chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: This medically confirmed health authority report (initial report 02-Dec-2014) concerns a 36 year old female patient. The patient had medical history of allergy to cephalexin. Her concomitant medications included prenatal docosahexanoic acid, sumatriptan and sertraline. On 11-Sep-2014, the patient received AFLURIA injection (batch number T58006) in the right arm. On 11-Sep-2014, the patient developed intermittent shoulder pain (more than two week post vaccination). The outcome was reported as not recovered.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Eye pruritus, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 49-year-old female patient. The patient had no medical history or current illness. The patient was on no medications at the time of vaccination. On 30-Sep-2014, the patient recei9ved intramuscular AFLURIA injection, (batch number T50707) in the right arm. On 30-Sep-2014, the patient experienced shortness of breath, hives, itchy eyes and hoarseness of voice. The outcome was recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 52 year old male patient. On the 27-Sep-2014, the patient received AFLURIA (batch number T58006) via the intramuscular route in the left arm. On the 28-Sep-2014, the patient noticed under the left arm two places that were swollen and red. The area was where the arm met the shoulder. He noticed that the area changed on the 28-Sep-2014 and it was slightly worse that day. He was advised to keep an eye on it for worsening symptoms and to contact the doctor. Outcome was unknown.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Immediate post-injection reaction, Injection site reaction, Pruritus, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 13-Nov-2014) concerns a 60-year old female patient. The patient had no medical history. On 13-Sep-2014, the patient received intramuscular AFLURIA (batch number: 09949221A) in the left arm. The same day, she also received subcutaneous ZOSTAVAX, (batch number K000726), also in the left arm. On 13-Sep-2014, the patient experienced extreme itching as soon as the ZOSTAVAX vaccine was administered. Two days later, she noticed a large welt at injection site. The patient was instructed to ice the affected arm and take diphenhydramine to decrease itching. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious. Case correction (12-Jun-2015): AE 2 re-coded.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 38 year old female patient who had a medical history of asthma. The patient had no current illness at the time of vaccination. On the 24-Sep-2014, the patient received AFLURIA syringe, (batch number T58006) in the right arm. On the 26-Sep-2014, the patient developed a red, swollen and warm arm at the injection site. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious. 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 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 review, 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. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Hyperaesthesia, Injection site pain, Pharyngeal oedema
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 29 year-old female patient. Her concomitant medications included prenatal vitamins, bupleurum and tang kuei herbals and mupirocin. She was not sure if she was pregnant as it was too early to know. She will know on 01-Oct-2014 when she miss her period. She previously received flu vaccine and developed a sore injection site, felt feverish with sensitive skin (see case 2014047168). On 24-Sep-2014 at around 14:40 hours, the patient received intramuscular AFLURIA (batch number "NDC 33332*0014-01") 0.5 mL. On 24-Sep-2014 at 19:00 hours, the patient noticed that her throat felt scratchy which progressed to difficulty breathing, elevated heart rate and a fever of about 0.5 degrees above normal. The inside of her throat felt swollen and the difficulty of breathing lasted for hours but was not bad enough to warrant her to go to the emergency room (ER). Outcome was reported as unknown. Reporter's comments: The reporter commented that it was 'a little scary'. The regulatory authority assessed the events as non-serious.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 29 year-old female patient. Her concomitant medications included prenatal vitamins, bupleurum and tang kuei herbals and mupirocin. She was not sure if she was pregnant as it was too early to know. She will know on 01-Oct-2014 when she miss her period. She previously received flu vaccine and developed a sore injection site, felt feverish with sensitive skin (see case 2014047168). On 24-Sep-2014 at around 14:40 hours, the patient received intramuscular AFLURIA (batch number "NDC 33332*0014-01") 0.5 mL. On 24-Sep-2014 at 19:00 hours, the patient noticed that her throat felt scratchy which progressed to difficulty breathing, elevated heart rate and a fever of about 0.5 degrees above normal. The inside of her throat felt swollen and the difficulty of breathing lasted for hours but was not bad enough to warrant her to go to the emergency room (ER). Outcome was reported as unknown. Reporter's comments: The reporter commented that it was 'a little scary'. The regulatory authority assessed the events as non-serious.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-DEC-2014) concerns a 60 year old male patient. The patient had no current illness or medical history. On 30-SEP-2014, the patient received intramuscular AFLURIA (batch number 454544) in the left arm. On 01-OCT-2014, the patient experienced injection site soreness and pain, systemic muscle pain, malaise, chills and fever (101.2). the outcome was reported as recovered. Reporter's comments: The  health authority assessed the events as non-serious.
Age: 56.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Glossodynia, Injection site pain, Injection site rash, Injection site warmth, Swollen tongue
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 56 year old male patient who had a medical history of "iILD", anxiety, chronic pain and no allergies. Concomitant medications included clonidine, clonazepam, oxycodone and colchicine. It was unknown whether the patient had any current illness. On the 26-Sep-2014, the patient experienced AFLURIA injection (batch number 'TS9306') dose 1 via the intramuscular route at an unknown site. The patient also received the ZOSTAVAX injection (batch number J014809) via the subcutaneous route at an unknown site. On the 28-Sep-2014, about 40 hours after, the patient developed a warm, sore rash at the injection site plus his tongue was sore like a charlie-horse with swelling and wheeze with no (-) SOB (shortness of breath). Treatment included diphenhydramine and with that, it resolved within 12 hours. Outcome was recovered.
Age: 56.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Wheezing
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 56 year old male patient who had a medical history of "iILD", anxiety, chronic pain and no allergies. Concomitant medications included clonidine, clonazepam, oxycodone and colchicine. It was unknown whether the patient had any current illness. On the 26-Sep-2014, the patient experienced AFLURIA injection (batch number 'TS9306') dose 1 via the intramuscular route at an unknown site. The patient also received the ZOSTAVAX injection (batch number J014809) via the subcutaneous route at an unknown site. On the 28-Sep-2014, about 40 hours after, the patient developed a warm, sore rash at the injection site plus his tongue was sore like a charlie-horse with swelling and wheeze with no (-) SOB (shortness of breath). Treatment included diphenhydramine and with that, it resolved within 12 hours. Outcome was recovered.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 54 year old female patient who had no medical history and no current illness at time of vaccination. On the 19-Sep-2014, the patient received AFLURIA (batch number T57906) in the right arm. On the 19-Sep-2014, the patient felt dizzy, weak and feverish several hours after vaccine administration. There was no reaction at the injection site. Outcome was recovered.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 56 year old female patient who had a known history of reactions to bee stings, penicillin and cephalexin. The patient had no current illness at the time of vaccination and was healthy. On the 15-Sep-2014, the patient received AFLURIA (batch number T58606) via the intramuscular route. On an unspecified date, the patient developed a maculopapular rash that did not respond to antihistamines. The patient required oral prednisone. Outcome was recovered.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 27 year old female patient who had no current illness at the time of vaccination, no medical history and no concomitant medications. On the 13-Sep-2014, the patient received AFLURIA (batch number T59006) via the intramuscular route in the left arm. On the 14-Sep-2014, the patient developed intense muscle pain that was still persistent three weeks after administration. Treatment included ibuprofen 800mg three times a day and 'IcyHot' patch topically when required. Outcome was not recovered.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report initial receipt 02-DEC-2014) concerns a 71 year old female patient. ON the 14-SEP-2014, the patient received AFLURIA (batch number T57005) via the intramuscular route in the left arm. On the 23-SEP-2014, the patient went to a pharmacy and complained of pain and bruising at the injection site. The patient was told to speak to her MD (medical doctor). Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 52 year old female patient with no applicable medical history. Concomitant medications included atomization, aloetin, spironolactone, levothyroxine and a statin. The patient had no current illness at the time of vaccination. On the 01-OCT-2014, the patient received AFLURIA (batch number T56805) via the intramuscular route via the left arm. On the 02-OCT-2014, the patient developed swelling, redness 50mm in diameter and pain on touch. No treatment was taken. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious. Batch record review for lot T56805 noted: All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product lot T56805 were reviewed and non were considered to have contributed to the adverse events reported. All QC 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 investigate (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 T56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This non-serious medically confirmed health authority report  (initial receipt 02-Dec-2014) concerns an 82 year old female patient who had no medical history and no illness at the time of vaccination. On the 28-Sep-2014, the patient received AFLURIA 2014-2015 (batch number not provided) via the intramuscular route. On the 01-Oct-2014, the patient developed a big red itchy patch approximately 6"x3" which continued on the 03-Oct-2014. No treatment was taken. Outcome was not recovered.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Oedema, Oedema peripheral
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 63 year old male patient. On the 12-Sep-2014, the patient received AFLURIA (batch number T58006) via the intramuscular route in the left arm. The patient also received ZOSTAVAX (batch number K003595) via the subcutaneous route in the left arm. On an unspecified date, 15 days after the shot, the patient developed joint pain, weakness, felt tired, was falling asleep and developed edema in the legs, arms and joints. Outcome was recovered. Reporter comments: the regulator reported the case as non-serious, reported that the patient presented at the Emergency Room, and reported the term 'oedema'. 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. Follow-up (23-Apr-2015): Batch Record Review results. Case correction (01-Jun-2015): AE #3 As Reported term updated, no changes to coding.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Somnolence
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 63 year old male patient. On the 12-Sep-2014, the patient received AFLURIA (batch number T58006) via the intramuscular route in the left arm. The patient also received ZOSTAVAX (batch number K003595) via the subcutaneous route in the left arm. On an unspecified date, 15 days after the shot, the patient developed joint pain, weakness, felt tired, was falling asleep and developed edema in the legs, arms and joints. Outcome was recovered. Reporter comments: the regulator reported the case as non-serious, reported that the patient presented at the Emergency Room, and reported the term 'oedema'. 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. Follow-up (23-Apr-2015): Batch Record Review results. Case correction (01-Jun-2015): AE #3 As Reported term updated, no changes to coding.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Injection site pain, Insomnia, Myalgia
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 66 year-old female patient who had a medical history of aortic valve replacement; aortic aneurysm and repair, mild seizures and Pseudo-Marfan's disease. Concomitant medications included warfarin, carvedilol, levetriracetam, meloxicam, misoprostol, spironolactone, olmesartan and olmesartan medoxmil. On 01-OCT-2014, the patient received intramuscular AFLURIA (batch number not provided) in the right arm. On 02-OCT-2014, the patient experienced really sore at the site of the flu shot, followed by general muscle and body aches everywhere. IT was then followed by (presumed) fever, chills, and racing heartbeat, followed by nausea and sleeplessness which was accompanied by extreme fatigue (?). The symptoms began to lessened by noon the next day. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Palpitations, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 66 year-old female patient who had a medical history of aortic valve replacement; aortic aneurysm and repair, mild seizures and Pseudo-Marfan's disease. Concomitant medications included warfarin, carvedilol, levetriracetam, meloxicam, misoprostol, spironolactone, olmesartan and olmesartan medoxmil. On 01-OCT-2014, the patient received intramuscular AFLURIA (batch number not provided) in the right arm. On 02-OCT-2014, the patient experienced really sore at the site of the flu shot, followed by general muscle and body aches everywhere. IT was then followed by (presumed) fever, chills, and racing heartbeat, followed by nausea and sleeplessness which was accompanied by extreme fatigue (?). The symptoms began to lessened by noon the next day. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed authority report (initial receipt 02-DEC-2014) concerns a 61 year old female patient with no medical history, no current illness and no medications at the time of vaccination. On the 03-OCT-2014, the patient received AFLURIA (batch number 33332) via the intramuscular route in the left arm. On the 03-OCT-2014, the patient developed chills, body aches, fever and dizziness. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 64 year old female patient who had no current illness at the time of vaccination. On the 26-SEP-2014, the patient received AFLURIA (batch number T59907) via an unknown route in the left arm. ON the 26-SEP-2014, the date of the vaccination, the patient had arm pain. The patient then had arm numbness two days later. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Feeling cold
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 75 year old female patient. The patient's concomitant medication included eszopiclone sleep medication. On 03-Oct-2014, the patient received intramuscular AFLURIA (batch number not reported) in the right arm. On 03-Oct-2014, the patient experienced injection site (arm) very sore, body very cold, shivering, blood pressure high, heart palpitations, confusion, vision change, dizziness, exhaustion and could not sleep most night. The patient did not under any lab tests and will have tests if adverse reactions continue. The outcome was reported as not recovered.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Injection site pain, Insomnia, Palpitations, Visual impairment
Clinical narrative: This medically confirmed health authority report (initial receipt: 02-Dec-2014) concerns a 75 year old female patient. The patient's concomitant medication included eszopiclone sleep medication. On 03-Oct-2014, the patient received intramuscular AFLURIA (batch number not reported) in the right arm. On 03-Oct-2014, the patient experienced injection site (arm) very sore, body very cold, shivering, blood pressure high, heart palpitations, confusion, vision change, dizziness, exhaustion and could not sleep most night. The patient did not under any lab tests and will have tests if adverse reactions continue. The outcome was reported as not recovered.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Fatigue, Glucose urine absent, Poor quality sleep, Urine ketone body absent
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 38 year old male patient who had a medical history of type 2 diabetes mellitus. The patient had no current illness. Concomitant medications included insulin lispro. On the 04-Oct-2014 the patient received ALFURIA (batch number TT59507) via the intramuscular route in the right arm. On the 04-Oct-2014, during the evening, the patient had persistent elevated blood sugar after receiving the flu injection requiring more than usual insulin injections. The patients was fatigued from poor sleep but showed no lasting effects. He reported to a clinic A+Ox3 with no significant clinical findings. The patient was sent home to convalesce. The patient's laboratory results showed a blood sugar reading of 81, negative urine glucose and negative urine ketone. Outcome was recovered.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 60 year old female patient who had no current illness. On the 29-SEP-2014, the patient received AFLURIA (batch number 09949221A) via the intramuscular route in the "AR" (arm). The patient also received ZOSTAVAX (batch number K003597) via the subcutaneous route in the "AR" (arm). ON the 29-SEP-2014, within two hours, the patient developed a red circle around and below the injection area. Two nights later, the patient had a pink ring around the red, raised area and it was warm to touch. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-Dec-2014) concerns a 61 year-old female patient. On 09-Sep-2014, the patient received intramuscular AFLURIA injection (batch number T59306) in the left arm. On 09-Sep-2014, at about 5pm, the patient experienced a temperature of 103.5 and muscle/joint aches. The patient took acetaminophen for high fever and later developed chills and sweating. The high fever and aches were intense overnight and lessened over the next three days at the time of reporting. The outcome was recovered. Reporter's comments: The regulatory assessed the case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Muscular weakness, Nausea, Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 21 year old female patient who had a medical history of pollen allergy, migraines and scoliosis. Concomitant medications included THOMAPYRIN N and calcium carbonate. The patient had no current illness at the time of vaccination. On the 06-Oct-2014, the patient received AFLURIA (batch number T59907) via the intramuscular route in the left arm. On the 07-Oct-2014, the patient felt nauseated, vomited and then had sharp chest pain after vomiting. The chest pain lasted about two minutes. Her temperature was 99.0. Both of her legs felt weak. Outcome was not recovered.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Dysphagia, Hyperhidrosis, Muscular weakness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 48 year old female patient who had a history with amoxycillin. Concomitant medications at the time of vaccination included levothyroxine, vitamin D, estradiol transdermal system and progesterone. The patient had no illness at the time of vaccination. On the 03-Oct-2014, the patient received AFLURIA (batch number T59507) via the intramuscular route in the left arm. On the 04-Oct-2014, the patient developed dizziness, sweating, profound extremity weakness, loss of appetite, nausea and difficulty swallowing. Outcome was unknown.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 48 year old female patient who had a history with amoxycillin. Concomitant medications at the time of vaccination included levothyroxine, vitamin D, estradiol transdermal system and progesterone. The patient had no illness at the time of vaccination. On the 03-Oct-2014, the patient received AFLURIA (batch number T59507) via the intramuscular route in the left arm. On the 04-Oct-2014, the patient developed dizziness, sweating, profound extremity weakness, loss of appetite, nausea and difficulty swallowing. Outcome was unknown.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 40 year old male patient who had no medical history and no current illness. Concomitant medications included fenofibrate, a multivitamin and famotidine. On the 25-Sep-2014, the patient received AFLURIA (batch number T58606) via the intramuscular route in the left arm. On the 25-Sep-2014, the patient developed severe pain in the left shoulder. The patient unable to rotate the shoulder or lift the arm due to severe pain. The shoulder was cramping with a limited range of motion. The pain was persisting x 2 weeks (for two weeks). The patient was scheduled to see a doctor. No laboratory data was completed. Outcome was not recovered.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Hypoaesthesia, Visual impairment
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 44 year-old female patient who had no known current illness. She had a medical history of allergy to cyclopentolate eye drops, depression and attention deficit disorder. Concomitant medications included escitalopram oxalate and atomoxetine hydrochloride. On 07-Oct-2014, the patient received intramuscular AFLURIA (batch number T57906) in the right arm. On 07-Oct-2014, following the flu vaccine administration, the patient felt funny and had tightness in the chest, numbness in face, light headedness with visual changes. The symptoms then progressed to feelings of passing out. She visited the emergency room and was given diphenhydramine and prednisolone. She later took more diphenhydramine and the symptoms abated. Outcome was recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 59 year old female patient who had a medical history of hypothyroidism. Concomitant medications included levothyroxine. The patient had no current illness at the time of vaccination. On the 07-Oct-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the left arm. On the 07-Oct-2014, the patient developed extreme pain at the injection site. Upon waking the next morning, the patient had a fever of 100.1 degrees. Outcome was recovered.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Vertigo
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 55 year-old male patient who had no known medical history, no known current illness and no concomitant medications at the time of vaccination. He received flu vaccines during the last 32 years without experiencing vertigo. On 05-Oct-2014, the patient received intramuscular AFLURIA injection (batch number not provided) in the right arm. On 05-Oct-2014, the patient experienced a sudden onset of vertigo. His head movement out of the vertical intensified the symptom which lasted for the remainder of the day. At bedtime, it subsided to the point that laying down did not aggravate the vertigo. On the next day, he felt out of sorts but did not have the vertigo. He did not receive any treatments or seeing a doctor. This was the first time the vertigo was an issue. The outcome was not recovered.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dizziness, Headache, Lip swelling, Nausea
Clinical narrative: This spontaneous medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 48-year-old female patient. The patient had medical history of PCN allergy, interstitial cystitis, fibromyalgia history of nine surgeries in prior three months for reaction/infection to polypropylene mesh implant and complications relating to mesh. Her concomitant medication included amitriptyline. On 03-OCT-2014, the patient received intramuscular AFLURIA (batch number T58506) in the left arm. On 03-OCT-2014, the patient experienced dizziness, nausea, severe itching, headache, pain from neck to base of spine and swollen lips. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious. The health authority reported symptoms include "back pain".
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pruritus, Spinal pain
Clinical narrative: This spontaneous medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 48-year-old female patient. The patient had medical history of PCN allergy, interstitial cystitis, fibromyalgia history of nine surgeries in prior three months for reaction/infection to polypropylene mesh implant and complications relating to mesh. Her concomitant medication included amitriptyline. On 03-OCT-2014, the patient received intramuscular AFLURIA (batch number T58506) in the left arm. On 03-OCT-2014, the patient experienced dizziness, nausea, severe itching, headache, pain from neck to base of spine and swollen lips. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious. The health authority reported symptoms include "back pain".
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Hypoaesthesia, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 51 year old female patient. On the 25-Sep-2014, the patient received AFLURIA (batch number T57305) via the intramuscular route in the left arm. On the 25-Sep-2014, about 15 minutes after the vaccine was administered, the patient complained about a funny taste in her mouth and her face was going number and her left arm was going numb on the way to the Emergency Room. Her face broke out in hives. Outcome was recovered.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Swelling face
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 68 year old male patient who had no current illness at the time of vaccination and no medical history. On the 07-Oct-2014, the patient received AFLURIA (batch number 'TS0607') via the intramuscular route in the left arm. On the 07-Oct-2014, the patient developed facial swelling and itching. Outcome was recovered.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Eye pruritus, Eyelid oedema, Local swelling, Rash
Clinical narrative: This non-serious regulator report (initial receipt 02-Dec-2014) concerns a 59 year old female patient who had a shellfish allergy. On the 30-Sep-2014, the patient received AFLURIA (batch number T50907) in an unknown route in the right arm. The patient also received PNEUMOVAX (batch number K007822) in an unknown route in the left arm. On an unspecified date, the patient developed itching, puffy eyes, difficulty breathing, a lumpy arm and a rash. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the term 'local swelling'.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Upper extremity mass
Clinical narrative: This non-serious regulator report (initial receipt 02-Dec-2014) concerns a 59 year old female patient who had a shellfish allergy. On the 30-Sep-2014, the patient received AFLURIA (batch number T50907) in an unknown route in the right arm. The patient also received PNEUMOVAX (batch number K007822) in an unknown route in the left arm. On an unspecified date, the patient developed itching, puffy eyes, difficulty breathing, a lumpy arm and a rash. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the term 'local swelling'.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 52 year old female patient. The patient had no current illness at the time of vaccination. On the 06-Oct-2014, the patient received AFLURIA (batch number not reported) dose 4, via the intramuscular route in the right arm. The patient also received PNEUMOVAX (batch number J011714) via the intramuscular route in the right arm. On the 07-Oct-2014, the patient developed a 101 degree fever, aches, pains, exhaustion and pain at the injection site. Outcome was recovered.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 30 year old female patient who had no current illness at the time of vaccination. The patient was taking an oral medications at the time of vaccination. On the 30-Sep-2014, the patient received AFLURIA (batch number T51608) via the intramuscular route. On the 30-Sep-2014, the patient developed dizziness, nausea, was lightheaded and weak for a couple of days. The patient saw a MD (Medical Doctor). The patient was better. Outcome was recovered.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 81 year old female patient who had no current illness at the time of vaccination. On the 01-Oct-2014, the patient received AFLURIA, batch number '0954211A' via the intramuscular route in the left arm. On the 02-Oct-2014, the patient developed a red, non-tender patch of about 6cm by 2cm. There was no evidence of a systemic reaction or cellulitis. Outcome was recovered.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 54 year-old female patient. On 30-Sep-2014, the patient received AFLURIA (batch number T57706, in the left arm. On 30-Sep-2014, the patient experienced pain and immobility in the vaccinated arm. It went worse since onset of these symptoms. The patient was concerned that the damage had occurred. Outcome was reported as not yet recovered. Reporter's comments: The regulatory authority assessed the events as non-serious. Batch record review for lot T57706 noted: All deviations related to the seedlot, MPH, formulated bulk vaccine and finished product lot T57706 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seeedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T57706 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) were 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.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Musculoskeletal pain, Pain, Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns an 88 year old male patient who had no current illness at the time of vaccination. Concomitant medications included pravastatin and atenolol. On the 26-SEP-2014, the patient received AFLURIA (batch number T590006) via the intramuscular route in the left arm. ON the 27-SEP-2014, the patient developed pain in the shoulder area when trying to lift the arm. The patient also experienced diarrhea and vomiting. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pyrexia, Rash erythematous
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 56 year old female patient. On the 01-Oct-2014, the patient received AFLURIA (batch number T50907) via the intramuscular route in the left arm. The patient also received ZOSTAVAX (batch number K003597) via the subcutaneous route in the left arm. On an unspecified date, the patient developed fever and a red raised rash about 2x2 inches. There was redness around the raised area which extended 1 1/2 inches around the raised area. The patient attended an Emergency Room (ER). Outcome was unknown.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Vertigo
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 30 year old female patient who had no current illness at the time of vaccination. On the 08-Oct-2014, the patient received AFLURIA (batch number not reported). On the 09-Oct-2014, the patient developed vertigo and felt that she may fall down. The events lasted approximately one hour. Outcome was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Eye swelling, Malaise, Musculoskeletal stiffness, Ocular hyperaemia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 43 year old female patient who was asymptomatic when the AFLURIA vaccine was administered. Concomitant medications included levothyroxine. On the 01-Oct-2014, the patient received AFLURIA (batch number T59607) dose 1, via the intramuscular route in the left arm. On the 01-Oct-2014, the patient stated she developed swollen and red eyes, a stiff neck at 20:00 on the 01-Oct-2014 and then developed body aches and soreness in the upper chest the following day. On the 09-Oct-2014, the patient felt a little under the weather. Outcome was recovered.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 43 year old female patient who was asymptomatic when the AFLURIA vaccine was administered. Concomitant medications included levothyroxine. On the 01-Oct-2014, the patient received AFLURIA (batch number T59607) dose 1, via the intramuscular route in the left arm. On the 01-Oct-2014, the patient stated she developed swollen and red eyes, a stiff neck at 20:00 on the 01-Oct-2014 and then developed body aches and soreness in the upper chest the following day. On the 09-Oct-2014, the patient felt a little under the weather. Outcome was recovered.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 43 year-old female patient. On 01-OCT-2014, the patient received intramuscular AFLURIA vaccine (batch number: T50007, dose 1). On the same day, the patient also received subcutaneous PNEUMOVAX (batch K010522, dose 1). Both vaccines were given in the left arm. On an unspecified date in 2014, the patient experienced fever (100-101) and aching. The injection site was swollen and red, and the area was getting larger since 01-OCT-2014. She went to a walk-in clinic and was informed by the on-call physician that the reaction was common. She saw another physician who prescribed trimethoprim/sulfamethoxazole double strength (1 tablet by mouth twice daily for 10 days). Outcome was not reported. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 36 year old female patient who had no medical history and no current illness at the time of vaccination. On the 07-Oct-2014, the patient received AFLURIA (batch number T58506) via the intramuscular route in the left arm. On the 08-Oct-2014, the patient developed a painful, warm, erythema and swollen circle, increasing in size about four centimeters wide. Outcome was not reported. Reporter comments: the regulator reported the case as non-serious.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 72 year old female patient. She had never had any reaction for the last 42 years to the Flu vaccine. On the 26-Sep-2014, the patient received AFLURIA, (batch number T51508) via the intramuscular route in the left arm. On the 27-Sep-2014, the patient developed a large pruritic erythematous reaction around the injection site. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Insomnia, Neck pain, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 35 year old female patient who had no current illness at the time of vaccination. Concomitant medications included nebivolol and losartan hydrochlorothiazide. The patient had an medical history with penicillin and atenolol. On the 09-Oct-2014, the patient received AFLURIA (batch number T50107) dose 1, via the intramuscular route in the left arm. On the 09-Oct-2014, the patient's neck progressively hurt. The patient was in extreme pain if she had tried to straighten or move her neck. Her arm where the shot was given was knotted but was not too sore. The patient kept her from sleeping. Treatment included heat, paracetamol and ibuprofen. The pharmacy instructed the patient to see her doctor. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious and reported the term 'injection site nodule'.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes normal, Fatigue, Gait disturbance, Impaired driving ability, Insomnia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 62 year old female patient who had a medical history of asthma but no current illness at the time of vaccination. Concomitant medications included escitalopram, salbutamol, mometasone, mometasone/eformoterol, fexofenadine/pseudoephedrine, montelukast, celecoxib, simvastatin, aspirin, metformin, omalizumab, T3T4 thyroid (levothyroxine), testosterone cream, probiotic, multivitamin, Coq10 and tumeric. On the 04-Oct-2012, the patient received AFLURIA (batch number not reported). On the 04-Oct-2014, the patient became fatigued and achy soon after at the grocery store. The patient went home and slept in the Lazy Boy chair for three hours. The whole night, the patient's right side on the body ached from neck to feet including arms and fingers. The patient started limping when stood up. The patient took two aspirin. The patient's body continued to ache through Sunday, Monday and was sleep disturbed. By Thursday, only the patient's leg ached and she continued to limp. She awoke on Friday morning in a lot of pain (she did clean the house the night before) and she had trouble sleeping in the night. She applied sports cream at midnight and continued to take aspirin. She went to urgent care to make sure nothing more serious was going on. The doctor did an electrolyte scan and checked for muscle enzymes. He said the tests were normal (October 10). The leg still hurt including the knee. It was hard to carry on normal movement and hard to drive a car. Outcome was unknown.