developed hives and facial swelling. Shortly after that the patient developed labored breathing. Treatment at the emergency was Epi shot, plus several others. Outcome of the events was recovered. Seriousness and causality of the events was not reported. Seriousness assessment of "hives", "facial swelling" and "labored breathing" was upgraded based on information in the source document.
Age: 47.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Impaired work ability, Influenza virus test positive, Malaise, Vaccination failure
Clinical narrative: Case number PHHY2016US053002, is an initial spontaneous report received from nurse via Vaccine Adverse Event Reporting System (VAERS ID: 622967) website on 18 Apr 2016. This report refers to a 47 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On 02 Feb 2016, the patient felt sick. On an unknown date, the patient tested in health center with positive flu, it was a vaccination failure. It was reported that, the patient had restriction as not work until 08 Jan 2016. The patient's laboratory data and corrective treatment was not reported. The outcome of events was not reported. The seriousness of the events was reported as non serious and causality not reported. Seriousness of the event "influenza virus test positive and vaccination failure" was upgraded based on information available in the source document.
Age: 47.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Influenza, Influenza virus test positive, Malaise, Vaccination failure
Clinical narrative: Case number PHHY2016US053002, is an initial spontaneous report received from nurse via Vaccine Adverse Event Reporting System (VAERS ID: 622967) website on 18 Apr 2016. This report refers to a 47 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On 02 Feb 2016, the patient felt sick. On an unknown date, the patient tested in health center with positive flu, it was a vaccination failure. It was reported that, the patient had restriction as not work until 08 Jan 2016. The patient's laboratory data and corrective treatment was not reported. The outcome of events was not reported. The seriousness of the events was reported as non serious and causality not reported. Seriousness of the event "influenza virus test positive and vaccination failure" was upgraded based on information available in the source document.
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Influenza like illness
Clinical narrative: Case number PHHY2016US053237, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 622974) website on 18 Apr 2016. This report refers to a male patient of an unknown age. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date (reported that he received the vaccine this year 2016). On an unspecified date, the patient experienced flu A/flu-like illness. The patient visited to the emergency room. The outcome of event was not reported. The final outcome of event was reported as condition unchanged. Seriousness of the event was reported as non serious. The causality of the event was not reported. Seriousness assessment of influenza like illness was upgraded to medically significant based on the information available in the source document.
Age: 76.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHHY2016US052881, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 623880) website on 18 Apr 2016. This report refers to a 76 years old female patient. Medical history was not reported. Preexisting conditions included diabetes, heart trouble and glaucoma eye. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm on 01 Dec 2015. On 01 Jan 2016 the patient experienced sore arm shoulder, neck stiffness and was unable to lift arm at times. Outcome of the events was recovered. Seriousness and causality of the events was not reported.
Age: 76.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHHY2016US052881, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 623880) website on 18 Apr 2016. This report refers to a 76 years old female patient. Medical history was not reported. Preexisting conditions included diabetes, heart trouble and glaucoma eye. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm on 01 Dec 2015. On 01 Jan 2016 the patient experienced sore arm shoulder, neck stiffness and was unable to lift arm at times. Outcome of the events was recovered. Seriousness and causality of the events was not reported.
Age: 80.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Furuncle, Pain, Pain in extremity, Rash macular
Clinical narrative: Case number PHHY2016US053138, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS 623945) website on 18 Apr 2016. This report refers to an 80 years old female patient. Past medical history was reported as no and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 01 Nov 2015. On 02 Nov 2015, the patient experienced sore arm and within a week it hurt to extend the arm, not in shoulder joint but upper arm. On an unknown date in Jan 2016, the patient had two large boils on same arm. The patient was treated with antibiotic (manufacturer unknown) and it has cured one. On 22 Feb 2016, it was reported that the arm still hurt to move but entire upper arm turned red with several splotches. The final outcome of the event two large boils on same arm was reported as condition improving and for other events it was reported as condition unchanged. The seriousness of the events was reported as non serious and causality not reported. Seriousness of the event pain and rash macular was upgraded based on information available in the source document.
Age: 80.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Erythema, Furuncle, Pain, Pain in extremity, Rash macular
Clinical narrative: Case number PHHY2016US053138, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS 623945) website on 18 Apr 2016. This report refers to an 80 years old female patient. Past medical history was reported as no and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on 01 Nov 2015. On 02 Nov 2015, the patient experienced sore arm and within a week it hurt to extend the arm, not in shoulder joint but upper arm. On an unknown date in Jan 2016, the patient had two large boils on same arm. The patient was treated with antibiotic (manufacturer unknown) and it has cured one. On 22 Feb 2016, it was reported that the arm still hurt to move but entire upper arm turned red with several splotches. The final outcome of the event two large boils on same arm was reported as condition improving and for other events it was reported as condition unchanged. The seriousness of the events was reported as non serious and causality not reported. Seriousness of the event pain and rash macular was upgraded based on information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Oropharyngeal pain, Upper-airway cough syndrome
Clinical narrative: Case number PHHY2016US051727, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 623986) website on 18 Apr 2016. This report refers to 33 years old female patient. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), intramuscularly on arm, on 11 Nov 2015. On 25 Nov 2015, she had post nasal drip, sore throat and cough. The final outcome of the events was complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 35.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Electromyogram, Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHHY2016US051565, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 624307) website on 18 Apr 2016. This report refers to 35 years old female patient. Medical history was not reported. Concurrent conditions included diabetes and hypertension. Concomitant medications included JANUVIA, HUMALOG, LANTUS, glipizide and diclofenac. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) subcutaneously into left arm on 18 Feb 2016. On the same day after vaccination the patient experienced numbness and tingling in arm. It was reported that electromyogram (EMG) was pending. Outcome of the events was reported as not recovered. The case was assessed as non-serious. Causality of the events was reported.
Age: 35.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Electromyogram, Hypoaesthesia, Incorrect route of drug administration, Paraesthesia
Clinical narrative: Case number PHHY2016US051565, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 624307) website on 18 Apr 2016. This report refers to 35 years old female patient. Medical history was not reported. Concurrent conditions included diabetes and hypertension. Concomitant medications included JANUVIA, HUMALOG, LANTUS, glipizide and diclofenac. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) subcutaneously into left arm on 18 Feb 2016. On the same day after vaccination the patient experienced numbness and tingling in arm. It was reported that electromyogram (EMG) was pending. Outcome of the events was reported as not recovered. The case was assessed as non-serious. Causality of the events was reported.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Granuloma annulare, Rash
Clinical narrative: Case number PHHY2016US051764, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 624653) website on 18 Apr 2016. This report refers to 06 years old female patient. Current condition included allergy to OMNICEF. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), in the right arm, on 28 Oct 2015. Soon after flu shot, she had spot came up on her right shoulder resembling a ringworm. Spot was treated with antifungal creams (unspecified) for one month but it got bigger. She did not complain of itching. On an unknown date, new spots noted to came up on her. She was taken to urgent care and was diagnosed with granuloma annulare. She was prescribed with steroid cream, which did not help her. She had granuloma annulare spots noted to be covering her arms, legs, abdomen, back and buttocks. She did not get the spots until after receiving the flu shot. On an unknown date, she went to an emergency room. The final outcome of the events was condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. Following an internal review done on 21 Apr 2016 for the data received on 18 Apr 2016, the following changes were done: Seriousness of the events granuloma annulare and skin discoloration was changed from serious to non serious.
Age: 6.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Granuloma annulare, Skin discolouration
Clinical narrative: Case number PHHY2016US051764, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 624653) website on 18 Apr 2016. This report refers to 06 years old female patient. Current condition included allergy to OMNICEF. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), in the right arm, on 28 Oct 2015. Soon after flu shot, she had spot came up on her right shoulder resembling a ringworm. Spot was treated with antifungal creams (unspecified) for one month but it got bigger. She did not complain of itching. On an unknown date, new spots noted to came up on her. She was taken to urgent care and was diagnosed with granuloma annulare. She was prescribed with steroid cream, which did not help her. She had granuloma annulare spots noted to be covering her arms, legs, abdomen, back and buttocks. She did not get the spots until after receiving the flu shot. On an unknown date, she went to an emergency room. The final outcome of the events was condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. Following an internal review done on 21 Apr 2016 for the data received on 18 Apr 2016, the following changes were done: Seriousness of the events granuloma annulare and skin discoloration was changed from serious to non serious.
Age: 66.0
Sex: F
Vaccine: FLUX, FLU3, FLUX
Symptoms: Neuropathy peripheral
Clinical narrative: Case number PHHY2016US053921, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 625826) website on 18 Apr 2016. This report refers to 66 years old female patient. Past historical condition and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date, after vaccination she experienced neuropathy and received LYRICA as a corrective treatment for the same. The final outcome of the event was condition unchanged (not recovered). The seriousness of the event was reported as non serious and causality was not reported. Seriousness assessment of neuropathy (medically significant) was upgraded based on information available in the source document.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Diarrhoea, Dizziness
Clinical narrative: Case number PHHY2016US052254, is an initial spontaneous report received from a consumer (patient) via a patient support program and other health care professional (clinically sponsored) via the Vaccine Adverse Event Reporting System (VAERS reference number: 626514) on 18 Apr 2016. This report refers to an 82 years old male patient. The patient had medical history of heart disease, chronic obstructive pulmonary disease and asthma. The patient had allergy to NEOSPORIN, Iodine, Intravenous Pyelogram dye and ZYCLARA. Past medication included PRALUENT at a dose of 75 mg every other week subcutaneously (lot/batch number: 5F005AC and expiry date unspecified) for mixed hyperlipidemia, high cholesterol, raised Low density lipoprotein and intermediate coronary syndrome on 24 Sep 2015. The patient stated that he experienced bleeding at the injection site immediately after the injection, lightheaded for 2 to 3 hours after the injection, abdominal cramping and increased bowel movements for several days after the injection. On 24 Sep 2015 (same day), the patient experienced upset stomach and had muscle pain and soreness to some extent. Concomitant drugs included IMDUR, PLAVIX, Aspirin and Atenolol (manufacture unknown), all for heart disease. The patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) and also received PRALUENT injection on 03 Dec 2015. After vaccination, on an unknown date in Dec 2015, he experienced stomach cramps, his face broke out with red spots and had diarrhea for 2 days. The final outcome of the events stomach cramps and face broke out with red spots was unknown while it was reported as complete recovery on an unknown date for diarrhea. The events were assessed as non serious and causality was not reported. The seriousness assessment of the events abdominal pain upper, diarrhea and rash erythematous were upgraded (medically significant) based on the information available in the source document.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Frequent bowel movements, Immediate post-injection reaction, Injection site haemorrhage, Myalgia, Pain
Clinical narrative: Case number PHHY2016US052254, is an initial spontaneous report received from a consumer (patient) via a patient support program and other health care professional (clinically sponsored) via the Vaccine Adverse Event Reporting System (VAERS reference number: 626514) on 18 Apr 2016. This report refers to an 82 years old male patient. The patient had medical history of heart disease, chronic obstructive pulmonary disease and asthma. The patient had allergy to NEOSPORIN, Iodine, Intravenous Pyelogram dye and ZYCLARA. Past medication included PRALUENT at a dose of 75 mg every other week subcutaneously (lot/batch number: 5F005AC and expiry date unspecified) for mixed hyperlipidemia, high cholesterol, raised Low density lipoprotein and intermediate coronary syndrome on 24 Sep 2015. The patient stated that he experienced bleeding at the injection site immediately after the injection, lightheaded for 2 to 3 hours after the injection, abdominal cramping and increased bowel movements for several days after the injection. On 24 Sep 2015 (same day), the patient experienced upset stomach and had muscle pain and soreness to some extent. Concomitant drugs included IMDUR, PLAVIX, Aspirin and Atenolol (manufacture unknown), all for heart disease. The patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) and also received PRALUENT injection on 03 Dec 2015. After vaccination, on an unknown date in Dec 2015, he experienced stomach cramps, his face broke out with red spots and had diarrhea for 2 days. The final outcome of the events stomach cramps and face broke out with red spots was unknown while it was reported as complete recovery on an unknown date for diarrhea. The events were assessed as non serious and causality was not reported. The seriousness assessment of the events abdominal pain upper, diarrhea and rash erythematous were upgraded (medically significant) based on the information available in the source document.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Rash erythematous
Clinical narrative: Case number PHHY2016US052254, is an initial spontaneous report received from a consumer (patient) via a patient support program and other health care professional (clinically sponsored) via the Vaccine Adverse Event Reporting System (VAERS reference number: 626514) on 18 Apr 2016. This report refers to an 82 years old male patient. The patient had medical history of heart disease, chronic obstructive pulmonary disease and asthma. The patient had allergy to NEOSPORIN, Iodine, Intravenous Pyelogram dye and ZYCLARA. Past medication included PRALUENT at a dose of 75 mg every other week subcutaneously (lot/batch number: 5F005AC and expiry date unspecified) for mixed hyperlipidemia, high cholesterol, raised Low density lipoprotein and intermediate coronary syndrome on 24 Sep 2015. The patient stated that he experienced bleeding at the injection site immediately after the injection, lightheaded for 2 to 3 hours after the injection, abdominal cramping and increased bowel movements for several days after the injection. On 24 Sep 2015 (same day), the patient experienced upset stomach and had muscle pain and soreness to some extent. Concomitant drugs included IMDUR, PLAVIX, Aspirin and Atenolol (manufacture unknown), all for heart disease. The patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) and also received PRALUENT injection on 03 Dec 2015. After vaccination, on an unknown date in Dec 2015, he experienced stomach cramps, his face broke out with red spots and had diarrhea for 2 days. The final outcome of the events stomach cramps and face broke out with red spots was unknown while it was reported as complete recovery on an unknown date for diarrhea. The events were assessed as non serious and causality was not reported. The seriousness assessment of the events abdominal pain upper, diarrhea and rash erythematous were upgraded (medically significant) based on the information available in the source document.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain upper, Diarrhoea, Rash, Rash erythematous
Clinical narrative: Case number PHHY2016US052254, is an initial spontaneous report received from a consumer (patient) via a patient support program and other health care professional (clinically sponsored) via the Vaccine Adverse Event Reporting System (VAERS reference number: 626514) on 18 Apr 2016. This report refers to an 82 years old male patient. The patient had medical history of heart disease, chronic obstructive pulmonary disease and asthma. The patient had allergy to NEOSPORIN, Iodine, Intravenous Pyelogram dye and ZYCLARA. Past medication included PRALUENT at a dose of 75 mg every other week subcutaneously (lot/batch number: 5F005AC and expiry date unspecified) for mixed hyperlipidemia, high cholesterol, raised Low density lipoprotein and intermediate coronary syndrome on 24 Sep 2015. The patient stated that he experienced bleeding at the injection site immediately after the injection, lightheaded for 2 to 3 hours after the injection, abdominal cramping and increased bowel movements for several days after the injection. On 24 Sep 2015 (same day), the patient experienced upset stomach and had muscle pain and soreness to some extent. Concomitant drugs included IMDUR, PLAVIX, Aspirin and Atenolol (manufacture unknown), all for heart disease. The patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) and also received PRALUENT injection on 03 Dec 2015. After vaccination, on an unknown date in Dec 2015, he experienced stomach cramps, his face broke out with red spots and had diarrhea for 2 days. The final outcome of the events stomach cramps and face broke out with red spots was unknown while it was reported as complete recovery on an unknown date for diarrhea. The events were assessed as non serious and causality was not reported. The seriousness assessment of the events abdominal pain upper, diarrhea and rash erythematous were upgraded (medically significant) based on the information available in the source document.
Age: 49.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US052329, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 626871) website on 18 Apr 2016. This report refers to a 49 years old female patient. Medical history was not reported. Concurrent conditions were unknown. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Oct 2008. On the same day after vaccination the patient experienced "Guillain Barre". Outcome of the event was recovered. The seriousness and causality of the event was not reported. Seriousness assessment of the event was upgraded based on the NVS-IME list.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Feeding disorder
Clinical narrative: Case number PHHY2016US052339, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 627028) website on 18 Apr 2016. This report refers to a 78-years-old male patient. Past medical history included pneumonia. Concurrent conditions included arthralgia multiple (airplane flying accident), asthma and emphysema. Concomitant medications included amlodipine (manufacturer unknown), FLONASE, SINGULAIR, NAPROSYN, PROAIR HFA, Aspirin (Baby) and prednisone (manufacturer unknown). The patient was administered ADVAIR DISKUS inhalation powder at a dose of 1 puff(s) daily for asthma and emphysema since Apr 2001. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly on 01 Oct 2015. In Oct 2015, on an unknown date after vaccination the patient experienced underdose. In Nov 2015, (approximately 30 days after vaccination) the patient experienced vaccination failure, influenza, shivering, difficulty breathing, weight loss, was unable to eat, tiredness, diarrhea and vomiting. It was reported that ADVAIR DISKUS was continued with no change. The outcome of the events underdose and vaccination failure was reported as unknown. Outcome of the events influenza, shivering, difficulty breathing, weight loss, was unable to eat, diarrhea and vomiting was reported as complete recovery and condition unchanged for the event tiredness. Seriousness of the events was not reported. The reporter considered the vaccination failure, influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to influenza vaccine. The reporter considered the influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to ADVAIR DISKUS. The patient believed that ADVAIR and flu shot had nothing to do with him experiencing flu including the multiple symptoms as listed above. The causality of the event underdose was not reported. The seriousness of the events vaccination failure and influenza, dyspnea, chills and fatigue was upgraded to medically significant based on the information available in the source document.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Influenza, Underdose, Vaccination failure, Vomiting, Weight decreased
Clinical narrative: Case number PHHY2016US052339, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 627028) website on 18 Apr 2016. This report refers to a 78-years-old male patient. Past medical history included pneumonia. Concurrent conditions included arthralgia multiple (airplane flying accident), asthma and emphysema. Concomitant medications included amlodipine (manufacturer unknown), FLONASE, SINGULAIR, NAPROSYN, PROAIR HFA, Aspirin (Baby) and prednisone (manufacturer unknown). The patient was administered ADVAIR DISKUS inhalation powder at a dose of 1 puff(s) daily for asthma and emphysema since Apr 2001. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly on 01 Oct 2015. In Oct 2015, on an unknown date after vaccination the patient experienced underdose. In Nov 2015, (approximately 30 days after vaccination) the patient experienced vaccination failure, influenza, shivering, difficulty breathing, weight loss, was unable to eat, tiredness, diarrhea and vomiting. It was reported that ADVAIR DISKUS was continued with no change. The outcome of the events underdose and vaccination failure was reported as unknown. Outcome of the events influenza, shivering, difficulty breathing, weight loss, was unable to eat, diarrhea and vomiting was reported as complete recovery and condition unchanged for the event tiredness. Seriousness of the events was not reported. The reporter considered the vaccination failure, influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to influenza vaccine. The reporter considered the influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to ADVAIR DISKUS. The patient believed that ADVAIR and flu shot had nothing to do with him experiencing flu including the multiple symptoms as listed above. The causality of the event underdose was not reported. The seriousness of the events vaccination failure and influenza, dyspnea, chills and fatigue was upgraded to medically significant based on the information available in the source document.