chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pain of skin
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 51 year-old female patient. On 06-OCT-2014, at about 11:30 AM, the patient received intramuscular AFLURIA injection (batch number: T50507) in the left arm.On 06-OCT-2014, at about 2:30 PM, the patient started coughing followed by a headache and a sore throat. By 4:30 PM, the patient had "severe" chills with shaking and reported "skin hurt". These subsided at about 8 PM. The patient work up this morning and described as feeling "fine, temperature was 98.5, pulse 83, blood pressure 106/66 and oxygen 97%". The outcome was recovered.  Reporter Comments: The regulatory assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 51 year-old female patient. On 06-OCT-2014, at about 11:30 AM, the patient received intramuscular AFLURIA injection (batch number: T50507) in the left arm.On 06-OCT-2014, at about 2:30 PM, the patient started coughing followed by a headache and a sore throat. By 4:30 PM, the patient had "severe" chills with shaking and reported "skin hurt". These subsided at about 8 PM. The patient work up this morning and described as feeling "fine, temperature was 98.5, pulse 83, blood pressure 106/66 and oxygen 97%". The outcome was recovered.  Reporter Comments: The regulatory assessed the case as non-serious.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Dyspnoea, Headache, Pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 56 year-old male patient. On 30-SEP-2014 at 16:20 hours, the patient received intramuscular AFLURIA (batch number T51808) in the right arm. On 30-SEP-2014, at about 22:30 hours, the patient experienced chills/cold sweats, heart racing, difficulty breathing, and severe headache. The patient also reported aches and pains. Treatment included ASA (acetylsalicylic acid) in the morning. On 01-OCT-2014 at 20:35 hours, the only symptom the patient had was a headache. The outcome was not recovered (all symptoms had recovered except for the headache). Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 56 year-old male patient. On 30-SEP-2014 at 16:20 hours, the patient received intramuscular AFLURIA (batch number T51808) in the right arm. On 30-SEP-2014, at about 22:30 hours, the patient experienced chills/cold sweats, heart racing, difficulty breathing, and severe headache. The patient also reported aches and pains. Treatment included ASA (acetylsalicylic acid) in the morning. On 01-OCT-2014 at 20:35 hours, the only symptom the patient had was a headache. The outcome was not recovered (all symptoms had recovered except for the headache). Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Joint range of motion decreased, Pain, Vaccination site pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 50 year-old female patient. On 22-SEP-2014, the patient received AFLURIA injection (batch number T57405) in the left arm. On 23-SEP-2014, the day after the vaccination, the patient experienced pain. It then progressed to reduced range of motion and severe pain with movement on day 9 post vaccination. Patient also had pain at vaccination site, no redness or swelling, and a decreased ability to lift objects and undress. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the term of "injection site pain", and reported that the patient presented at the "Emergency Room".
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling of body temperature change, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 44 year old female patient who had a medical history of asthma and PTSD (Post-Traumatic Stress Disorder). The patient had no current illness. On the 30-SEP-2014, the patient received AFLURIA (batch number J58706 via an unknown route in the left arm. On the 01-OCT-2014, the patient developed vomiting, had hot and cold flashes the next morning and then noticed the arm was sore and would not move (was hard to move) and stiff. The patient did not go into the doctor. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the terms 'feeling of body temperature change' and 'mobility decreased".
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Frostbite, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-Dec-2014) concerns a 52 year-old female patient who had no known current illness and no lab data available at the time of vaccination. Her medical history included 'contrast iodine'. On 04-Oct-2041, the patient received intramuscular AFLUIRA, (batch number T57706) in the right arm. On 04-Oct-2014, the patient experienced right arm severely painful, induration and erythematous. On the next day, 05-Oct-2014, it was 4 inches in diameter and was serpiginous in shape. There were also ice-burned areas. Three days later, the swelling subsided and pruritis developed. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious. Batch record review for lot T57706 noted: All deviations relating 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 issues identified that may have caused the adverse events reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-Dec-2014) concerns a 52 year-old female patient who had no known current illness and no lab data available at the time of vaccination. Her medical history included 'contrast iodine'. On 04-Oct-2041, the patient received intramuscular AFLUIRA, (batch number T57706) in the right arm. On 04-Oct-2014, the patient experienced right arm severely painful, induration and erythematous. On the next day, 05-Oct-2014, it was 4 inches in diameter and was serpiginous in shape. There were also ice-burned areas. Three days later, the swelling subsided and pruritis developed. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious. Batch record review for lot T57706 noted: All deviations relating 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 issues identified that may have caused the adverse events reported.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Local swelling, Nodule, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 34 year-old female patient who had no known current illness and no significant medical history at the time of vaccination. On 02-OCT-2014, the patient received intramuscular AFLURIA injection (batch number T58306) in the left arm. On 02-OCT-2014, the  patient experienced swelling on left side of neck (knot), swelling at medical clavicle (knot) left side, arm tingling and occasional numbness (left side arm), and left axillary swelling. The outcome was not reported. Reporter comments:  The regulatory assessed the case as non-serious, reported that the patient presented at the Emergency Room and reported the terms of "nodule" and Oedema peripheral".
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt ; 18-SEP-2014) concerns a 48-year-old female patient. The patient had no pertinent medical history. The patient received the last AFLURIA injection on 26-SEP-2013. The patient did not receive any other concurrent vaccine when AFLURIA was administered. ON 16-SEP-2014, the patient received intramuscular AFLURIA injection (batch number: "TS7706") at 0.5 ml annually. On 16-SEP-2014, few hours after vaccination, the patient developed severe aches throughout her left arm, where the injection occurred. The patient treated herself with naproxen (Aleve) daily. She also took generic flexeril at night. Both the treatments did not stop the aching. The outcome was reported as not yet recovered as the patient was still in great deal of pain. Batch record review for lot T57706 noted: All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product to T57706 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seed lot, MPH, formulated bulk vaccine and finished product process stages associated with lot T57706 was 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: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt ; 18-SEP-2014) concerns a 48-year-old female patient. The patient had no pertinent medical history. The patient received the last AFLURIA injection on 26-SEP-2013. The patient did not receive any other concurrent vaccine when AFLURIA was administered. ON 16-SEP-2014, the patient received intramuscular AFLURIA injection (batch number: "TS7706") at 0.5 ml annually. On 16-SEP-2014, few hours after vaccination, the patient developed severe aches throughout her left arm, where the injection occurred. The patient treated herself with naproxen (Aleve) daily. She also took generic flexeril at night. Both the treatments did not stop the aching. The outcome was reported as not yet recovered as the patient was still in great deal of pain. Batch record review for lot T57706 noted: All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product to T57706 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seed lot, MPH, formulated bulk vaccine and finished product process stages associated with lot T57706 was 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: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Swollen tongue
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 43 year old female patient who had a medical history with pineapple and codeine. It was unknown if the patient was taking medications at the time of vaccination. The patient had no current illness at the time of vaccination. ON the 27-OCT-2014, the patient received AFLURIA (batch number: T51608) via the intramuscular route in the "AR". On the 28-OCT-2014, the patient developed tongue swelling and a sore throat. The patient took fexofenadine with some partial symptom relief. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Posture abnormal
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 48 year old male patient. The patient had no current illness. The patient had a medical history of having a "psycho-somatic" reaction to medical situations when he "thinks about it too much". He stated that he fainting occurs when visiting the dentist. The patient also explained that he did not eat breakfast in the morning and was hungry and should not have asked for a flu vaccine since he did not  eat that day. On 29-OCT-2014, the patient received intramuscular AFLURIA (batch number T52708). On 29-OCT-2014, after vaccination, the patient was sitting in the vaccine office and moved to his hands and knees to compose himself and then was on his back. He revived within 10 seconds. The outcome was reported as  recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 38 year-old male patient who had no known current illness at the time of vaccination. On 27-OCT-2014, the patient received intramuscular AFLURIA injection (batch number T53909). On 27-OCT-2014, the patient experienced fever, nausea and body aches. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 27 year-old female patient who had no know current illness and medical history at the time of vaccination. On 28-OCT-2014 at 2 PM, the patient received AFLURIA injection (batch number T53019) in the left arm. On 28-OCT-2014, following the vaccination, the patient went home and took a nap. At 5 PM, the patient woke up and noticed itching and hives on the legs. She took diphenhydramine. The symptoms were resolving. The outcome was resolving. Reporter's comments: The regulatory authority assessed the case as non-serious and outcome of "recovered" (however, the description is "resolving").
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Weight bearing difficulty, X-ray normal
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 53  year-old female patient. The patient had no current illness or history. On 10-OCT-2014, the patient received AFLURIA (batch number T52808) in the left arm. On 11-OCT-2014 in the morning, the patient experienced right ankle swelling and was unable to weight bear. The patient underwent x-ray which was negative. She received inflammatories/antibiotics as treatment. The outcome was not recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 64 year old female patient. The patient had no allergies or no concurrent illness. She did not take any prescribed medication. On 25-OCT-2014, the patient received intramuscular AFLURIA (batch number "TS3409") in the left arm. On 25-OCT-2014, the patient experienced generalized body aches and pain which worsened at night. The patient self-treated herself with naproxen sodium and paracetamol. The patient continued for one week and then her left leg began to burn. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 25-year old female patient. The patient's medical history and current illness were unknown. The patient received flu shot for the first time. On 22-OCT-2014, the patient received intramuscular AFLURIA (batch number "T53609A") in the left arm. On 22-OCT-2014, the patient developed tenderness and soreness on the left arm where she received the vaccine, which lasted through 24-OCT-2014. The patient was fine but noticed the symptoms again on 31-OCT-2014. She reported no redness or swelling around the injection site. The outcome was reported as unknown.  Reporter's comments: The health authority assessed the events as non-serious.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 28 year old female patient with a medical history of "penicillin" (sic), sulfa drugs and latex. At the time of vaccination, the patient was concomitantly on metoprolol and norethindrone/mestranol. The patient had no illness at the time of vaccination. On the 21-OCT-2014, the patient received AFLURIA (batch number T52708) in the left arm. On the 21-OCT-2013, three hours after receiving the influenza vaccination, the patient developed severe itching and slight rash but no hives. Treatment included diphenhydramine and the events resolved 24 hours later. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 46 year old female patient who had a medical history of childhood asthma. The patient had no current illness at the time of vaccination. On the 24-SEP-2014, the patient received AFLURIA syringe (batch number T50707)  dose 1 in the left arm. On the 24-SEP-2014, the patient had pain continue at the injection site. The patient denied numbness, tingling, paresthesia or loss of grip strength. There was no erythema or swelling noted. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Muscle spasms
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 33 year old male patient who had a history of back problems, which possibly required surgery however details were not provided. The patient had no current illness at the time of vaccinations. On the 21-OCT-2014, the patient received AFLURIA (batch number 10449221A) via the intramuscular route in the left arm. On the 21-OCT-2014, the evening of the vaccine administration, the patient developed the expected soreness in the left arm where the vaccine was administer but also unexpectedly developed pain and spasm down the left side of his back from the shoulder down. Over a few days, the pain in the arm  subsided but he continued to complain of pain in the back. Ten days later, he reported that the pain in the back (and possibly arms) persisted. He was advised to see his MD (Medical Doctor) on the 27-OCT-2014 for an evaluation when it became clear the symptoms were persisting. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported that the patient felt the events were definitely related to the vaccine.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 29 year old female patient who had no current illness. On the 02-NOV-2014, the patient received AFLURIA (batch number T51708) via syringe in the left arm. On the 02-NOV-2014, the patient's arm swelled at the site of the injection, became red and swollen and felt warm to the touch. The patient called the pharmacy and was told to take an antihistamine and apply ice. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Malaise
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 12 year-old female patient who had no known current illness and no medical history at the time of vaccination. On 03-NOV-2014, the patient received intramuscular AFLURIA injection (batch number T59006) in the left arm. On 04-NOV-2014, the patient experienced extreme malaise upon waking in the morning for school. She was not feeing well and around 9:30 AM, She reported that she was tired, her stomach was aching, and felt sick. She went home early from school early as well (at 11:10 AM). Her mother gave her some ibuprofen and she slept for several hours. She did not have an appetite nor did she want to drink anything. At about 8:00 PM, she woke up and was feeling slightly better. The outcome was not provided. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 42 year old female patient who had no medical history and no current illness. On an unspecified date, the patient received AFLURIA injection (batch number T51508) via the intramuscular route in the left arm. ON an unspecified date, the patient developed upper arm pain that had not resolved since she received the immunization sevens days prior. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Impaired work ability, Injection site erythema, Injection site vesicles, Vaccination site swelling
Clinical narrative: This medically confirmed regulatory report (intiial receipt 15-DEC-2014) concerns a 55 year-old female patient who had no known current illness at the time of vaccination. Her medical history included high blood pressure and heart murmur. On 16-OCT-2014, the patient received intramuscular AFLURIA injection (batch number T51908) in the right arm. On the same day, the patient also received intramuscular ZOSTAVAX (batch number: K00883) in the left arm. On 17-OCT-2014, the site where the vaccine was given turned red, then arm swelled down to elbow and then blistered. The patient was treated at urgent care adn family doctor given anti-viral medication (sulfatendthoxizole). The patient missed a week of work. The outcome was reported as not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the term "vaccination site swelling", and reported that the patient presented at the Emergency Room.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Pain, Renal pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 54 year old female patient and who had no medical history and no current illness. Concomitant medications included paroxetine and nabumetone. On the 03-NOV-2014, the patient received AFLURIA (batch number "33332-0014-01') via the intramuscular route in the left arm. On the 03-NOV-2014, about 20 minutes after the injection, the patient had an immediate onset of severe kidney pain to the point of not being able to sit or stand without assistance. Two days later, the pain had gone from a 10 to about 6 but was still severe with movement. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the term "immediate post injection reaction".
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Peripheral swelling, Rash
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 31 year-old female patient who had no known current illness at the time of vaccination. On 31-OCT-2014, the patient received intramuscular AFLURIA (batch number not provided). On 31-OCT-2014, the patient experienced swelling, ecchymosis, and rash on arm - not near the injection site. The outcome was reported as recovered. Reporter's comments: The regulatory authority assessed the case as non-serious and reported the term "local swelling".
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 75 year old male patient with no medical history and no current illness. On the 16-OCT-2014, the patient received AFLURIA (batch number T52308) via syringe in the "AR" (arm) and PNEUMOVAX (batch number H010522) via syringe in the "AR" (arm). on the 16-OCT-2014, the patient developed terrible pain in the left arm and could not move the arm for three days. Treatment included pain pills and heating pad during the day and night. Then the pain moved over to the right side for three days. Treatment also included pain pills and heading pad. The patient did not go to the doctor as he did not think they could do any better. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious. The patient stated that if he was still working, he would have lost a week of work.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dysphonia, Dyspnoea, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 43 year old female patient. Concomitant medications included citalopram. The patient was a paximate patient and was not ill prior to the vaccine. On the 30-OCT-2014, the patient received the AFLURIA vaccine (batch number not reported). On the 30-OCT-2014, the patient developed fever, coughing, was wheezy, dizzy, felt weak, had shortness of breath and breathing problems, was hoarse (no voice), body aches, and the arm was sore where she ws vaccinated. Treatment included a cough syrum, "muccus ded" and rest. The patient had to pay for an extra prescription and missed school. The patient went to an "Emergency Room". Outcome was recovering. Reporter comments: The regulator assessed the case as non-serious.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia, Wheezing
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 43 year old female patient. Concomitant medications included citalopram. The patient was a paximate patient and was not ill prior to the vaccine. On the 30-OCT-2014, the patient received the AFLURIA vaccine (batch number not reported). On the 30-OCT-2014, the patient developed fever, coughing, was wheezy, dizzy, felt weak, had shortness of breath and breathing problems, was hoarse (no voice), body aches, and the arm was sore where she ws vaccinated. Treatment included a cough syrum, "muccus ded" and rest. The patient had to pay for an extra prescription and missed school. The patient went to an "Emergency Room". Outcome was recovering. Reporter comments: The regulator assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 50 year old female patient with no medical history and no current illness. On the 13-OCT-2014, the patient received AFLURIA (batch number T51708) via a unknown route in the right arm. The patient also received PNEUMOVAX (batch number not reported) dose 1 via an unknown route in the right arm. ON the 14-OCT-2014, the patient developed redness around the area of injection and reported bumps around the injection site. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Abdominal pain, Dizziness, Syncope
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 12 year old female patient with no medical history and no current illness. On the 13-OCT-2014, the patient received AFLURIA (batch number T58506) via an unknown route in the left arm. The patient also received GARDASIL (batch number K001681) via an unknown route in the right arm. On the 14-OCT-2014, the patient experienced syncope, was light headed and had abdominal pain one day after the vaccine. No treatment was needed. The patient went to the Emergency Room. Outcome was recovered.  Reporter comments: The regulator reported the case as non-serious.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed report (initial) receipt 15-Oct-2014) concerns a 43 year old female patient who had a medical history of an injured shoulder (the patient does not remember which shoulder) four years ago which was work related and on the day of vaccination, dealt with a combative student. The patient had received the flu shot in the past. On the 08-Oct-2014 at 08:30, the patient received AFLURIA (batch number T59607) 0.5 mL annually in the left arm via the intramuscular route for the prevention of influenza. On the 08-Oct-2014, in the afternoon/evening, she developed pain in her joints (not at or around the injection site). The left arm hurt upon movement and was sore in the evening and continued to hurt until the 13-Oct-2014. On the 14-Oct-2014, it was about the same. She was not sure whether the pain was from the vaccine or something else. Treatment included ibuprofen to treat the pain, which helped. She also placed ice on it, which did not help- it was painful. The patient had received the flu shot in the past however this is the first time she experienced this. Outcome was not recovered.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 49 year old female patient. On the 12-OCT-2014, the patient received AFLURIA (batch number T57706) via the intramuscular route at an unknown site. The patient also received PNEUMOVAX (batch number K007824) via the intramuscular route in the left arm. ON the 12-OCT-2014, the patient developed swelling at the site of the flu vaccine and the patient went to the emergency room. Outcome was recovered. Reporter comments: the regulator reported the case as non-serious.  Batch record review for lot T57706 noted: All deviations relating to the seed lot, 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 seed lot, MPH, formulated bulk vaccine and finished product 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: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: This non-serious medically confirmed health authority report initial receipt 15-DEC-2014) concerns a 39 year old female patient. On the 07-OCT-2014, the patient received AFLURIA (batch number T57305) dose 1 via the intramuscular route in the left arm. On the 08-OCT-2014, the patient developed a fever, chills, and rash. Outcome was unknown. Reporter comments: The regulator reported the case as non serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Joint range of motion decreased, Pain in extremity
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 47 year-old female patient who had no current illness and no medical history at the time of vaccination. Concomitant medication taken at time of vaccination was generic SYNTHROID. On 01-OCT-2014, the patient received AFLURIA injection (batch number "ndc33332-0014?") in the right arm. On 01-OCT-2014, the patient experienced a typical arm soreness which continued as of 06-NOV-2014. The pain was high on the arm which caused limited range of motion and discomfort even while sleeping. It was slowly improving but persisted. The outcome was not reported.  Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns an 85 year-old female patient who had a current illness of CODP (chronic obstructive pulmonary disease) at the time of vaccination. Concurrent medications included umeclidinium/vilanterol and albuterol sulfate. On 04-NOV-2014, the patient received intramuscular AFLURIA injection (batch number T57505) in the left arm. On 04-NOV-2014, about 8 hours following the flu vaccination, the patient experienced a low-grade fever, chills, nausea and dizziness. Treatment included ibuprofen which resolved some symptoms. The outcome was recovered.  Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Vision blurred
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 64 year old female patient who had no current illness. On the 27-OCT-2014, the patient received AFLURIA (batch number 'T52503") via syringe in the left arm. On an unspecified date, one week post vaccination, the patient developed a bruise and pain at the injection site. The patient also reported blurry vision in the right eye. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 61 year old female patient who had a medical history if mitral valve prolapse and HBP (high blood pressure) and a history of PCN (penicillin), erythromycin, lovastatin, sulfa drugs and alendronate. The patient had no current illness. Concomitant medications included rosuvastatin, diltiazem and condensate Eulexin. On the 26-OCT-2014, the patient received AFLURIA (batch number: T58606) via the intramuscular route in the left arm. On the 26-OCT-2014, the patient's arm at the injection site became very sore - the muscle was painful when touched and continued to be sore then days later and she had to restrict arm movement. No laboratory data was done. Outcome was not recovered. Reporter comments: The regulator reported the case as not recovered.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Myalgia, X-ray limb
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 43 year-old female patient who had no known current illness at the time of vaccination. On 15-OCT-2014, the patient received AFLURIA injection (batch number T58306) in the left arm. On 15-OCT-2014, the patient experienced pain to the lateral superior deltoid. The patient was unable to raise her lt (left) arm above shoulder since the vaccination. The patient had an x-ray of the left shoulder/limb. The outcome was not reported. Reporter's comments; The regulatory authority assessed the case as non-serious, and reported the terms of "mobility decreased" and "x-ray limb".
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 49 year-old female patient who was healthy and had no known current illness at the time of vaccination. Concomitant medication included hydrocodone/acetaminophen. Her medical history included an allergy to levofloxacin, sulfa drugs and morphine. On 24-OCT-2014, the patient received intramuscular AFLURIA injection (batch number T50707) in the left arm. On 24-OCT-2014, the patient experienced severe left shoulder pain and a decreased range of motion. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the terms of "injected limb mobility decreased" and "injection site pain", and reported that the patient presented at the Emergency Room.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Malaise
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 53 year old female patient who had a current illness of a slight cold and medical history of "penicilli" and "nickle". Concomitant medications included dextromethorphan/paracetamol/pseudoephedrine and hydrocodone bitartrate/paracetamol. ON 05-NOV-2014, the patient received intramuscular AFLURIA (batch number T58106) in the left arm. On 05-NOV-2014, the patient experienced violent chills, severe headache, nausea, body aches, general ill feeling, shakes, sweating, weak, and vomited once. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Tremor, Vomiting
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 53 year old female patient who had a current illness of a slight cold and medical history of "penicilli" and "nickle". Concomitant medications included dextromethorphan/paracetamol/pseudoephedrine and hydrocodone bitartrate/paracetamol. ON 05-NOV-2014, the patient received intramuscular AFLURIA (batch number T58106) in the left arm. On 05-NOV-2014, the patient experienced violent chills, severe headache, nausea, body aches, general ill feeling, shakes, sweating, weak, and vomited once. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Pain, Pyrexia
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-DEC-2014) concerns a 32 year-old female patient who had known current illness at the time of vaccination. Her medical history included a nickel allergy. On 05-NOV-2014, the patient received intramuscular AFLURIA injection (batch number not provided) in the left arm. On 06-NOV-2014, the patient experienced a fever of 100, body aches especially lower half of body, painful joints, hips, knees and lower back. Treatment included acetaminophen and later ibuprofen. The outcome was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain, Vaccine positive rechallenge
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 62 year old female patient who had no known current illness. Concomitant medications included Zolpidem, paracetamol/hydrocodone, paracetamol/codeine and "Bulinus". On the 21-OCT-2014, the patient received AFLURIA (batch number: "T5705") dose 1 via an unknown route in the left arm. On the 22-OCT-2014, the patient reported swelling of the lymph nodes and pain in the collar bone area. She had the same reaction last year (see 2015048071). Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test, Antinuclear antibody, Chest discomfort, Complement factor C3, Complement factor C4
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 43-year old female patient who had a medical history with hydromorphone, morphine, acetaminophen/oxycodone and ketorolac. ON the 22-OCT-2014, the patient received AFLURIA (batch number T57405) via the intramuscular route in the right arm. ON the 22-OCT-2014, the patient developed hives, itching UE (upper extremity) and lower back, tingling lips, hoarseness, chest tightness, nausea, vomiting, loose stools and extreme fatigue. Laboratory tests included allergy tests, CBS (complete blood count), CMP (complete metabolic panel), C3 and C4, ANA (anti-nuclear antibody) and ESR (erythrocyte sedimentation rate). Treatment included diphenhydramine, steroids, hydroxyzine and an allergy consult. The patient went to the Emergency Room. Outcome was recovered. Reporter comments: The regulator assessed the case as non-serious and reported the events of "allergy test", "anti-nuclear antibody", complement factor C3', "complement factor C4', "full blood count", "metabolic function test", "red blood cell sedimentation rate increased".
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dysphonia, Fatigue, Full blood count, Metabolic function test
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 43-year old female patient who had a medical history with hydromorphone, morphine, acetaminophen/oxycodone and ketorolac. ON the 22-OCT-2014, the patient received AFLURIA (batch number T57405) via the intramuscular route in the right arm. ON the 22-OCT-2014, the patient developed hives, itching UE (upper extremity) and lower back, tingling lips, hoarseness, chest tightness, nausea, vomiting, loose stools and extreme fatigue. Laboratory tests included allergy tests, CBS (complete blood count), CMP (complete metabolic panel), C3 and C4, ANA (anti-nuclear antibody) and ESR (erythrocyte sedimentation rate). Treatment included diphenhydramine, steroids, hydroxyzine and an allergy consult. The patient went to the Emergency Room. Outcome was recovered. Reporter comments: The regulator assessed the case as non-serious and reported the events of "allergy test", "anti-nuclear antibody", complement factor C3', "complement factor C4', "full blood count", "metabolic function test", "red blood cell sedimentation rate increased".
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia oral, Pruritus, Red blood cell sedimentation rate, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 43-year old female patient who had a medical history with hydromorphone, morphine, acetaminophen/oxycodone and ketorolac. ON the 22-OCT-2014, the patient received AFLURIA (batch number T57405) via the intramuscular route in the right arm. ON the 22-OCT-2014, the patient developed hives, itching UE (upper extremity) and lower back, tingling lips, hoarseness, chest tightness, nausea, vomiting, loose stools and extreme fatigue. Laboratory tests included allergy tests, CBS (complete blood count), CMP (complete metabolic panel), C3 and C4, ANA (anti-nuclear antibody) and ESR (erythrocyte sedimentation rate). Treatment included diphenhydramine, steroids, hydroxyzine and an allergy consult. The patient went to the Emergency Room. Outcome was recovered. Reporter comments: The regulator assessed the case as non-serious and reported the events of "allergy test", "anti-nuclear antibody", complement factor C3', "complement factor C4', "full blood count", "metabolic function test", "red blood cell sedimentation rate increased".
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 43-year old female patient who had a medical history with hydromorphone, morphine, acetaminophen/oxycodone and ketorolac. ON the 22-OCT-2014, the patient received AFLURIA (batch number T57405) via the intramuscular route in the right arm. ON the 22-OCT-2014, the patient developed hives, itching UE (upper extremity) and lower back, tingling lips, hoarseness, chest tightness, nausea, vomiting, loose stools and extreme fatigue. Laboratory tests included allergy tests, CBS (complete blood count), CMP (complete metabolic panel), C3 and C4, ANA (anti-nuclear antibody) and ESR (erythrocyte sedimentation rate). Treatment included diphenhydramine, steroids, hydroxyzine and an allergy consult. The patient went to the Emergency Room. Outcome was recovered. Reporter comments: The regulator assessed the case as non-serious and reported the events of "allergy test", "anti-nuclear antibody", complement factor C3', "complement factor C4', "full blood count", "metabolic function test", "red blood cell sedimentation rate increased".
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 63 year old female patient who had no medical history and no current illness. ON the 02-OCT-2o14, the patient received AFLURIA injection (batch number "T580076") via an unknown route in the left arm. The patient reported on the 15-OCT-2013, that her arm still hurt and did not have a full range of motion. Outcome was not recovered. Reporter comments: The regulator assessed the case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 47 year old female patient who had no medical history. Concomitant medications included venlafaxine, nebivololo, HCTZ (hydrochlorothiazide) and norgestimate/ethinyl estradiol. The patient had no current illness. On the 24-OCT-2014, the patient received AFLURIA injection (batch number 09649211A) dose 0 via th ID (Intradermal) route in the left arm. On the 24-OCT-2014, the patient developed itching, redness, swelling (3" circumference) and pain that lasted 5 days. Outcome was recovered.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 67 year old female patient who had a medical history of a pacemaker, thyroid, low blood sugar and high blood pressure. Concomitant medications included levothyroxine, valsartan and metoprolol (sic). Last year, the patient developed a headache that lasted one month after the flu vaccine (see 201504904). On the 29-SEP-2014, the patient received AFLURIA (batch number not reported) via a syringe in the right arm. On the 25-OCT--2014, the patient developed a severe headache which was still present as of the 09-NOV. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.