chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 45 year old female patient. The patient had medical history of diabetes and hypertension. She also received dapagliflozin, metformin and lisinopril. On 08-Dec-2014, the patient received intramuscular AFLURIA (batch number T57505) in the left arm. The same day, patient also received intramuscular PNEUMOVAX (batch number K009874) in the left arm and intramuscular BOOSTRIX (batch number 3HG7R) in the right arm. On 09-Dec-2014, approximately 24 hours after receiving the vaccine, the patient was not feeling well, had fever and some injection site swelling. In the following 48 hours, she continued to run a fever and had pain in arm. On the fourth day following vaccination, she came into the pharmacy with rash around the injection, which was described as being warm and painful. She was advised to go to the urgent care. She was diagnosed with cellulitis and received antibiotics. The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious and patient presented at the Emergency Room.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 45 year old female patient. The patient had medical history of diabetes and hypertension. She also received dapagliflozin, metformin and lisinopril. On 08-Dec-2014, the patient received intramuscular AFLURIA (batch number T57505) in the left arm. The same day, patient also received intramuscular PNEUMOVAX (batch number K009874) in the left arm and intramuscular BOOSTRIX (batch number 3HG7R) in the right arm. On 09-Dec-2014, approximately 24 hours after receiving the vaccine, the patient was not feeling well, had fever and some injection site swelling. In the following 48 hours, she continued to run a fever and had pain in arm. On the fourth day following vaccination, she came into the pharmacy with rash around the injection, which was described as being warm and painful. She was advised to go to the urgent care. She was diagnosed with cellulitis and received antibiotics. The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious and patient presented at the Emergency Room.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cataract, Discomfort, Eye pain, Iritis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 65 year old female patient. The patient developed iritis with prior influenza virus vaccine (seasonal) vaccinations (refer to case 2015048239). At the time of vaccination, the patient was taking meclizine for Meniere's disease. On 17-Nov-2014, the patient received intramuscular AFLURIA (batch number T57405) in the right arm. On 01-Dec-2014, upon awakening the patient experienced general aching in the left eye. The discomfort was not severe and the patient waited until 12-Dec-2014 to see her physician, where she was diagnosed with iritis. She had cataract in both eyes, but was worse in left which was the eye always affected by iritis 2 weeks following flu vaccination. The outcome was not reported. Reporter comments: The health authority assessed the events as non-serious. The patient attended the Emergency Room.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Demyelination, Laboratory test abnormal, Neuropathy peripheral
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 51-year-old male patient who had no known medical history. The patient's concurrent condition included neuropathy. On 22-Nov-2013, the patient received AFLURIA (batch number R54307) in the left arm. On 12-Dec-2013, within 30 days of vaccination, the patient developed neuropathy and was admitted to shock trauma. His laboratory data showed cervical (+) demyelination, neuropathy/limb. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as serious (hospitalisation) and reported the symptoms 'condition aggravated' and 'laboratory test abnormal'.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Abscess drainage, Culture wound, Injection site abscess, Injection site reaction, Staphylococcal infection
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 37 year old female patient. The patient's concomitant medication included carbamazepine. On 02-Oct-2014, the patient received AFLURIA (batch number: T59106) in the left arm via 'SYR' route. On 17-Oct-2014, the patient developed abscess at injection site which was drained four times and was cultured. It determined to be staphylococcus infection. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as non-serious. The authority reported symptoms were: injection site reaction, staphylococcus test positive and ultrasound scan.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Staphylococcus test positive, Ultrasound scan
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 37 year old female patient. The patient's concomitant medication included carbamazepine. On 02-Oct-2014, the patient received AFLURIA (batch number: T59106) in the left arm via 'SYR' route. On 17-Oct-2014, the patient developed abscess at injection site which was drained four times and was cultured. It determined to be staphylococcus infection. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as non-serious. The authority reported symptoms were: injection site reaction, staphylococcus test positive and ultrasound scan.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Generalised tonic-clonic seizure, Postictal state
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 20 year-old male patient who had no known current illness at the time of vaccination. Her medical history included seizure which she had the last episode in March 2014. Concomitant medication included levetiracetam. On 26-Dec-2014, the patient received intramuscular AFLURIA (batch number not provided) in the right arm. On 27-Dec-2014, the patient experienced a tonic clonic seizure which lasted about 45 seconds with postictal phase of 5 minutes. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chest X-ray, Full blood count, Granulocyte count, Influenza
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 29 year-old female patient who had no known current illness at the time of vaccination and no previous drug allergies. On 29-Sep-2014, the patient received AFLURIA injection (batch number T51908) in the right arm (deltoid) and PNEUMOVAX (batch number K006681) in the left arm (deltoid). On 29-Sep-2014, the patient was seen for fever and leukocytosis and was instructed to return for repeat complete blood count (CBC). The patient felt better but still had a running fever to 130 degrees overnight. The patient reported temperature reading at home was up to 102 degrees and had body aches. White blood cell count was 20,000 with L shift, chest x-ray was negative. No treatment was recommended but to return to the doctor for re-evaluation. The patient returned to the doctor the next day for re-evaluation and repeat labs. The patient's left deltoid was slightly swollen and warm to touch and 'TTP'. The patient denied of sick exposures, and reported no cough, sore throat, dysuria, abdominal pain, nausea/vomiting and diarrhoea. The patient did not do any traveling. The patient also experienced redness and warmth at the injection site as well as flu symptoms. Investigations on 02-Oct-2014: Influenza A and B PCR (polymerase chain reaction) were negative. H1N1 PCR was not detected. HEENT-canals were clear, tympanic membranes pearly gray. Nares clear, no discharge. Pharynx pink, clear, no discharge. Lung-CTAB ant/post. Heart - RRR (regular rate and rhythm), S1S2, no m/g/r. Abdomen was soft, non-tender, bowel sound presented 4x quadrants. Extremity examination showed left deltoid at the injection site had moderate amount of oedema limited to the injection site area, no erythema noted. Neurology examination showed central nervous II-XII grossly intact. White blood count on 29-Sep-2014 was 9.2 and today 20.5 with granulocytes 16.7. Chemistry 7 -negative. Urinalysis was negative. Urine pregnancy test was negative. Chest x-ray was pending. Leukocytosis was negative. There was also head-to-toe physical examination. The outcome was reported as recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptoms of 'chest x-ray', 'culture negative', 'full blood count normal', 'granulocyte count', 'influenza A virus test negative', 'laboratory test normal', 'polymerase chain reaction', and 'pregnancy urine test negative'.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza A virus test negative, Influenza B virus test, Injection site warmth, Laboratory test normal, Leukocytosis
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 29 year-old female patient who had no known current illness at the time of vaccination and no previous drug allergies. On 29-Sep-2014, the patient received AFLURIA injection (batch number T51908) in the right arm (deltoid) and PNEUMOVAX (batch number K006681) in the left arm (deltoid). On 29-Sep-2014, the patient was seen for fever and leukocytosis and was instructed to return for repeat complete blood count (CBC). The patient felt better but still had a running fever to 130 degrees overnight. The patient reported temperature reading at home was up to 102 degrees and had body aches. White blood cell count was 20,000 with L shift, chest x-ray was negative. No treatment was recommended but to return to the doctor for re-evaluation. The patient returned to the doctor the next day for re-evaluation and repeat labs. The patient's left deltoid was slightly swollen and warm to touch and 'TTP'. The patient denied of sick exposures, and reported no cough, sore throat, dysuria, abdominal pain, nausea/vomiting and diarrhoea. The patient did not do any traveling. The patient also experienced redness and warmth at the injection site as well as flu symptoms. Investigations on 02-Oct-2014: Influenza A and B PCR (polymerase chain reaction) were negative. H1N1 PCR was not detected. HEENT-canals were clear, tympanic membranes pearly gray. Nares clear, no discharge. Pharynx pink, clear, no discharge. Lung-CTAB ant/post. Heart - RRR (regular rate and rhythm), S1S2, no m/g/r. Abdomen was soft, non-tender, bowel sound presented 4x quadrants. Extremity examination showed left deltoid at the injection site had moderate amount of oedema limited to the injection site area, no erythema noted. Neurology examination showed central nervous II-XII grossly intact. White blood count on 29-Sep-2014 was 9.2 and today 20.5 with granulocytes 16.7. Chemistry 7 -negative. Urinalysis was negative. Urine pregnancy test was negative. Chest x-ray was pending. Leukocytosis was negative. There was also head-to-toe physical examination. The outcome was reported as recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptoms of 'chest x-ray', 'culture negative', 'full blood count normal', 'granulocyte count', 'influenza A virus test negative', 'laboratory test normal', 'polymerase chain reaction', and 'pregnancy urine test negative'.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pregnancy test, Urine analysis, White blood cell count
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 29 year-old female patient who had no known current illness at the time of vaccination and no previous drug allergies. On 29-Sep-2014, the patient received AFLURIA injection (batch number T51908) in the right arm (deltoid) and PNEUMOVAX (batch number K006681) in the left arm (deltoid). On 29-Sep-2014, the patient was seen for fever and leukocytosis and was instructed to return for repeat complete blood count (CBC). The patient felt better but still had a running fever to 130 degrees overnight. The patient reported temperature reading at home was up to 102 degrees and had body aches. White blood cell count was 20,000 with L shift, chest x-ray was negative. No treatment was recommended but to return to the doctor for re-evaluation. The patient returned to the doctor the next day for re-evaluation and repeat labs. The patient's left deltoid was slightly swollen and warm to touch and 'TTP'. The patient denied of sick exposures, and reported no cough, sore throat, dysuria, abdominal pain, nausea/vomiting and diarrhoea. The patient did not do any traveling. The patient also experienced redness and warmth at the injection site as well as flu symptoms. Investigations on 02-Oct-2014: Influenza A and B PCR (polymerase chain reaction) were negative. H1N1 PCR was not detected. HEENT-canals were clear, tympanic membranes pearly gray. Nares clear, no discharge. Pharynx pink, clear, no discharge. Lung-CTAB ant/post. Heart - RRR (regular rate and rhythm), S1S2, no m/g/r. Abdomen was soft, non-tender, bowel sound presented 4x quadrants. Extremity examination showed left deltoid at the injection site had moderate amount of oedema limited to the injection site area, no erythema noted. Neurology examination showed central nervous II-XII grossly intact. White blood count on 29-Sep-2014 was 9.2 and today 20.5 with granulocytes 16.7. Chemistry 7 -negative. Urinalysis was negative. Urine pregnancy test was negative. Chest x-ray was pending. Leukocytosis was negative. There was also head-to-toe physical examination. The outcome was reported as recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the symptoms of 'chest x-ray', 'culture negative', 'full blood count normal', 'granulocyte count', 'influenza A virus test negative', 'laboratory test normal', 'polymerase chain reaction', and 'pregnancy urine test negative'.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 41-year old female patient. The patient had medical history of diabetes. Her concomitant medications included insulin glargine and insulin glulisine. The patient had no current illness. On 02-Nov-2014, the patient received intramuscular AFLURIA (batch number not reported) in the left arm. On 22-Dec-2014, the patient developed Bell's palsy left side facial paralysis. The patient presented at the ER (emergency room) and was undergoing ER evaluation. The outcome was reported as unknown. Reporter's comments: The health authority assessed the case as non-serious.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthropathy, C-reactive protein normal, Nuclear magnetic resonance imaging abnormal, Osteoarthritis, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. On 22-Sep-2014, the patient received AFLURIA injection (batch number not provided) in the arm. On 23-Sep-2014, the patient experienced severe arm pain, minimal swelling at the vaccination site, limited arm ROM (range of motion) and DJD (degenerative joint disease). Investigations included ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) which were normal; MRI (magnetic resonance imaging) of the shoulder which showed tear and advanced arthropathy. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the 'Emergency Room', and reported the terms of 'C-reactive protein normal', 'nuclear magnetic resonance imaging abnormal', 'Red blood cell sedimentation rate normal' and 'rotator cuff syndrome'.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Red blood cell sedimentation rate normal, Rotator cuff syndrome, Vaccination site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. On 22-Sep-2014, the patient received AFLURIA injection (batch number not provided) in the arm. On 23-Sep-2014, the patient experienced severe arm pain, minimal swelling at the vaccination site, limited arm ROM (range of motion) and DJD (degenerative joint disease). Investigations included ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) which were normal; MRI (magnetic resonance imaging) of the shoulder which showed tear and advanced arthropathy. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the 'Emergency Room', and reported the terms of 'C-reactive protein normal', 'nuclear magnetic resonance imaging abnormal', 'Red blood cell sedimentation rate normal' and 'rotator cuff syndrome'.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Blood test abnormal, Hypersensitivity, Mobility decreased
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. On 22-Sep-2014, the patient received AFLURIA injection (batch number not provided) in the arm. On 23-Sep-2014, the patient experienced severe arm pain, minimal swelling at the vaccination site, limited arm ROM (range of motion) and DJD (degenerative joint disease). Investigations included ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) which were normal; MRI (magnetic resonance imaging) of the shoulder which showed tear and advanced arthropathy. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the 'Emergency Room', and reported the terms of 'C-reactive protein normal', 'nuclear magnetic resonance imaging abnormal', 'Red blood cell sedimentation rate normal' and 'rotator cuff syndrome'.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Musculoskeletal pain, Myalgia, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. On 22-Sep-2014, the patient received AFLURIA injection (batch number not provided) in the arm. On 23-Sep-2014, the patient experienced severe arm pain, minimal swelling at the vaccination site, limited arm ROM (range of motion) and DJD (degenerative joint disease). Investigations included ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) which were normal; MRI (magnetic resonance imaging) of the shoulder which showed tear and advanced arthropathy. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the 'Emergency Room', and reported the terms of 'C-reactive protein normal', 'nuclear magnetic resonance imaging abnormal', 'Red blood cell sedimentation rate normal' and 'rotator cuff syndrome'.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Surgery, X-ray
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. On 22-Sep-2014, the patient received AFLURIA injection (batch number not provided) in the arm. On 23-Sep-2014, the patient experienced severe arm pain, minimal swelling at the vaccination site, limited arm ROM (range of motion) and DJD (degenerative joint disease). Investigations included ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) which were normal; MRI (magnetic resonance imaging) of the shoulder which showed tear and advanced arthropathy. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the 'Emergency Room', and reported the terms of 'C-reactive protein normal', 'nuclear magnetic resonance imaging abnormal', 'Red blood cell sedimentation rate normal' and 'rotator cuff syndrome'.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthropathy, C-reactive protein normal, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Osteoarthritis
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. On 22-Sep-2014, the patient received AFLURIA injection (batch number not provided) in the arm. On 23-Sep-2014, the patient experienced severe arm pain, minimal swelling at the vaccination site, limited arm ROM (range of motion) and DJD (degenerative joint disease). Investigations included ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) which were normal; MRI (magnetic resonance imaging) of the shoulder which showed tear and advanced arthropathy. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the 'Emergency Room', and reported the terms of 'C-reactive protein normal', 'nuclear magnetic resonance imaging abnormal', 'Red blood cell sedimentation rate normal' and 'rotator cuff syndrome'.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Rotator cuff syndrome, Vaccination site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 71 year-old female patient who had no known current illness at the time of vaccination. On 22-Sep-2014, the patient received AFLURIA injection (batch number not provided) in the arm. On 23-Sep-2014, the patient experienced severe arm pain, minimal swelling at the vaccination site, limited arm ROM (range of motion) and DJD (degenerative joint disease). Investigations included ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) which were normal; MRI (magnetic resonance imaging) of the shoulder which showed tear and advanced arthropathy. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the 'Emergency Room', and reported the terms of 'C-reactive protein normal', 'nuclear magnetic resonance imaging abnormal', 'Red blood cell sedimentation rate normal' and 'rotator cuff syndrome'.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neuralgia, Neuritis
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 50 year-old female patient. The patient had no current illness or medical history at the time of vaccination. On 31-Dec-2014, the patient received intramuscular AFLURIA injection (batch number: T53109). On 31-Dec-2014, the patient experienced neuralgia/neuritis in right shoulder and arm. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Electrocardiogram, Exposure during pregnancy, Ultrasound antenatal screen, X-ray
Clinical narrative: This medically confirmed spontaneous report (initial receipt 20-Jan-2015) concerns a 34 year-old female patient who was in her 26th week (6.5 months) of pregnancy. She had no issues with previous influenza vaccines (not known if she previously administered AFLURIA), and no known medical conditions, concomitant medications or drug allergies. She was allergic to latex. On 19-Jan-2015, the pregnant patient received intramuscular AFLURIA injection (batch number T58006) 0.5mL once in the left arm. AFLURIA was stored correctly. No other immunization was given on that day. This was her first time receiving AFLURIA. On 19-Jan-2015, two hours following the vaccination, the patient experienced shortness of breath and throat tightening. She went to the emergency room at a hospital and was told that she had an anaphylactic reaction. The right side of her airways were closed. She was treated with a breathing treatment and corticosteroids in the emergency room. She was given steroids. The patient underwent electrocardiogram, x-ray and ultrasound of unborn baby was performed. She was discharged later on in the same day with albuterol, prednisone and a salbutamol inhaler. The outcome was reported as not recovered. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Reporter comments: The reporter assessed the events as serious (life-threatening) and related to AFLURIA. However, the regulatory authority assessed the events as non-serious. Follow-up (20-Apr-2015): VAERS ID, reporter outcome, new events, lab data, formulation for AFLURIA, reporter comments, treatment. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Electrocardiogram, Exposure during pregnancy, Obstructive airways disorder
Clinical narrative: This medically confirmed spontaneous report (initial receipt 20-Jan-2015) concerns a 34 year-old female patient who was in her 26th week (6.5 months) of pregnancy. She had no issues with previous influenza vaccines (not known if she previously administered AFLURIA), and no known medical conditions, concomitant medications or drug allergies. She was allergic to latex. On 19-Jan-2015, the pregnant patient received intramuscular AFLURIA injection (batch number T58006) 0.5mL once in the left arm. AFLURIA was stored correctly. No other immunization was given on that day. This was her first time receiving AFLURIA. On 19-Jan-2015, two hours following the vaccination, the patient experienced shortness of breath and throat tightening. She went to the emergency room at a hospital and was told that she had an anaphylactic reaction. The right side of her airways were closed. She was treated with a breathing treatment and corticosteroids in the emergency room. She was given steroids. The patient underwent electrocardiogram, x-ray and ultrasound of unborn baby was performed. She was discharged later on in the same day with albuterol, prednisone and a salbutamol inhaler. The outcome was reported as not recovered. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Reporter comments: The reporter assessed the events as serious (life-threatening) and related to AFLURIA. However, the regulatory authority assessed the events as non-serious. Follow-up (20-Apr-2015): VAERS ID, reporter outcome, new events, lab data, formulation for AFLURIA, reporter comments, treatment. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat tightness, Ultrasound antenatal screen, X-ray
Clinical narrative: This medically confirmed spontaneous report (initial receipt 20-Jan-2015) concerns a 34 year-old female patient who was in her 26th week (6.5 months) of pregnancy. She had no issues with previous influenza vaccines (not known if she previously administered AFLURIA), and no known medical conditions, concomitant medications or drug allergies. She was allergic to latex. On 19-Jan-2015, the pregnant patient received intramuscular AFLURIA injection (batch number T58006) 0.5mL once in the left arm. AFLURIA was stored correctly. No other immunization was given on that day. This was her first time receiving AFLURIA. On 19-Jan-2015, two hours following the vaccination, the patient experienced shortness of breath and throat tightening. She went to the emergency room at a hospital and was told that she had an anaphylactic reaction. The right side of her airways were closed. She was treated with a breathing treatment and corticosteroids in the emergency room. She was given steroids. The patient underwent electrocardiogram, x-ray and ultrasound of unborn baby was performed. She was discharged later on in the same day with albuterol, prednisone and a salbutamol inhaler. The outcome was reported as not recovered. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Reporter comments: The reporter assessed the events as serious (life-threatening) and related to AFLURIA. However, the regulatory authority assessed the events as non-serious. Follow-up (20-Apr-2015): VAERS ID, reporter outcome, new events, lab data, formulation for AFLURIA, reporter comments, treatment. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Acne, Blister, Herpes zoster, Hyperaesthesia, Hypoaesthesia
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered. Reporter Comments: The regulatory assessed the events as non-serious and the start date as 12-Jan-2015. Follow-up (20-Apr-2015): New Reporter added; Reporter seriousness criteria and serious added; Suspect Drug #1 dose form added; As reported term updated for AE #2, 4-6, 8, and 9; Reporter comments added; New AEs #10-12. Case correction (15-May-2015): AE 8 split and re-coded to 'blister' and 'ulcer'.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neck pain, Pain, Paraesthesia, Post herpetic neuralgia, Pruritus
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered. Reporter Comments: The regulatory assessed the events as non-serious and the start date as 12-Jan-2015. Follow-up (20-Apr-2015): New Reporter added; Reporter seriousness criteria and serious added; Suspect Drug #1 dose form added; As reported term updated for AE #2, 4-6, 8, and 9; Reporter comments added; New AEs #10-12. Case correction (15-May-2015): AE 8 split and re-coded to 'blister' and 'ulcer'.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Scab, Spinal X-ray
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered. Reporter Comments: The regulatory assessed the events as non-serious and the start date as 12-Jan-2015. Follow-up (20-Apr-2015): New Reporter added; Reporter seriousness criteria and serious added; Suspect Drug #1 dose form added; As reported term updated for AE #2, 4-6, 8, and 9; Reporter comments added; New AEs #10-12. Case correction (15-May-2015): AE 8 split and re-coded to 'blister' and 'ulcer'.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neck pain, Pain in extremity, Paraesthesia, Post herpetic neuralgia, Pruritus
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered. Reporter Comments: The regulatory assessed the events as non-serious and the start date as 12-Jan-2015. Follow-up (20-Apr-2015): New Reporter added; Reporter seriousness criteria and serious added; Suspect Drug #1 dose form added; As reported term updated for AE #2, 4-6, 8, and 9; Reporter comments added; New AEs #10-12. Case correction (15-May-2015): AE 8 split and re-coded to 'blister' and 'ulcer'.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Scab, Skin ulcer
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered. Reporter Comments: The regulatory assessed the events as non-serious and the start date as 12-Jan-2015. Follow-up (20-Apr-2015): New Reporter added; Reporter seriousness criteria and serious added; Suspect Drug #1 dose form added; As reported term updated for AE #2, 4-6, 8, and 9; Reporter comments added; New AEs #10-12. Case correction (15-May-2015): AE 8 split and re-coded to 'blister' and 'ulcer'.
Age: 55.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Pruritus, Rash, Skin lesion, Varicella, Varicella virus test negative
Clinical narrative: This medically confirmed report (initial receipt 03-Apr-2015) concerns a 55 year old female patient who had a medical history of GBS (Guillain Barre Syndrome) in 2010 and allergies to sulfamethoxazole/trimethoprim and IV (intravenous) dye. On the 15-Oct-2014, the patient received an influenza vaccine (manufacturer and batch number not reported) and ZOSTAVAX (batch number not reported) 0.65mL via the subcutaneous route. On the 20-Oct-2014, since receiving the vaccine, the patient has experienced three to four vesicular rashes/shingles outbreaks. On the 20-Oct-2014, the first lesions appeared and resolved on an unspecified date. On the 20-Jan-2015, another lesion appeared and resolved on an unspecified date. The rash was cultured and tested on the 03-Feb-2015 and was diagnosed as HSV (Herpes Simplex Virus). On the 06-Feb-2015 another lesion appeared and she was diagnosed with bronchitis, both resolved on an unspecified date. On the 27-Feb-2015, another lesion appeared and she was diagnosed with bronchitis again and had not recovered from either illness. Treatment included Valacyclovir and doxycycline on unspecified date. She was assessed by a NP (nurse practitioner) on unspecified date. On the 19-Mar-2015, the patient had stated that she was having the fifth or sixth outbreak. New lesions appeared on her low back and right buttock which were very itchy and not painful. Outcome was not recovered.
Age: 55.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Bronchitis, Herpes simplex, Herpes zoster, Rash vesicular, Simplex virus test positive
Clinical narrative: This medically confirmed report (initial receipt 03-Apr-2015) concerns a 55 year old female patient who had a medical history of GBS (Guillain Barre Syndrome) in 2010 and allergies to sulfamethoxazole/trimethoprim and IV (intravenous) dye. On the 15-Oct-2014, the patient received an influenza vaccine (manufacturer and batch number not reported) and ZOSTAVAX (batch number not reported) 0.65mL via the subcutaneous route. On the 20-Oct-2014, since receiving the vaccine, the patient has experienced three to four vesicular rashes/shingles outbreaks. On the 20-Oct-2014, the first lesions appeared and resolved on an unspecified date. On the 20-Jan-2015, another lesion appeared and resolved on an unspecified date. The rash was cultured and tested on the 03-Feb-2015 and was diagnosed as HSV (Herpes Simplex Virus). On the 06-Feb-2015 another lesion appeared and she was diagnosed with bronchitis, both resolved on an unspecified date. On the 27-Feb-2015, another lesion appeared and she was diagnosed with bronchitis again and had not recovered from either illness. Treatment included Valacyclovir and doxycycline on unspecified date. She was assessed by a NP (nurse practitioner) on unspecified date. On the 19-Mar-2015, the patient had stated that she was having the fifth or sixth outbreak. New lesions appeared on her low back and right buttock which were very itchy and not painful. Outcome was not recovered.