chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: HIBV
Symptoms: Sinusitis, Spleen disorder, Syncope, Tachypnoea
Clinical narrative: Information has been received from the authors in a published literature article. A 36 year old male with history of acute lymphoblastic leukemia status post bone marrow transplant (BMT), in remission and on no immunosuppressive medications, presented the emergency department for evaluation of syncope in the context of several days of fever, productive cough and dyspnea, gradual onset of headache, diffuse back pain and a few loose stools. He was treated presumed community-acquired pneumonia but progressively became more tachypneic, hypotensive and developed altered mental status requiring intubation, central line placement and vasopressors. He was admitted to the ICU under these conditions. The blood cultures were positive for gram negative bacillus and the lumbar puncture was indicative of bacterial meningitis. Bacterial speciation of the cultures confirmed the pathogen was Haemophilus influenza. The patient had successful immunization post BMT, as confirmed by serology. The final diagnoses for this patient were invasive Haemophilus influenza (serotype A) with meningitis, bacteremia and presumed sinusitis with susceptibility to Haemophilus influenza secondary to previously undiagnosed functional hyposplenism. Haemophilus influenza is a pleomorphic, non-motile, facultative anaerobic gram-negative coccobacillus and a human-specific pathogen. There are encapsulated (typeable) and unencapsulated (nontypeable) strains. Prior to the development of the vaccine, the capsule was thought to be the primary virulence factor, with serotype B being the predominant strain causing clinical disease. Therefore, serotype B is the target of immunizations against Haemophilus influenza. The epidemiology of invasive disease has shifted after widespread, vaccination, with nontypeable strains causing the majority of invasive infections in all age groups. Despite the common belief that immunizations have eliminated Haemophilus influenza from authors differential diagnoses, in the post vaccine era, the most common presentations of invasive Haemophilus influenza are bacteremia and meningitis. Both encapsulated (non-serotype B) and unencapsulated strains can lead to invasive disease, therefore it is imperative that physicians recognize that, in the case of Haemophilus influenza, immunization does not equal eradication. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016). The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 months old child patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a 53 year old female patient reporting on herself. The patient's pertinent medical history was not provided. The patient had no known drug reactions/allergies. On 30-JUL-2014, the patient received one dose of ZOSTAVAX, (Lot # reported as K-000328, expiration date reported as 06-MAR-2015). Co-suspect therapy and concomitant medications were not provided. The patient reported that on 01-AUG-2014 at 04:00 AM, the patient woke up with a burning, painful dark pink egg-sized knot at the injection site after getting ZOSTAVAX two days ago. The reporter added that the site itched a little and felt hot. The patient did not receive any treatment for the event and sought medical attention by calling the pharmacy. At the time of the report the patient had not recovered. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Erythema, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a 53 year old female patient reporting on herself. The patient's pertinent medical history was not provided. The patient had no known drug reactions/allergies. On 30-JUL-2014, the patient received one dose of ZOSTAVAX, (Lot # reported as K-000328, expiration date reported as 06-MAR-2015). Co-suspect therapy and concomitant medications were not provided. The patient reported that on 01-AUG-2014 at 04:00 AM, the patient woke up with a burning, painful dark pink egg-sized knot at the injection site after getting ZOSTAVAX two days ago. The reporter added that the site itched a little and felt hot. The patient did not receive any treatment for the event and sought medical attention by calling the pharmacy. At the time of the report the patient had not recovered. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-JUL-2014 the patient was vaccinated intramuscularly with an expired 0.5 ml dose of PNEUMOVAX 23 (lot # not reported, expiration date 11-JUL-2014). No adverse effects reported. No further information provided. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Myalgia, Pain
Clinical narrative: Fever up to 102.7, myalgias, chills, body aches, dizziness, headache.  Patient used Tylenol and Ibuprofen PRN.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever up to 102.7, myalgias, chills, body aches, dizziness, headache.  Patient used Tylenol and Ibuprofen PRN.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Pain in her right upper arm since her last visit. No redness or swelling.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Parent reports that a few hours after leaving clinic a small reddened ring with some swelling and warmth beginning forming near area of injection site.
Age: 32.0
Sex: M
Vaccine: MMR, TYP, YF
Symptoms: Nausea, Vomiting
Clinical narrative: Pt became nauseated and vomited while getting into his car to go to lunch. Pt was brought in by his supervisor and reported to flight medicine. pt was given 1L of NS, given promethazine, and observed until his recovery at about 1430 and released to his supervisor to return home.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Arthralgia, Arthropod bite, Atrial fibrillation, Blister
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood osmolarity decreased, Blood sodium decreased, Body temperature decreased, Burning sensation, Bursitis
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac failure congestive, Constipation, Dermatitis, Dysuria, Essential hypertension
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Hyperlipidaemia, Hypertonic bladder, Hyponatraemia
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Mammogram normal, Musculoskeletal chest pain, Nausea, Oedema
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oesophageal motility disorder, Oesophagogastroduodenoscopy abnormal, Pain, Pain in extremity, Pruritus
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash vesicular, Rhinitis allergic
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Type V hyperlipidaemia, Urinary tract infection, Vaginal infection, Vulvovaginitis
Clinical narrative: Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Exposure during pregnancy, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient complaint of headache, sore throat, chills and fever. No localized inflammation noted at injection site. Instructed by doctor to take Tylenol, gargle with salt water and drink warm tea for sore throat. ER warning signs given. B/P 120/68, Pulse 103, Temp 97.3 F. Positive fetal movement.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Dizziness
Clinical narrative: A few days after I got the first Gardasil shot, I became very dizzy, fatigued, nauseated, and light headed. At first, we didn't link the symptoms to the shot. Then I had the second Gardasil shot on 12/09/2010 and by the end of that month I had become extremely ill. I was fatigued, light headed and dizzy, nauseated, and later developed palpitations and bad chest pain. I was diagnosed with pericaridtis in March 2011. I was also diagnosed with endometriosis in May 2011.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Echocardiogram, Electrocardiogram, Endometriosis, Fatigue, Laparoscopy
Clinical narrative: A few days after I got the first Gardasil shot, I became very dizzy, fatigued, nauseated, and light headed. At first, we didn't link the symptoms to the shot. Then I had the second Gardasil shot on 12/09/2010 and by the end of that month I had become extremely ill. I was fatigued, light headed and dizzy, nauseated, and later developed palpitations and bad chest pain. I was diagnosed with pericaridtis in March 2011. I was also diagnosed with endometriosis in May 2011.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Nausea, Palpitations, Pericarditis, Vaccine positive rechallenge
Clinical narrative: A few days after I got the first Gardasil shot, I became very dizzy, fatigued, nauseated, and light headed. At first, we didn't link the symptoms to the shot. Then I had the second Gardasil shot on 12/09/2010 and by the end of that month I had become extremely ill. I was fatigued, light headed and dizzy, nauseated, and later developed palpitations and bad chest pain. I was diagnosed with pericaridtis in March 2011. I was also diagnosed with endometriosis in May 2011.
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: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 59-year-old female. On an unknown date, the patient received Influenza flu vaccine, manufacturer and batch number not provided). On an unknown date, two days following influenza vaccination, the patient developed left upper arm and neck pain. The patient presented at the clinic 1 week following the vaccination and was examined for complaints of worsening left upper arm and neck pain. On the physical examination, there was tenderness and a palpable 3 cm/3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity. Otherwise, the musculoskeletal exam was non-contributory. CBC and ESR were normal on laboratory assessment. BMI was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after the vaccine injection. The MRI demonstrated a minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The MR imaging showed minimal infiltrative edema within the subcutaneous fat and striations within the deltoid muscle. 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. The MR imaging showed absence of bursal fluid and rotator cuff tear, however, the soft tissue signal showed subcutaneous edema. The bone marrow signal was normal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. The patient had full range of motion. Her white blood cell count and erythrocyte sedimentation rate were normal. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. Outcome was reported as recovered. Author's comments: Shoulder injury related to vaccine administration presents with persisting and severe shoulder pain may relate to deltoid bursitis, tendonitis, rotator cuff tear, frozen shoulder, impingement syndrome, adhesive capsulitis and shoulder bursitis. Localised intrasubstance oedema like signal in deltoid muscle is most common finding.
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: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 59-year-old female. On an unknown date, the patient received Influenza flu vaccine, manufacturer and batch number not provided). On an unknown date, two days following influenza vaccination, the patient developed left upper arm and neck pain. The patient presented at the clinic 1 week following the vaccination and was examined for complaints of worsening left upper arm and neck pain. On the physical examination, there was tenderness and a palpable 3 cm/3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity. Otherwise, the musculoskeletal exam was non-contributory. CBC and ESR were normal on laboratory assessment. BMI was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after the vaccine injection. The MRI demonstrated a minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The MR imaging showed minimal infiltrative edema within the subcutaneous fat and striations within the deltoid muscle. 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. The MR imaging showed absence of bursal fluid and rotator cuff tear, however, the soft tissue signal showed subcutaneous edema. The bone marrow signal was normal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. The patient had full range of motion. Her white blood cell count and erythrocyte sedimentation rate were normal. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. Outcome was reported as recovered. Author's comments: Shoulder injury related to vaccine administration presents with persisting and severe shoulder pain may relate to deltoid bursitis, tendonitis, rotator cuff tear, frozen shoulder, impingement syndrome, adhesive capsulitis and shoulder bursitis. Localised intrasubstance oedema like signal in deltoid muscle is most common finding.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: White blood cell count normal
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 59-year-old female. On an unknown date, the patient received Influenza flu vaccine, manufacturer and batch number not provided). On an unknown date, two days following influenza vaccination, the patient developed left upper arm and neck pain. The patient presented at the clinic 1 week following the vaccination and was examined for complaints of worsening left upper arm and neck pain. On the physical examination, there was tenderness and a palpable 3 cm/3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity. Otherwise, the musculoskeletal exam was non-contributory. CBC and ESR were normal on laboratory assessment. BMI was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after the vaccine injection. The MRI demonstrated a minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The MR imaging showed minimal infiltrative edema within the subcutaneous fat and striations within the deltoid muscle. 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. The MR imaging showed absence of bursal fluid and rotator cuff tear, however, the soft tissue signal showed subcutaneous edema. The bone marrow signal was normal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. The patient had full range of motion. Her white blood cell count and erythrocyte sedimentation rate were normal. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. Outcome was reported as recovered. Author's comments: Shoulder injury related to vaccine administration presents with persisting and severe shoulder pain may relate to deltoid bursitis, tendonitis, rotator cuff tear, frozen shoulder, impingement syndrome, adhesive capsulitis and shoulder bursitis. Localised intrasubstance oedema like signal in deltoid muscle is most common finding.
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: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 59-year-old female. On an unknown date, the patient received Influenza flu vaccine, manufacturer and batch number not provided). On an unknown date, two days following influenza vaccination, the patient developed left upper arm and neck pain. The patient presented at the clinic 1 week following the vaccination and was examined for complaints of worsening left upper arm and neck pain. On the physical examination, there was tenderness and a palpable 3 cm/3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity. Otherwise, the musculoskeletal exam was non-contributory. CBC and ESR were normal on laboratory assessment. BMI was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after the vaccine injection. The MRI demonstrated a minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The MR imaging showed minimal infiltrative edema within the subcutaneous fat and striations within the deltoid muscle. 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. The MR imaging showed absence of bursal fluid and rotator cuff tear, however, the soft tissue signal showed subcutaneous edema. The bone marrow signal was normal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. The patient had full range of motion. Her white blood cell count and erythrocyte sedimentation rate were normal. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. Outcome was reported as recovered. Author's comments: Shoulder injury related to vaccine administration presents with persisting and severe shoulder pain may relate to deltoid bursitis, tendonitis, rotator cuff tear, frozen shoulder, impingement syndrome, adhesive capsulitis and shoulder bursitis. Localised intrasubstance oedema like signal in deltoid muscle is most common finding.
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: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 59-year-old female. On an unknown date, the patient received Influenza flu vaccine, manufacturer and batch number not provided). On an unknown date, two days following influenza vaccination, the patient developed left upper arm and neck pain. The patient presented at the clinic 1 week following the vaccination and was examined for complaints of worsening left upper arm and neck pain. On the physical examination, there was tenderness and a palpable 3 cm/3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity. Otherwise, the musculoskeletal exam was non-contributory. CBC and ESR were normal on laboratory assessment. BMI was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after the vaccine injection. The MRI demonstrated a minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The MR imaging showed minimal infiltrative edema within the subcutaneous fat and striations within the deltoid muscle. 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. The MR imaging showed absence of bursal fluid and rotator cuff tear, however, the soft tissue signal showed subcutaneous edema. The bone marrow signal was normal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. The patient had full range of motion. Her white blood cell count and erythrocyte sedimentation rate were normal. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. Outcome was reported as recovered. Author's comments: Shoulder injury related to vaccine administration presents with persisting and severe shoulder pain may relate to deltoid bursitis, tendonitis, rotator cuff tear, frozen shoulder, impingement syndrome, adhesive capsulitis and shoulder bursitis. Localised intrasubstance oedema like signal in deltoid muscle is most common finding.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Tendonitis
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 59-year-old female. On an unknown date, the patient received Influenza flu vaccine, manufacturer and batch number not provided). On an unknown date, two days following influenza vaccination, the patient developed left upper arm and neck pain. The patient presented at the clinic 1 week following the vaccination and was examined for complaints of worsening left upper arm and neck pain. On the physical examination, there was tenderness and a palpable 3 cm/3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity. Otherwise, the musculoskeletal exam was non-contributory. CBC and ESR were normal on laboratory assessment. BMI was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after the vaccine injection. The MRI demonstrated a minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The MR imaging showed minimal infiltrative edema within the subcutaneous fat and striations within the deltoid muscle. 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. The MR imaging showed absence of bursal fluid and rotator cuff tear, however, the soft tissue signal showed subcutaneous edema. The bone marrow signal was normal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. The patient had full range of motion. Her white blood cell count and erythrocyte sedimentation rate were normal. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. Outcome was reported as recovered. Author's comments: Shoulder injury related to vaccine administration presents with persisting and severe shoulder pain may relate to deltoid bursitis, tendonitis, rotator cuff tear, frozen shoulder, impingement syndrome, adhesive capsulitis and shoulder bursitis. Localised intrasubstance oedema like signal in deltoid muscle is most common finding.
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: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 36-year-old male. On an unknown date, the patient received flu vaccine (manufacturer and batch number not provided). On an unknown date, 6-8 hours following influenza vaccination, the patient developed local symptoms at the injection site. One week following the vaccination, the patient presented at the clinic with complaints of severe pain localised to the injection site following flu vaccination. There was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal CBC with ESR was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder magnetic resonance (MR) were completed 1 week after vaccination. MR results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes, and small fluid within the subdeltoid bursa. 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 the oblique coronal T1-weighted sequence. The MRI showed absence of bursal fluid and rotator cuff tear. The soft tissue signal showed intrasubstance deltoid edema and bone marrow signal showed subcortical high T2 signal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Conservative treatment with short-term non-steroidal anti-inflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
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: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 36-year-old male. On an unknown date, the patient received flu vaccine (manufacturer and batch number not provided). On an unknown date, 6-8 hours following influenza vaccination, the patient developed local symptoms at the injection site. One week following the vaccination, the patient presented at the clinic with complaints of severe pain localised to the injection site following flu vaccination. There was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal CBC with ESR was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder magnetic resonance (MR) were completed 1 week after vaccination. MR results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes, and small fluid within the subdeltoid bursa. 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 the oblique coronal T1-weighted sequence. The MRI showed absence of bursal fluid and rotator cuff tear. The soft tissue signal showed intrasubstance deltoid edema and bone marrow signal showed subcortical high T2 signal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Conservative treatment with short-term non-steroidal anti-inflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
Age: 36.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Local reaction, Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 36-year-old male. On an unknown date, the patient received flu vaccine (manufacturer and batch number not provided). On an unknown date, 6-8 hours following influenza vaccination, the patient developed local symptoms at the injection site. One week following the vaccination, the patient presented at the clinic with complaints of severe pain localised to the injection site following flu vaccination. There was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal CBC with ESR was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder magnetic resonance (MR) were completed 1 week after vaccination. MR results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes, and small fluid within the subdeltoid bursa. 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 the oblique coronal T1-weighted sequence. The MRI showed absence of bursal fluid and rotator cuff tear. The soft tissue signal showed intrasubstance deltoid edema and bone marrow signal showed subcortical high T2 signal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Conservative treatment with short-term non-steroidal anti-inflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
Age: 36.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Bone marrow oedema, Bursa disorder, Full blood count normal, Inflammation, Injection site pain
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 36-year-old male. On an unknown date, the patient received flu vaccine (manufacturer and batch number not provided). On an unknown date, 6-8 hours following influenza vaccination, the patient developed local symptoms at the injection site. One week following the vaccination, the patient presented at the clinic with complaints of severe pain localised to the injection site following flu vaccination. There was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal CBC with ESR was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder magnetic resonance (MR) were completed 1 week after vaccination. MR results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes, and small fluid within the subdeltoid bursa. 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 the oblique coronal T1-weighted sequence. The MRI showed absence of bursal fluid and rotator cuff tear. The soft tissue signal showed intrasubstance deltoid edema and bone marrow signal showed subcortical high T2 signal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Conservative treatment with short-term non-steroidal anti-inflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
Age: 36.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Muscle oedema, Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal, Soft tissue disorder
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 36-year-old male. On an unknown date, the patient received flu vaccine (manufacturer and batch number not provided). On an unknown date, 6-8 hours following influenza vaccination, the patient developed local symptoms at the injection site. One week following the vaccination, the patient presented at the clinic with complaints of severe pain localised to the injection site following flu vaccination. There was a subjective decrease in range of motion due to pain. Physical examination was otherwise normal. A normal CBC with ESR was noted. BMI was recorded as 22 kg/m2. Findings on the shoulder magnetic resonance (MR) were completed 1 week after vaccination. MR results showed subcortical bone marrow edema involving the greater tuberosity (without associated cortical destruction), periosseous inflammatory changes, and small fluid within the subdeltoid bursa. 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 the oblique coronal T1-weighted sequence. The MRI showed absence of bursal fluid and rotator cuff tear. The soft tissue signal showed intrasubstance deltoid edema and bone marrow signal showed subcortical high T2 signal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Conservative treatment with short-term non-steroidal anti-inflammatory agents was initiated with complete resolution of symptoms within 2 months, and normal clinical exam at 2-year follow-up. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Body mass index increased, Bone disorder, Bone marrow oedema, Bursal fluid accumulation, Bursitis
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 39-year-old male. On an unknown date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unknown date, immediately following influenza vaccination, the patient developed left shoulder pain. On an unknown date, two months following the vaccination, the patient presented at the clinic with prolonged, increasing left shoulder pain. The physical examination was normal. On laboratory assessment, leukopenia was noted on CBC (3-4,700 on serial tests for 4 months) without defined source, although counts were otherwise normal. ESR was normal. BMI was recorded as 25.7 kg/m2. The MRI of the shoulder was performed three months following vaccination. It showed Magnetic resonance imaging showed oblique coronal image and oblique sagittal fat-saturated T2 weighted image which showed focal subcortical bone marrow edema-like signal within the greater tuberosity, without associated obvious cortical destruction. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Hyperintense T2 signal along the periosteum indicated periosteal reaction. There were periosseous soft tissue inflammatory changes and small subacromial/subdeltoid bursal fluid. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Sagittal T1-weighted imaging showed hypointense bone marrow signal. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Full blood count abnormal, Immediate post-injection reaction, Inflammation, Leukopenia, Musculoskeletal pain
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 39-year-old male. On an unknown date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unknown date, immediately following influenza vaccination, the patient developed left shoulder pain. On an unknown date, two months following the vaccination, the patient presented at the clinic with prolonged, increasing left shoulder pain. The physical examination was normal. On laboratory assessment, leukopenia was noted on CBC (3-4,700 on serial tests for 4 months) without defined source, although counts were otherwise normal. ESR was normal. BMI was recorded as 25.7 kg/m2. The MRI of the shoulder was performed three months following vaccination. It showed Magnetic resonance imaging showed oblique coronal image and oblique sagittal fat-saturated T2 weighted image which showed focal subcortical bone marrow edema-like signal within the greater tuberosity, without associated obvious cortical destruction. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Hyperintense T2 signal along the periosteum indicated periosteal reaction. There were periosseous soft tissue inflammatory changes and small subacromial/subdeltoid bursal fluid. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Sagittal T1-weighted imaging showed hypointense bone marrow signal. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal, Soft tissue inflammation
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 39-year-old male. On an unknown date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unknown date, immediately following influenza vaccination, the patient developed left shoulder pain. On an unknown date, two months following the vaccination, the patient presented at the clinic with prolonged, increasing left shoulder pain. The physical examination was normal. On laboratory assessment, leukopenia was noted on CBC (3-4,700 on serial tests for 4 months) without defined source, although counts were otherwise normal. ESR was normal. BMI was recorded as 25.7 kg/m2. The MRI of the shoulder was performed three months following vaccination. It showed Magnetic resonance imaging showed oblique coronal image and oblique sagittal fat-saturated T2 weighted image which showed focal subcortical bone marrow edema-like signal within the greater tuberosity, without associated obvious cortical destruction. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Hyperintense T2 signal along the periosteum indicated periosteal reaction. There were periosseous soft tissue inflammatory changes and small subacromial/subdeltoid bursal fluid. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Sagittal T1-weighted imaging showed hypointense bone marrow signal. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
Age: 39.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Atrial fibrillation, Bone marrow oedema, Leukopenia, Muscle oedema, Musculoskeletal pain
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 39-year-old male. On an unknown date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unknown date, immediately following influenza vaccination, the patient developed left shoulder pain. On an unknown date, two months following the vaccination, the patient presented at the clinic with prolonged, increasing left shoulder pain. The physical examination was normal. On laboratory assessment, leukopenia was noted on CBC (3-4,700 on serial tests for 4 months) without defined source, although counts were otherwise normal. ESR was normal. BMI was recorded as 25.7 kg/m2. The MRI of the shoulder was performed three months following vaccination. It showed Magnetic resonance imaging showed oblique coronal image and oblique sagittal fat-saturated T2 weighted image which showed focal subcortical bone marrow edema-like signal within the greater tuberosity, without associated obvious cortical destruction. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Hyperintense T2 signal along the periosteum indicated periosteal reaction. There were periosseous soft tissue inflammatory changes and small subacromial/subdeltoid bursal fluid. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Sagittal T1-weighted imaging showed hypointense bone marrow signal. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.