chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Mouth swelling, Pharyngeal oedema
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 47 year old female patient. On the 16-Sep-2014, the patient received AFLURIA (batch number T57005) via the intramuscular route in the right arm. On the 16-Sep-2014, the patient developed a cough, swelling of the throat and mouth and SOB (shortness of breath). The patient was treated in the emergency room with hydrocortisone, diphenhydramine and famotidine. Outcome was reported as recovered. Reporter comments: The regulator reported the case as serious and life threatening.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Paraesthesia oral, Throat tightness
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 37 year-old female patient. On 19-Sep-2014, the patient received AFLURIA (batch number T57906) in the left arm. On 19-Sep-2014, about 5 minutes following the vaccination, the patient started feeling tingling of lips, tightening of throat and difficulty in breathing. Treatment included EPIPEN 0.3mg. Her breathing improved. Ambulance 911 was called and she left the clinic in ambulance. Outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes virus infection, Skin lesion
Clinical narrative: This serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 54 year-old female patient. Her concomitant medications included glimepiride, omeprazole, atorvastatin, mometasone, fluticasone and montelukast. She was allergic to latex, sulfa, hydrocodone and hydromorphone. Her medical history included diabetes (borderline), hypertension, hypercholesterolemia, herpes simplex and a bladder mesh.  On 18-Sep-2014, the patient received intramuscular AFLURIA (batch number T59006) in the right arm. On 19-Sep-2014, the patient experienced a severe herpes virus infection outbreak. She had multiple lesions on the lip, inside nose, on buttocks and groin area. She began taking diphenhydramine 25mg for 2 days then increased to 50mg on 21-Sep-2014. Outcome was reported as not recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dry skin, Erythema, Pruritus, Swelling face
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 65 year-old female patient who had no known current illness and no known medical history. On 09-Sep-2014 at approximately 3pm, the patient received intramuscular AFLURIA vaccine (batch number T57005) in the right arm. On 09-Sep-2014, the patient had a reaction to the flu shot a few hours after it was administered. The patient had some itching and mild puffy face. On 12-Sep-2014, it was reported her symptoms somewhat improved - at that time she had puffy dry red itchy face that went down to her upper neck. Treatment included self-medicated with diphenhydramine. Outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 47 year-old female patient who had no known current illness. She had an unspecified surgery 11 weeks ago and received and was an oncology patient. On 18-Sep-2014, the patient received intramuscular AFLURIA vaccine (batch number T50507) in the left arm. On 23-Sep-2014, the patient had shingles outbreak. Acyclovir was prescribed by her primary care doctor. Outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site abscess, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 60 year-old female patient who had no known current illness and no known medical history. On 19-Sep-2014, the patient received intramuscular AFLURIA vaccine (batch number reported as '757105') in the site of 'AR'. On 19-Sep-2014, the patient developed about 2.5-3 inches round, red rash at the injection site. It was warm to touch and not raised. Outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious and reported the symptom of 'injection site abscess'.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 19 year old male patient who had a medical history of depression. Concomitant medications included sertraline and quetiapine. On the 19-Sep-2014, the patient received AFLURIA (batch number T57105) via the intramuscular route in the left arm. The patient did not develop adverse events after the vaccine. On the 20-Sep-2014, the patient passed away in his sleep. Outcome was fatal. Reporter comments: The regulator reported the case as serious (death).
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site cellulitis
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 35 year old female patient who had a medical history of asthma and hypothyroidism. Current illness at the time of vaccination was cellulitis. On the 22-Sep-2014, the patient received AFLURIA (batch number T59106) via the intramuscular route in the left arm. On the 23-Sep-2014, the patient developed cellulitis at the vaccination site. The patient went to the emergency room. Outcome was recovered. Reporter comments: the regulator reported the case as non-serious.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Feeling hot, Flushing, Heart rate increased, Paraesthesia oral
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns 23-year-old female patient. The only medical history the patient had in the past 7 years was anemia. On 18-Sep-2014 at 10:10 am, the patient received intramuscular AFLURIA (batch number: 09949221A) in the left arm through the employee health flu vaccine clinic. On 18-Sep-2014, the patient started feeling lips tingle and skin flushed. She felt hot, shaking, her heart rate increased and had difficulty swallowing. She was admitted under care of a doctor. Unknown diagnosis continued progression to what seemed to be a neurologic issue. No diagnosis was made. The outcome was unknown. Reporter's comments: The health authority assessed the case as serious (life-threatening and required hospitalisation).
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns 23-year-old female patient. The only medical history the patient had in the past 7 years was anemia. On 18-Sep-2014 at 10:10 am, the patient received intramuscular AFLURIA (batch number: 09949221A) in the left arm through the employee health flu vaccine clinic. On 18-Sep-2014, the patient started feeling lips tingle and skin flushed. She felt hot, shaking, her heart rate increased and had difficulty swallowing. She was admitted under care of a doctor. Unknown diagnosis continued progression to what seemed to be a neurologic issue. No diagnosis was made. The outcome was unknown. Reporter's comments: The health authority assessed the case as serious (life-threatening and required hospitalisation).
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 28 year old female patient. Concomitant medications included propranolol, aripiprazole, lamotrigine. On the 24-Sep-2014, the patient received AFLURIA (batch number T57906) in the left arm. On the 24-Sep-2014, within seconds of being administered the flu shot, the patient passed out. The patient went to the Emergency Room. Outcome was reported as recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Foetal death, Ultrasound Doppler, Ultrasound antenatal screen abnormal, Uterine dilation and evacuation
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 41-year-old pregnant female patient. The patient had no current illness. On 12-Sep-2014, the patient received AFLURIA (batch number not reported) in the left arm via 'syr' route. On 13-Sep-2014, within 24 hours of vaccination, the patient had fetal demise. One week later, she required emergency uterine dilation and evacuation. The outcome was reported as unknown. Reporter's comments: The health authority assessed the case as non-serious. The authority reported symptoms included- 'Ultrasound antenatal screen' and 'Uterine dilation and evacuation'.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Flushing
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 48 year old female patient. The patient had a medical history of allergies to penicillin, sulfa drugs and azithromycin. Her concomitant medications included levothyroxine sodium and acetylsalicylic acid. On 22-Sep-2014, the patient received intramuscular AFLURIA (batch number: T57405) in the left arm. On 22-Sep-2014, the patient felt flushed and had difficulty swallowing (which were similar to symptoms from allergic reaction in the past). The patient did not experience shortness of breath or angioedema. The patient called the ambulance and received treatment with intravenous diphenhydramine and subcutaneous epinephrine enroute to hospital. The patient was treated in the emergency room and received intravenous famotidine (20 m) and one intravenous methylprednisolone sodium succinate. The patient was stable and was discharged home on 22-Sep-2014 at approximately 15:31 hours. The outcome was reported as recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Swelling face
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 24 year old female patient who had a penicillin allergy. On the 26-Sep-2014, the patient received AFLURIA (batch number T56905) dose 2 via the intramuscular route in the left arm. On the 26-Sep-2014, the patient developed swelling on her left jaw. The patient went to the Emergency Room (ER). The doctor recommended diphenhydramine. On the 27-Sep-2014 at about 12 pm, the patient went to the pharmacy and reported that the swelling had gone down and she was feeling better. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the term 'feeling abnormal'. The doctor in the ER thought it was not vaccine related.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Dyspnoea, Hypoaesthesia, Nausea
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 45 year-old female patient. The patient had a medical history of hypothyroidism, Fabry's disease and allergies to trimethoprim/sulfamethoxazole, aspirin and ibuprofen. Concomitant medications included valsartan and thyroid tablets. On 24-Sep-2014, the patient received intramuscular AFLURIA vaccine (batch number T58306) in the left arm. On 24-Sep-2014, at 2:30pm, the patient experienced dizziness, difficulty breathing and swallowing, felt like "throat was closing", nausea and numbness in both hands (left was worse than the right). There were no hives or rash and no audible wheezing. Treatment included oxygen, 1.5L face mask, BENADRYL 25mg intramuscularly in the right deltoid at 2:30pm and EPIPEN 0.3mg intramuscularly in the left thigh at 2:53pm. At 3:05pm the patient went to the emergency room via ambulance. Outcome was recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 45 year-old female patient. The patient had a medical history of hypothyroidism, Fabry's disease and allergies to trimethoprim/sulfamethoxazole, aspirin and ibuprofen. Concomitant medications included valsartan and thyroid tablets. On 24-Sep-2014, the patient received intramuscular AFLURIA vaccine (batch number T58306) in the left arm. On 24-Sep-2014, at 2:30pm, the patient experienced dizziness, difficulty breathing and swallowing, felt like "throat was closing", nausea and numbness in both hands (left was worse than the right). There were no hives or rash and no audible wheezing. Treatment included oxygen, 1.5L face mask, BENADRYL 25mg intramuscularly in the right deltoid at 2:30pm and EPIPEN 0.3mg intramuscularly in the left thigh at 2:53pm. At 3:05pm the patient went to the emergency room via ambulance. Outcome was recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neuralgia, Peripheral swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 49 year-old female patient who had no known allergies. She had a medical history of sickle cell disease, ventricular tachycardia with dropped QRS and a herniated disc. Her concomitant medications included diltiazem, folic acid and oxycodone. On 01-Oct-2014, the patient received intramuscular AFLURIA vaccine (batch number not provided), in the right arm. On the same day, the patient also received intramuscular PNEUMOVAX (batch number not provided) in the left arm. On 01-Oct-2014, the patient's deltoid area severely swelled up to about 4 times in size and had neuritic complaints with any motion or movement of the shoulder. Treatment included IV (intravenous) methylprednisolone sodium succinate (x1) and diphenhydramine 25mg po. Outcome was unknown. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pharyngeal oedema, Pruritus generalised, Swelling face
Clinical narrative: This medically confirmed spontaneous report (initial receipt 01-Oct-2014) concerns a 43-year-old female patient. Medical history included high blood pressure. Her concomitant medication included an unspecified blood pressure medication. No concurrent vaccine was administered to the patient. The patient was non-pregnant. The patient had no known allergies and did receive AFLURIA in Sep-2013. On 30-Sep-2014 at 3 pm, the patient received intramuscular AFLURIA injection (batch number-10649211A) at 0.5 mL in the right arm. The vaccine had been stored correctly at 36-46 degrees Fahrenheit. On 30-Sep-2014 at 10 pm, the patient developed swollen face, chest tightness, chest discomfort, swollen throat and her body was itching all over. No fever was reported. The patient sought medical attention and was admitted to the emergency department. She was treated with intravenous diphenhydramine and was sent home on oral diphenhydramine. The patient was okay but still itchy all over. The outcome was recovered on 02-Oct-2014. Reporter comments: The health care professional reported the case as possible in relation to the AFLURIA vaccine and reported the event as non-serious however the patient was hospitalised. The reporter stated that the hospital stated that the patient may have had a reaction to the flu vaccine however the reporter stated that it was just as likely to be a food allergy and the timing of the shot was coincidental. The regulator assessed the events as non-serious. Follow up (17-Oct-2014): Medical history, outcome, reporter comments. Follow-up (02-Dec-2014): new AEs, AFLURIA injection site, Reporter comment.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Gingival pain, Glossodynia, Headache
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 59 year old male patient. The patient's concomitant condition included hypertension. His concomitant medication included atenolol. On 01-Oct-2014, the patient received intramuscular AFLURIA (batch number: T51508) in the right arm at the employee health clinic. On 01-Oct-2014, at about 07:30 pm, the patient developed a dry cough and his tongue and gums felt painful. The patient went to bed at 10pm and awoke at 1.30am with headache, severe swollen tongue, severe facial swelling and his eyes were completely blood shot. The patient was concerned with possible anaphylaxis and contemplated going to emergency room. He went back to bed at 04:30am as his airway was patent and his wife frequently checked on him. The patient got up at 08:30am with headache, facial swelling and numbness but the tongue was less swollen and not as painful. His eyes were not as blood shot but he felt very fatigued. The outcome was reported as recovered. Reporter's comments: The health authority assessed the event as non-serious.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Ocular hyperaemia, Swelling face, Swollen tongue
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 59 year old male patient. The patient's concomitant condition included hypertension. His concomitant medication included atenolol. On 01-Oct-2014, the patient received intramuscular AFLURIA (batch number: T51508) in the right arm at the employee health clinic. On 01-Oct-2014, at about 07:30 pm, the patient developed a dry cough and his tongue and gums felt painful. The patient went to bed at 10pm and awoke at 1.30am with headache, severe swollen tongue, severe facial swelling and his eyes were completely blood shot. The patient was concerned with possible anaphylaxis and contemplated going to emergency room. He went back to bed at 04:30am as his airway was patent and his wife frequently checked on him. The patient got up at 08:30am with headache, facial swelling and numbness but the tongue was less swollen and not as painful. His eyes were not as blood shot but he felt very fatigued. The outcome was reported as recovered. Reporter's comments: The health authority assessed the event as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site warmth, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 54 year old female patient. The patient had no current illness. On 29-Sep-2014, the patient received intramuscular AFLURIA (Batch number T58306) in the left arm. On the same day in the afternoon, the patient also received subcutaneous PNEUMOVAX (batch number not reported) in the left arm. On 01-Oct-2014, the patient developed redness around the left deltoid area that was red, warm to touch and had no streaking. The doctor stated that it was possible cellulitis. The patient was treated with cephalexin at 500 mg twice daily for 10 days. The patient had severe pain which affected the activities of daily living with the left arm. Outcome was recovered. Reporter comments: The health authority assessed the events as non-serious.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Staphylococcal infection, Streptococcal infection
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a male patient. On the 23-Sep-2014, the patient received AFLURIA (batch number T58606) via the intramuscular route in an unknown arm. The patient also received PNEUMOVAX (batch number J004387) via the intramuscular route in the left arm. On the 24-Sep-2014, the patient had cellulitis in the upper left arm and elbow. The patient went to the doctor twice and urgent care twice and was given two antibiotic and penicillin shots. Laboratory data showed the patient had subcutaneous staph or strep. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 85 year old female patient. On the 03-Oct-2012, the patient received AFLURIA (batch number '0400036'). On the next day, the patient developed severe pain and could not even walk, all down her right side. The patient was still suffering pain, near two years. Treatment included shots in the shoulder, which help, three every three months. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain, Paraesthesia oral, Throat irritation
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 28 year-old male patient who had no known current illness. On 02-Oct-2014, the patient received intramuscular AFLURIA vaccine (batch number T57606) at the site of 'AR'. On 02-Oct-2014, 10 minutes following the flu vaccine administration, the patient experienced throat irritation and asked for diphenhydramine. Fifteen minutes later, the patient had a sore throat and his tongue felt like jello, and had problem with breathing. EPIPEN 0.3mg was administered. The ambulance was then called and the paramedics gave him epinephrine and methylprednisolone sodium succinate and took him to the hospital. the patient was hospitalised for 1 day. Outcome was not recovered. Reporter's comments: The regulatory authority assessed the events as serious (patient was hospitalised).
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Intensive care, Muscular weakness, Paralysis
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 65 year-old male patient. The patient had medical history of vitamin D deficiency, hypothyroidism, depression, hypertension, type 2 diabetes mellitus, hepatitis C, benign prostatic hyperplasia and post-traumatic stress disorder. The patient had no other allergies. The patient previously received flu shot 4 other times without any problems. On 27-Sep-2013, the patient received AFLURIA (batch number: R52607, dose 1) via 'SYR' route in the right arm. On 22-Oct-2013, the patient presented to the emergency department with leg weakness and paralysis. At 3AM, the patient was admitted to intensive care unit in the hospital. Guillain-Barre Syndrome was not ruled out. The patient was hospitalised for 14 days. The patient was recommended not to have another flu shot again. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as serious (led to hospitalisation), and reported the symptom of 'Intensive care'.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, Cellulitis, Erythema, Full blood count, HIV test
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 50 year old female patient who had a medical history of thyroidectomy in 2012. The patient had no allergies to any vaccine or medication. Concomitant medications included levothyroxine 125 mg, calcium 1500mg and vitamin D 50,000 IU. The patient had no current illness at the time of vaccination. On the 30-Sep-2014, the patient received AFLURIA (batch number 'TS9406') via the intramuscular route in the left arm. On the 30-Sep-2014, the patient's left arm presented with redness, swelling, cellulitis and pain radiating to the fingers and left side of the shoulder and neck areas. The patient went to the Emergency Room. Laboratory tests included CBC (Complete Blood Count), CK (Creatine Kinase) and HIV blood test. Treatment included antibiotics, muscle relaxants and anti-inflammatory medications which were taken for seven days. The patient was referred to a physiatrist [sic] for evaluation and therapy. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the terms 'blood creatinine phosphokinase', 'full blood count', 'HIV test', 'injection site pain', 'local swelling'.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Musculoskeletal pain, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 50 year old female patient who had a medical history of thyroidectomy in 2012. The patient had no allergies to any vaccine or medication. Concomitant medications included levothyroxine 125 mg, calcium 1500mg and vitamin D 50,000 IU. The patient had no current illness at the time of vaccination. On the 30-Sep-2014, the patient received AFLURIA (batch number 'TS9406') via the intramuscular route in the left arm. On the 30-Sep-2014, the patient's left arm presented with redness, swelling, cellulitis and pain radiating to the fingers and left side of the shoulder and neck areas. The patient went to the Emergency Room. Laboratory tests included CBC (Complete Blood Count), CK (Creatine Kinase) and HIV blood test. Treatment included antibiotics, muscle relaxants and anti-inflammatory medications which were taken for seven days. The patient was referred to a physiatrist [sic] for evaluation and therapy. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the terms 'blood creatinine phosphokinase', 'full blood count', 'HIV test', 'injection site pain', 'local swelling'.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 43 year old female patient who had no current illness at the time of vaccination. On the 30-Sep-2014, the patient received AFLURIA (batch number T57005) via the intramuscular route in the left arm. The injection went into the shoulder joint. On the 01-Oct-2014, the patient developed severe pain and the inability to use the arm. The patient went to see the doctor and received treatments of steroids, antibiotics and a muscle relaxer. The patient went to the Emergency Room. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious, and reported the term of 'Injection site joint pain'.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Malaise, Syncope
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 21 year-old female patient who had no known current illness. She had a medical history of ulcerative colitis. On 04-Oct-2014, the patient received intramuscular AFLURIA vaccine (batch number T59907). On 04-Oct-2014, following the flu vaccine administration, the patient did not feel well and had syncope 10-15 minutes post vaccination. She hit her head when she fell, but did not have any major injury. The ambulance was called and she laid on the floor until the ambulance arrived. Outcome was recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 63 year old female patient. On the 16-Sep-2014, the patient received AFLURIA (batch number T58706) via the intramuscular route. On the same day, the patient also received ZOSTAVAX (Merck, batch number not provided) via the subcutaneous route. On the 23-Sep-2014, the patient developed shingles. The patient went to the Emergency Room. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Feeling abnormal, Headache
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 A-fib (atrial fibrillation) and stenosis of the spinal cord. Concomitant medications included sotalol, warfarin and diazepam. The patient was perfectly healthy. On the 26-Sep-2014, the patient received AFLURIA (batch number T50107) via the intramuscular route in the left arm. On the 27-Sep-2014, the patient developed a dark red throat and sinus and a bad headache. The patient was in bed for a week with the flu along with a 102.2 temperature. It spiked for 1 and a half days. The patient was severely dizzy with seizure like movements, trouble breathing, no bath and swelling. The patient rode it out at home but felt crazy for two days. Outcome was reported as recovered. Reporter comments: The regulator reported the case as serious (life threatening) and reported the terms of 'body temperature increased' and 'seizure like phenomena'.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pharyngeal erythema, Seizure like phenomena, Sinus disorder
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 A-fib (atrial fibrillation) and stenosis of the spinal cord. Concomitant medications included sotalol, warfarin and diazepam. The patient was perfectly healthy. On the 26-Sep-2014, the patient received AFLURIA (batch number T50107) via the intramuscular route in the left arm. On the 27-Sep-2014, the patient developed a dark red throat and sinus and a bad headache. The patient was in bed for a week with the flu along with a 102.2 temperature. It spiked for 1 and a half days. The patient was severely dizzy with seizure like movements, trouble breathing, no bath and swelling. The patient rode it out at home but felt crazy for two days. Outcome was reported as recovered. Reporter comments: The regulator reported the case as serious (life threatening) and reported the terms of 'body temperature increased' and 'seizure like phenomena'.
Age: 52.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Cellulitis, Chills, Erythema, Pain, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 52 year old female patient who had no current illness. On the 09-Oct-2014, the patient received the AFLURIA vaccine (batch number T51908) via the intramuscular route in the right arm. The patient also received INFANRIX (batch number 5SR2L) via the intramuscular route in the left arm. On the 10-Oct-2014, the patient developed fever, chills and expanding local pain, redness and swelling. Cellulitis was diagnosed and treatment was given. The patient went to the Emergency Room. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 52.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 52 year old female patient who had no current illness. On the 09-Oct-2014, the patient received the AFLURIA vaccine (batch number T51908) via the intramuscular route in the right arm. The patient also received INFANRIX (batch number 5SR2L) via the intramuscular route in the left arm. On the 10-Oct-2014, the patient developed fever, chills and expanding local pain, redness and swelling. Cellulitis was diagnosed and treatment was given. The patient went to the Emergency Room. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site rash, Myalgia
Clinical narrative: This serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 59 year-old female patient who had no current illness at the time of vaccination. On 29-Sep-2014, the patient received AFLURIA (batch number 10049221B) and PNEUMOVAX (batch number K007773). Both vaccines were given intramuscularly in the left arm. On 30-Sep-2014, the patient experienced fever, chills and muscle aches. On 01-Nov-2014, a red, painful rash around the injection site developed. The patient went to the doctor and received clindamycin prescription for possible cellulitis. The patient went to the Emergency Room. Outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the events as non-serious and reported the terms 'injection site reaction' and 'rash erythematous'.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This serious medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 59 year-old female patient who had no current illness at the time of vaccination. On 29-Sep-2014, the patient received AFLURIA (batch number 10049221B) and PNEUMOVAX (batch number K007773). Both vaccines were given intramuscularly in the left arm. On 30-Sep-2014, the patient experienced fever, chills and muscle aches. On 01-Nov-2014, a red, painful rash around the injection site developed. The patient went to the doctor and received clindamycin prescription for possible cellulitis. The patient went to the Emergency Room. Outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the events as non-serious and reported the terms 'injection site reaction' and 'rash erythematous'.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 61 year old male patient. On the 31-Aug-2014, the patient received AFLURIA (batch number T57205) via the intramuscular route in the left arm.  On the 31-Aug-2014, the patient developed soreness in the deltoid which came on in a couple of hours in the left deltoid. The intensity vacillates from mild to severe pain and was restricting the use of the arm. This had been 33 days and counting. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Haematemesis, Syncope
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 50 year old female patient who had a history of gastric bypass. The patient felt faint before her AFLURIA shot. On the 26-Sep-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route. On the 26-Sep-2014, within five minutes of receiving the vaccine, the patient experienced syncope and was vomiting blood. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Loss of consciousness
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 41 year-old male patient who had no known allergies. On 02-Oct-2014, the patient received AFLURIA vaccine (batch number T50907, syringe), in the left arm. On the same day, the patient also received PNEUMOVAX (batch number K004016, syringe) in the right arm. The patient received PNEUMOVAX first, then followed by AFLURIA. On 02-Oct-2014, the patient passed out after receiving the second injection, AFLURIA. The patient reported that he "sometimes pass out after an injection". Outcome was reported as recovered. Reporter's comments: The reporter assessed the event as non-serious.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 43 year old female patient. The patient had no current illness at the time of vaccination and no medical history. On the 02-Oct-2014, the patient received AFLURIA (batch number T59907) via the intramuscular route in the left arm. The flu vaccine was not cleaned with an alcohol pad prior to administration. On the 02-Oct-2014, that evening, the patient noticed a rash and went to the Emergency Room where she had laboratory tests and was informed that she had a staph (staphylococcus) infection at the site of the flu vaccine administration. Treatment included cephalexin. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose normal, Electrocardiogram normal, Loss of consciousness, Pallor
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 23 year old female patient who had a medical history of low iron. Concomitant medications included ORTHO TRI-CYCLEN LO. The patient had no current illness at the time of vaccination. On the 10-Oct-2014 at 20:10, the patient received AFLURIA (batch number T58906) in the left arm. On the 10-Oct-2014 at 20:13, three minutes after vaccination, the patient passed out in an aisle of the store. The patient was very pale. The patient was given candy and water. The patient had not eaten since noon. The patient's blood pressure, blood sugar, heart rate and an EKG (electrocardiogram) was normal. She was weak but better shortly after the events. The patient went to the emergency room. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious. The regulator reported the symptoms of 'blood glucose normal' and 'electrocardiogram normal'.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 45 year-old female patient who had a history of 'latex (latex free vaccine)'. On 02-Oct-2014, the patient received AFLURIA vaccine (batch number reported as '1064922A') in the left arm. On 02-Oct-2014, the patient experienced facial hives and required an emergency department visit. She was given IV (intravenous) steroids, IV diphenhydramine and IV famotidine, and was monitored for two hours in the emergency department. Outcome was recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 55-year-old female patient. On 10-Oct-2014, the patient received AFLURIA (batch number: T 51308). On the same day, the patient also received PNEUMOVAX (batch number U009105). On 11-Oct-2014, the patient experienced red, swollen and warm 5 inch circle on right arm. She went to urgent care on 12-Oct-2014 and received treatment with 10 courses of cephalexin. The outcome was unknown. Reporter's comments: The health authority assessed the case as non-serious.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness unilateral
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 77 year old female patient. On the 19-Sep-2014, the patient received AFLURIA ([thimerosal-containing], batch number 10249211A) in the left arm. Approximately one week after receiving the flu vaccine, the patient complained of loss of vision in the right eye. On the 10-Oct-2014, the patient stated that the only improvement had been a little brightness in peripheral vision. Outcome was not recovered. Reporter comments: the regulator reported the case as non-serious and the preferred term of 'blindness'.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pallor, Paraesthesia, Peripheral coldness, Presyncope
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 14 year old female patient. The patient had no medical history and no current illness. On the 12-Oct-2014, the patient received AFLURIA (batch number T59206) via the intramuscular route. On the 12-Oct-2014, after approximately 15 seconds of flu administration, the patient looked pale. The patient's mother was by her side. She fainted briefly for five to ten seconds and then came back to alertness. The patient's hands were stiff and cold. The patient complained of a tingling sensation. The patient went to the Emergency Room and she was diagnosed with a vagal nerve over-reaction. Outcome was reported as recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 14 year old female patient. The patient had no medical history and no current illness. On the 12-Oct-2014, the patient received AFLURIA (batch number T59206) via the intramuscular route. On the 12-Oct-2014, after approximately 15 seconds of flu administration, the patient looked pale. The patient's mother was by her side. She fainted briefly for five to ten seconds and then came back to alertness. The patient's hands were stiff and cold. The patient complained of a tingling sensation. The patient went to the Emergency Room and she was diagnosed with a vagal nerve over-reaction. Outcome was reported as recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature, Cellulitis, Local reaction, Vomiting
Clinical narrative: This medically confirmed health authority report (initial receipt- 15-Dec-2014), concerns a 36 year old female patient. On 15-Oct-2014, the patient received intramuscular AFLURIA (batch number T51808) in the left arm. The same day, the patient also received PNEUMOVAX (batch number: K007826) in the left arm. On 15-Oct-2014, the patient developed temperature, vomiting, local reaction and cellulitis. The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious. Case correction (09-Jan-2015) Coding AE#2.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 25-year-old female patient. The patient denied symptoms of illness at the time of vaccine administration. She had no history and no medications at the time of vaccination. On 09-Oct-2014, the patient received intramuscular AFLURIA (batch number-T59406) on the left arm. On 09-Oct-2014, shortly after vaccine administration, the patient went home and became nauseated and later noticed swelling and itching on face and arm. She reported to the emergency room for treatment and received treatment with intravenous methylprednisolone sodium succinate at 125 mg and intravenous diphenhydramine at 25 mg. She was also given intravenous 1000 cc normal saline. At 09:17 am, the patient was assessed and stated that the symptoms were improving. At 10:39 am, the patient was reassessed and the symptoms had resolved. The patient was discharged with methylprednisolone pack and diphenhydramine (50 mg) to continue to take at home and instructed to return to the ER, if the symptoms did not improve or returned. The patient returned home. Two days later, the symptoms returned. She took diphenhydramine and the symptoms resolved. The patient was contacted for follow up from the clinic registered nurse and stated that the symptoms have not returned since incident. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious. The as reported term was -Local Swelling.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Nodule, Pain, Tendon injury
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 63 year-old female patient. The patient had no medical history. Her concomitant medication included Insulin isophane and insulin regular. On 27-Sep-2014, the patient received intramuscular AFLURIA (batch number: T57606) in the left arm, approximately 1 to 1.5 inches posterolateral of shoulder blade. On 27-Sep-2014, after vaccination the patient had no immediate pain and only complained of 'normal soreness', in the evening after the shot. However, the pain increased daily to the point of affecting her activities of daily living and ability to perform her job. She stated that it hurt to turn the steering wheel left. On 21-Oct-2014, she visited a PCP who stated that her tendon was pierced, however, no imaging was done. She was prescribed exercises and told to apply heat regularly. The patient stated that it felt similar to bursitis. She had no bruising, no swelling and only had pain. There was no mark on the skin of any kind but she and her doctor could palpate a 'knot'. She was referred to a physical therapist. The outcome was reported as not recovered. Reporter comments: The health authority assessed the events as non-serious. The patient was suggested to request imaging to determine if this ADR was actually due to vaccine administration error or if it was a side effect of actual vaccine.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: This medically confirmed health authority report (initial receipt- 15-Dec-2014), concerns a 23-year-old female patient who had no current illness and N/K (no known) medications at the time of vaccination. On 28-Oct-2014, the patient received intramuscular AFLURIA (batch number: T58906) in the left arm. On 28-Oct-2014, the patient was nauseous and then passed out. She was unresponsive for 3-5 minutes, was sweating and had dizziness when she awoke. After about 20-30 minutes, she felt better but still had nausea and headache. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: This medically confirmed health authority report (initial receipt- 15-Dec-2014), concerns a 23-year-old female patient who had no current illness and N/K (no known) medications at the time of vaccination. On 28-Oct-2014, the patient received intramuscular AFLURIA (batch number: T58906) in the left arm. On 28-Oct-2014, the patient was nauseous and then passed out. She was unresponsive for 3-5 minutes, was sweating and had dizziness when she awoke. After about 20-30 minutes, she felt better but still had nausea and headache. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, VIIth nerve paralysis
Clinical narrative: This medically confirmed health authority report (initial receipt- 15-Dec-2014), concerns a 56 year old female patient. The patient had a medical history of peripheral vascular disease, migraine, hypertension, allergy to iodine and fexofenadine. She does the allergy shots weekly. Her concomitant medications included losartan hydrochlorothiazide, diltiazem and mometasone furoate. She had no current illness. On 25-Oct-2014, the patient received intramuscular AFLURIA (batch number T58706) in the left arm. On 26-Oct-2014, the patient developed Bell's palsy. The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious. The as reported term was- 'Computerised tomogram head normal'.