chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle enzyme, Pain, Sleep disorder, Somnolence
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.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Tremor
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. Concomitant medications included ipratropium/albutamol 0.5-3 (.5) mg/3 ml, fluticasone propionate 05 mcg spray, montelukast sodium 10mg tablets, ranitidine 150mg tablet, albuterol 2.5mg/0.5mL solution, salbutamol HFA 90 mcg inhaler and ibuprofen 800mg. On the 10-Oct-2014, the patient received AFLURIA syringe (batch number not reported) in the left arm and PNEUMOVAX syringe (batch number not reported) in the left arm. On the 10-Oct-2014, the patient had a bad dizzy spell that lasted about two hours and horrible shaking that has been going on more than five hours without improving. The pharmacist told the patient to go to the hospital if it continued. Outcome was not recovered.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 20 year old male patient who had no medical history, no current illness and no medications at the time of vaccination. The patient was screened for adverse reactions prior to the flu administration at the mass flu shot and had indicated that he had an adverse reaction as a child at the age of five with vomiting and hives. The patient was screened and was recommended to have the shot. On the 10-Oct-2014, the patient received AFLURIA (batch number T59406) dose 1 via the intramuscular route in the left arm using a 25 G (gauge) needle and the patient was observed for symptoms. On 10-Oct-2014, approximately 10 minutes later, the patient developed several small hives localised in the area of injection. Treatment included 50mg diphenhydramine and the patient was monitored. The patient's vital signs remained stable and the patient was released without further reaction. No laboratory data was completed. Outcome was recovered.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 28 year old female patient who had no pre-existing diagnoses, conditions, birth defects nor allergies. Concomitant medications included the etonogestrel/ethinylestradiol vaginal ring. The patient had no present illnesses at the time of vaccination. On the 10-Oct-2014, the patient received AFLURIA (batch number T59907) via the intramuscular route in the right arm. On the 10-Oct-2014, five hours post vaccination, the patient developed 'c/o' facial itching. The itching slowly started on the neck and arm. Slight hives were noted on the right arm, back and near the left chest area. The patient did not have difficulty breathing and no stridor was noted. Outcome was unknown.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Flushing, Headache, Lethargy
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 49 year old female patient who had a medical history of COPD. Concomitant medications included conjugated estrogens. The patient did not have any currently illness at the time of vaccination. On the 10-Oct-2014, the patient received AFLURIA (batch number T50107) via the intramuscular route in the left arm. On the 10-Oct-2014, the patient developed severe chills, fever (100.5), vomiting, lethargy, mild facial swelling, facial flushing, headache and felt he had restricted breathing. Outcome was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Swelling face, Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 49 year old female patient who had a medical history of COPD. Concomitant medications included conjugated estrogens. The patient did not have any currently illness at the time of vaccination. On the 10-Oct-2014, the patient received AFLURIA (batch number T50107) via the intramuscular route in the left arm. On the 10-Oct-2014, the patient developed severe chills, fever (100.5), vomiting, lethargy, mild facial swelling, facial flushing, headache and felt he had restricted breathing. Outcome was not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Ear pain, Injected limb mobility decreased, Malaise
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 63 year old female patient. The patient had no medical history. Her concomitant medication included- acetylsalicylic acid. Two years ago, the patient received flu shot and developed pain in arm that she had to use a PT to lift her arm (refer to case: 2014047328). On 08-Oct-2014, the patient received intramuscular AFLURIA (batch number not provided) in the left arm. On 09-Oct-2014, the patient felt really sick from it. The reaction was not life-threatening but a very strong reaction. She developed a sharp pain in her ear that traveled down her jaw and into the spine. Then, she developed fever, body aches and weakness and abdominal pain that lasted for 3 days. The patient felt better and reported that the reaction was more debilitating than she had ever had. Her arm was just sore, but the physical side effects were way stronger. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pain in jaw, Pyrexia, Spinal pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 63 year old female patient. The patient had no medical history. Her concomitant medication included- acetylsalicylic acid. Two years ago, the patient received flu shot and developed pain in arm that she had to use a PT to lift her arm (refer to case: 2014047328). On 08-Oct-2014, the patient received intramuscular AFLURIA (batch number not provided) in the left arm. On 09-Oct-2014, the patient felt really sick from it. The reaction was not life-threatening but a very strong reaction. She developed a sharp pain in her ear that traveled down her jaw and into the spine. Then, she developed fever, body aches and weakness and abdominal pain that lasted for 3 days. The patient felt better and reported that the reaction was more debilitating than she had ever had. Her arm was just sore, but the physical side effects were way stronger. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Influenza like illness, Peripheral swelling
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 asthma. On the 29-Sep-2014, the patient received AFLURIA (batch number T59707) via the intramuscular route. The patient also received PNEUMOVAX  (batch number not reported). On the 30-Sep-2014, the patient developed severe flu-like symptoms the next three days after the shot. The patient's arm was severely red and swollen the next several days and required a trip to urgent care and treatment with ibuprofen 800mg. A physical exam was undertaken in urgent care. Outcome was recovered.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 37 year old female patient. The patient had medical history of environmental allergies. Her concomitant medications included losartan, metoprolol, hydrochlorothiazide, iron, tramadol, lorazepam, naproxen, omeprazole and famotidine. On 01-Oct-2014, the patient received intramuscular AFLURIA (batch number T59106) in the right arm, dose 1. On 01-Oct-2014, the patient experienced a little itchiness, when she went to bed. On 02-Oct-2014, the patient woke up with very itchy on right side, right arm, arm pit, breast, shoulder, up the neck and right side of scalp and ear. The same day, at 09:30 am, she received diphenhydramine at 25 mg. The patient's temperature was 99.1 (T 99.1) and the patient received a prescription from the doctor (rx dr). Outcome was reported as recovered.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Rash, Rash erythematous
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 40 year old male patient who had no current illness at the time of vaccination and no medical history. Concomitant medications included magnesium 500mg vitamin. On the 11-Oct-2014, the patient received AFLURIA (batch number not reported) dose 1 via the intramuscular route in the left arm. On the 11-Oct-2014, the patient developed cold chills, headache, felt lightheaded and developed a red rash on the abdominal area (front and back). Outcome was unknown.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Myalgia, Nausea
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 46 year old female patient who had a medical history and no current illness at the time of vaccination. Concomitant medications included ethinylestradiol/norethindrone and loratadine. On the 11-Oct-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the left arm. On the 11-Oct-2014, the patient developed joint and muscle pain, fever, chills, nausea and lightheadedness. Outcome was recovered.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 46 year old female patient who had a medical history and no current illness at the time of vaccination. Concomitant medications included ethinylestradiol/norethindrone and loratadine. On the 11-Oct-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the left arm. On the 11-Oct-2014, the patient developed joint and muscle pain, fever, chills, nausea and lightheadedness. Outcome was recovered.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 63 year old female patient who had a medical history of sinus/rhinorrhoea. Concomitant medications included mometasone nasal spray. On the 10-Oct-2014, the patient received AFLURIA (batch number T52308) via the intramuscular route in the left arm. On the 10-Oct-2014, the patient developed fever of 104 and chills. Treatment included aspirin. Outcome was recovered.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Dysphonia, Wheezing
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 52 year old female patient who had a medical history with supha. Concomitant medications included esomeprazole. On the 07-Oct-2014, the patient received AFLURIA (batch number 10249221A) via the intramuscular route in the left arm. On the 07-Oct-2014, the patient developed a sudden onset of wheezing, throat constriction, a hoarse voice, trouble swallowing and dizziness. Outcome was recovered.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Pain
Clinical narrative: This medically confirmed health authority report (initial report 02-Dec-2014) concerns a 54 year-old female patient who had no known current illness and concomitant medications at the time of vaccination. On 23-Sep-2014, the patient received AFLURIA (batch number T58306). On 23-Sep-2014, the patient developed rigors for about 45 minutes and about an hour later she took naproxen 220mg. Two hours later, she still felt hot and achy. She checked her temperature and it was 101.8 oral. She felt fine within about 24 hours. The outcome was reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 48 year old female patient. Concomitant medications included insulin and cholesterol medications. On the 22-Sep-2014, the patient received AFLURIA (batch number 09949211a) via the intramuscular route in the right arm. On the 23-Sep-2014, the patient awoke on Tuesday morning with a rash covering the entire body with severe itching and hives on the back. Outcome was unknown.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 44 year old female patient. The patient had medical history of drug allergies to penicillin and erythromycin. Her concomitant medications included esomeprazole magnesium, sucralfate, nitrofurantoin, valacyclovir hydrochloride, alprazolam, amitriptyline hydrochloride, propranolol and tramadol. On 26-Sep-2014, the patient received intramuscular AFLURIA (batch number: T58406) in the left arm. On 27-Sep-2014, the day following vaccination, the injection site and surrounding area were very swollen, red and hot to touch. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 64 year old female patient. On the 30-Sep-2014, the patient received AFLURIA (batch number T57105) via the intramuscular route in the left arm. The patient also received ZOSTAVAX (batch number J014568) via the intramuscular route in the right arm. On an unspecified date, one week after receiving the vaccine, the patient called the pharmacy and said that he had rash and hives and was advised to call the physician on that day for treatment. Outcome was not recovered.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Neck pain, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 31 year-old female patient who had no known medical history, concomitant medications and lab data at the of vaccination. On 01-Oct-2014, the patient received AFLURIA (batch number T50807) in the left arm. On 01-Oct-2014, 4-5 hours following the vaccination, the patient experienced severe pain in left shoulder shooting into neck. She was unable to lift arm and more across her chest. The outcome was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 50 year-old female patient who had no known currrent illness at the time of vaccination. On 06-Oct-2014, the patient received AFLURIA (batch number 0994911A) in the left arm. On 06-Oct-2014, the patient developed red big circle about 1 inch. There was no difficulty in breathing or pain. The outcome was not recovered.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 41 year old female patient with NKA (no known allergies) and no known health problems. The patient had no current illness. Concomitant medications included drospirenone/ethinylestradiol. On the 19-Sep-2014, the patient received AFLURIA (batch number T57906) via the intramuscular route in the left arm. The patient also received HAVRIX (batch number XD72G) via the intramuscular route in the right arm and ADACEL (batch number U4874AA) via the intramuscular route in the left arm. On the 19-Sep-2014, the patient experienced difficulty breathing and throat tightness. The patient took 50mg of diphenhydramine and within 30 minutes the symptoms dissipitated. Later that day, the patient's temperature was 101.5. The patient went to the Emergency Room. The patient saw all allergist in the 02-Oct-2014 and the results were pending. Outcome was recovered.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dizziness, Dyspnoea, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 51 year-old female patient who had no known concurrent illness. She had prior allergy to tetanus, but no prior allergy to flu vaccine. On 02-Oct-2014, the patient received intramuscular AFLURIA vaccine injection (batch number T57505) in the right arm. On 02-Oct-2014, the patient was anxious immediately after the injection. She began to sweat and felt dizzy, anxious and lightheaded after about 10-15 minutes. About 15 minutes after the injection, she became short of breath (SOB). Emergency personnel arrived and administered 2x EPIPEN. Outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious and visited the 'Emergency room'.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 40 year old female patient. On 19-Sep-2014, the patient received AFLURIA (batch number 'JS9907') via the intramuscular route in the left arm. On the 19-Sep-2014, the patient developed severe arm pain that lasted for almost three weeks. Outcome was not recovered.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a female patient. The patient had no current illness at the time of vaccination. On the 07-Oct-2014 at approximately 08:00, the patient received AFLURIA syringe (batch number T52208) in the left arm. On the 07-Oct-2014, the patient developed soreness, swelling and redness. On the 08-Oct-2014, the patient showed the administrating registered nurse. The swelling was up to 3 1/4 inches in diameter and was still red and tender to touch. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lip swelling, Oropharyngeal pain, Paraesthesia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 54 year-old female patient who was allergic to penicillin and sulfa drugs. Her concomitant medications included conjugated estrogens and levothyroxin sodium. On 07-Oct-2014, at about 16:00 hours, the patient received intramuscular AFLURIA vaccine (batch number T51508) in the left arm. On 07-Oct-2014 at 10pm, the patient experienced chills and sore throat. On 08-Oct-2014 at about 7am, the patient had tingling on the right side of her face and swollen right side of her lips. Outcome was unknown.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Injection site pain, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 22-year-old female patient. The patient had medical history of hives from penicillin. Her concomitant medication included levonorgestrel. The patient developed flu-like symptoms from influenza vaccine received in the past (refer to case: 2014047333). On 30-SEP-2014, the patient received intramuscular AFLURIA (batch number: T51708) in the left arm. ON 30-SEP-2014, the patient experienced fever at 105.2 degrees F, chills, cough, headache and pain at injection site that started about five hours ago. The patient visited the Emergency Room and was treated with acetaminophen at 1000 mg and ibuprofen at 800 mg. The outcome was reported as recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Vision blurred
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 9 year old female patient who had non-specified medical history and no medications or current illness at the time of vaccination. On the 07-Oct-2014, the patient received AFLURIA (batch number T59807a) via the intramuscular route in the left arm. On the 07-Oct-2014, the patient developed dizziness, blurry vision and a stomach upset. The patient was followed up hours later and her father said she had recovered and perhaps it was anxiety related. Outcome was reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 59-year old female patient. The patient's concomitant disease included fibromyalgia. Her concomitant medication included duloxetine hydrochloride and levothyroxine. The patient experienced lightheadedness from an unspecified vaccine prior to AFLURIA vaccination. On 08-Oct-2014 at approximately 15:20, the patient received intramuscularly AFLURIA (batch no. T59707) in the left arm. On 08-Oct-2014, five minutes after vaccination, the patient felt lightheaded and slightly dizzy. The patient lied down flat. The nurse checked her pulse. Her pulse was regular with no abnormal signs observed. The same day at 15:50, the patient resolved and the patient had no lightheadedness. Her pulse was regular. The outcome was reported as recovered.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 66 year old female patient. The patient had the flu shot before within a pharmacy without any reactions. On the 08-Oct-2014, the patient received AFLURIA (batch number T57105) via the intramuscular route. On the 09-Oct-2014, around 12pm the night of the immunization, the patient developed redness around the area, inflammation and warmness at the site of injection. Outcome was recovered.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Night sweats, Pain, Pruritus
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 45 year old female patient. On the 07-Oct-2014, the patient received AFLURIA (batch number T51808) dose 1, via the intramuscular route in the arm. On the 07-Oct-2014, the patient's arm was itching, she felt aching, her eye was itching and was sweating at night. She woke up with swollen eyes and went to the emergency room. Outcome was recovered.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 55 year old female patient. On 04-Oct-2041, the patient received AFLURIA, (batch number T59807A) via the intramuscular route in the left arm. On the 05-Oct-2014, the patient's left pinky (finger) was tingling about one week after vaccination. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Influenza like illness, Swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 58 year-old male patient. On 30-Sep-2014, in the afternoon, the patient received intramuscular AFLURIA (batch number T57305). On 30-Sep-2014, the patient developed a bump approximately 1 inch from the skin immediately following the vaccination. There was no pain or burning. At 6pm, the patient had flu-like symptom and went to the Emergency Room where she was treated and released. The outcome was recovered.
Age: 58.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 58 year old patient. On an unspecified date, the patient received AFLURIA (batch number R55708) in the left arm. On an unspecified date, the patient experienced an unevaluable event. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Dizziness, Pain in extremity, Vision blurred
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 51 year old female patient who had a medical history of Chronic Obstructive Pulmonary Disease, degenerative arthritis disease, fibromyalgia and chronic pain. Concomitant medications included gabapentin, acetaminophen/hydrocodone, fibromyalgia and chronic pain. Concomitant medications included gabapentin, acetaminophen/hydrocodone, sertraline, beclomethasone, tiotropium, alprazolam, salbutamol, pregabalin, cyclobenzaprine. On the 16-Aug-2014, the patient received AFLURIA (batch number T58006) in the left arm. The patient also received PNEUMOVAX (batch number J011998) in the right arm. On the 16-Aug-2014, several hours after the administration of the vaccines, the patient felt dizzy, lightheaded with blurred vision, chills along with intense right arm pain and she could not put her shirt on. Outcome was unknown.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Syncope
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns an 18 year-old female patient who had no known current illness. On 09-OCT-2014, the patient received intramuscular AFLURIA (batch number reported as "J50007") in the left arm. On 09-OCT-2014, within 5 minutes of the flu vaccine administration, the patient fainted and fell on the ground. The emergency service was called and the patient was taken to the hospital. Outcome was recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Generalised erythema, Pruritus, Skin discolouration, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 51 year old female patient. On an unspecified date, the patient received AFLURIA (batch number T59006) via the intramuscular route. The patient also received PNEUMOVAX (batch number J009723) via the intramuscular route. On an unspecified date, the patient developed all over redness, swelling, itchy, blisters and a patch appearing as a dark colour. The patient went to the Emergency Room. Outcome was recovered.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 21 year old female patient who had no medical history and no current illness at the time of vaccination. On the 17-Aug-2014, the patient received AFLURIA (batch number T58706) via the intramuscular route in the left arm. On the 18-Aug-2014, the patient developed shooting pain whenever she lifted her left arm and it was severe for about six weeks. The past two weeks it had been more minor pain with movement. Outcome was recovered. Reporter comments: the regulator reported the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site mass, Injection site pain, Sensory disturbance
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 64 year old female patient who had a long term health problem which was not specified. The patient had no current illness at the time of vaccination. On the 26-Sep-2014, the patient received AFLURIA (batch number T50007) via the intramuscular route in the left arm. On the 27-Sep-2014, the patient developed bruising and a lump at the injection site for a few days and a radiating sensation down the arm and neck. The patient also developed a tender arm at the injection site for approximately one week. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 63 year old female patient with no medical history and no current illness at the time of vaccination. On the 24-Sep-2014, the patient received AFLURIA (batch number T50007) via the intramuscular route in the right arm. On the 10-Oct-2014, the patient developed discomfort with movement of the arm that injected with the vaccine. Outcome was recovered.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Mass, Nausea, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 57 year old female patient who had no current illness. On the 03-OCT-2014, the patient received AFLURIA (batch number T57305) via the intramuscular route at an unknown site. On the 03-OCT-2014, the patient developed am low grade fever, nausea, lumps and bruising. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Discomfort, Erythema, Local swelling, Skin warm
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 71 year old female patient with no medical history and no current illness at the time of vaccination. On the 08-Oct-2014, the patient received AFLURIA (batch number T57706) dose 1, via the intramuscular route in the left arm. The patient also received PREVNAR 13 (batch number G95400) via the intramuscular route in the left arm. On the 13-Oct-2014, the patient developed a distinct red raised circle on the arm, was warm to touch and had mild discomfort. Outcome was unknown.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-Dec-2014) concerns a 48 year-old female patient. On 16-Sep-2014, the patient received AFLURIA (batch number T58906) in the left arm. On 16-Sep-2014, following the AFLURIA administration, the patient experienced pain, soreness, and limited range of movement. It had continued at the time of reporting. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-Dec-2014) concerns a 48 year-old female patient. On 16-Sep-2014, the patient received AFLURIA (batch number T58906) in the left arm. On 16-Sep-2014, following the AFLURIA administration, the patient experienced pain, soreness, and limited range of movement. It had continued at the time of reporting. 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: Injected limb mobility decreased, Injection site pain, Insomnia, Musculoskeletal chest pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 61 year old female patient. Concomitant medications included levothyroxine 175 mcg, es omeprazole 20mg, alprazolam 0.25mg, cyclobenzaprine 10mg, es zopiclone 3mg and hydrocodone. On the 05-OCT-2014, the patient received AFLURIA (batch number T50207) via the intramuscular route in the RA (right arm). On the 05-OCT-2014, the patient's right arm where the injection was given still hurt badly and the pain had gone into the ribs The patient could not raise her arm over her head. She could not sleep on the right side as it hurt. The patient was aware that soreness could occur for a few days however this had been three weeks of pain and not lessening at all. The patient went to the Emergency Room.  Outcome was unknown. Reporter comments: The regulator reported the case as non-serious. The regulator reported the term "insomnia'.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site discomfort, Injection site pain, Pain, Vaccination site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 55 year-old female patient. Concomitant medications included mometasone furoate, desonide and montelukast. On 04-Oct-2014, the patient received intramuscular AFLURIA (batch number T59807A) in the left arm. On 04-Oct-2014, the patient stated the vaccine site was very painful with increasing pain which started with discomfort up and after the shot and was very painful about 2 days later. The site was painful to the touch but not warm, swollen or red. The patient stated it was very painful when raising arm in certain positions and could not remove shirt without assistance. No report of fever. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported that the patient presented at the Emergency Room. Case correction (12-Jun-2015): Coding AE#1 and split terms Case correction (22-Jun-2015): AE 1 re-coded
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 59 year-old female patient. On 10-OCT-2014, the patient received intramuscular AFLURIA (batch number T50207) in the left arm. On 10-OCT-2014, following receiving the flu shot, the patient experienced a large bump over the flu shot while visiting the Rph (physician). The patient went to the Emergency Room and was diagnosed with allergic reaction. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious and presented at the "Emergency Room".
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 58 year-old female patient. On 23-OCT-2014, the patient received intramuscular AFLURIA (batch number T51408) in the right arm and intramuscular PNEUMOVAX (batch number K00915) in the left arm. On 24-OCT-2014, the patient experienced a severe local inflammation and getting worse over time from PNEUMOVAX 23. The doctor prescribed  doxycycline 100 mg BID for 10 days. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious and presented at the "Emergency Room".
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 51 year-old female patient who had no current illness, lab data, concomitant medication or medical history at the time of vaccination. On 26-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T57806) in the left arm. On 26-Oct-2014, the patient experienced cough, fever, throwing up, wheezing, chest tightness, and runny nose. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 51 year-old female patient who had no current illness, lab data, concomitant medication or medical history at the time of vaccination. On 26-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T57806) in the left arm. On 26-Oct-2014, the patient experienced cough, fever, throwing up, wheezing, chest tightness, and runny nose. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered, Fatigue, Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 29 year old female patient who had no current illness and no medical history. On the 26-Sep-2014, the patient received AFLURIA (batch number T57405) via the intramuscular route in the left arm instead of the Tdap vaccine. The patient had received the flu vaccine in late August and this was the second dose of the flu vaccine for 2014-2015 this year. The manufacturer was contacted and told that the patient may experience more of the injection side effect. The patient then also received ADACEL (batch number U4965AA) via the intramuscular route in the left arm. The next day, the patient was fine and just felt tired and was sore at the injection site. Outcome was recovered.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Disorientation, Fatigue, Memory impairment
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 72 year old male patient who had an allergy to cephalosporins but no current illness. On the 20-Oct-2014, in the morning, the patient received AFLURIA (batch number 'TS3909') via the intramuscular route in the left arm. The patient also received ZOSTAVAX (batch number K009770) via the subcutaneous route in the right arm. On the 21-Oct-2014, the patient went and worked out and went home feeling very tired. He stated that he was feeling weak, disoriented and had lapses of memory and kept asking his wife what shots he had. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns an 81-year-old female patient. The patient's concomitant medications included metoprolol, omeprazole, calcitonin salmon, solifenacin, Lisinopril, atorvastatin, desipramine hydrochloride and alprazolam. On 24-Oct-2014, the patient received intramuscular AFLURIA injection, (batch number R56008) in the left arm. On 25-Oct-2041, the patient woke up with severe pain at the injection site. There was no pain at the injection site at the time of administration or later that day. On 29-Oct-2041, she still had pain int he arm. The patient received acetaminophen for pain and applied heat in the area. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 74.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Fatigue
Clinical narrative: This medically confirmed spontaneous report (initial receipt 22-Oct-2014) concerns a 74-year-old female patient. On 11-Oct-2014, the patient received unspecified influenza vaccine (manufacturer and batch number not provided). The same day, patient also received ZOSTAVAX (batch number: K010732). The patient received both vaccines in opposite arms. On 11-Oct-2014, the patient experienced tiredness. Outcome was reported as recovered. Reporter's comments: The reporter stated that tiredness was related to her receiving an unspecified influenza vaccine.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2041) concerns a 39 year-old female patient who had no medical history at the time of vaccination. On 16-Oct-2014, the patient received intramuscular AFLURIA injection, (batch number T57505) in the right arm. On 16-Oct-2014, the patient stated that during the vaccination, the patient did not feel anything except for the feeling of serum going in and had not felt that in the past. On 25-Oct-2014, about 1 week later, the patient experienced pain in the arm area that was not there immediately after receiving the vaccine. The pain and weakness in arm which was somewhat relieved by heat/ibuprofen therapy. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Cough, Malaise, Throat tightness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 24-year-old female patient. The patient had medical history of allergy to BACTRIM. The patient was otherwise healthy without any medication or medical history. Her concomitant medication included oral contraceptive pills. On 24-Oct-2014, the patient received AFLURIA injection (batch number T50307) in the right arm. On 29-Oct-2014, the patient experienced sudden onset of cough, chest pain and felt throat constriction. The patient had some relief with diphenhydramine. The symptoms continued throughout the night. The patient was seen at the health services the following morning. The patient complained of malaise/achy joints and chest pain. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 29-Oct-2014) concerns a 57-year-old female patient. The patient's medical history included a nickel allergy, foam allergy and rubber allergy. Medications at the time of vaccination included olmesartan, montelukast, atorvastatin and lorazepam. The patient had no current illness at the time of vaccination. On 08-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T56805) at 0.5 ml for influenza vaccination in the right arm. The injection was uneventful. On 08-Oct-2014, about five to five and a half hours after vaccination injection, the patient experienced severe upper arm rating 5 initially (on the 1-10 scale) and later rated 5 during the day and 8 to 10 during the night. The patient complained of prolonged and severe pain at the injection site. The patient also stated that she was unable to sleep at night and had right hand numbness. The patient had an appointment with the PCT on 29-Oct-2014, who recommended contact of pharma company. No lab data was provided. The outcome was reported as not recovered. 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 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 any trends of concern for lot T56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Follow-up (15-Dec-2014): AE onset date, AFLURIA dosage form, medical history, concomitant medications, clinical course, and reporter comments. Follow-up (02-Apr-2015): Batch Record Review results.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain in extremity, Peripheral coldness
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-Dec-2014) concerns a 38-year-old female patient who had no known current illness at the time of vaccination. Medical history included a penicillin allergy. Concomitant medication included sertraline. On 08-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T56805) in the left arm. On 08-Oct-2014, the patient experienced pain during the injection process from the site of fingers which was rated 8 on the 1-10 scale for the remainder of the day and into day 3. Since the injection, the pain was from the upper arm to fingers. It was continuous dull ache with severe pain upon use. The patient was unable to sleep on the left side. The patient also had left hand coldness. The patient had an appointment with PCP on 20-Oct-2014 and was treated with ice and ibuprofen and had a follow-up appointment on 07-Nov-2014. The outcome was not recovered.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Insomnia, Pain in extremity, Peripheral coldness
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-Dec-2014) concerns a 38-year-old female patient who had no known current illness at the time of vaccination. Medical history included a penicillin allergy. Concomitant medication included sertraline. On 08-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T56805) in the left arm. On 08-Oct-2014, the patient experienced pain during the injection process from the site of fingers which was rated 8 on the 1-10 scale for the remainder of the day and into day 3. Since the injection, the pain was from the upper arm to fingers. It was continuous dull ache with severe pain upon use. The patient was unable to sleep on the left side. The patient also had left hand coldness. The patient had an appointment with PCP on 20-Oct-2014 and was treated with ice and ibuprofen and had a follow-up appointment on 07-Nov-2014. The outcome was not recovered.