chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 52 year old female patient. The patient had no medical history or current illness. The patient had slight headache before vaccination. On 05-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T58106) in the left arm. On 05-Nov-2014, the patient experienced fever, chills, headache and no appetite which lasted until 08-Nov-2014. Her arm at the injection site remained tender. The outcome was reported as not recovered.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns an 11 year-old male patient who had no listed allergies, birth defects, medical conditions or current illness present at the time of vaccination. On 08-Nov-2014, the patient received intramuscular AFLURIA injection, (batch number T53709) in the right arm. On 09-Nov-2014, the patient experienced slightly swollen and red arm at the site of injection. The patient's mother first noticed it on 09-Nov-2014 and said the patient had no issues the night of the injection. Treatment included diphenhydramine and ice pack, and to watch for further reactions. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: This consumer spontaneous report (initial receipt 06-Nov-2014) concerns a 59 year-old female patoent who had pertinent medical history of high blood pressure, asthma, and allergies to penicillin, methoxazole/trimethoprim and meloxicam. Concomitant medications included lisinopril and montelukast. On 17-Oct-2014, the patient received Influenza virus vaccine (manufacturer and batch number not provided) in the right arm. She also received ZOSTAVAX (batch number: K009771) in the left arm. On 25-Oct-2014, the patient experienced a painful rash on her left arm and blisters on her left arm after receiving the ZOSTAVAX vaccine on her left arm. She also had one blister on her left chest, a whole big cluster under her left armpit and two small spots on her left forearm. She saw a physician's assistance at an urgent care clinic and was diagnosed as having shingles. Treatment included valicyclovir. The outcome was not recovered.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2015) concerns a 59 year old female patient who had no current illness. The patient had a medical history of high blood pressure, under active thyroid, acid reflux and high cholesterol which were all treated and under control by prescription medication. Concomitant medications included verapamil, levothyroxine, atorvastatin, omeprazole, alprazolam (0.25mg), senior multivitamin, 81 mg aspirin, krill oil, vitamin D3, glucosamine and chondroitin. On the 02-Oct-2014, the patient received AFLURIA (batch number 'NDC333320014') via the intramuscular route in the left arm. On the 07-Oct-2015, the vaccination location was very sore. Pain continually worsened to the point where the shoulder and upper arm muscle pained when used. The patient developed an inability to lift the arm over the head or lift items with the vaccination arm due to weakness. Three days after finishing a prescribed prednisone medication, the pain in the upper arm and shoulder returned. The patient attended an Emergency Room. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2015) concerns a 56 year old male patient who had no medical history and no current illness. Concomitant medications included carisoprodol on a limited and on an as-needed basis, Naproxen on an as-needed basis (both medications at low doses and infrequent dosing). The patient did not remember having any previous reactions to any previous flu shots in past years. On the 31-Oct-2014, the patient received AFLURIA (batch number 'T53609A') via the intramuscular route in the left arm. On the 31-Oct-2014, the patient developed a very sore and swollen arm with pain. The patient presented with fever in the arm and what he thought was a mild systemic fever with mild aching. The patient felt much better but was concerned about the reaction. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Malaise, Palpitations
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 35 year old female patient. The patient had medical history of seasonal allergy and allergy to animal dander. She had no current illness or medication at the time of vaccination. On 21-Oct-2014, the patient received AFLURIA injection (batch number T53109) in the right arm. On 21-Oct-2014, within five minutes of vaccination, the patient was lightheaded and developed malaise, blurred vision, heart palpitations, chest tightness and SOB (shortness of breath) (assessed). The patient was monitored. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 35 year old female patient. The patient had medical history of seasonal allergy and allergy to animal dander. She had no current illness or medication at the time of vaccination. On 21-Oct-2014, the patient received AFLURIA injection (batch number T53109) in the right arm. On 21-Oct-2014, within five minutes of vaccination, the patient was lightheaded and developed malaise, blurred vision, heart palpitations, chest tightness and SOB (shortness of breath) (assessed). The patient was monitored. The outcome was reported as recovered. Reporters comments: The health authority assessed the events as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: This medically confirmed health authority report (initial receipt 13-Nov-2014) concerns a 4 year old female patient. The patient did not have any history of shoulder pain or injuries. On 12-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T51808).  The patient believed that the injection was administered more in the shoulder vs the muscle. On 12-Nov-2014, the patient experienced pain in the upper part of her shoulder with limited range of motion, which began a few hours post injection. The patient did not sought medical treatment and had been doing stretching to increase her range of motion. The outcome was reported as not recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: This medically confirmed health authority report (initial receipt 13-Nov-2014) concerns a 4 year old female patient. The patient did not have any history of shoulder pain or injuries. On 12-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T51808).  The patient believed that the injection was administered more in the shoulder vs the muscle. On 12-Nov-2014, the patient experienced pain in the upper part of her shoulder with limited range of motion, which began a few hours post injection. The patient did not sought medical treatment and had been doing stretching to increase her range of motion. The outcome was reported as not recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 64 year old female patient. Concomitant medications included zolpidem, omeprazole and atorvastatin. On the 12-Nov-2014, the patient received AFLURIA (batch number T51808) via the intramuscular route in the left arm. It was possibly an inaccurate injection site - the patient stated it was given too high in the arm/shoulder in the deltoid. On the 12-Nov-2014, the patient developed a lack of range of motion and shoulder pain. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the term 'injection site pain'.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 64 year old female patient. Concomitant medications included zolpidem, omeprazole and atorvastatin. On the 12-Nov-2014, the patient received AFLURIA (batch number T51808) via the intramuscular route in the left arm. It was possibly an inaccurate injection site - the patient stated it was given too high in the arm/shoulder in the deltoid. On the 12-Nov-2014, the patient developed a lack of range of motion and shoulder pain. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious and reported the term 'injection site pain'.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Joint range of motion decreased
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 38-year-old male patient. The patient had no medication at the time of vaccination. The patient had no medical history or current illness. On 03-Oct-2014, the patient received intramuscular AFLURIA injection (batch number not reported) in the left arm. On 03-Oct-2014, the patient developed severe shoulder pain in the area where the flu shot was administered. The patient also experienced limited range of motion and trouble sleeping (due to the pain). The patient attempted to treat with periodic ibuprofen until visit to the pharmacy care doctor, one week later. The patient was prescribed a 2 week course of NSAID. The patient continued for 6 weeks after vaccine administration. The patient had appointment to see shoulder orthopaedist on 05-Dec-2014, after the second visit to primary care doctor. The outcome was reported as not recovered.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 15-Dec-2014) concerns a 24 year-old female patient. Concomitant medications include levothyroxine sodium and anovlar. On 07-Oct-2014, the patient received intramuscular AFLURIA, (batch number "758106") in the left arm. On 07-Oct-2014, the patient had an immediate severe pain in the left shoulder/armpit region after receiving the Flu shot. The injection was given very high on the patient's arm, which was about 1 inch toward her back from the top of her shoulder. The patient also experienced a painful range of motion in shoulder. The patient went to the doctor on 12-Nov-2014 and was prescribed a steroid and physical therapy type exercises/stretches to perform daily until healed. The patient was instructed to not exercise using her left shoulder until healed. As of 13-Nov-2014, the pain did not subside and there was still painful range of motion. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the terms of 'immediate post-injection reaction' and 'injection site pain'.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Rash
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 55 year old female patient who had no current illness and no medical history except for a history of penicillins. Concomitant medications included estrogens (1.25mg daily). On the 11-Nov-2014, the patient received AFLURIA (batch number 09949211A) via the intramuscular route in the left arm. On the 13-Nov-2014, the patient developed a rash. The next day, it turned into a bruise approximately three inches in diameter. Patient then had pain three days later. The rash had disappeared but the bruise remained. No laboratory data was taken- the patient was monitoring. Outcome was unknown.
Age: 29.0
Sex: F
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 29 year-old pregnant female patient who had a current illness of "prophylaxis". She had no known drug reactions/allergies and no pertinent medical history. The patient's history of previous pregnancies and live births were not known. On 25-SEP-2012, the patient received AFLURIA injection (batch number not provided). ON the same day, the patient also received DTAP (manufacturer and batch number not provided) and VARIVAX batch number not provided). All three vaccines were given the route of "SYR" in an unknown site.  On 25-SEP-2012, at the time when she received these three vaccines, she did not know she was pregnant. She then found out that she was two months pregnant, hence exposed to these vaccines during trimester 1. Her last menstrual period (LMP) was on approximately 13-AUG-201 and estimated delivery date (EDD) was approximately 20-MAY-2013. No treatment was given. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention - she spoke to a physician. Follow-up information received from a registered nurse who stated that the physician had no information to share concerning this patient. The complete medical records were unavailable. No further information was available. Additional information was not expected. The outcome of the pregnancy and fetus was unknown. Reporter's comments: The regulatory assessed the case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Back pain, Injection site pain, Mobility decreased, Neck pain
Clinical narrative: This non-serious medically confirmed helath authority report (initial receipt 20-Jan-2015) concerns a 49 year old female patient who had a medical history of reflex sympathetic dystrophy but was in remission. The patient had no current illness and was not on any medications at the time of vaccination. On the 17-Sep-2014, the patient received AFLURIA, (batch number T59507) via an unknown route in the left arm. On the 17-Sep-2014, the injection hurt horribly. The plunger stuck in the arm and it hurt getting it out. The arm was very sore that day and was worse as time progressed. By 2-Oct-2041 and 3-Oct-2041, the patient could not raise the arm to dress. It hurt so bad. Burning pain started and radiated to the back, neck and down the arm. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This non-serious medically confirmed helath authority report (initial receipt 20-Jan-2015) concerns a 49 year old female patient who had a medical history of reflex sympathetic dystrophy but was in remission. The patient had no current illness and was not on any medications at the time of vaccination. On the 17-Sep-2014, the patient received AFLURIA, (batch number T59507) via an unknown route in the left arm. On the 17-Sep-2014, the injection hurt horribly. The plunger stuck in the arm and it hurt getting it out. The arm was very sore that day and was worse as time progressed. By 2-Oct-2041 and 3-Oct-2041, the patient could not raise the arm to dress. It hurt so bad. Burning pain started and radiated to the back, neck and down the arm. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Disorientation, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 79 year old male patient who had no medical history and no current illness. On an unspecified date, the patient received AFLURIA (batch number T5708) dose 1, via an unknown route in the left arm. On an unspecified date, the patient developed fever, disorientation and lower body weakness. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 77.0
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 77 year old female patient who had no known history and no current illness. On the 27-OCT-2014, the patient received AFLURIA (batch number T59106) via the intramuscular route in the left arm. On the 27-OCT-2014, the patient developed a sore shoulder around the administration site a few hours after vaccine administration. 18 days later, the patient presented to the pharmacy with the same pain - no better or worse. IT only hurt when laying down on the arm. There was no visual disturbance and no limited motion. The pharmacist suggested ibuprofen and heat therapy twice daily. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Injected limb mobility decreased, Nasopharyngitis, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 52 year old female patient. The current illness and medical history was not reported. On 03-NOV-2014, the patient received intramuscular AFLURIA injection (batch number T52708) in the left arm. On 03-NOV-2014, the patient developed a cold and bad headache. She also complained of rash and swollen/sore arm after the vaccine for couple of days. The patient had hard time lifting her left (vaccinated) arm for two days after getting the vaccine. Four days after receiving the vaccine, the patient reported the events and her arm no longer had rash or was swollen but she felt sick with cold/flu. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash
Clinical narrative: This medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 52 year old female patient. The current illness and medical history was not reported. On 03-NOV-2014, the patient received intramuscular AFLURIA injection (batch number T52708) in the left arm. On 03-NOV-2014, the patient developed a cold and bad headache. She also complained of rash and swollen/sore arm after the vaccine for couple of days. The patient had hard time lifting her left (vaccinated) arm for two days after getting the vaccine. Four days after receiving the vaccine, the patient reported the events and her arm no longer had rash or was swollen but she felt sick with cold/flu. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 37 year old female patient who had no medical history and no current illness. The patient was not taking medications at the time of vaccination. On the 07-Nov-2041, the patient received AFLURIA, (batch number T53109) via the intramuscular route in the right arm, dose 10. On the 07-Nov-2041, the patient developed right shoulder soreness and difficulty with range of motion. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the term 'injection site pain'.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Hyperhidrosis, Syncope
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 54 year old female patient with bio medical history and no current illness. On the 18-Nov-2014, the patient received AFLURIA (batch number 09949211A) via the intramuscular route in the left arm. On the 18-Nov-2014, whilst the patient was at the register, the patient fainted and fell down. With help, she was helped out to a chair in the waiting room area. She felt dizzy and was sweating. EMS (Emergency Services) arrived in 15 minutes and monitored her. She signed off that she was fine and they (EMS) left after 20 minutes. The patient left after 30 minutes. No laboratory data was completed. Outcome was recovered.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 52 year old female patient who had no medical history and no current illness at the time of vaccination. Concomitant medications included levothyroxine and atorvastatin. On the 14-Nov-2014 in the afternoon, the patient received AFLURIA (batch number T53709) via the intramuscular route in the right arm. The patient also received PNEUMOVAX (batch number K004483) via the intramuscular route in the right arm. On the 15-Nov-2014, the patient woke up with a swollen arm, a fever of 102 degrees F (Fahrenheit), feeling fatigued and nauseated. She contacted her PCP (Primary Care Physician) and had been taking diphenhydramine. On the 18-Nov-2014, her arm was still swollen but she was feeling better but tired from the diphenhydramine. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 48 year-old female patient who had no known current illness and known medical history at the time of vaccination. On 23-Oct-2014, the patient received intramuscular AFLURIA, (batch number 10749221A) in the left arm. On 23-Oct-2014, the patient experienced left shoulder discomfort. The patient visited the orthopaedic. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious and reported the term 'Injection site discomfort'.
Age: 69.0
Sex: M
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 69 year old male patient who had no current illness. Concomitant medications included atenolol, folic acid, glipizide, lisinopril and metformin. On the 12-Nov-2014, the patient received AFLURIA injection (batch number T51608) via an unknown route in the left arm. On the 13-Nov-2014, following the flu shot in the left arm for the next 48 hours, the upper left quarter was so painful that the patient could not move the arm or even breathe without pain. There were no other symptoms - no temperature, no nausea. Outcome was not reported. Reporter comments: The regulator reported the case as non-serious.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 35 year-old male patient who had no known current illness and no known medical history at the time of vaccination. On 01-Oct-2014, the patient received AFLURIA injection (batch number T59907) in the left arm, dose 1. On 03-Oct-2014, the patient experienced muscle pain. The outcome was not reported. Reporter's comments; The regulatory authority assessed the case as non-serious.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site joint pain, Pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 52-year-old male patient. On 23-Oct-2014, the patient received intramuscular AFLURIA injection, (batch number T56805) in the left arm. On 23-Oct-2014, the patient experienced left shoulder joint pain with certain motions, such as putting on coat. As of 19-Nov-2014, the patient was still having pain in the joint area. The outcome was reported as missing. Reporter Comments: The regulatory assessed the events as non-serious, and reported the term of 'Injection site joint pain'. Batch record review for lot T56805 noted: All deviations related to the seedlot, MPH, formulated bulk vaccine and finished product lot T56805 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T56805 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. Lot T56805 was placed on routine stability trial as it was the first lot of the pre filled syringe presentation to be filled. A review of the stability data to date shows that all results are within limits and that there have been no out of specification results or any trends of concern for lot T56805. In conclusion, there were no batch related issues identified that may have caused the adverse events reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Palpitations
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 67 year-old male patient who had no known current illness and no known medical history at the time of vaccination. On 23-Oct-2013, the patient received intramuscular AFLURIA injection (batch number not provided). On 23-Oct-2013, 3-4 hours post vaccination, the patient experienced heart palpitations. There was also breathing difficulty. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 37 year-old male patient who had no known current illness and a medical history of COPD at the time of vaccination. Concomitant medication included ibuprofen. On 17-Nov-2014, the patient received intramuscular AFLURIA (batch number "TS1308") in the left arm, and subcutaneous PNEUMOVAX (batch number K010465) in the right arm. On 18-Nov-2014, the patient experienced red, swollen and painful. The outcome was recovered.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site urticaria, Rash, Rash erythematous, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 65 year old female patient with no medical history and no current illness. On the 10-Nov-2014, the patient received AFLURIA (batch number T51808) via an unknown route in the left arm. On the 10-Nov-2014, the patient developed a red rash and hives down the entire forearm and at the injection site and also developed blurred vision. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 65 year old female patient with no medical history and no current illness. On the 10-Nov-2014, the patient received AFLURIA (batch number T51808) via an unknown route in the left arm. On the 10-Nov-2014, the patient developed a red rash and hives down the entire forearm and at the injection site and also developed blurred vision. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 42 year old female patient who had no medical history and no current illness. Concomitant medications included levothyroxine. On the 05-Nov-2014, the patient received AFLURIA injection (batch number not reported) via the intramuscular route in the right arm. On the 15-Nov-2014, the patient could not raise the arm that received the injection past shoulder level and over the head and other various positions. The patient went to the emergency room. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jun-2015) concerns a 37 year old female patient who had no medical history and no current illness. Concomitant medications included citalopram. On the 18-Nov-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the right arm. On 19-Nov-2014, the patient developed muscle aches, fatigue, fever, headache and pain radiated from the injection site to the underarm and side. No laboratory data was done. Outcome was unknown.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jun-2015) concerns a 37 year old female patient who had no medical history and no current illness. Concomitant medications included citalopram. On the 18-Nov-2014, the patient received AFLURIA (batch number not reported) via the intramuscular route in the right arm. On 19-Nov-2014, the patient developed muscle aches, fatigue, fever, headache and pain radiated from the injection site to the underarm and side. No laboratory data was done. Outcome was unknown.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 41 year-old female patient). On 22-Oct-2014, the patient received AFLURIA injection (batch number T51806) in the left arm. On 22-Oct-2014, the patient experienced are numbness upon administration. The pharmacist who administered the immunization had her sit in the waiting area for 10-15 minutes. The patient then left stating she was ok. The patient went to the emergency room (ER) the next day due to her arm going numb again. The patient was prescribed a steroid at the ER. The outcome was reported  as unknown. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the term 'immediate post-injection reaction'.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 68 year-old female patient. On 07-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T51708) in the right arm. On the same day, the patient also received PNEUMOVAX (batch number K099106) via the intramuscular route in the right arm. On an unspecified date, the patient experienced  hot, red and swollen. The doctor prescribed amoxicillin/clavulanic acid 875 mg twice daily for 10 days. The outcome was not reported. Reporter comments: The regulatory assessed the events as non-serious, and reported that the patient presented at the Emergency Room.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 44 year-old female patient who had no current illness and no medical history at the time of vaccination. Concomitant medication included duloxetine hydrochloride. On 30-Sep-2014, the patient received AFLURIA injection (batch number T50707) in the left arm. On 30-Sep-2014, the patient experienced a prolonged local pain and mass. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Myositis
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 19 year old male patient who had a medical history of not myositis (COPD-Chronic Obstructive Pulmonary Disease). The patient had no current illness at the time of vaccination. On the 29-OCT-2014, the patient received AFLURIA (batch number T506007) via syringe in the left arm. ON the 29-OCT-2014, the patient had myositis in the left arm at the time of injection. It also occurred in 2013 as per patient but it was not evaluated medically (see 2015048753). Outcome was unknown. Reporter comment: The regulator reported the case as non-serious.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 43 year old female patient. On the 22-Oct-2014, the patient received AFLURIA (batch number T58406) via a syringe in the left arm. On the 22-Oct-2014, the patient developed muscle soreness at the site of the injection since the injection. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the term 'injection site reaction'.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Erythema, Pain, Swelling face
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 57 year old female patient who had no medical history. At the time, the patient was chilled. The patient was not taking any prescription or non-prescription medications. On the 20-Nov-2014, the patient received AFLURIA (batch number not reported) dose 1 via syringe in the left arm. On the 20-Nov-2014, the patient developed body aches particularly the legs, redness on the stomach and face (looked like sunburn), swelling of the face, dizziness and weakness. Outcome was recovered.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Tenderness, Tendonitis
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 55 year old male patient who had a medical history of high blood pressure. Current illness included a chest cold in which the patient was receiving amoxycillin/clavulanic acid. On the 18-Nov-2014, the patient received AFLURIA (batch number T57505) via the intramuscular route in the left arm. The patient also received PNEUMOVAX  (batch number K010523) via the intramuscular route in the right arm/deltoid. On the 18-Nov-2014, the patient developed right arm tenderness and redness away from the site of injection. Pain extended to the wrist in which the patient described it to be like tendonitis and stated he had some neck tenderness. The area of injection was not inflamed or raised. The patient was told to follow up with the physician and to take ibuprofen for the swelling, if there was fever and pain. Outcome was unknown.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site warmth, Insomnia, Malaise
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 63 year old female patient who had a history with penicillin, sulfa, azithromycin, seasonal pollens, pinyon and juniper trees, cats and dogs, strawberries. Medical conditions were good. The patient had no current illness. Medications at the time of vaccination included clonidine, furosemide, aspirin, cetirizine, ranitidine, sertraline, losartan, carvedilol, atorvastatin and omeprazole. On the 15-Nov-2014, the patient received AFLURIA (batch number T52708) via the intramuscular route in the left arm. The patient also received PNEUMOVAX (batch number 00006-4943-00) via the intramuscular route in the right arm. On 15-Nov-2014, shortly after the injection site became very hot and sore. The arm swelled to twice it's size. The pain was so horrible that the patient could not life arm. The patient had to hold it down with the forearm folded along her waist. A large patch of bright red welted rash appeared. The patient could not sleep for two nights. The patient could not move for the rest of Saturday, all of Sunday and most of Monday. Diphenhydramine and paracetamol were of no help. On Monday, the patient went to work and told her boss she was ill and may need to leave. The symptoms lingered until Wednesday. The patient had the flu shot in the left arm which was also agitated by this event. The patient did not feel good at all. Outcome was recovered.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 63 year old female patient who had a history with penicillin, sulfa, azithromycin, seasonal pollens, pinyon and juniper trees, cats and dogs, strawberries. Medical conditions were good. The patient had no current illness. Medications at the time of vaccination included clonidine, furosemide, aspirin, cetirizine, ranitidine, sertraline, losartan, carvedilol, atorvastatin and omeprazole. On the 15-Nov-2014, the patient received AFLURIA (batch number T52708) via the intramuscular route in the left arm. The patient also received PNEUMOVAX (batch number 00006-4943-00) via the intramuscular route in the right arm. On 15-Nov-2014, shortly after the injection site became very hot and sore. The arm swelled to twice it's size. The pain was so horrible that the patient could not life arm. The patient had to hold it down with the forearm folded along her waist. A large patch of bright red welted rash appeared. The patient could not sleep for two nights. The patient could not move for the rest of Saturday, all of Sunday and most of Monday. Diphenhydramine and paracetamol were of no help. On Monday, the patient went to work and told her boss she was ill and may need to leave. The symptoms lingered until Wednesday. The patient had the flu shot in the left arm which was also agitated by this event. The patient did not feel good at all. Outcome was recovered.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 43 year old male patient. On the 07-Oct-2014, the patient received AFLURIA, (batch number T50707) dose 1, via the intramuscular route in the left arm. On the 07-Oct-2014, the patient developed pain and numbness in the left arm since the vaccination. The patient also lost feeling int he left hand the day after the shot. The patient went to see the doctor twice and was referred to another doctor and was waiting to go for an appointment. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported that the patient went to the Emergency Room.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
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. Concomitant medications included drosperinone/ethinyestradiol. On the 16-Sep-2015, the patient received AFLURIA (batch number T57105) via the intramuscular route at an unknown site. On 16-Sep-2015, four hours after injection, the patient developed redness all over the face, neck and chest. At the time of the injection, the patient developed swelling after the shot. The patient felt fine other than a dermatologist reaction. She sent a picture to the dermatologist who saw nothing to be worried about. The patient recovered the next day. Outcome was recovered.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Ear pain, Gastroenteritis viral, Oropharyngeal pain, Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a 61 year-old female patient. Concomitant medications included lamotrigine, dicylcoverine hydrochloride and rizatriptan. ON 20-OCT-2014, the patient received intramuscularly AFLURIA injection (batch number T51808) in the right arm, and intramuscular PNEUMOVAX (batch number K004483) in the right arm. On 21-OCT-2014, the patient described getting stomach flu-like symptoms, vomiting and diarrhea. Since then, the patient had an earache and sore throat. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the term "Influenza like illness".
Age: 64.0
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 64 year old female patient who had no current illness and no medical history. Concomitant mediations included levothyroxine. On the 22-SEP-2014, the patient received AFLURIA (batch number T50007) via an unknown route in the left arm. On the 23-SEP-2014, after the administration, the patient's left arm was sore. The next morning, the patient could not fully extend the left arm. Two months later, the patient could not fully extend the arm.  Outcome was not recovered.  Reporter comments: The regulator reported the case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: On the 22-Nov-2014, the patient received AFLURIA injection (batch number T57405) via the intramuscular route in the left arm. On the 22-Nov-2014, the patient developed extreme nausea and dizziness. The patient stayed in all day. The patient felt better on the 24-Nov-2014 but still had lingering nausea. Outcome was unknown.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 10 year old female patient who had no medical history. Current illness included chronic tonsil inflammation with no fever. Concomitant medications included ibuprofen 20mg. On the 22-Nov-2014, the patient received AFLURIA (batch number 'TS2908') via the intramuscular route in the right arm. On the 23-Nov-2014, the patient developed a swollen, red and warm upper arm from the elbow to the shoulder. Outcome was unknown.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain, Swelling, Tenderness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 69 year old male patient who had a medical history of HTN, DM, psoriasis and hyperlipidemia. The patient did not have any current illness. The patient had a reaction to a tetanus toxoid vaccine as a young child. On the 19-Nov-2014, the patient received AFLURIA (batch number T53009) via the intramuscular route in the left arm. The patient also received PNEUMOVAX (batch number K007825) via the intramuscular route in the right arm. On the 19-Nov-2014, the patient developed pain, tenderness, redness, warmth and swelling. The patient went to the Emergency Room. Outcome was recovered.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Painful respiration
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 hypercholeterolaemia and DM. The patient had no current illness. On the 30-Oct-2014, the patient received AFLURIA (batch number T531090 via the intramuscular route in the left arm. On the 30-Oct-2014, two hours after the vaccine, the patient developed chest pain and developed shortness of breath. The patient complained that it hurt to breath. The patient attended the Emergency Room. An EKG showed NSR. The chest showed no acute cardiomyopathy disease. Treatment included intramuscular Ketorolac. Outcome was recovered.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Muscle tightness, Myalgia, Pain
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 at the time of vaccination. The patient's medical history included allergy to yellow jackets (administered monthly injection for 20 years) and more   than 1 year status postprostatectomy. On 07-NOV-2014, the patient received intramuscular AFLURIA injection (batch number T53909) in the left arm. On an unspecified date, the patient experienced moderate to severe pain in large joints (elbows, primarily the knees) and pain and extreme tightness in the large muscles (thighs, hamstrings, and also ACL (anterior cruciate ligament) of left knee,biceps), persistent full body aching with gradual left up over 4-5 days. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint pain, Joint range of motion decreased
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 58 year old female patient who had a history with penicillin but no current illness. Concomitant medications included balsalazide. On the 24-Oct-2014, the patient received AFLURIA (batch number T52408) via the intramuscular route in the left arm. On the 24-Oct-2014, the patient developed constant pain in the left shoulder joint, limited range of arm movement and a limited amount of ability to lift weight. No laboratory data was done. Outcome was not recovered.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Confusional state, Contusion, Feeling abnormal, Headache
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: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Impaired work ability, Joint stiffness, Muscular weakness, Myalgia
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.