chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asterixis, Blood test, Hypoaesthesia, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 22 year old female patient who had no current illness. On the 13-Jan-2015, the patient received AFLURIA injection (batch number 'T53609A') via an unknown route in the left arm. On the 14-Jan-2015 in the AM (morning), the patient complained of numbness/tingling in the hands but this quickly resolved. The patient participated in a swim practice on the 14-Jan-2015 and left arm flapping occurred. She stated that this did not stop unless she squeezed a stress ball. It did not occur during sleep. On the 15-Jan-2015, the patient lifted weights and participated in a swim practice. On the 16-Jan-2015, the patient attended an ER (Emergency Room) and was told it was stress related. The patient underwent an MRI (Magnetic Resonance Imaging), UA (Urine Analysis) and blood work. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the symptoms of 'blood test', 'Nuclear Magnetic Resonance Imaging' and urine 'analysis'.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arrhythmia, Borrelia test negative, Cardiac imaging procedure normal, Echocardiogram normal, Electromyogram abnormal
Clinical narrative: Case number PHHY2015US052630, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 562261) website on 21 Apr 2015. This report refers to a 61 year old male patient. Medical history was not reported. His concomitant medications included BYSTOLIC for hypertension and NEXIUM for gastrooesophageal reflux disease. On 16 Sep 2013, he was vaccinated with FLUVIRIN, (batch number: 1308201) intramuscularly in left arm. On 01 Nov 2013, he developed cardiac arrhythmia with palpitations. Cardiac evaluation was normal except for frequent premature ventricular contractions. He developed Guillain Barre Syndrome and was hospitalized. A nerve conduction velocity test and electromyogram confirmed polyneuropathy with numbness in all extremities and face. Vitamin, thyroid and "Lyme" levels were normal. Hence, these parameters were ruled out to be a cause of neuropathy. Echocardiogram, thallium stress test and cardiac magnetic resonance imaging test were normal. He was given high dose steroid therapy, which did not improve the symptoms. Final outcome was reported as condition unchanged (symptoms persist without any change). Causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Laboratory test normal, Nerve conduction studies abnormal, Palpitations
Clinical narrative: Case number PHHY2015US052630, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 562261) website on 21 Apr 2015. This report refers to a 61 year old male patient. Medical history was not reported. His concomitant medications included BYSTOLIC for hypertension and NEXIUM for gastrooesophageal reflux disease. On 16 Sep 2013, he was vaccinated with FLUVIRIN, (batch number: 1308201) intramuscularly in left arm. On 01 Nov 2013, he developed cardiac arrhythmia with palpitations. Cardiac evaluation was normal except for frequent premature ventricular contractions. He developed Guillain Barre Syndrome and was hospitalized. A nerve conduction velocity test and electromyogram confirmed polyneuropathy with numbness in all extremities and face. Vitamin, thyroid and "Lyme" levels were normal. Hence, these parameters were ruled out to be a cause of neuropathy. Echocardiogram, thallium stress test and cardiac magnetic resonance imaging test were normal. He was given high dose steroid therapy, which did not improve the symptoms. Final outcome was reported as condition unchanged (symptoms persist without any change). Causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Polyneuropathy, Scan myocardial perfusion normal, Thyroid function test normal, Ventricular extrasystoles
Clinical narrative: Case number PHHY2015US052630, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 562261) website on 21 Apr 2015. This report refers to a 61 year old male patient. Medical history was not reported. His concomitant medications included BYSTOLIC for hypertension and NEXIUM for gastrooesophageal reflux disease. On 16 Sep 2013, he was vaccinated with FLUVIRIN, (batch number: 1308201) intramuscularly in left arm. On 01 Nov 2013, he developed cardiac arrhythmia with palpitations. Cardiac evaluation was normal except for frequent premature ventricular contractions. He developed Guillain Barre Syndrome and was hospitalized. A nerve conduction velocity test and electromyogram confirmed polyneuropathy with numbness in all extremities and face. Vitamin, thyroid and "Lyme" levels were normal. Hence, these parameters were ruled out to be a cause of neuropathy. Echocardiogram, thallium stress test and cardiac magnetic resonance imaging test were normal. He was given high dose steroid therapy, which did not improve the symptoms. Final outcome was reported as condition unchanged (symptoms persist without any change). Causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arrhythmia, Borrelia test negative, Cardiac imaging procedure abnormal, Echocardiogram normal, Electromyogram abnormal
Clinical narrative: Case number PHHY2015US052630, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 562261) website on 21 Apr 2015. This report refers to a 61 year old male patient. Medical history was not reported. His concomitant medications included BYSTOLIC for hypertension and NEXIUM for gastrooesophageal reflux disease. On 16 Sep 2013, he was vaccinated with FLUVIRIN, (batch number: 1308201) intramuscularly in left arm. On 01 Nov 2013, he developed cardiac arrhythmia with palpitations. Cardiac evaluation was normal except for frequent premature ventricular contractions. He developed Guillain Barre Syndrome and was hospitalized. A nerve conduction velocity test and electromyogram confirmed polyneuropathy with numbness in all extremities and face. Vitamin, thyroid and "Lyme" levels were normal. Hence, these parameters were ruled out to be a cause of neuropathy. Echocardiogram, thallium stress test and cardiac magnetic resonance imaging test were normal. He was given high dose steroid therapy, which did not improve the symptoms. Final outcome was reported as condition unchanged (symptoms persist without any change). Causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Nerve conduction studies abnormal, Palpitations, Polyneuropathy
Clinical narrative: Case number PHHY2015US052630, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 562261) website on 21 Apr 2015. This report refers to a 61 year old male patient. Medical history was not reported. His concomitant medications included BYSTOLIC for hypertension and NEXIUM for gastrooesophageal reflux disease. On 16 Sep 2013, he was vaccinated with FLUVIRIN, (batch number: 1308201) intramuscularly in left arm. On 01 Nov 2013, he developed cardiac arrhythmia with palpitations. Cardiac evaluation was normal except for frequent premature ventricular contractions. He developed Guillain Barre Syndrome and was hospitalized. A nerve conduction velocity test and electromyogram confirmed polyneuropathy with numbness in all extremities and face. Vitamin, thyroid and "Lyme" levels were normal. Hence, these parameters were ruled out to be a cause of neuropathy. Echocardiogram, thallium stress test and cardiac magnetic resonance imaging test were normal. He was given high dose steroid therapy, which did not improve the symptoms. Final outcome was reported as condition unchanged (symptoms persist without any change). Causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Scan myocardial perfusion normal, Thyroid function test normal, Ventricular extrasystoles
Clinical narrative: Case number PHHY2015US052630, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 562261) website on 21 Apr 2015. This report refers to a 61 year old male patient. Medical history was not reported. His concomitant medications included BYSTOLIC for hypertension and NEXIUM for gastrooesophageal reflux disease. On 16 Sep 2013, he was vaccinated with FLUVIRIN, (batch number: 1308201) intramuscularly in left arm. On 01 Nov 2013, he developed cardiac arrhythmia with palpitations. Cardiac evaluation was normal except for frequent premature ventricular contractions. He developed Guillain Barre Syndrome and was hospitalized. A nerve conduction velocity test and electromyogram confirmed polyneuropathy with numbness in all extremities and face. Vitamin, thyroid and "Lyme" levels were normal. Hence, these parameters were ruled out to be a cause of neuropathy. Echocardiogram, thallium stress test and cardiac magnetic resonance imaging test were normal. He was given high dose steroid therapy, which did not improve the symptoms. Final outcome was reported as condition unchanged (symptoms persist without any change). Causality of the events was not reported.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 67 year old male patient who had an allergy to cocaine and no current illness. On the 14-Nov-2014, the patient received AFLURIA injection (batch number 10449211A) via the intramuscular route in the left arm. On the 14-Nov-2014, the patient developed left hand and finger tingling and numbness, was dizzy and lightheaded. The patient contacted the pharmacy and told if it didn't get better, the patient should go to the doctor. Outcome was not recovered. Reporter comments: The regulator reported the case as serious (permanent disability) and reported that the patient attended the Emergency Room.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 74 year old female patient. The patient had medical history of 'afib' (atrial fibrillation). Her concomitant medication included warfarin. On 24-Sep-2014, the patient received intramuscular AFLURIA injection (batch number: T57205) in the right arm. On 24-Sep-2014, the patient experienced severe right arm pain. The limiting activities included combing hair and cooking. The patient was treated with steroids and pain medications. The patient had appointment with an orthopaedic doctor the week of 26-Jan-2015. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as serious as they were life-threatening.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Adhesiolysis, Biopsy lymph gland abnormal, Blood cholesterol increased, Blood homocysteine normal, Blood thyroid stimulating hormone normal
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 42 year old male patient. The patient had a medical history of hypertension, obstructive sleep apnoea, hypercholesterolemia and facial swelling (from Aspirin). His past medication included acetylsalicylic acid. His concomitant medications included telmisartan, omeprazole, atorvastatin and diclofenac sodium. On 06-Oct-2011, the patient received intramuscular AFLURIA injection (batch number "1459121A") in the left arm. On 07-Oct-2011, within one to two days of vaccination, the patient experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever. After one to two days, fever resolved but oedema continued and he developed a mass over the next several months. The patient had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthema, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve and he waited for almost six months but eventually pursued evaluation which resulted in mass excision from his axilla. On 08-Oct-2011, his pathology showed a lipoma and one lymph node with otherwise normal pathology. The results showed 5.0 x 4.0 x 2.0 cm soft tissue in left axilla, excisional biopsy showed benign mature adipose tissue consistent with lipoma - benign incidental lymph node. The patient had subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately six months. On 31-Oct-2011, the patient underwent laboratory results for CBC (complete blood count), CMP (complete metabolic panel), A1C (glycosylated haemoglobin), TSH WNL (thyroid stimulating hormone within normal limits), vitamin D15. His lipid profile showed cholesterol at 215, HDL at 143, and homocysteine 9.4. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included blood homocysteine normal, blood thyroid stimulating hormone normal, full blood count normal, glycosylated haemoglobin normal, lipids, metabolic function test normal, vitamin D, and pathology test.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Full blood count normal, Glycosylated haemoglobin normal, High density lipoprotein normal, Lipids, Lipoma
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 42 year old male patient. The patient had a medical history of hypertension, obstructive sleep apnoea, hypercholesterolemia and facial swelling (from Aspirin). His past medication included acetylsalicylic acid. His concomitant medications included telmisartan, omeprazole, atorvastatin and diclofenac sodium. On 06-Oct-2011, the patient received intramuscular AFLURIA injection (batch number "1459121A") in the left arm. On 07-Oct-2011, within one to two days of vaccination, the patient experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever. After one to two days, fever resolved but oedema continued and he developed a mass over the next several months. The patient had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthema, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve and he waited for almost six months but eventually pursued evaluation which resulted in mass excision from his axilla. On 08-Oct-2011, his pathology showed a lipoma and one lymph node with otherwise normal pathology. The results showed 5.0 x 4.0 x 2.0 cm soft tissue in left axilla, excisional biopsy showed benign mature adipose tissue consistent with lipoma - benign incidental lymph node. The patient had subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately six months. On 31-Oct-2011, the patient underwent laboratory results for CBC (complete blood count), CMP (complete metabolic panel), A1C (glycosylated haemoglobin), TSH WNL (thyroid stimulating hormone within normal limits), vitamin D15. His lipid profile showed cholesterol at 215, HDL at 143, and homocysteine 9.4. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included blood homocysteine normal, blood thyroid stimulating hormone normal, full blood count normal, glycosylated haemoglobin normal, lipids, metabolic function test normal, vitamin D, and pathology test.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Local swelling, Lymphadenopathy, Lymphangitis, Mass, Metabolic function test normal
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 42 year old male patient. The patient had a medical history of hypertension, obstructive sleep apnoea, hypercholesterolemia and facial swelling (from Aspirin). His past medication included acetylsalicylic acid. His concomitant medications included telmisartan, omeprazole, atorvastatin and diclofenac sodium. On 06-Oct-2011, the patient received intramuscular AFLURIA injection (batch number "1459121A") in the left arm. On 07-Oct-2011, within one to two days of vaccination, the patient experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever. After one to two days, fever resolved but oedema continued and he developed a mass over the next several months. The patient had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthema, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve and he waited for almost six months but eventually pursued evaluation which resulted in mass excision from his axilla. On 08-Oct-2011, his pathology showed a lipoma and one lymph node with otherwise normal pathology. The results showed 5.0 x 4.0 x 2.0 cm soft tissue in left axilla, excisional biopsy showed benign mature adipose tissue consistent with lipoma - benign incidental lymph node. The patient had subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately six months. On 31-Oct-2011, the patient underwent laboratory results for CBC (complete blood count), CMP (complete metabolic panel), A1C (glycosylated haemoglobin), TSH WNL (thyroid stimulating hormone within normal limits), vitamin D15. His lipid profile showed cholesterol at 215, HDL at 143, and homocysteine 9.4. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included blood homocysteine normal, blood thyroid stimulating hormone normal, full blood count normal, glycosylated haemoglobin normal, lipids, metabolic function test normal, vitamin D, and pathology test.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Oedema, Pain, Pathology test, Pyrexia, Seroma
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 42 year old male patient. The patient had a medical history of hypertension, obstructive sleep apnoea, hypercholesterolemia and facial swelling (from Aspirin). His past medication included acetylsalicylic acid. His concomitant medications included telmisartan, omeprazole, atorvastatin and diclofenac sodium. On 06-Oct-2011, the patient received intramuscular AFLURIA injection (batch number "1459121A") in the left arm. On 07-Oct-2011, within one to two days of vaccination, the patient experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever. After one to two days, fever resolved but oedema continued and he developed a mass over the next several months. The patient had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthema, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve and he waited for almost six months but eventually pursued evaluation which resulted in mass excision from his axilla. On 08-Oct-2011, his pathology showed a lipoma and one lymph node with otherwise normal pathology. The results showed 5.0 x 4.0 x 2.0 cm soft tissue in left axilla, excisional biopsy showed benign mature adipose tissue consistent with lipoma - benign incidental lymph node. The patient had subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately six months. On 31-Oct-2011, the patient underwent laboratory results for CBC (complete blood count), CMP (complete metabolic panel), A1C (glycosylated haemoglobin), TSH WNL (thyroid stimulating hormone within normal limits), vitamin D15. His lipid profile showed cholesterol at 215, HDL at 143, and homocysteine 9.4. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included blood homocysteine normal, blood thyroid stimulating hormone normal, full blood count normal, glycosylated haemoglobin normal, lipids, metabolic function test normal, vitamin D, and pathology test.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Vitamin D
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 42 year old male patient. The patient had a medical history of hypertension, obstructive sleep apnoea, hypercholesterolemia and facial swelling (from Aspirin). His past medication included acetylsalicylic acid. His concomitant medications included telmisartan, omeprazole, atorvastatin and diclofenac sodium. On 06-Oct-2011, the patient received intramuscular AFLURIA injection (batch number "1459121A") in the left arm. On 07-Oct-2011, within one to two days of vaccination, the patient experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever. After one to two days, fever resolved but oedema continued and he developed a mass over the next several months. The patient had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthema, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve and he waited for almost six months but eventually pursued evaluation which resulted in mass excision from his axilla. On 08-Oct-2011, his pathology showed a lipoma and one lymph node with otherwise normal pathology. The results showed 5.0 x 4.0 x 2.0 cm soft tissue in left axilla, excisional biopsy showed benign mature adipose tissue consistent with lipoma - benign incidental lymph node. The patient had subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately six months. On 31-Oct-2011, the patient underwent laboratory results for CBC (complete blood count), CMP (complete metabolic panel), A1C (glycosylated haemoglobin), TSH WNL (thyroid stimulating hormone within normal limits), vitamin D15. His lipid profile showed cholesterol at 215, HDL at 143, and homocysteine 9.4. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included blood homocysteine normal, blood thyroid stimulating hormone normal, full blood count normal, glycosylated haemoglobin normal, lipids, metabolic function test normal, vitamin D, and pathology test.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Axillary mass, Biopsy, Blood cholesterol increased, Blood homocysteine normal, Blood thyroid stimulating hormone normal
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 42 year old male patient. The patient had a medical history of hypertension, obstructive sleep apnoea, hypercholesterolemia and facial swelling (from Aspirin). His past medication included acetylsalicylic acid. His concomitant medications included telmisartan, omeprazole, atorvastatin and diclofenac sodium. On 06-Oct-2011, the patient received intramuscular AFLURIA injection (batch number "1459121A") in the left arm. On 07-Oct-2011, within one to two days of vaccination, the patient experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever. After one to two days, fever resolved but oedema continued and he developed a mass over the next several months. The patient had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthema, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve and he waited for almost six months but eventually pursued evaluation which resulted in mass excision from his axilla. On 08-Oct-2011, his pathology showed a lipoma and one lymph node with otherwise normal pathology. The results showed 5.0 x 4.0 x 2.0 cm soft tissue in left axilla, excisional biopsy showed benign mature adipose tissue consistent with lipoma - benign incidental lymph node. The patient had subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately six months. On 31-Oct-2011, the patient underwent laboratory results for CBC (complete blood count), CMP (complete metabolic panel), A1C (glycosylated haemoglobin), TSH WNL (thyroid stimulating hormone within normal limits), vitamin D15. His lipid profile showed cholesterol at 215, HDL at 143, and homocysteine 9.4. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included blood homocysteine normal, blood thyroid stimulating hormone normal, full blood count normal, glycosylated haemoglobin normal, lipids, metabolic function test normal, vitamin D, and pathology test.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Full blood count normal, Glycosylated haemoglobin normal, High density lipoprotein increased, Lipoma, Local swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 42 year old male patient. The patient had a medical history of hypertension, obstructive sleep apnoea, hypercholesterolemia and facial swelling (from Aspirin). His past medication included acetylsalicylic acid. His concomitant medications included telmisartan, omeprazole, atorvastatin and diclofenac sodium. On 06-Oct-2011, the patient received intramuscular AFLURIA injection (batch number "1459121A") in the left arm. On 07-Oct-2011, within one to two days of vaccination, the patient experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever. After one to two days, fever resolved but oedema continued and he developed a mass over the next several months. The patient had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthema, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve and he waited for almost six months but eventually pursued evaluation which resulted in mass excision from his axilla. On 08-Oct-2011, his pathology showed a lipoma and one lymph node with otherwise normal pathology. The results showed 5.0 x 4.0 x 2.0 cm soft tissue in left axilla, excisional biopsy showed benign mature adipose tissue consistent with lipoma - benign incidental lymph node. The patient had subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately six months. On 31-Oct-2011, the patient underwent laboratory results for CBC (complete blood count), CMP (complete metabolic panel), A1C (glycosylated haemoglobin), TSH WNL (thyroid stimulating hormone within normal limits), vitamin D15. His lipid profile showed cholesterol at 215, HDL at 143, and homocysteine 9.4. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included blood homocysteine normal, blood thyroid stimulating hormone normal, full blood count normal, glycosylated haemoglobin normal, lipids, metabolic function test normal, vitamin D, and pathology test.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lymphadenopathy, Lymphangitis, Mass excision, Metabolic function test, Oedema
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 42 year old male patient. The patient had a medical history of hypertension, obstructive sleep apnoea, hypercholesterolemia and facial swelling (from Aspirin). His past medication included acetylsalicylic acid. His concomitant medications included telmisartan, omeprazole, atorvastatin and diclofenac sodium. On 06-Oct-2011, the patient received intramuscular AFLURIA injection (batch number "1459121A") in the left arm. On 07-Oct-2011, within one to two days of vaccination, the patient experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever. After one to two days, fever resolved but oedema continued and he developed a mass over the next several months. The patient had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthema, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve and he waited for almost six months but eventually pursued evaluation which resulted in mass excision from his axilla. On 08-Oct-2011, his pathology showed a lipoma and one lymph node with otherwise normal pathology. The results showed 5.0 x 4.0 x 2.0 cm soft tissue in left axilla, excisional biopsy showed benign mature adipose tissue consistent with lipoma - benign incidental lymph node. The patient had subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately six months. On 31-Oct-2011, the patient underwent laboratory results for CBC (complete blood count), CMP (complete metabolic panel), A1C (glycosylated haemoglobin), TSH WNL (thyroid stimulating hormone within normal limits), vitamin D15. His lipid profile showed cholesterol at 215, HDL at 143, and homocysteine 9.4. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included blood homocysteine normal, blood thyroid stimulating hormone normal, full blood count normal, glycosylated haemoglobin normal, lipids, metabolic function test normal, vitamin D, and pathology test.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pathology test, Pyrexia, Seroma, Vitamin D
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 42 year old male patient. The patient had a medical history of hypertension, obstructive sleep apnoea, hypercholesterolemia and facial swelling (from Aspirin). His past medication included acetylsalicylic acid. His concomitant medications included telmisartan, omeprazole, atorvastatin and diclofenac sodium. On 06-Oct-2011, the patient received intramuscular AFLURIA injection (batch number "1459121A") in the left arm. On 07-Oct-2011, within one to two days of vaccination, the patient experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever. After one to two days, fever resolved but oedema continued and he developed a mass over the next several months. The patient had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthema, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve and he waited for almost six months but eventually pursued evaluation which resulted in mass excision from his axilla. On 08-Oct-2011, his pathology showed a lipoma and one lymph node with otherwise normal pathology. The results showed 5.0 x 4.0 x 2.0 cm soft tissue in left axilla, excisional biopsy showed benign mature adipose tissue consistent with lipoma - benign incidental lymph node. The patient had subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately six months. On 31-Oct-2011, the patient underwent laboratory results for CBC (complete blood count), CMP (complete metabolic panel), A1C (glycosylated haemoglobin), TSH WNL (thyroid stimulating hormone within normal limits), vitamin D15. His lipid profile showed cholesterol at 215, HDL at 143, and homocysteine 9.4. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included blood homocysteine normal, blood thyroid stimulating hormone normal, full blood count normal, glycosylated haemoglobin normal, lipids, metabolic function test normal, vitamin D, and pathology test.
Age: 28.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 28 year old male patient. On the 23-Jan-2015, the patient received AFLURIA injection (batch number 'T53806') dose 1 via an unknown route in the left arm. On the 23-Jan-2015, the patient had a vasovagal episode in which the patient lost consciousness. The patient's vitals remained stable and the patient was given an ice pack, was laid down and give PO (oral) fluids. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Alopecia, Skin disorder, Visual impairment
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 69 year-old female patient who had no known current illness and a medical history of chickenpox two times. On 29-Jan-2013, the patient received intramuscular AFLURIA injection (batch number "071922A" [thimerosal containing]) in the right arm, and subcutaneous ZOSTAVAX (batch number H019040) in the left arm. On 30-Jan-2013, the patient developed scalp and facial dots. The patient's hair fell out, eyebrows fell out, and vision problems. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious and reported the presented at the Emergency Room.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Alopecia, Rash, Skin disorder, Visual impairment
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 69 year-old female patient who had no known current illness and a medical history of chickenpox two times. On 29-Jan-2013, the patient received intramuscular AFLURIA injection (batch number "071922A" [thimerosal containing]) in the right arm, and subcutaneous ZOSTAVAX (batch number H019040) in the left arm. On 30-Jan-2013, the patient developed scalp and facial dots. The patient's hair fell out, eyebrows fell out, and vision problems. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious and reported the presented at the Emergency Room.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Bursitis, Injected limb mobility decreased, Injection site pain, Tendonitis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 38 year old female patient. The patient received AFLURIA in the past and experienced tendonitis (refer to case: 2015050890). The patient had no medical history, no medications at the time of vaccination and no current illness. On 15-Nov-2014, the patient received intramuscular AFLURIA injection (batch number 'T59208') in the left arm. On 16-Nov-2014, the patient experienced muscular/shoulder pain on the administered arm, lack of strength and flexibility resulting in tendonitis/bursitis. The patient was prescribed physical therapy. Outcome was reported as unknown. Reporter comments: The regulator reported the case as non-serious. The regulator reported the symptom 'injection site pain' and 'asthenia'.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Bursitis, Injected limb mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 38 year old female patient. The patient received AFLURIA in the past and experienced tendonitis (refer to case: 2015050890). The patient had no medical history, no medications at the time of vaccination and no current illness. On 15-Nov-2014, the patient received intramuscular AFLURIA injection (batch number 'T59208') in the left arm. On 16-Nov-2014, the patient experienced muscular/shoulder pain on the administered arm, lack of strength and flexibility resulting in tendonitis/bursitis. The patient was prescribed physical therapy. Outcome was reported as unknown. Reporter comments: The regulator reported the case as non-serious. The regulator reported the symptom 'injection site pain' and 'asthenia'.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tendonitis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 38 year old female patient. The patient received AFLURIA in the past and experienced tendonitis (refer to case: 2015050890). The patient had no medical history, no medications at the time of vaccination and no current illness. On 15-Nov-2014, the patient received intramuscular AFLURIA injection (batch number 'T59208') in the left arm. On 16-Nov-2014, the patient experienced muscular/shoulder pain on the administered arm, lack of strength and flexibility resulting in tendonitis/bursitis. The patient was prescribed physical therapy. Outcome was reported as unknown. Reporter comments: The regulator reported the case as non-serious. The regulator reported the symptom 'injection site pain' and 'asthenia'.
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Bursitis, Injected limb mobility decreased, Injection site pain, Tendonitis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a female patient. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed tendonitis. The outcome was not reported. Linked case: 2015050889 (same patient).
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Bursitis, Injected limb mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a female patient. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed tendonitis. The outcome was not reported. Linked case: 2015050889 (same patient).
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tendonitis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a female patient. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed tendonitis. The outcome was not reported. Linked case: 2015050889 (same patient).
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 60 year old female patient. On the 13-Oct-2014, the patient received AFLURIA injection (batch number T51808) via syringe in the left arm. On an unspecified date, the patient developed arm pain and was treated in the physician's office with a steroid injection into the bursa because the patient had symptoms of bursitis. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported that the patient went to the Emergency Room.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 46 year old female patient. On the 14-Oct-2014, the patient received AFLURIA injection (batch number T51808) via a syringe in the left arm. On the 28-Oct-2014, the patient had arm pain since the date of injection. She had limited range of motion. The injection was given on the 14-Oct-2014 and the arm pain was reported on the 28-Oct-2014 and on the 1/30/14 [sic] went to report the continued range of motion issues which prompted the report. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the patient attended the Emergency Room.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Burning sensation, CSF oligoclonal band present, Hemiparesis, Hyperaesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 31 year old female patient who had no medical history and took no medications at the time of vaccinations. On the 01-Oct-2014, the patient received AFLURIA injection (batch number 09749221A [thimerosal containing]) via the intramuscular route in the left arm. On the 05-Oct-2014, the patient developed left-sided numbness, weakness and burning pain in the back, feet and legs. The patient developed muscle spasms and hypersensitivity to light touch. A MRI (Magnetic Resonance Imaging) of the brain was normal and an MRI of the cervical spine showed a 16mm demyelinating lesion at the cervicomedullary junction. CSF (Cerebrospinal fluid) was positive for oligoclonal bands. Treatment included methylprednisolone IV (intravenous) for three days. Outcome was not recovered. Reporter comments: The regulator reported the case as serious (disability) and reported the symptoms of 'nuclear magnetic resonance imaging brain normal' and 'nuclear magnetic resonance imaging spinal abnormal'.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscle spasms, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 31 year old female patient who had no medical history and took no medications at the time of vaccinations. On the 01-Oct-2014, the patient received AFLURIA injection (batch number 09749221A [thimerosal containing]) via the intramuscular route in the left arm. On the 05-Oct-2014, the patient developed left-sided numbness, weakness and burning pain in the back, feet and legs. The patient developed muscle spasms and hypersensitivity to light touch. A MRI (Magnetic Resonance Imaging) of the brain was normal and an MRI of the cervical spine showed a 16mm demyelinating lesion at the cervicomedullary junction. CSF (Cerebrospinal fluid) was positive for oligoclonal bands. Treatment included methylprednisolone IV (intravenous) for three days. Outcome was not recovered. Reporter comments: The regulator reported the case as serious (disability) and reported the symptoms of 'nuclear magnetic resonance imaging brain normal' and 'nuclear magnetic resonance imaging spinal abnormal'.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Back pain, Burning sensation, CSF oligoclonal band present, Central nervous system lesion
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 31 year old female patient who had no medical history and took no medications at the time of vaccinations. On the 01-Oct-2014, the patient received AFLURIA injection (batch number 09749221A [thimerosal containing]) via the intramuscular route in the left arm. On the 05-Oct-2014, the patient developed left-sided numbness, weakness and burning pain in the back, feet and legs. The patient developed muscle spasms and hypersensitivity to light touch. A MRI (Magnetic Resonance Imaging) of the brain was normal and an MRI of the cervical spine showed a 16mm demyelinating lesion at the cervicomedullary junction. CSF (Cerebrospinal fluid) was positive for oligoclonal bands. Treatment included methylprednisolone IV (intravenous) for three days. Outcome was not recovered. Reporter comments: The regulator reported the case as serious (disability) and reported the symptoms of 'nuclear magnetic resonance imaging brain normal' and 'nuclear magnetic resonance imaging spinal abnormal'.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Demyelination, Hyperaesthesia, Hypoaesthesia, Muscle spasms, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 31 year old female patient who had no medical history and took no medications at the time of vaccinations. On the 01-Oct-2014, the patient received AFLURIA injection (batch number 09749221A [thimerosal containing]) via the intramuscular route in the left arm. On the 05-Oct-2014, the patient developed left-sided numbness, weakness and burning pain in the back, feet and legs. The patient developed muscle spasms and hypersensitivity to light touch. A MRI (Magnetic Resonance Imaging) of the brain was normal and an MRI of the cervical spine showed a 16mm demyelinating lesion at the cervicomedullary junction. CSF (Cerebrospinal fluid) was positive for oligoclonal bands. Treatment included methylprednisolone IV (intravenous) for three days. Outcome was not recovered. Reporter comments: The regulator reported the case as serious (disability) and reported the symptoms of 'nuclear magnetic resonance imaging brain normal' and 'nuclear magnetic resonance imaging spinal abnormal'.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 31 year old female patient who had no medical history and took no medications at the time of vaccinations. On the 01-Oct-2014, the patient received AFLURIA injection (batch number 09749221A [thimerosal containing]) via the intramuscular route in the left arm. On the 05-Oct-2014, the patient developed left-sided numbness, weakness and burning pain in the back, feet and legs. The patient developed muscle spasms and hypersensitivity to light touch. A MRI (Magnetic Resonance Imaging) of the brain was normal and an MRI of the cervical spine showed a 16mm demyelinating lesion at the cervicomedullary junction. CSF (Cerebrospinal fluid) was positive for oligoclonal bands. Treatment included methylprednisolone IV (intravenous) for three days. Outcome was not recovered. Reporter comments: The regulator reported the case as serious (disability) and reported the symptoms of 'nuclear magnetic resonance imaging brain normal' and 'nuclear magnetic resonance imaging spinal abnormal'.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Myalgia, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 51-year old female patient. On 20-Dec-2014, the patient received intramuscular AFLURIA injection (batch number T50907) in the left arm. On 22-Dec-2014, after the influenza shot, the patient complained of muscle pain and described it like she was given a tetanus shot. Two days later, she felt more of an ache. On 12-Feb-2015, she went to the physician and was told that she could have bursitis and was referred to an orthopedic surgeon and MRI (Magnetic Resonance Imaging). The patient received tramadol, NSAIDS (Non-Steroidal Anti-Inflammatories) and was told to ice. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.