chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tremor
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 41 year old female patient who had a medical history of fibromyalgia, TBI, essential tremors, polycystic ovarian disease, low thyroid and corn sensitivities. Concomitant medications included levothyroxine, citalopram and norethindrone-ethinylestradiol. On the 08-Oct-2014, the patient received AFLURIA (batch number T50807) dose 1 via the intramuscular route in the left arm. On the 14-Oct-2014, the patient developed continued bruising and swelling, joint stiffness, muscle pain, numbness, headaches and confusion. The patient had increased tremors throughout the body. All symptoms continued to worsen and the patient was unable to work due to the pain, numbness, mental fog and limb weakness and control. The patient was waiting for neurology and rheumatology specialist appointments. The symptoms were not getting better. Outcome was not recovered.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 43 year old female patient. On the 06-Oct-2014, the patient received AFLURIA (batch number T57706) via an unknown route in the left arm. On the 07-Oct-2014, the patient experienced pain and decreased mobility in the shoulder of the arm in which she received the shot. She stated that she had to attend physical therapy. Outcome was unknown. A Batch record review for lot T57706 noted: All deviations relating to the affect, MPH, formulated bulk vaccine and finished product lot T57706 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T57706 were reviewed, and all results were satisfactory with no out-of-specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically-derived process control limits. In conclusion, there were no batch-related issues identified that may have caused the adverse events reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 50 year old female patient who had NKDA (no known drug allergies) but didhave a medical history of anemia, DM2 (diabetes mellitus type 2),HTN (hypertension) and GERD (Gastroesophageal Reflux Disease). Concomitnat medications included metformin, levemir, insulin apart, medoxyprogesterone, lisinopril, esomeprazole and iron. The patient denied any new medications and foods. On the 12-NOV-2014, in the late morning, the patient received AFLURIA (batch number T59607) via the intramuscular route in the left arm. On the 12-NOV-2014, later that evening, the patient broke out in  hives over tghe lower body. Te patient went to the ER (Emergency Room) and received intramuscular diphenhydramine and the received an oral prescription. The hives subsided. Outcome was recovered.  Reporter comments: The regulator reported the case as non-serious.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Headache, Influenza like illness, Injection site swelling, Respiratory tract congestion
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 57 year old male patient. The patient had no medical history or current illness. On 12-Nov-2014, the patient received intramuscular AFLURIA injection (batch number 09849211A) in the right arm. On 13-Nov-2014, the patient's right arm was swollen from deltoid to elbow for few days. The patient also felt flu-like symptoms, lower back pain, headache and respiratory congestion. The outcome was reported recovered. Reporter's comments: The health authority assessed the events as non-serious. The authority reported symptom included 'injection site swelling'.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Dysphonia, Eye pain, Nasal congestion, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 50 year old female patient who had a medical history of sleep disturbance and was a colon cancer survivor. The patient had no current illness. Concomitant medications included zolpidem. On the 24-Nov-2014, the patient received AFLURIA (batch number T53909) via an unknown route in the left arm. On the 24-Nov-2014 at 3:45, the patient developed throat pressure, pain, a hoarse voice, painful red eyes, nasal congestion, crackling ears. At 4.45, the symptoms increased. At 8:30pm the patient was seen by an urgicare MD. Symptoms decreased. Outcome was recovered.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 50 year old female patient who had a medical history of sleep disturbance and was a colon cancer survivor. The patient had no current illness. Concomitant medications included zolpidem. On the 24-Nov-2014, the patient received AFLURIA (batch number T53909) via an unknown route in the left arm. On the 24-Nov-2014 at 3:45, the patient developed throat pressure, pain, a hoarse voice, painful red eyes, nasal congestion, crackling ears. At 4.45, the symptoms increased. At 8:30pm the patient was seen by an urgicare MD. Symptoms decreased. Outcome was recovered.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerning a 70-year-old female patient. The patient had no medical history or current illness. Her concomitant medications included rosuvastatin, furosemide and lisinopril. On 04-Nov-2014, the patient received intramuscular AFLURIA (batch number: T57706) in the top of her left arm. On 05-Nov-2014, in the morning, the patient could not move her arm without extreme pain. She called the pharmacy and was asked to take ibuprofen and use ice. It did not get better and the patient saw her doctor on 13-Nov-2014. She was prescribed treatment with prednisone at 20 mg (one tablet 2 times a day for 5 days). The outcome was reported as recovered. Batch record review for lot T57706 noted: All deviations related to the seedlot, MPH, formulated bulk vaccine and finished product lot T57706 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T57706 were reviewed, and all results were satisfactory with no out-of-specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically-derived process control limits. In conclusion, there were no batch-related issued identified that may have caused the adverse events reported. Reporter's comments: The health authority assessed the events as non-serious.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN 2015) concerns a 46 year old female patient who had no medical history and no current illness. Concomitant medications included levothyroxine. On the 26-NOV-2014 the patient received AFLURIA (batch number T51308) via the intramuscular route in the right arm. On the 26-NOV-2014, shortly after vaccination approximately 15 minutes, the patient presented with a red, round, raised area around where the shot was given. The patient did not have any trouble breathing or shortness of breath of itchy throat. The patient received a dose of diphenhydramine from the ER kit. She was asked to return for a follow up. On an unspecified date, the patient returned to the pharmacy in the morning. It was still raised and sore. She was given a small pack of acetaminophen, ibuprofen, diphenhydramine and an ice pack. she was instructed on how to use the pain reliever and to try the ice pack to see if that helped. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose, Syncope
Clinical narrative: This non-serious medically confirmed  health authority report (initial receipt 20-JAN-2015) concerns a 15 year old female patient. It was unknown if the patient had current illness, a medical history or was taking concomitant medications. ON the 28-NOV-2014, the patient received AFLURIA (batch number T52408) via the intramuscular route in the left arm. ON the 28-NOV-2014, approximately 10 minutes after receiving the vaccine, the patient fainted. The patient's blood pressure, oxygenation and blood sugar were checked by the EMT's (Emergency Medical Technician). Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 47 year old female patient who had no medical history and no current illness. On the 05-Nov-2014, the patient received AFLURIA (batch number T51908) via the intramuscular route in the left arm. On the 06-Nov-2014, the patient noticed the morning after the injection that her arm was very sore and lost range of motion. On the 29-Nov-2014, the patient presented back to the pharmacy, still with very limited range of motion in the left arm and experiencing significant amounts of pain. The patient went to the Emergency Room. Outcome was not reported.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 48 year old male patient. Concomitant medications included rosuvastatin and sertraline 75mg. On the 20-OCT-2014, the patient received AFLURIA (batch number T52208) via the intramuscular route in the right arm. On the 21-OCT-2014, the patient developed a severe headache. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Muscle tightness
Clinical narrative: On 16-Oct-2014, the patient received ALFURIA (batch number T56805) 0.5 mL for the prevention of influenza. No other injections were administered on 16-Oct-2014. On 16-Oct-2014, during the administration of AFLURIA, the injection felt very painful. Immediately afterwards, the patient felt tension in her arm which appeared with arm movement at the injection site. The patient was still in pain as of 01-Dec-2014 and did not notify her primary care provider. She did not take any medications to self-treat herself. Outcome was not yet recovered.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: On 16-Oct-2014, the patient received ALFURIA (batch number T56805) 0.5 mL for the prevention of influenza. No other injections were administered on 16-Oct-2014. On 16-Oct-2014, during the administration of AFLURIA, the injection felt very painful. Immediately afterwards, the patient felt tension in her arm which appeared with arm movement at the injection site. The patient was still in pain as of 01-Dec-2014 and did not notify her primary care provider. She did not take any medications to self-treat herself. Outcome was not yet recovered.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Muscle tightness
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 21 year-old female patient who had no lab data at the time of vaccination. Her medical history included allergy to amoxicillin and anxiety. Concomitant medications included paroxetine hydrochloride and etonogestrol. On 16-Oct-2014, the patient received intramuscular AFLURIA (batch number T56805) in the left arm. On 16-Oct-2014, the patient felt like the vaccine hurt more than normal upon administration. The patient experiencing pinching of left arm with movement which continued. The pain varied from 3-6 on the 1-10 scale. No redness, swelling or fever. The patient declined appointment in student health services. The outcome was not recovered.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 21 year-old female patient who had no lab data at the time of vaccination. Her medical history included allergy to amoxicillin and anxiety. Concomitant medications included paroxetine hydrochloride and etonogestrol. On 16-Oct-2014, the patient received intramuscular AFLURIA (batch number T56805) in the left arm. On 16-Oct-2014, the patient felt like the vaccine hurt more than normal upon administration. The patient experiencing pinching of left arm with movement which continued. The pain varied from 3-6 on the 1-10 scale. No redness, swelling or fever. The patient declined appointment in student health services. The outcome was not recovered.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 53 year old female patient. On 06-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T51908) in the left arm. On 16-Nov-2014, the patient developed numbness, pains and needles pain on her left arm where the vaccine was administered. The patient did not experience fever but the pain radiated to the back of her arm making it difficult to carry normal function. This was over a 10 day period. The outcome was reported as unknown.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Back pain
Clinical narrative: This non-serious medically confirmed report (initial receipt 13-NOV-2014) concerns a 66 year old male patient who had a medical history of back pain. On the 05-NOV-2014, the patient received the influenza vaccine (manufacturer and batch number not reported). The patient concomitantly received the Pneumovax vaccine (batch number not reported) 0.5 ml via the intramuscular route for vaccination. The vaccines were given in the same arm approximately two inches apart. On the 05-NOV-2014, 10-15 minutes after vaccination, the patient experienced severe lower back pain. The pharmacist called the ambulance and the patient was taken away on a stretcher. Outcome was not reported. Reporter comments: The reporter stated the events are not related to vaccination because the patient had a history of back pain. The reporter did not remember the name of the influenza vaccine administered.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity, Tenderness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 72 year old female patient. On the 28-Oct-2014, the patient received AFLURIA injection, (batch number T50907) via the intramuscular route in the left arm. On the 28-Oct-2015, the patient developed muscle pain/soreness. The patient said it felt like she had been hit by a baseball and couldn't put any pressure on the arm without it hurting. She slept on the opposite side. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the term 'tenderness'.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 31 year old male patient who had stable epididymitis. The patient had no medications noted on his charge at the time of vaccination and had no current illness. The patient had never received the flu vaccines as an injection in the past - only nasal administration. The patient was not allergic to gelatin, antibiotics, eggs or latex. The patient did not have Guillain Barre Syndrome in the past. On the 21-Oct-2014, the patient received AFLURIA (batch number T53008) dose 1 via syringe in the left arm. On the 23-Oct-2014, the patient complained of pain (6/10) in the left arm at the site of injection for the past two days. The patient stated that the arm was swollen but denied redness around the site. The patient was advised to put an ice pack on the arm and to take paracetamol and ibuprofen as needed for the pain. The patient was advised to call back in a few days if there was improvement. On the 24-Oct-2014, the patient was seen by the PCP. The PCP advised the patient not to get the flu shot in the future and to continued taking ibuprofen as needed. The patient was also advised to go to ED if the condition worsened or did not resolve. No laboratory data was completed. Outcome was unknown.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 32 year old male patient who had no current illness and no medical history. On the 29-Sep-2014, the patient received AFLURIA, batch number T59106) via the intramuscular route in the left arm. On an unspecified date, the patient developed an unevaluable event. Outcome was unknown.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 40 year old female patient who had no current illness and no medical history at the time of vaccination. On the 29-Sep-2014, the patient received AFLURIA injection (batch number T58006) via the intramuscular route in the left arm). It was given high in the arm. On the 30-Sep-2015, the patient developed left shoulder pain after receiving the flu vaccine. Outcome was unknown. Reporter comments: the regulator reported the case as non-serious and reported the term 'injection site pain'. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviews and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot t58006 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Follow-up (23-APR-2015): Batch Record Review results.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This non-serious medically confirmed health authority report (initial report 20-Jan-2015) concerns a 30 year old male patient who had no medical history, no medications at the time of vaccination and no current illness. On the 28-Sep-2014, the patient received AFLURIA injection (batch number T58006) via the intramuscular route in the left arm. On the 29-Sep-2014, the patient developed deltoid pain/deep aching usually two to three out of ten on the pain scale and some movement (6-7/10). The patient declined medical treatment. Outcome was unknown.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 28 year old female patient who had no current illness and no medical history. On the 21-OCT-2014, the patient received AFLURIA, batch # T59106 via the intramuscular route in the left arm. On the 21-OCT-2014, the patient became short of breath and was taken to the ER (Emergency Room). Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 39 year old female patient who had no current illness and no medical history. On the 29-Sep-2014, the patient received AFLURIA, (batch number T58006) via the intramuscular route in the left arm. The vaccine was given high in the arm. On the 29-Sep-2014, the patient developed burning down the left arm after receiving the Flu vaccine and continued to have pain, especially in the morning after sleeping on the arm. The patient declined treatment. Outcome was unknown. Reporter comments: the regulator reported the case as non-serious. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out-of-specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically-derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 29 year old female patient. Concomitant medications included BCP (birth control pills). The patient had no current illness and no medial history. On the 29-SEP-2014, the patient received AFLURIA (batch number T58006) via the intramuscular route in the left arm. The vaccine was given high on the arm. On the 29-SEP-2014, the patient developed pain in the left shoulder. An MRI (Magnetic Resonance Imaging) was done and the patient underwent physical therapy.  Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the term "injection site pain" and "nuclear magnetic resonance imaging". Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seed lot,MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product lotT58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for th seed lot, MPH, formulated bulk vaccine and finish product process stags associated with lot T58006were 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 with statistically-derived process control limits. In conclusion, there were no batch-related issues identified that may have caused the adverse events reported.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Rash
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 64 year old male patient who had no current illness and no medical history. On the 27-Nov-2014, the patient received AFLURIA (batch number T51408) via an unknown route in the left arm. On an unspecified date, the patient developed a rash on both arms and felt warm but was not sure if he was feverish. The patient was treated with diphenhydramine and felt better. Outcome was unknown.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 71 year-old female patient. On 03-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T58106) in the right arm. On the same day, the patient also received intramuscular PNEUMOVAX (batch number K006681) on the left arm. On 04-Nov-2014, the patient experienced left arm pain with some swelling, pruritus and redness. The outcome was not reported.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Vision blurred
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 12 year-old female patient who had no known current illness and no known medical history at the time of vaccination. On 03-Dec-2014, the patient received intramuscular AFLURIA injection (batch number T53209) in the left arm. On 03-Dec-2014, about 2-3 minutes post administration, the patient felt dizzy and fell face down. She complained of dizziness and blurry vision. The ambulance responded. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Lymphadenopathy, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 54 year old female patient who had no medical history and no current illness. Medications at the time of vaccination included HCTZ (hydrochlorothiazide). On the 03-Dec-2014, the patient received AFLURIA injection, (batch number 10449221A) via the intramuscular route in the left arm. On the 03-Dec-2014, the patient developed pain, local swelling and swollen supraclavicular and axillary nodes. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 68 year-old female patient. On 23-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T56905) in the right arm. On 24-Nov-2014, the patient developed diarrhoea, aches and chills after receiving the second dose of the flu vaccine for the season. The outcome was recovered. Reporter comments: The regulatory assessed the events as non-serious and that the vaccine was administered by an intern under the supervision of Rph.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site scab
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 58 year-old female patient who had no known current illness and medical history at the time of vaccination. On 08-Oct-2014, the patient received intramuscular AFLURIA injection, (batch number T51808) in the left arm. On 29-Oct-2014, the patient developed scab and redness at the injection site that opened and re-appeared surrounded by redness size of a quarter. It appeared three weeks after the injection and lasted for 3 weeks. The area was still tender. The outcome was reported as recovered. Reporter Comments: The regulatory assessed the events as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chills, Cough, Headache, Muscle tightness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 60 year old female patient who had no current illness and no medical history. Concomitant medications included calcium carbonate and Vitamin C. On the 03-DEC-2014, the patient received AFLURIA injection (batch number not reported) via the intramuscular route in the left arm. On the 03-DEC-2014, the patient developed chills, coughing, headache, body aches,  hands and arms felt like they were on fire, sinus and jaws started locking up. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the term "muscle tightness and "pain in extremity".
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Sinus disorder, Trismus
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 60 year old female patient who had no current illness and no medical history. Concomitant medications included calcium carbonate and Vitamin C. On the 03-DEC-2014, the patient received AFLURIA injection (batch number not reported) via the intramuscular route in the left arm. On the 03-DEC-2014, the patient developed chills, coughing, headache, body aches,  hands and arms felt like they were on fire, sinus and jaws started locking up. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the term "muscle tightness and "pain in extremity".
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Nuclear magnetic resonance imaging spinal normal, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 61 year old male patient who had an existing lumbar issues. The patient had no current illness. On the 09-Oct-2014, the patient received AFLURIA (batch number T51808) dose 2, via an unknown route in the left arm. On the 22-Oct-2014, the patient developed increased pain, weakness and numbness. The patient felt like it was related to the existing lumbar issue but it continued to worsen and therefore contacted the MD. The patient continued with pain medicine and started physical therapy. An MRI was used to rule out worsening of the spinal issue. Outcome was not recovered.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 30-Jan-2015) concerns a 50 year-old female patient. On 17-Oct-2014, the patient received AFLURIA injection (batch number T50707) in the left arm. On 17-Oct-2014, the patient experienced a prolonged, severe pain in the left deltoid muscle. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns an 84 year old male patient who had no medical history, no current illness and no medication at the time of vaccination. On the 25-NOV-2014, the patient received AFLURIA injection (batch number T51908) via the intramuscular route in the right arm, dose 1. The patient also received PNEUMOVAX (batch number K016295) via the intramuscular route in the right arm. ON the 26-NOV-2014, the patient developed pain and soreness on the side of the body (the chest) and arm where the vaccine was administered. The pain lasted approximately one week but now the patient was feeling OK with no pain or discomfort. No laboratory data was done.  Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the term "injection site pain".
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 72 year old female patient. On the 27-Oct-2014, the patient received AFLURIA IM (batch number T57105) via an unknown route in the left arm (deltoid muscle). On the 28-Oct-2014, the patient developed muscle pain in the arm of the injection site and soreness not allowing the patient to lift the arm up all the way even after six weeks after receiving the vaccination. Outcome was unknown.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 52 year-old female patient. Concomitant medications included esomeprazole magnesium, kliogest and lisinopril. On 23-Nov-2014, the patient received AFLURIA injection (batch number 09649221A) in the left arm. On 23-Nov-2014, the patient had an approximately 2" in diameter bruise at the injection site. The patient went back to the pharmacy on 23-Nov-2014. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Exposure during pregnancy, Headache, Hypoaesthesia oral, Nausea
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 20 year old female patient who was pregnant. The patient had no current illness and no medications at the time of vaccination. The patient never had any problems breathing. On the 08-Dec-2014, the patient received AFLURIA (batch number T53309) via the intramuscular route in the left arm. On the 08-Dec-2014, the patient originally complained of numb lips and felt nauseous. Later, the patient also was experiencing tightness in the chest and had a headache. It was never emergent enough to need adrenaline or diphenhydramine but the paramedics were called as a precaution and they ended up taking her to hospital for observation. Outcome was unknown. Reporter comments: The regulator report the case as non-serious.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-20150 concerns a 77 year old male patient. On the 24-Nov-2014, the patient received AFLURIA (batch number T52908) dose 1 via an unknown route in the left arm. On the 26-Nov-2014, the patient broke out in  a body rash. The patient had no other new medications or environmental changes. Outcome was recovered. Reporter comments:  The regulator reported the case as non-serious.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Injection site pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 39 year old female patient who had no current illness at the time of vaccination and had a medical history of a member being in car accident on the 31-Jul-2014. Concomitant medications included ibuprofen 800, cyclobenzaprine and tramadol. On 02-Nov-2013, the patient developed an adverse event after the influenza vaccine (see 2015048660). On the 07-Dec-2014, the patient received AFLURIA (batch number T52308) dose 1 in the RA (right arm) via the intramuscular route. On the 08-Dec-2014, the patient's right arm felt sore and a bit of pain was at the site. The patient developed redness. Outcome was unknown. Reporter comments: Seriousness: non-serious. Listedness: unlisted. Causality: possible.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Adverse event
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 39 year old female patient who had no current illness at the time of vaccination and had a medical history of a member being in car accident on the 31-Jul-2014. Concomitant medications included ibuprofen 800, cyclobenzaprine and tramadol. On 02-Nov-2013, the patient developed an adverse event after the influenza vaccine (see 2015048660). On the 07-Dec-2014, the patient received AFLURIA (batch number T52308) dose 1 in the RA (right arm) via the intramuscular route. On the 08-Dec-2014, the patient's right arm felt sore and a bit of pain was at the site. The patient developed redness. Outcome was unknown. Reporter comments: Seriousness: non-serious. Listedness: unlisted. Causality: possible.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Injection site pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 38 year old female patient. On the 02-Nov-2013, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed an adverse event. Outcome was not reported. Linked to 2015048659.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Adverse event
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 38 year old female patient. On the 02-Nov-2013, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed an adverse event. Outcome was not reported. Linked to 2015048659.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 57 year old male patient. On the 22-Oct-2014, the patient received AFLURIA (batch number T59907) via a syringe in the left arm. On an unspecified date, one month after vaccination, the patient developed left arm pain. There was no swelling or redness. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 33.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 33 year old female patient. The patient had no medical history or current illness. On 01-Dec-2014, around 13:00, the patient received intramuscular AFLURIA injection (batch number: T3809) in the left arm. The same day, she also received intramuscular VAQTA (batch number: K005323) in the left arm. On 01-Dec-2014, at night, the patient developed hives on her arm. The outcome was reported as recovered.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 50 year old female patient with no current illness and no medical history at the time of vaccination. On 10-Nov-2014, the patient received AFLURIA injection (batch number T52108) via an unknown route in the left arm. On an unspecified date, since she received the flu shot, she developed pain in the arm for almost 18 days. Outcome was not reported.
Age: 83.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous consumer report (initial receipt 13-NOV-2014) concerns an 83 year old female patient. The patient had medical history of breast cancer and had drug reactions/allergy to sulfa and penicillin. She received ZOSTAVAX vaccine last year. Her concomitant medications included a lot of miscellaneous prescription tablets and capsules. On 27-OCT-2014, the patient received flu vaccine (batch number not reported) in the left arm. The same day, she also received an injection of PNEUMOVAX23 (batch number not reported) in the right arm. On an unspecified date after vaccination, the patient experienced rash, redness and puffiness along with intense itching sensation on her right arm where the PNEUMOVAX was administered. On 29-OCT-2014, the patient stated that the influenza vaccination site was "hot to touch". The patient was advised to put heat on the area and told to take diphenhydramine and apply cold compress. The outcome was reported as not yet recovered.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Lymph node pain, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 52 year old male patient who had no medical history, no current illness and no medications at the time of vaccination. This was the 2nd year in a row the patient experienced the same event to this influenza vaccine (see 2015048756). On the 27-Oct-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the left arm. On the 05-Nov-2014, the patient developed left axilla lymph node tenderness, redness and swelling (two or three marble sized nodes). Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the term 'lymphadenopathy'.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 42 year old female patient. On the 07-Oct-2014, the patient received AFLURIA, (batch number T50607) via the intramuscular route in the left arm. On the 08-Oct-2014, the patient did not suffer any reactions due to the vaccine, but was given the vaccine in the upper arm/shoulder area with resulting pain and decreased ROM (range of motion). Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 42 year old female patient. On the 08-Dec-2014, the patient received AFLURIA (batch number T50507) via the intramuscular route in the right arm. On the 08-Dec-2014, four hours after the flu vaccine was administered, the patient started with chills, fever of 102 degrees, nausea and body aches which lasted 24 hours. No laboratory data was completed. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pruritus, Urticaria, Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 63 year old male patient who denied any medication changes in the last 12 weeks and there were no changes to soap or perfumes. ON the 15-OCT-2014, the patient received AFURIA (batch number T5409) dose 1 via an unknown route in the right arm. On the 15-OCT-2014, the patient developed urticaria, pruritis, nausea and vomiting. Treatment included diphenhydramine and methylprednisolone. Outcome was unknown. Reporter comments: The regulator reported the  case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 47 year-old female patient who had possible milk protein allergy and IGG type. On 11-Nov-2014, the patient received intramuscular AFLURIA (batch number T50207) in the left arm. On 11-Nov-2014, approximately 3 hours following the AFLURIA administration (around midday), the patient experienced vomiting. The outcome was recovered. Reporter's comments; The regulatory authority assessed the case as non-serious.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: This non serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 45 year old female patient who had no current illness. The patient's medical history was unknown. On the 08-NOV-2014, the patient received AFLURIA (batch number T57505). The vaccine was not give at the reporter's location. On the 11-NOV-2014, the patient developed a 12 cm raised area around the injection site, fever and body aches. The patient was given an antibiotic and an allergy medication, cetirizine. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 62 year old female patient who had no medical history and no illnesses at the time of vaccination. On the 10-Dec-2014, the patient received AFLURIA (batch number 'TS0007') via the intramuscular route in the left arm. The patient also received ZOSTAVAX (batch number K003603) via the subcutaneous route in the right arm. On the 11-Dec-2014, the patient developed chills and was achy which she attributed to the AFLURIA shot on the morning of the 11-Dec-2014. The redness, swelling and warm to the touch on her right arm did not start until noon of the 11-Dec-2014 and had gotten worse on the 12-Dec-2014. Outcome was unknown.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 84 year-old female patient who had no known current illness and no known medical history at the time of vaccination. Concomitant medications included Lisinopril 20mg and atenolol 100mg. On 10-Dec-2014, the patient received intramuscular AFLURIA (batch T50007) in the left arm. On 12-Dec-2014, the patient experienced itchy, red rash on cheeks and forehead. The outcome was recovered. Reporter's comments: The regulatory authority assessed teh case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypopnoea, Injection site swelling, Nasal congestion, Respiratory tract congestion
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 58 year old female patient who had no medical history and no current illness. Medications at the time of vaccination included rosuvastatin. On the 13-Dec-2014, the patient received AFLURIA (batch number T51208) via the intramuscular route in the left arm. On the 13-Dec-2014, the patient developed tightness in the chest, chest congestion, could not take a deep breath, extreme nasal congestion but there was little or no swelling at the injection site. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 64 year old female patient. The patient's concomitant medication included Lisinopril. The patient had no medical history or current conditions. The patient received AFLURIA in the past and developed pain in left arm (refer to case: 2015049676). On 10-Nov-2014, the patient received AFLURIA injection (batch number not reported) in the left arm. On 10-Nov-2014, the patient experienced severe pain in the left arm that continued to be very restrictive. The outcome was reported as not recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 64 year old female patient. The patient's concomitant medication included Lisinopril. The patient had no medical history or current conditions. The patient received AFLURIA in the past and developed pain in left arm (refer to case: 2015049676). On 10-Nov-2014, the patient received AFLURIA injection (batch number not reported) in the left arm. On 10-Nov-2014, the patient experienced severe pain in the left arm that continued to be very restrictive. The outcome was reported as not recovered.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a female patient. On an unspecified date, the patient received seasonal AFLURIA injection, (batch number not reported). On an unspecified date, the patient experienced pain in left arm. The outcome was not reported. Case linked to 2015049642.