chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on an unknown date. The patient received expired FLUMIST QUARDIVALENT. The outcome of the event of administered expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a Health Professional (Registered Nurse) via medical representative concerning a patient of unknown gender. No information regarding medical history, concomitant disease or concomitant medication was provided. A nurse reported that they had a patient who receive FLUMIST QUARDIVALENT and then later test positive for the flu. Action taken with FLUMIST QUARDIVALENT and outcome of the event was unknown. The report was considered to be non-serious by the reporter.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Expired drug administered, Influenza like illness, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns an 8 year old, male patient. The reporter reported for two children and this case was related to male child. The patient's medical history and concurrent diseases were not provided. The patient's concomitant medications were not provided. The reporter reported that his children received expired FLUMIST QUARDIVALENT (intranasal) on Monday and they were now having flu like symptoms started on 13-Jan-2014. It was also reported that the patients have had runny nose and were coughing on that day. The Lot number was unknown. The expiry date of FLUMIST QUARDIVALENT was reported as Dec-2013. The patient was not hospitalized. The outcome of the events was unknown. The reporter reported the events of flu like symptoms, runny nose and coughing and assessed them as non-serious. The company physician identified the event of received expired FLUMIST QUARDIVALENT from the case narrative and assessed it as non-serious.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Physician concerning a patient, Male subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on 14-Jan-2014. The patient received expired FLUMIST QUARDIVALENT. The outcome of the event of received expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on an unknown date. The patient was administered expired FLUMIST QUARDIVALENT. The outcome of the event of administered expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Pharmacist concerning a 6 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 10-Jan-2014. The patient received expired FLUMIST on 10-Jan-2014. The outcome of the event of expired FLUMIST/we accidentally gave a patient an expired dose of FLUMIST is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. Health Professional reported that they administered expired FLUMIST. The outcome of the event of administered expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Physician concerning a 3 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 15-Jan-2014. The patient received expired FLUMIST on 15-Jan-2014. The outcome of the event of gave expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. Medical assistant reported that they inadvertently gave expired FLUMIST QUADRIVALENT on 15-Jan-2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date.  The patient was administered expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. Health Professional reported that they administered expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. Licensed practical nurse reported that they administered expired FLUMIST QUADRIVALENT to eleven patients. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by reporter.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a physician concerning an 8 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Reporter reported that they gave expired FLUMIST on 15-Jan-2014. The outcome of the event of gave expired FLUMIST is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a physician concerning a patient, female subject, who had been receiving nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The reporter received expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. Health Professional reported that they administered expired FLUMIST for 11 patients. The outcome of the event of administered expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a physician concerning a 3 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The reporter inadvertently gave expired FLUMIST to three patients on 15-Jan-2014. The outcome of the event of gave expired FLUMIST is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. Health Professional reported that they administered expired FLUMIST QUADRIVALENT to 11 patients. The outcome of the event expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Physician concerning a 12 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 06-Jan-2014. The patient received expired FLUMIST QUADRIVALENT on 06-Jan-2014. The outcome of the event of received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a physician concerning a 15 year old, female subject, who had been receiving nasal FLUIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 14-Jan-2014. It was reported by physician that eight patients were received expired FLUMIST QUADRIVALENT on 14-Jan-2014. The outcome of the event of received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 14-Jan-2014. The nurse reported that the patient had received expired FLUMIST which started on 14-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse refers to a 24 year old female patient. Patient had no previous medical history. On 09-JUL-2014 the patient was vaccinated with a dose of VARIVAX (Merck), 1 single shot, subcutaneous injection, (lot # J012383 and expiry date 03-OCT-2015) (dose and dose number not reported). No concomitant medications were reported. The nurse reported that before administration of VARIVAX (Merck), the patient was asked if she was pregnant and said no. On the same day, a few hours after she received VARIVAX (Merck), she took pregnancy test and was confirmed as pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) was unknown. The pregnancy outcome was pending. No adverse effect was reported. Patient sought medical attention and no treatment was provided. The outcome of the patient's events was unknown. Follow-up information has been received from a registered nurse. It was reported that on 20-JUL-2014 the patient miscarried. The outcome of miscarriage was not reported. The relatedness between the events and VARIVAX (Merck) was not reported. Upon internal review, the event of miscarriage was considered to be medically significant. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse refers to a 24 year old female patient. Patient had no previous medical history. On 09-JUL-2014 the patient was vaccinated with a dose of VARIVAX (Merck), 1 single shot, subcutaneous injection, (lot # J012383 and expiry date 03-OCT-2015) (dose and dose number not reported). No concomitant medications were reported. The nurse reported that before administration of VARIVAX (Merck), the patient was asked if she was pregnant and said no. On the same day, a few hours after she received VARIVAX (Merck), she took pregnancy test and was confirmed as pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) was unknown. The pregnancy outcome was pending. No adverse effect was reported. Patient sought medical attention and no treatment was provided. The outcome of the patient's events was unknown. Follow-up information has been received from a registered nurse. It was reported that on 20-JUL-2014 the patient miscarried. The outcome of miscarriage was not reported. The relatedness between the events and VARIVAX (Merck) was not reported. Upon internal review, the event of miscarriage was considered to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Brachial plexopathy, Bursal fluid accumulation, Colectomy, Full blood count normal, Hypoaesthesia
Clinical narrative: Case number PHHY2014US102404 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 66-year-old female patient with no past medical history. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 3 hours after vaccination she experienced left arm pain which exacerbated by motion. Her symptoms included cool, numb, heavy sensation in her left hand with radiation down the arm, neck and scapular region. Despite intense clinical presentation, physical examination was normal. Her erythrocyte sedimentation rate increased at 43 mm/hr, body mass index (BMI) was recorded as 25.7 kg/m2 and CBC was normal. On an unknown date, nine days after presentation, left upper extremity venous duplex ultrasound and MRI cervical spine excluded venous thrombosis and radiculopathy and coincidental diagnosis reported as partial colectomy and osteoarthritis. Degenerative changes were noted on cervical spine MR images. Bone marrow signal on MRI was normal. Incidentally noted were low-grade undersurface tears in the posterior margin supraspinatus and anterior margin infraspinatus tendons. The measurement of subcutaneous fat thickness was noted to be 6.6 mm on oblique coronal T1-weighted MR images. No medical or surgical intervention was initiated. The patient received NSAIDs and physical therapy. A follow-up exam revealed a normal musculoskeletal exam within 30 days. The patient had another normal musculoskeletal exam 2.5 years after the event. The author concluded that this case with abnormal soft tissue findings on MR related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Case number PHHY2014US102404 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 66-year-old female patient with no past medical history. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 3 hours after vaccination she experienced left arm pain which exacerbated by motion. Her symptoms included cool, numb, heavy sensation in her left hand with radiation down the arm, neck and scapular region. Despite intense clinical presentation, physical examination was normal. Her erythrocyte sedimentation rate increased at 43 mm/hr, body mass index (BMI) was recorded as 25.7 kg/m2 and CBC was normal. On an unknown date, nine days after presentation, left upper extremity venous duplex ultrasound and MRI cervical spine excluded venous thrombosis and radiculopathy and coincidental diagnosis reported as partial colectomy and osteoarthritis. Degenerative changes were noted on cervical spine MR images. Bone marrow signal on MRI was normal. Incidentally noted were low-grade undersurface tears in the posterior margin supraspinatus and anterior margin infraspinatus tendons. The measurement of subcutaneous fat thickness was noted to be 6.6 mm on oblique coronal T1-weighted MR images. No medical or surgical intervention was initiated. The patient received NSAIDs and physical therapy. A follow-up exam revealed a normal musculoskeletal exam within 30 days. The patient had another normal musculoskeletal exam 2.5 years after the event. The author concluded that this case with abnormal soft tissue findings on MR related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Osteoarthritis, Pain, Pain in extremity, Peripheral coldness, Radiculopathy
Clinical narrative: Case number PHHY2014US102404 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 66-year-old female patient with no past medical history. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 3 hours after vaccination she experienced left arm pain which exacerbated by motion. Her symptoms included cool, numb, heavy sensation in her left hand with radiation down the arm, neck and scapular region. Despite intense clinical presentation, physical examination was normal. Her erythrocyte sedimentation rate increased at 43 mm/hr, body mass index (BMI) was recorded as 25.7 kg/m2 and CBC was normal. On an unknown date, nine days after presentation, left upper extremity venous duplex ultrasound and MRI cervical spine excluded venous thrombosis and radiculopathy and coincidental diagnosis reported as partial colectomy and osteoarthritis. Degenerative changes were noted on cervical spine MR images. Bone marrow signal on MRI was normal. Incidentally noted were low-grade undersurface tears in the posterior margin supraspinatus and anterior margin infraspinatus tendons. The measurement of subcutaneous fat thickness was noted to be 6.6 mm on oblique coronal T1-weighted MR images. No medical or surgical intervention was initiated. The patient received NSAIDs and physical therapy. A follow-up exam revealed a normal musculoskeletal exam within 30 days. The patient had another normal musculoskeletal exam 2.5 years after the event. The author concluded that this case with abnormal soft tissue findings on MR related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Red blood cell sedimentation rate increased, Sensation of heaviness, Spinal osteoarthritis, Tendon rupture, Ultrasound scan normal
Clinical narrative: Case number PHHY2014US102404 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 66-year-old female patient with no past medical history. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 3 hours after vaccination she experienced left arm pain which exacerbated by motion. Her symptoms included cool, numb, heavy sensation in her left hand with radiation down the arm, neck and scapular region. Despite intense clinical presentation, physical examination was normal. Her erythrocyte sedimentation rate increased at 43 mm/hr, body mass index (BMI) was recorded as 25.7 kg/m2 and CBC was normal. On an unknown date, nine days after presentation, left upper extremity venous duplex ultrasound and MRI cervical spine excluded venous thrombosis and radiculopathy and coincidental diagnosis reported as partial colectomy and osteoarthritis. Degenerative changes were noted on cervical spine MR images. Bone marrow signal on MRI was normal. Incidentally noted were low-grade undersurface tears in the posterior margin supraspinatus and anterior margin infraspinatus tendons. The measurement of subcutaneous fat thickness was noted to be 6.6 mm on oblique coronal T1-weighted MR images. No medical or surgical intervention was initiated. The patient received NSAIDs and physical therapy. A follow-up exam revealed a normal musculoskeletal exam within 30 days. The patient had another normal musculoskeletal exam 2.5 years after the event. The author concluded that this case with abnormal soft tissue findings on MR related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Colectomy, Full blood count normal, Hypoaesthesia, Nuclear magnetic resonance imaging spinal abnormal, Osteoarthritis
Clinical narrative: Case number PHHY2014US102404 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 66-year-old female patient with no past medical history. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 3 hours after vaccination she experienced left arm pain which exacerbated by motion. Her symptoms included cool, numb, heavy sensation in her left hand with radiation down the arm, neck and scapular region. Despite intense clinical presentation, physical examination was normal. Her erythrocyte sedimentation rate increased at 43 mm/hr, body mass index (BMI) was recorded as 25.7 kg/m2 and CBC was normal. On an unknown date, nine days after presentation, left upper extremity venous duplex ultrasound and MRI cervical spine excluded venous thrombosis and radiculopathy and coincidental diagnosis reported as partial colectomy and osteoarthritis. Degenerative changes were noted on cervical spine MR images. Bone marrow signal on MRI was normal. Incidentally noted were low-grade undersurface tears in the posterior margin supraspinatus and anterior margin infraspinatus tendons. The measurement of subcutaneous fat thickness was noted to be 6.6 mm on oblique coronal T1-weighted MR images. No medical or surgical intervention was initiated. The patient received NSAIDs and physical therapy. A follow-up exam revealed a normal musculoskeletal exam within 30 days. The patient had another normal musculoskeletal exam 2.5 years after the event. The author concluded that this case with abnormal soft tissue findings on MR related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Pain in extremity, Peripheral coldness, Red blood cell sedimentation rate increased, Rotator cuff syndrome
Clinical narrative: Case number PHHY2014US102404 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 66-year-old female patient with no past medical history. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 3 hours after vaccination she experienced left arm pain which exacerbated by motion. Her symptoms included cool, numb, heavy sensation in her left hand with radiation down the arm, neck and scapular region. Despite intense clinical presentation, physical examination was normal. Her erythrocyte sedimentation rate increased at 43 mm/hr, body mass index (BMI) was recorded as 25.7 kg/m2 and CBC was normal. On an unknown date, nine days after presentation, left upper extremity venous duplex ultrasound and MRI cervical spine excluded venous thrombosis and radiculopathy and coincidental diagnosis reported as partial colectomy and osteoarthritis. Degenerative changes were noted on cervical spine MR images. Bone marrow signal on MRI was normal. Incidentally noted were low-grade undersurface tears in the posterior margin supraspinatus and anterior margin infraspinatus tendons. The measurement of subcutaneous fat thickness was noted to be 6.6 mm on oblique coronal T1-weighted MR images. No medical or surgical intervention was initiated. The patient received NSAIDs and physical therapy. A follow-up exam revealed a normal musculoskeletal exam within 30 days. The patient had another normal musculoskeletal exam 2.5 years after the event. The author concluded that this case with abnormal soft tissue findings on MR related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Sensation of heaviness, Spinal osteoarthritis, Ultrasound scan normal
Clinical narrative: Case number PHHY2014US102404 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 66-year-old female patient with no past medical history. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 3 hours after vaccination she experienced left arm pain which exacerbated by motion. Her symptoms included cool, numb, heavy sensation in her left hand with radiation down the arm, neck and scapular region. Despite intense clinical presentation, physical examination was normal. Her erythrocyte sedimentation rate increased at 43 mm/hr, body mass index (BMI) was recorded as 25.7 kg/m2 and CBC was normal. On an unknown date, nine days after presentation, left upper extremity venous duplex ultrasound and MRI cervical spine excluded venous thrombosis and radiculopathy and coincidental diagnosis reported as partial colectomy and osteoarthritis. Degenerative changes were noted on cervical spine MR images. Bone marrow signal on MRI was normal. Incidentally noted were low-grade undersurface tears in the posterior margin supraspinatus and anterior margin infraspinatus tendons. The measurement of subcutaneous fat thickness was noted to be 6.6 mm on oblique coronal T1-weighted MR images. No medical or surgical intervention was initiated. The patient received NSAIDs and physical therapy. A follow-up exam revealed a normal musculoskeletal exam within 30 days. The patient had another normal musculoskeletal exam 2.5 years after the event. The author concluded that this case with abnormal soft tissue findings on MR related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Body mass index increased, Full blood count normal, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Case number PHHY2014US103357 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 59-year-old female patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 2 days after vaccination she experienced left upper arm and neck pain. On physical examination, there was tenderness and a palpable 3 cm x 3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity, otherwise the musculoskeletal exam was non-contributory. Complete blood count (CBC) and erythrocyte sedimentation rate (ESR) were normal on laboratory assessment. Body mass index (BMI) was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after vaccine injection and results showed minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The bursal fluid was absent. There was no evidence of a dominant mass or abscess/hematoma on MR images. Neither bone marrow signal changes nor bursitis were found. The subcutaneous fat thickness was 2.1 cm measured on the oblique coronal T1-weighted MR images and reported as subcutaneous edema. Coincidental diagnosis reported as colon polyp and achilles tendinitis. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Laboratory test normal, Neck pain, Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal, Scan bone marrow normal
Clinical narrative: Case number PHHY2014US103357 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 59-year-old female patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 2 days after vaccination she experienced left upper arm and neck pain. On physical examination, there was tenderness and a palpable 3 cm x 3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity, otherwise the musculoskeletal exam was non-contributory. Complete blood count (CBC) and erythrocyte sedimentation rate (ESR) were normal on laboratory assessment. Body mass index (BMI) was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after vaccine injection and results showed minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The bursal fluid was absent. There was no evidence of a dominant mass or abscess/hematoma on MR images. Neither bone marrow signal changes nor bursitis were found. The subcutaneous fat thickness was 2.1 cm measured on the oblique coronal T1-weighted MR images and reported as subcutaneous edema. Coincidental diagnosis reported as colon polyp and achilles tendinitis. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: White blood cell count normal
Clinical narrative: Case number PHHY2014US103357 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 59-year-old female patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 2 days after vaccination she experienced left upper arm and neck pain. On physical examination, there was tenderness and a palpable 3 cm x 3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity, otherwise the musculoskeletal exam was non-contributory. Complete blood count (CBC) and erythrocyte sedimentation rate (ESR) were normal on laboratory assessment. Body mass index (BMI) was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after vaccine injection and results showed minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The bursal fluid was absent. There was no evidence of a dominant mass or abscess/hematoma on MR images. Neither bone marrow signal changes nor bursitis were found. The subcutaneous fat thickness was 2.1 cm measured on the oblique coronal T1-weighted MR images and reported as subcutaneous edema. Coincidental diagnosis reported as colon polyp and achilles tendinitis. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Bursa disorder, Full blood count normal, Injection site mass, Large intestine polyp, Neck pain
Clinical narrative: Case number PHHY2014US103357 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 59-year-old female patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 2 days after vaccination she experienced left upper arm and neck pain. On physical examination, there was tenderness and a palpable 3 cm x 3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity, otherwise the musculoskeletal exam was non-contributory. Complete blood count (CBC) and erythrocyte sedimentation rate (ESR) were normal on laboratory assessment. Body mass index (BMI) was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after vaccine injection and results showed minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The bursal fluid was absent. There was no evidence of a dominant mass or abscess/hematoma on MR images. Neither bone marrow signal changes nor bursitis were found. The subcutaneous fat thickness was 2.1 cm measured on the oblique coronal T1-weighted MR images and reported as subcutaneous edema. Coincidental diagnosis reported as colon polyp and achilles tendinitis. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Oedema, Pain in extremity, Red blood cell sedimentation rate normal, Tenderness
Clinical narrative: Case number PHHY2014US103357 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 59-year-old female patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 2 days after vaccination she experienced left upper arm and neck pain. On physical examination, there was tenderness and a palpable 3 cm x 3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity, otherwise the musculoskeletal exam was non-contributory. Complete blood count (CBC) and erythrocyte sedimentation rate (ESR) were normal on laboratory assessment. Body mass index (BMI) was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after vaccine injection and results showed minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The bursal fluid was absent. There was no evidence of a dominant mass or abscess/hematoma on MR images. Neither bone marrow signal changes nor bursitis were found. The subcutaneous fat thickness was 2.1 cm measured on the oblique coronal T1-weighted MR images and reported as subcutaneous edema. Coincidental diagnosis reported as colon polyp and achilles tendinitis. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Tendonitis
Clinical narrative: Case number PHHY2014US103357 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 59-year-old female patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 2 days after vaccination she experienced left upper arm and neck pain. On physical examination, there was tenderness and a palpable 3 cm x 3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity, otherwise the musculoskeletal exam was non-contributory. Complete blood count (CBC) and erythrocyte sedimentation rate (ESR) were normal on laboratory assessment. Body mass index (BMI) was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after vaccine injection and results showed minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The bursal fluid was absent. There was no evidence of a dominant mass or abscess/hematoma on MR images. Neither bone marrow signal changes nor bursitis were found. The subcutaneous fat thickness was 2.1 cm measured on the oblique coronal T1-weighted MR images and reported as subcutaneous edema. Coincidental diagnosis reported as colon polyp and achilles tendinitis. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 36.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Body mass index normal, Bone disorder, Bone marrow oedema, Bursal fluid accumulation, Full blood count normal
Clinical narrative: Case number PHHY2014US103401 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 36-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 6-8 hours after vaccination he experienced severe pain localized to the injection site and there was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal complete blood count with erythrocyte sedimentation rate (ESR) was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder MR exam completed 1 week after vaccination and results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes and bursal fluid absent (small amount present) and with intrasubstance deltoid edema. No dominant mass lesion, hematoma, or abscess was present. Subcutaneous fat thickness at the proposed site of injection was measured to be 4.2 mm on oblique coronal T1-weighted sequence. Conservative treatment with short-term non-steroidal antiinflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.
Age: 36.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Inflammation, Injected limb mobility decreased, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Case number PHHY2014US103401 is an initial literature report received on 16 Aug 2014. The author discussed about advanced imaging results of four cases with shoulder complaints after flu vaccine injection. This report refers to a 36-year-old male patient. The patient was vaccinated with flu vaccine (manufacturer and batch number: not reported, so conservatively coded as Seasonal influenza vaccine INN) on an unknown date. On an unknown date, 6-8 hours after vaccination he experienced severe pain localized to the injection site and there was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal complete blood count with erythrocyte sedimentation rate (ESR) was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder MR exam completed 1 week after vaccination and results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes and bursal fluid absent (small amount present) and with intrasubstance deltoid edema. No dominant mass lesion, hematoma, or abscess was present. Subcutaneous fat thickness at the proposed site of injection was measured to be 4.2 mm on oblique coronal T1-weighted sequence. Conservative treatment with short-term non-steroidal antiinflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. The author concluded that this case with abnormal findings on MRI related to recent influenza vaccination. Although most complications from influenza vaccination were self-limited and do not warrant imaging, severe signs or symptoms, local or systemic, may necessitate imaging. As a retrospective review without patient or vaccination standardization, the bone and soft tissue changes are presumed to be the consequence of technique (needle length and orientation) and/or inflammation due to chemical constituents.