chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain in extremity, Peripheral coldness
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 29-Oct-2014) concerns a 39 year old female patient. On 08-Oct-2014, the patient received intramuscular AFLURIA, (batch number T56805) at 0.5 ml. On 08-Oct-2014, the patient experienced pain during the inejction in the upper arm which continueed to her fingers. The pain was described as continuous dull ache and rated the pain at 8. She was unable to sleep on her side and also had left hand coldness. She saw her primary care physician on 20-Oct-2014 and was prescirbed ibuprofen and ice. She will be following up with her primary care physician on 11-Nov-2014. The outcome was reportd as unknown. Batch record review for lot T56805 noted: All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T56805 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 T56805 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 statisticvally derived process control limits. Lot T56805 was placed on routine stability trial as it was the first lot of the pre filled syringe presentation to be filled. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or any trends of concern for lot T56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Insomnia, Pain in extremity, Peripheral coldness
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 29-Oct-2014) concerns a 39 year old female patient. On 08-Oct-2014, the patient received intramuscular AFLURIA, (batch number T56805) at 0.5 ml. On 08-Oct-2014, the patient experienced pain during the inejction in the upper arm which continueed to her fingers. The pain was described as continuous dull ache and rated the pain at 8. She was unable to sleep on her side and also had left hand coldness. She saw her primary care physician on 20-Oct-2014 and was prescirbed ibuprofen and ice. She will be following up with her primary care physician on 11-Nov-2014. The outcome was reportd as unknown. Batch record review for lot T56805 noted: All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T56805 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 T56805 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 statisticvally derived process control limits. Lot T56805 was placed on routine stability trial as it was the first lot of the pre filled syringe presentation to be filled. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or any trends of concern for lot T56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 29-Oct-2014) concerns a female patient. On 08-Oct-2014, the patient received intramuscular AFLURIA (batch number T56805) at 0.5 ml. On an unspecified date after vaccination, the patient developed soreness from shoulder to elbow and was unable to sleep on her side. The patient's rate of pain was at 6 during the day and at 10 at night that was still ongoing. The patient also developed a numb dull ache that continued during the day. The patient had minimal relief with ibuprofen during the day and took paracetamol at night. The outcome was reported as unknown. Reporter's comments: The reporter assessed the events as non-serious. batch record review for lot T56805 noted: All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T56805 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 T56805 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. Lot T56805 was placed on routine stability trial as it was the first lot of the pre filled syringe presentation to be filled for the 2014 2015 season. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or any trends of concern for lot Y56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Follow-up (02-Apr-2015): Batch Record Review Results.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 29-Oct-2014) concerns a female patient. On 08-Oct-2014, the patient received intramuscular AFLURIA (batch number T56805) at 0.5 ml. On an unspecified date after vaccination, the patient developed soreness from shoulder to elbow and was unable to sleep on her side. The patient's rate of pain was at 6 during the day and at 10 at night that was still ongoing. The patient also developed a numb dull ache that continued during the day. The patient had minimal relief with ibuprofen during the day and took paracetamol at night. The outcome was reported as unknown. Reporter's comments: The reporter assessed the events as non-serious. batch record review for lot T56805 noted: All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T56805 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 T56805 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. Lot T56805 was placed on routine stability trial as it was the first lot of the pre filled syringe presentation to be filled for the 2014 2015 season. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or any trends of concern for lot Y56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Follow-up (02-Apr-2015): Batch Record Review Results.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 48 year old female patient who had no medical history and no current illness. Concomitant medications included losartan, lorazepam and nebivolol. On the 08-Oct-2014, the patient received AFLURIA (batch number T56805) via the intramuscular route in the left arm. On the 08-Oct-2014, the patient received AFLURIA (batch number T56805) via the intramuscular route in the left arm. On the 08-Oct-2014, upon injection, the patient felt the needle and the vaccine enter her arm. She developed soreness and pain from the shoulder to the elbow. The numb, dull ache continued during the day. There was minimal relief with ibuprofen during the day and paracetamol at night. The patient was unable to sleep on either side. Pain was a six during the day and ten during the night on 1-10 scale. No laboratory data was done. Outcome was not recovered. A batch record review for lot T56805 noted: All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T56805 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 T56805 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. Lot T56805 was placed on routine stability trial as it was the first lot of the pre filled syringe presentation to be filled for the 2014 US season. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or trends of concern for lot T56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 48 year old female patient who had no medical history and no current illness. Concomitant medications included losartan, lorazepam and nebivolol. On the 08-Oct-2014, the patient received AFLURIA (batch number T56805) via the intramuscular route in the left arm. On the 08-Oct-2014, the patient received AFLURIA (batch number T56805) via the intramuscular route in the left arm. On the 08-Oct-2014, upon injection, the patient felt the needle and the vaccine enter her arm. She developed soreness and pain from the shoulder to the elbow. The numb, dull ache continued during the day. There was minimal relief with ibuprofen during the day and paracetamol at night. The patient was unable to sleep on either side. Pain was a six during the day and ten during the night on 1-10 scale. No laboratory data was done. Outcome was not recovered. A batch record review for lot T56805 noted: All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T56805 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 T56805 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. Lot T56805 was placed on routine stability trial as it was the first lot of the pre filled syringe presentation to be filled for the 2014 US season. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or trends of concern for lot T56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Peripheral swelling, Skin warm
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 29 year-old female patient. On 23-Oct-2014, the patient received intramuscular AFLURIA injection, (batch number 09449221A (thiomersal containing) in the left arm and PNEUMOVAX, (batch number K00681) in the right arm. On 24-Oct-2014, the patient experienced swollen right arm. On 25-Oct-2015, her arm was red and warm to the touch which spread downward. She took diphenhydramine which improved the symptoms. By 27-Oct-2014, the symptoms resolved. The outcome was recovered on 27-Oct-2014. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the term 'local swelling', and reported the patient presented at the Emergency Room.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 63 year old female patient. Concomitant medications included losartan, levothyroxine, potassium and amlodipine. On 28-Oct-2014, the patient received AFLURIA (batch number 09949221A) via the intramuscular route at an unknown route. The patient also received ZOSTAVAX (batch number K009772) via the subcutaneous route at an unknown site. On the 28-Oct-2014, the patient developed a red raised rash at the injection site with blisters which were very painful. The patient needed to sleep with the arm raised. It was treated with numbing topical agent. The patient also experienced joint pain, muscle pain and swollen glands. Outcome was recovered.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 63 year old female patient. Concomitant medications included losartan, levothyroxine, potassium and amlodipine. On 28-Oct-2014, the patient received AFLURIA (batch number 09949221A) via the intramuscular route at an unknown route. The patient also received ZOSTAVAX (batch number K009772) via the subcutaneous route at an unknown site. On the 28-Oct-2014, the patient developed a red raised rash at the injection site with blisters which were very painful. The patient needed to sleep with the arm raised. It was treated with numbing topical agent. The patient also experienced joint pain, muscle pain and swollen glands. Outcome was recovered.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 57 year-old male patient who had no known current illness, lab data and medical history at the time of vaccination. On 20-OCT-2014, the patient received intramuscular AFLURIA injection (batch number T518081). On 20-OCT-2014, the patient developed a fever and had it for 3 days. The patient also  had severe nausea and vomiting, which lasted almost 3 days. She also felt like diarrhea. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Migraine
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 63 year old female patient. The patient had medical history of cancer and NKA. Her concurrent condition included migraine. On 23-Sep-2014, the patient received intramuscular AFLURIA (batch number T58406) in the left arm. On 23-Sep-2014, one hour after receiving vaccination, the patient experienced migraine and it lasted for a week. The outcome was recovered.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 51 year old female patient who had no medical history and no current illness at the time of vaccination. No medications were known to be taken at the time of vaccination. On the 30-OCT-2014, the patient received AFLURIA (batch number T57606) via the intramuscular route in the right arm. The patient also received ADACEL (batch number C4695AA) via the intramuscular route in the left arm. On the 30-OCT-2014, the patient started to feel tingling and itching in the arm the vaccine was given. She also noted noticeable swelling in her fingers to much her rings had to be taken off because they felt tight. She experienced all symptoms within ten minutes of vaccine administration. No laboratory data was reported from the paramedics. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 30-Oct-2014) concerns a 47-year-old female patient. On 08-Oct-2014, the patient received intramuscular AFLURIA (batch number T56805). AFLURIA was stored correctly. On 08-Oct-2014, immediately after receiving the vaccine, the patient had pain at the injection site that felt like the needle hit her bone. She had also experienced limited range of motion in the arm where the vaccine was administered due to the pain. Outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious. Batch record review for lot T56805 noted: All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T56805 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 T56805 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. Lot T56805 was placed on routine stability trial as it was the first lot of the prefilled syringe presentation to be filled for the 2014 2015 season. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or any trends of concern for lot T56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 57 year old male patient who had no known current illness and medical history at the time of vaccination. On 29-OCT-2014, the patient received AFLURIA injection (batch number not provided). On 29-OCT-2014, the patient experienced coughing and headache. The strong headache continued to bedtime. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 25 year-old female patient who had no known current illness and medical history reported at the time of vaccination. On 30-Oct-2014, the patient received intramuscular AFLURIA injection (batch number 'TS9907') in the arm. On 31-Oct-2014, the patient noticed pain and swelling while she was in the shower. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye pruritus, Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 60-year-old female patient. The patient had medical history of seasonal allergies and controlled high blood pressure. She had no current illness. On 27-OCT-2014, the patient received AFLURIA injection (batch number not reported) in the left arm (route: SYR). On 27-OCT-2014, the patient developed rash on thighs, itching all over and in the eyes, nasal congestion, sore throat, body aches, chills, fatigue and felt groggy. The outcome was reported as missing. Reporter's comments: The health authority assessed the events as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus generalised, Rash, Somnolence
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 60-year-old female patient. The patient had medical history of seasonal allergies and controlled high blood pressure. She had no current illness. On 27-OCT-2014, the patient received AFLURIA injection (batch number not reported) in the left arm (route: SYR). On 27-OCT-2014, the patient developed rash on thighs, itching all over and in the eyes, nasal congestion, sore throat, body aches, chills, fatigue and felt groggy. The outcome was reported as missing. Reporter's comments: The health authority assessed the events as non-serious.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 25 year old female patient who had a medical history of allergy to sulfa drugs. The patient had no current illness at the time of vaccination. On the 30-OCT-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the left arm On the 30-OCT-2014, the patient was tender and sore initially and woke up at 03:00 hours with swollen shoulder/upper arm at and below the injection site, it was painful and hot. The swelling decreased gradually through the day. By 19:00 hours, it was just tender at the site. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site bruising, Injection site pain, Insomnia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 56 year old female patient who had no medical history and no current illness. On the 16-OCT-2014, the patient received AFLURIA (batch number T58906) via the intramuscular route in the left arm. On the 16-OCT-2014, the patient developed severe pain to the injection site at the upper left arm. The injection was administered very very high on the arm. Pain was increasing with intensity over the next few days. Bruising was present at the site within a few days. There was restricted range of motion of the left arm. The patient was unable to lift the arm due to severe pain. The pain increased at night and sleeping was hampered due to pain. Outcome was not recovered. Reporter comments: the regulator reported the case as non-serious.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cough, Disorientation, Throat tightness, Wheezing
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 69 year old male patient. On the 27-Oct-2014, the patient received AFLURIA (batch number T52808) dose 1 via an unknown route in the LA (left arm). On the 27-Oct-2014, the patient developed a cough, wheeze, throat tightening, weakness and slight disorientation. Outcome was recovered. Reporter comments:  The regulator reported the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 30 year old female patient. Concomitant medications included a multivitamin, pantothenic acid and Free and Easy Wanderer herbal supplement. The patient had no current illness. On the 22-Oct-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the left arm. The patient noticed the injection was high. On the 22-Oct-2014, the patient experienced progressive immobility of the shoulder, weakness and extreme pain. The problem persisted. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Electromyogram, Injected limb mobility decreased, Mobility decreased, Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt 03-Nov-2014) concerns a 41 year old female patient. She experienced elbow pain one week prior to receiving the vaccination. The patient was BRCA2 positive. Concomitant medication included norgestimate/ethinylestradiol. The patient had no current illness. On 16-Oct-2014, the patient received intramuscular AFLURIA (batch number T58206) at 0.5 mL in her left deltoid for protection against seasonal influenza virus. AFLURIA was stored correctly. On 16-Oct-2014, eleven hours after the vaccination, the patient developed extreme and sharp pain (on a scale of 9 out of 10) in her left elbow arm and elbow. She was having difficulty moving her arm and fingers due to the pain. Pain subsided after 24 hours. On the 20-Oct-2014, the patient followed up with the PMD (Primary Medical Doctor). PT (Physical Therapy) was recommended The pain returned and the patient was unable to move the fingers. The pain persisted on and off to date. On the 07-Nov-2014, an EMG (electromyography) was completed. The outcome was not recovered.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Ear discomfort, Hypoaesthesia oral, Paraesthesia oral, Throat tightness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 49 year old female patient who had no current illness. Last year (2013) the patient received the FLUZONE and within 1/2 hour developed circumoral numbness and tingling. On the 30-Oct-2014, the patient received AFLURIA, (batch number T52070) via the intramuscular route in the right arm. On the 30-Oct-2014, within minutes of receiving the vaccine, the patient's mouth was flooded with metallic taste followed by circumoral numbnes and tingling within the next five minutes, followed by fullness in the ears and throat (as is typical during an allergic reaction). The numbness/tingling lasted only about 5-10 minutes. The metallic taste and full sensation in the ears and throat lasted throughout the evening. The symptoms had just about completely resolved by 11PM. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 48 year-old female patient who had no known current illness at the time of vaccination. On 24-OCT-2014, the patient received AFLURIA injection (batch number T51608) in the left arm. On 25-OCT-2014 Saturday morning,  the patient started having rigors and chills. The at night on the same day she was unable to move or get out of bed due to body aches, other symptoms which lasted until Sunday morning. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site discolouration, Injection site pain, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2015) concern a 53 year old female patient who had a medical history of cervical ankylosing spondylitis and carcinoid cancer. Concomitant medications included duloxetine (60mg, qd), hydrocodone (10/325 prn when required) and tizanidine (4mg prn when required). On the 13-Oct-2014, the patient received AFLURIA (batch number T56805) via the intramuscular route in the left arm. On the 17-Oct-2014, the patient developed the usual soreness at the injection site. After three to four days, the discomfort extended to the shoulder with pain whilst raising the arm overhead and abducting the arm, limiting the range of motion. This had not worsened since then but had not improved either. The patient also experienced occasional twinges of tingling and numbness in the hand. Outcome was not recovered. A Batch record review for lot T56805 noted: All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished produce lot T56805 were reviewed and none were considered to have contributed to the adverse events reported. All QA test results for the seed lot, MPH, formulated bulk vaccine and finished product process stages associated with lot T56805 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. Lot T56805 was placed on routine stability trial as it was the first lot of the pre filled syringe presentation to be filled for the 2014 2015 season. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or any trends of concern for lot T58605. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Reporter comments: the regulator reported the case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2015) concern a 53 year old female patient who had a medical history of cervical ankylosing spondylitis and carcinoid cancer. Concomitant medications included duloxetine (60mg, qd), hydrocodone (10/325 prn when required) and tizanidine (4mg prn when required). On the 13-Oct-2014, the patient received AFLURIA (batch number T56805) via the intramuscular route in the left arm. On the 17-Oct-2014, the patient developed the usual soreness at the injection site. After three to four days, the discomfort extended to the shoulder with pain whilst raising the arm overhead and abducting the arm, limiting the range of motion. This had not worsened since then but had not improved either. The patient also experienced occasional twinges of tingling and numbness in the hand. Outcome was not recovered. A Batch record review for lot T56805 noted: All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished produce lot T56805 were reviewed and none were considered to have contributed to the adverse events reported. All QA test results for the seed lot, MPH, formulated bulk vaccine and finished product process stages associated with lot T56805 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. Lot T56805 was placed on routine stability trial as it was the first lot of the pre filled syringe presentation to be filled for the 2014 2015 season. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or any trends of concern for lot T58605. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Reporter comments: the regulator reported the case as non-serious.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain, Upper-airway cough syndrome
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 71 year-old female patient. Concomitant medications included ergocalciferol, amitriptyline and venlafaxine. On 28-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T58206) in the left arm. On 28-Oct-2014, when she got home, the patient started experiencing post nasal drip and then a sore throat. The patient then had labored breathing, but after about an hour the breathing normalised and resolved on its own. The outcome was recovered.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 62 year old female patient with no medical history. The patient had no current illness at the time of the vaccination. Concomitant medications included atorvastatin, levothyroxine, nebivolol, losartan and letrozole. On the 01-Nov-2014, the patient received AFLURIA (batch number T50307) via the intramuscular route in the left arm. On the 01-Nov-2014, the patient developed pain on injection, bleeding, swelling, redness within several hours and heat at the injection site. The swelling increased to the size of a baseball and the injection site was aching, hot and red. On the 02-Nov-2014 until the 04-Nov-2014, the patient had a flushed face. The patient took an anti-inflammatory on the 03-Nov-2014. On the 04-Nov-2014, the redness at the injection site and heat continued. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the terms 'feeling hot', 'erythema' and 'post-injection reaction.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 62 year old female patient with no medical history. The patient had no current illness at the time of the vaccination. Concomitant medications included atorvastatin, levothyroxine, nebivolol, losartan and letrozole. On the 01-Nov-2014, the patient received AFLURIA (batch number T50307) via the intramuscular route in the left arm. On the 01-Nov-2014, the patient developed pain on injection, bleeding, swelling, redness within several hours and heat at the injection site. The swelling increased to the size of a baseball and the injection site was aching, hot and red. On the 02-Nov-2014 until the 04-Nov-2014, the patient had a flushed face. The patient took an anti-inflammatory on the 03-Nov-2014. On the 04-Nov-2014, the redness at the injection site and heat continued. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the terms 'feeling hot', 'erythema' and 'post-injection reaction.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Dysphagia, Dyspnoea, Headache, Ocular hyperaemia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 52 year-old female patient who had no current illness at the time of vaccination. The patient had a medical history of Multiple Sclerosis, Hashimoto's hypothyroid, and no allergies. Concomitant medications included glatiramer acetate 20mg and levothyroxine sodium 50mg. On 03-Nov-2014, the patient received intramuscular AFLURIA injection, (batch number T50307). On 03-Nov-2014, the patient experienced difficulty breathing, loss of voice, severe headache, blood red eyes and difficulty swallowing. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported that the patient presented at the Emergency Room.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspepsia, Feeling cold, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 47 year-old male patient who had no current illness, concomitant medication or medical history at the time of vaccination. On 22-Oct-2014, the patient received intramuscular AFLURIA injection, (batch number T51408) in the left arm. On 22-Oct-2014, the patient experienced lump in throat, heartburn, vomiting, hot/sweating a couple hours later, and couldn't get warm at night/bedtime. On the next day, the patient had a headache. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Sensation of foreign body, Vomiting
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 47 year-old male patient who had no current illness, concomitant medication or medical history at the time of vaccination. On 22-Oct-2014, the patient received intramuscular AFLURIA injection, (batch number T51408) in the left arm. On 22-Oct-2014, the patient experienced lump in throat, heartburn, vomiting, hot/sweating a couple hours later, and couldn't get warm at night/bedtime. On the next day, the patient had a headache. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This non-serious medically confirmed health authority reports (initial receipt 15-Dec-2014) concerns an female patient who had no other concomitant medications and it was unknown whether she had current illness. On the 04-Oct-2014, the patient received AFLURIA (batch number not reported) via an unknown route and unknown site. The patient also received the ZOSTAVAX vaccine (batch number not reported) 1 shot injection via an unknown route at unknown site. On the 04-Oct-2014 or approximately 06-Oct-2014, the patient developed an injection-site reaction that included swelling, redness and itchiness 48 hours after receiving ZOSTAVAX. With 24 hours of the unspecified flu shot, she had flu-like symptoms. It was not specified whether the patient sought medical attention or not. The outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site mass, Injection site pain, Insomnia
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 06-Nov-2014) concerns a 45 year-old female patient who had a medical history of Hodgkin's 12 years ago. Concomitant medications included ibuprofen, omeprazole and fexofenadine. On 08-Oct-2014, the patient received AFLURIA (batch number T56805) 0.5mL via the intramuscular route in the left arm for protection against seasonal influenza virus. The product had been stored correctly. On 08-Oct-2014, the patient felt a sharp pain during the administration. Immediately after receiving the vaccine, the patient noticed a sharp pain and tenderness around the injection site which was continuous and was rated as a 7 on a 1-10 scale (with pain of 9 in the morning). The patient also noticed a lump underneath the skin at the injections site on the same day (08-Oct-2014). The patient was having difficulty performing daily activities due to the pain such as difficulty dressing and applying deodorant and difficulty sleeping on that side. There was no redness/swelling or fever. All the adverse events have not resolved. Outcome was reported as not recovered.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis, Influenza like illness, Insomnia, Malaise, Rhinorrhoea
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 65 year-old male patient who was taking NIACIN SR (vitamin B3) and had no current illness at the time of vaccination. Concomitant medications included valsartan, amlodipine, rosuvastatin, acetylsalicylic acid and fish oil. On 01-Nov-2014, the patient received intramuscular AFLURIA injection (batch number not provided) in the left arm. On 02-Nov-2014, the patient started experienced flu-like symptoms, runny nose, sinus congestion, epistaxis (unilateral), malaise, and difficulty with sleeping. The outcome was recovered.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Sinus congestion
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 65 year-old male patient who was taking NIACIN SR (vitamin B3) and had no current illness at the time of vaccination. Concomitant medications included valsartan, amlodipine, rosuvastatin, acetylsalicylic acid and fish oil. On 01-Nov-2014, the patient received intramuscular AFLURIA injection (batch number not provided) in the left arm. On 02-Nov-2014, the patient started experienced flu-like symptoms, runny nose, sinus congestion, epistaxis (unilateral), malaise, and difficulty with sleeping. The outcome was recovered.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein, Chills, Headache, Liver function test, Muscle spasms
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 36 year old female patient. The patient had medical history of DTAP, Selective serotonin reuptake inhibitors (SSRI) and morphine allergy and bee stings. The patient had no birth defects and no medical conditions. No current illness was reported. Her concomitant medications included doxycycline, diazepam, obetrol, melatonin and diphenhydramine hydrochloride. On 14-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T52208) in the left arm. On 14-Oct-2014, the patient developed muscle aches, severe cramping, headache, fever at 103.0 degree F without relief with acetaminophen, chills and nausea. The patient underwent laboratory tests for c-reactive protein and liver function tests. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included- c-reactive protein and liver function test.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 36 year old female patient. The patient had medical history of DTAP, Selective serotonin reuptake inhibitors (SSRI) and morphine allergy and bee stings. The patient had no birth defects and no medical conditions. No current illness was reported. Her concomitant medications included doxycycline, diazepam, obetrol, melatonin and diphenhydramine hydrochloride. On 14-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T52208) in the left arm. On 14-Oct-2014, the patient developed muscle aches, severe cramping, headache, fever at 103.0 degree F without relief with acetaminophen, chills and nausea. The patient underwent laboratory tests for c-reactive protein and liver function tests. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious. The authority reported symptoms included- c-reactive protein and liver function test.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Myalgia, Presyncope
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-Dec-2014) concerns a 45 year-old female patient. On 11-Oct-2014 at 07:00 hours, the patient received AFLURIA injection (batch number T57806) in the arm. On 11-Oct-2014 at 12:00 hours, the patient experienced a headache which became severe by 3pm. At 3pm, the patient also had chills, and by 9pm the patient had rigors. The patient also experienced presyncope and severe generalised joint and muscle pain. No treatment was sought. On the following day, all symptoms resolved. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 15-Dec-2014) concerns a 27 year-old female patient who had no known no current illness and no lab data at the time of reporting. On 14-Oct-2014, the patient received AFLURIA injection (batch number T557806) in the left arm. On 14-Oct-2014, the patient experienced sharp pain on left arm where the injection was given along with numbness down to hand and difficult grip at times. Treatment included methylprednisolone dose pack. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious and reported the term of 'Pain'.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 78 year old female patient. The patient had medical history of hypertension-controlled (Kw/Rxs) and was allergy to dust, mold and grasses. Her concomitant medications included levothyroxine, amlodipine besylate and losartan. On 20-Oct-2014 at 12:45 pm, the patient received AFLURIA injection (batch number not reported) in the upper left arm (route 'SYR'). On 21-Oct-2014 at 02:00 am, the patient woke up with severe redness and itching on back of both legs from ankle to knee and front of left leg from ankle upward towards knee extending at 4 inches. At 02:45 am, the patient took one 10 mg loratadine and the itching subsided within half an hour. The patient called the nurse health line who suggested that she did the right thing and further suggested her to apply to cold, wet washcloth to legs to relieve itching. Her redness and itching went away by 04:00 am. Immediately thereafter,  a large circle approximately 4 inches in diameter appeared on outside of and immediately above right knee. The patient applied cold wet rag to the area and itching went away after 15 minutes. All itching sites were bright red but cool to the touch. The patient did not feel as if she had fever. On 21-Oct-2014 at 11:30 pm, the patient developed red leg and itching ankle to knee on outside and middle of leg and right side of left knee. The patient used cold wet rag to relieve itching. On 22-Oct-2014 at 06:30 am, the patient had red and itching right leg from ankle to half way up inside of calf. The patient took 10 mg loratadine and used wet washcloth on leg. Itching subsided within approximately half an hour. On 23-Oct-2014, the patient woke up after mid night. She experienced severe redness, itching and stinging on left leg outside. The patient developed big red circle at 4 inches in diameter. The patient again used wet cloth and applies aloe vera gel (too soon to take loratadine). Itching was gone by 01:00 am '(cont 'd) 10:00 pm'. The patient continued to have redness, itching and stinging from right ankle upwards about 4 inches on front of leg and right side of ankle. At 10.35 pm, she took 10 mg loratadine and the redness, itching and stinging disappeared by 11:00 pm. The outcome was reported as recovered.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 55-year-old female patient who had no current illness and no medical history at the time of vaccination. On 01-OCT-2014, approximately 2-3 days later, the patient felt pain in arm tingling to hand, which was noticed after the massage therapy and did not subside. Treatment included ice and warm pack with no relief. The patient had appointment with chiropractor but no relief. The patient called the physician on 27-OCT-2014 and talked to the nurse. On 04-NOV-2014, the patient was seen by a physician and was placed on prednisone. The patient felt better in the morning but hurt toward the evening. The outcome was  unknown.  Reporter's comments: The regulatory authority assessed the case as non-serious.