chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a female patient. On an unspecified date, the patient received seasonal AFLURIA injection, (batch number not reported). On an unspecified date, the patient experienced pain in left arm. The outcome was not reported. Case linked to 2015049642.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 20-Jan-2015) concerns a 66 year-old male patient who had a medical history of 'sulfa' at the time of vaccination. On 07-Oct-2014, the patient received intramuscular AFLURIA (batch number T58206). On 07-Oct-2014, the patient complained of chest tightness which lasted a few hours. The outcome was recovered. Reporter's comments; The regulatory authority assessed the case as non-serious.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain, Rash, Skin lesion
Clinical narrative: This non-serious medically confirmed report (initial receipt 12-Dec-2014) concerns a 62 year old male patient who had no pertinent medical history and no drug reactions/allergies. Concomitant medications included lisinopril 20mg. On the 04-Nov-2014, the patient received AFLURIA (batch number not reported) and ZOSTAVAX (batch number K012921) 0.65mL via the subcutaneous route. On the 24-Nov-2014, the patient developed a rash with lesions that started on his left leg and then spread to his right leg and up to his trunk on an unspecified date. The lesions that were on both of the patient's legs and up his trunk were about an inch long and a half of an inch wide. The patient reported that the lesions were painful however it was not specified when the pain started. On the 26-Nov-2014, the patient spoke to the pharmacist. Outcome was not recovered.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 26 year old male patient. On the 28-SEP-2014, the patient received AFLURIA injection (batch number T57906) via the intramuscular route in the "AR". The patient concomitantly received PNEUMOVAX (batch number K00917) via the intramuscular route in the "AR". On the 28-SEP-2014, the patient developed welling at the injection site and bruising at and around the site. The patient presented to the emergency room. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 35 year-old female patient who had no known current illness and no medical history at the time of vaccination. Concomitant medication included cetirizine. On 13-Oct-2014 the patient received intramuscular AFLURIA injection (batch number T56905) in the left arm. On 13-Oct-2014, the patient felt a wave came across her chest at the time of vaccination. The patient then felt acute pain in her left shoulder, which started 1-2 weeks after vaccination. The patient also had difficulty putting on clothing or put her arm above her head. The patient had been ebbing and flowing since but had gradually subsided. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the term 'Injection site pain'.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Myositis, Nerve injury
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 54 year-old female patient who had no current illness at the time of vaccination. The patient's medical history was unknown. On 25-Sep-2014, the patient received intramuscular AFLURIA (batch number T58606). On 29-Sep-2014, the patient developed nerve damage and muscle inflammation. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This non-serious consumer report (initial receipt 13-Nov-2014) concerns a 58 year old female patient who had a medical history of migraine headaches and the patient thought she had a prior case of shingles in 2006. Concomitant medications included tramadol and zopiclone. On the 02-Oct-2014, the patient received a flu shot (manufacturer and batch number not specified) and ZOSTAVAX injection (batch number not reported) for the prevention of shingles. On the 09-Oct-2014, the patient experienced an extreme painful itch on the back side of her arm where she received her ZOSTAVAX vaccine. When the patient scratched the area, it turned into a fiery red. On the 03-Nov-2014, the patient looked at the area and she saw raised bumps and the area looked bruised. The patient had experienced an itching sensation for the last three weeks (unspecified dates) and the affected area was spreading and her symptoms were not subsiding. Treatments included diphenhydramine tablets and cream, alcohol and hydrocortisone. Outcome was not recovered.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Extra dose administered, Swelling, Wrong drug administered
Clinical narrative: This medically confirmed regulatory report (initial receipt 16-FEB-2015) concerns a 70 year-old female patient who had no known current illness and no known allergies at the time of vaccination. Concomitant medication included simvastatin 80 mg. On 15-DEC-2014, the patient received intramuscular AFLURIA injection (batch number T52708) in the left arm when the patient requested ZOSTAVAX. On the same say, the patient also received subcutaneous ZOSTAVAX (batch number K014836) in the right arm. On an unspecified dat4e, approximately four weeks prior to 15-DEC-2014, the patient received a flu shot. Approximately 20 hours later, the patient noted "swelling". The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: On 30-Nov-2014, the patient received AFLURIA injection (batch number not provided). On 06-Dec-2014, the patient experienced ache adn pain in the muscles of right arm. The outcome was not provided.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Crepitations, Injected limb mobility decreased, Injection site pain, Insomnia, Weight bearing difficulty
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 52 year old who had no current illness and no medical history. The patient was not on any medications at the time of vaccination. ON the 20-SEP-2014, the patient received AFLURIA injection (batch number 10042911A) via the intramuscular route in the left arm. On the 15-OCT-2014, the patient developed pain in the upper arm where the shot was administered. There were some crackling sounds. The patient was unable to sleep on the left side or lift heavy objects. The movement of the arm was constrained. Outcome was not recovered.  Reporter comments: The regulator reported the case as non-serious and reported the term "weight bearing difficulty".
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a female patient. The patient had NKA (no known allergies). On an unspecified date, the patient received AFLURIA injection (batch number T58706) via an unknown route in the right arm. On an unspecified date, the patient developed continued pain and had an MRI as well as physical therapy. Outcome was not recovered.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nerve conduction studies normal, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 19 year old female patient. The patient had no medical history or current illness. On 21-Oct-2014, the patient received intramuscular AFLURIA injection, (batch number: T58806) in the left arm. On 29-Oct-2014, the patient experienced ongoing left shoulder pain around vaccine injection site. The patient complained of area hurting to touch and increased pain with the use of left shoulder. The patient had no visible injury to the injection site and no diminished range of motion or tenderness to injection site on 14 Nov-2014 and 02-Dec-2014. The NVI, motor and sensory exams were normal and the patient did not have any physical disability. The outcome was reported as missing. Reporter's comments: The health authority assessed the events as non-serious.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 62 year old male patient who had a history of amoxicillin but no current illness. Concomitant medications included low dose aspirin 81mg and a multivitamin daily. On the 06-Oct-2014, the patient received AFLURIA (batch number 'NDC: 33332-0014) via the intramuscular route in the left arm. On the 09-Oct-2014, the patient developed otherwise unexplained joint and muscle pain. There was no unusual physical exertion on the shoulder socket, hip, knee or wrist. The patient had muscle soreness the next day after minor exertion. This was an ongoing issue. No laboratory data was done to date. Outcome was recovered.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 55 year-old female patient who had no known current illness and no medical history at the time of vaccination. On 18-NOV-2014, the patient received AFLURIA injection (batch number T53809) in the right arm. On 18-NOV-2014 at 7PM, the patient felt very dizzy and needed to sit down. At 7:15 PM, the patient felt weak and laid down until 8:15 PM which the weakness went away. She was still feeling dizzy the whole time. At 11:30 PM, the dizzy was almost gone. On 19-NOV-2014, by 4 PM, the patient felt better. Her right arm hurt like someone punched her in arm since 7 PM on 18-NOV-2014. It was still hurting but not as bad on 19-NOV-2014. At the time of reporting, only a slight feeling of pain if the patient press on it. The outcome was recovered. Reporter's comments: The  regulatory authority assessed the case as non-serious.
Age: 40.0
Sex: M
Vaccine: FLU3, TYP, YF
Symptoms: Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 40 year-old male patient. On 20-NOV-2014, the patient received intramuscular AFLURIA injection (batch number T52508) in the left arm. On the same day, the patient also received VIVOTIF (batch number not provided) and subcutaneous YF-VAX (batch number UI078AA) in the left arm. The oral typhoid course was completed on 20-NOV-2014. On 30-NOV-2014, ten days after the vaccination course, the patient developed hives on feet and lower legs. Treatment included diphenhydramine, cetirizine and loratadine.  The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Injection site reaction, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 35 year old male patient who had a medical history of kidney stones and PTSD (Post Traumatic Stress Disorder). Concomitant medications included lisinopril and topiramate. The patient had no current illness. ON the 12-NOV-2014, the patient received AFLURIA injection (batch number T58406) via the intramuscular route in the right arm. On the 12-NOV-2014, the patient developed neck and upper back pain for the first five days which subsided and then the pain was in the right upper shoulder/tendon ever since. The patient had a limited range of motion, soreness and stiffness. Outcome was not recovered. Reporter comments" The regulator reported the case as non-serious.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain, Tendon pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 35 year old male patient who had a medical history of kidney stones and PTSD (Post Traumatic Stress Disorder). Concomitant medications included lisinopril and topiramate. The patient had no current illness. ON the 12-NOV-2014, the patient received AFLURIA injection (batch number T58406) via the intramuscular route in the right arm. On the 12-NOV-2014, the patient developed neck and upper back pain for the first five days which subsided and then the pain was in the right upper shoulder/tendon ever since. The patient had a limited range of motion, soreness and stiffness. Outcome was not recovered. Reporter comments" The regulator reported the case as non-serious.
Age: 34.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Arthralgia, Chills, Pyrexia, Rash generalised
Clinical narrative: This medically confirmed regulatory report (initial receipt 16-Feb-2015) concerns a 34 year-old male patient who had no known medical history, no concomitant medications, no lab data, and no current illness of the time of reporting. On 01-Dec-2014, the patient received AFLURIA injection (batch number T52308) in the left arm. On the same day, the patient also received VARIVAX (batch number K005428) in the left arm. On 09-Dec-2014 or 10-Dec-2014, the patient started experiencing bump all over body as well as fevers, chills and joint aches. Patient did not receive any treatment so far. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: This medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 78 year-old elderly male patient. On 11-NOV-2014, the patient received intramuscular AFLURIA injection (batch number T57906) in the left arm. On an unspecified date, the patient experienced bruising and soreness of the upper left arm. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 38 year-old female patient who had no known current illness at the time of vaccination. On 18-Dec-2014, the patient received intramuscular AFLURIA injection (batch number 10149221A) in the left arm. On 18-Dec-2014, about 15 minutes after the injection, the patient complained of bump and slight itching. There was slight redness around the injection site on left deltoid. The patient was observed for 20 minutes, blood pressure was 128/83 at 8:45 am and 120/82 at 09:05 am. Ice was applied for about 10 minutes. The itching relieved. On 19-Dec-2014, the patient reported that she felt better, however the arm was only a little sore. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, and reported the term 'Pain'.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 66-year-old female patient. The patient had medical history of seasonal, animals, moulds and acetaminophen allergy, chronic obstructive pulmonary disease, reactive airways disease, asthma, hypertension and high cholesterol. She did not have any current illness. Her concomitant medications included seretide, salbutamol nebuliser, chromium sodium solution nebuliser, beclomethasone nasal spray, fexofenadine, fluoxetine hydrochloride, fluticasone propionate, cromoglycate sodium, atorvastatin calcium, perbutalol acetate, metformin, salbutamol sulfate, montelukast, fenofibrate, verapamil and triamcinolone acetonide. On 15-Oct-2014, the patent received intramuscular AFLURIA, (batch number T50507) in the left arm. On 15-Oct-2014, the patient developed pain in the left arm and pinpointed to what appeared to be the injection site. The pain radiated up and down the arm, across the shoulders and sometimes into the right arm and into the left upper chest. The pain was not constant and ranged from 0 to 7-8. The patient used heat pad and NSAIDs to help alleviate. The patient saw the chiropractor for neck adjustments but did not help. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: This medically confirmed regulatory report (initial receipt 16-FEB-2015) concerns a 56 year-old female patient who had no known medical history and was not ill at the time of vaccination. On 21-DEC-2014, the patient received intramuscular AFLURIA (batch number T53709) in the left arm. On 22-DEC-2014, the patient experienced redness and a knot at the injection site, and it felt warm. The patient flinched during the injection. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious and reported the term "circumstance or information capable of leading to medication error".
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: This medically confirmed spontaneous report (initial receipt 23-Dec-2014) concerns a 59-year old female patient with no relevant medical history. On 19-Nov-2014, the patient received intramuscular AFLURIA (batch number-T53709) at 0.5 ml once for protection against seasonal influenza virus. On 20-Nov-2014, the patient developed soreness in the arm where she received the injection. On 23-Dec-2014, the patient contacted the pharmacist and stated that her arm still felt weak and that she was having troubles moving it. Outcome was reported as not yet recovered.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Muscular weakness, Pain in extremity, Syringe issue
Clinical narrative: This medically confirmed spontaneous report (initial receipt 23-Dec-2014) concerns a 59-year old female patient with no relevant medical history. On 19-Nov-2014, the patient received intramuscular AFLURIA (batch number-T53709) at 0.5 ml once for protection against seasonal influenza virus. On 20-Nov-2014, the patient developed soreness in the arm where she received the injection. On 23-Dec-2014, the patient contacted the pharmacist and stated that her arm still felt weak and that she was having troubles moving it. Outcome was reported as not yet recovered.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 59 year old female patient who had a medical history of a sulfa allergy and hypertension. Medications at the time of vaccination were not known. The patient had no current illness. On the 19-NOV-2014, the patient received AFLURIA (batch number TS3709) via intramuscular route in the left arm. While administering the vaccine and depressing the plunger, it felt like the plunger had stopped so the needle was withdrawn. When the needle was  withdrawn, it was realized that the total volume of the shot had not been given. The remaining volume was given in the same arm spaced out at least an inch from the first shot. The patient was counseled that she may be more sore because of the extra shot. The patient was followed up the following day. Her arm was sore and she was counseled to take paracetamol or ice pack for the soreness and to call if there were any issues. The patient returned to the pharmacy on the 23-DEC-2014 and the arm was still weak from the shot and sometimes found it hard lifting the arm and putting on clothes. She said her arm started to get weak about six days after the shot. She was advised to see her physician to make sure it was nothing serious and the manufacturer was contact who instructed the patient should be seen by a physician and the arm weakness could be caused by a number of  thing not necessarily the shot. Outcome was unknown.  Reporter comments: The regulator reported the case as non-serious and reported that the patient attended the Emergency Room.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Muscular weakness, Pain in extremity, Syringe issue
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 59 year old female patient who had a medical history of a sulfa allergy and hypertension. Medications at the time of vaccination were not known. The patient had no current illness. On the 19-NOV-2014, the patient received AFLURIA (batch number TS3709) via intramuscular route in the left arm. While administering the vaccine and depressing the plunger, it felt like the plunger had stopped so the needle was withdrawn. When the needle was  withdrawn, it was realized that the total volume of the shot had not been given. The remaining volume was given in the same arm spaced out at least an inch from the first shot. The patient was counseled that she may be more sore because of the extra shot. The patient was followed up the following day. Her arm was sore and she was counseled to take paracetamol or ice pack for the soreness and to call if there were any issues. The patient returned to the pharmacy on the 23-DEC-2014 and the arm was still weak from the shot and sometimes found it hard lifting the arm and putting on clothes. She said her arm started to get weak about six days after the shot. She was advised to see her physician to make sure it was nothing serious and the manufacturer was contact who instructed the patient should be seen by a physician and the arm weakness could be caused by a number of  thing not necessarily the shot. Outcome was unknown.  Reporter comments: The regulator reported the case as non-serious and reported that the patient attended the Emergency Room.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Hypoaesthesia oral, Lip pruritus, Paraesthesia oral
Clinical narrative: This medically confirmed heath authority report (initial receipt 16-FEB-2015) concerns a 27 year-old female patient who had no known no current illness at the time of reporting. Medical history included a lot of sensitivities, and lab data showed several sensitivities to allergic reaction. On 27-SEP-2014, the patient received intramuscular AFLURIA injection (batch number T50707). On 27-SEP-2014, 45 minutes after receiving the vaccine, the patient's lips went numb and started to itch and tingle. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the Emergency Room, and reported the term "hypersensitivity".
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 63 year old male patient. The patient did not have any medical history. His concomitant medication included rosuvastatin. On 10-NOV-2014, the patient received intramuscular AFLURIA injection (batch number: T51208) in the arm. On 24-NOV-2014, the patient experienced shoulder pain and was unable to lift arm up (soreness). The outcome was reported as recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pruritus, Skin warm, Tenderness, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 30 year old female patient who had no current illness. On the 19-DEC-2014, the patient received AFLURIA (batch number T53109) via an unknown route in the right arm. On the 20-DEC-2014, the patient developed burning and itching, tender, hot up (r) right neck and urticaria. It lasted until 21-DEC morning. it was resolving. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chapped lips, Lip swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 74 year old female patient. The patient had no current illness. Her concomitant medications included levothyroxine sodium, low dose acetylsalicylic acid, silybum marianum, red yeast rice, 'K2R' and calcium. On 24-Oct-2041, the patient received AFLURIA syringe, (batch number not reported, route 'SYR, NDC 33332-0014-01). On 25-Oct-2014, the patient experienced chapped and swollen upper lip 2/3 in length, which lasted for five days. The patient was suggested to take diphenhydramine to decrease the swelling. The outcome was reported as recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 16-FEB-2015. concerns a 66-year old male patient who had no know no current illness at the time of reporting. Medical history included diabetes and hypertension. Concomitant medications included liraglutide, bisoprolol, zolpidem, simvastatin, lisinopril, metformin, possibly amoxicillin/clavulanate. On 29-DEC-2014, the patient received intramuscular AFLURIA injection (batch number 09949221A in the right arm. ON 29-DEC-2014, the patient experienced swelling directly under/above injection site and slight bleeding. Upon following up with the patient a few hours after vaccination, the patient was feeling fine but the swelling was still there. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This medically confirmed regulatory report (initial receipt 16-Feb-2015) concerns a 61 year-old female patient. On 18-Oct-2014, the patient received AFLURIA injection, (batch number T51908) in the right arm, and ZOSTAVAX, (batch number K008885) in the right arm. On 19-Oct-2014, the patient experienced a local reaction, and her arm was red, hot, inflamed and swelled to the size of the softball at the ZOSTAVAX injection site. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Insomnia
Clinical narrative: This medically confirmed health authority report (initial receipt: 16-Feb-2015) concerns a 59 year old male patient. No medical history or current illness was reported. On 01-Jan-2015, the patient received intramuscular AFLURIA (batch number not reported). On 01-Jan-2015, the patient experienced insomnia. The outcome was reported as unknown.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 17 year-old female patient who had no known no current illness and no medical history at the time of reporting. On 02-Jan-2015, the patient received intramuscular AFLURIA injection (batch number 10349222A) in the left arm. On 03-Jan-2015, the patient experienced itchy rash on feet, trunk and face. The outcome was unknown.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash pruritic
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 17 year-old female patient who had no known no current illness and no medical history at the time of reporting. On 02-Jan-2015, the patient received intramuscular AFLURIA injection (batch number 10349222A) in the left arm. On 03-Jan-2015, the patient experienced itchy rash on feet, trunk and face. The outcome was unknown.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Heart rate increased, Wheezing
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2014) concerns a 32 year old female patient who had a medical history of asthma. Concomitant medications included a daily multivitamin and a daily vitamin D3 2,000. On the 05-JAN-2015, the patient received AFLURIA (batch number T53909) dose 1 via the intramuscular route in the left arm. ON the 05-JAN-2015, the patient developed coughing, wheezing, chest pressure, difficulty breathing and a rapid heart rate. The patient received albuterol via an inhaler, 50mg diphenhydramine and 4 mg methylprednisolone. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Cough, Heart rate increased, Wheezing
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 16-FEB-2014) concerns a 32 year old female patient who had a medical history of asthma. Concomitant medications included a daily multivitamin and a daily vitamin D3 2,000. On the 05-JAN-2015, the patient received AFLURIA (batch number T53909) dose 1 via the intramuscular route in the left arm. ON the 05-JAN-2015, the patient developed coughing, wheezing, chest pressure, difficulty breathing and a rapid heart rate. The patient received albuterol via an inhaler, 50mg diphenhydramine and 4 mg methylprednisolone. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: This medically confirmed health authority report (initial receipt 16-FEB-2015) concerns 57 year old female patient. The patient has no medical history or current illness. Her concomitant medication included estradiol. On 21-OCT-2014, the patient received intramuscular AFLURIA injection (batch number T58706) in the left arm. On 23-OCT-2014, the patient experienced severe swelling and tenderness of left underarm (arm pit) area (on the same side that the shot was given). The patient consulted the doctor and received treatment with diphenhydramine. The outcome was reported as recovered after about seven days. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 52 year old male patient. The patient had no current illness or history. On 30-Dec-2014, the patient received intramuscular AFLURIA, (batch number: T51808) in the left arm. On 30-Dec-2014, approximately 30 minutes after vaccination, the patient experienced redness and swelling at injection site. The patient received treatment with ice pack and was observed in waiting area for 30 minutes. The swelling and redness subsided. The patient was called to follow-up and had completely resolved. The outcome was reported as recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This medically confirmed regulatory report (initial receipt 16-FEB-2015) concerns a 47 year-old female patient who had no known current illness at the time of vaccination. The patient was allergic to penicillin, erythromycin, contrast dyes and a very large variety of plants, pollens, dust, cosmetics and fragrances. Concomitant medications included atenolol 50 mg and levothyroxine 150 mcg. On 04-JAN-2015, the patient received intramuscular ALFURIA injection, (batch number not provided) in the right arm. On 05-JAN-2015, the patient experienced a large, round, red inflamed area around the AFLURIA 2014-2015 injection site. IT was very warm to the touch with an itching and burning sensation, and the formation of dozens of tiny fluid filled blisters which cracked open upon scratching and then became crusty. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the Emergency Room, and reported the terms "injection site pain" and "injection site reaction".
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site vesicles, Injection site warmth, Scab
Clinical narrative: This medically confirmed regulatory report (initial receipt 16-FEB-2015) concerns a 47 year-old female patient who had no known current illness at the time of vaccination. The patient was allergic to penicillin, erythromycin, contrast dyes and a very large variety of plants, pollens, dust, cosmetics and fragrances. Concomitant medications included atenolol 50 mg and levothyroxine 150 mcg. On 04-JAN-2015, the patient received intramuscular ALFURIA injection, (batch number not provided) in the right arm. On 05-JAN-2015, the patient experienced a large, round, red inflamed area around the AFLURIA 2014-2015 injection site. IT was very warm to the touch with an itching and burning sensation, and the formation of dozens of tiny fluid filled blisters which cracked open upon scratching and then became crusty. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the Emergency Room, and reported the terms "injection site pain" and "injection site reaction".
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site reaction
Clinical narrative: This medically confirmed regulatory report (initial receipt 16-FEB-2015) concerns a 47 year-old female patient who had no known current illness at the time of vaccination. The patient was allergic to penicillin, erythromycin, contrast dyes and a very large variety of plants, pollens, dust, cosmetics and fragrances. Concomitant medications included atenolol 50 mg and levothyroxine 150 mcg. On 04-JAN-2015, the patient received intramuscular ALFURIA injection, (batch number not provided) in the right arm. On 05-JAN-2015, the patient experienced a large, round, red inflamed area around the AFLURIA 2014-2015 injection site. IT was very warm to the touch with an itching and burning sensation, and the formation of dozens of tiny fluid filled blisters which cracked open upon scratching and then became crusty. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented at the Emergency Room, and reported the terms "injection site pain" and "injection site reaction".
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: This non-serious medically confirmed regulatory report (initial receipt 16-FEB-2015) concerns a 26 year-old female patient who had no known medical history at the time of vaccination. ON 03-DEC-2014, the patient received intramuscular ALFURIA injection (batch number T59206) in the arm. ON 03-DEC-2014, the patient e experienced arm soreness which was still sore 1 month after vaccine administered. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Muscle spasms, Muscular weakness
Clinical narrative: This medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 62  year-old female patient. The patient had no medical history or current illness. On 10-DEC-2014, the patient received intramuscular AFLURIA (batch number "T54000") site: "UN". On an unspecified date, the patient started coughing at night. It turned into muscle weakness that was constant and not getting better. Occasionally, she also had muscle spasms. The outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendonitis
Clinical narrative: This medically confirmed health authority report (initial receipt 16-FEB-2015) concerns a 54 year old female patient. The patient had medical history of thyroid disease, her concomitant medication was unknown. On 20-SEP-2014, the patient received AFLURIA injection (batch number T57907) in the left arm (dose 2). On 20-SEP-2014, the patient developed tendonitis as a result of the vaccine. The patient was prescribed anti-inflammatory medication as a result. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scab
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 68 year old male patient. No concurrent conditions or medical history were reported. On 05-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (Lot No. K021624 Expiration date: February 2016), 0.65 ml once, subcutaneous in the left arm. Concomitant therapies included clonazepam, clopidogrel, metoprolol and oxycodone. On approximately 05-FEB-2015, reported as "since he received the shot", the patient experienced a scab at his injection site. The patient consulted his physician who froze off the scab in early June 2015. On an unknown date in 2015 the patient developed an injection site reaction, he believed that the injection site reaction had resolved, and on 01-JUL-2015, the patient returned to the pharmacy to report that his injection site "still hurts". The patient did not report that he experienced a rash, and no rash was observed. The outcome of injection site scab and injection site reaction was unknown. The outcome of injection site pain was not recovered. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site scab
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 68 year old male patient. No concurrent conditions or medical history were reported. On 05-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (Lot No. K021624 Expiration date: February 2016), 0.65 ml once, subcutaneous in the left arm. Concomitant therapies included clonazepam, clopidogrel, metoprolol and oxycodone. On approximately 05-FEB-2015, reported as "since he received the shot", the patient experienced a scab at his injection site. The patient consulted his physician who froze off the scab in early June 2015. On an unknown date in 2015 the patient developed an injection site reaction, he believed that the injection site reaction had resolved, and on 01-JUL-2015, the patient returned to the pharmacy to report that his injection site "still hurts". The patient did not report that he experienced a rash, and no rash was observed. The outcome of injection site scab and injection site reaction was unknown. The outcome of injection site pain was not recovered. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 years old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 16.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Chills, Condition aggravated, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Information has been received from a physician via a field representative referring to a 16 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On 13-DEC-2013, the patient start the vaccination of GARDASIL. On 30-JUN-2015 the patient was vaccinated with the third dose of GARDASIL (0.5 ml, lot number not provided) intramuscularly. The patient's had no concomitant medication. On 30-JUN-2015, the patient experienced an elevated temperature, hypotension, sweating and tingling in her hands and feet. The patient sought medical attention via seeing her doctor. Blood pressure and glucose was tested as lab diagnostics studies (result not provided). MOTRIN was given as a treatment for the events. The outcome of the events were reported as recovered on 01-JUL-2015. The reporter did not assess the causality between the events to GARDASIL. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Feeling of body temperature change, Hyperhidrosis, Pain, Skin discolouration, Skin sensitisation
Clinical narrative: Information has been received from a physician via a field representative referring to a 16 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On 13-DEC-2013, the patient start the vaccination of GARDASIL. On 30-JUN-2015 the patient was vaccinated with the third dose of GARDASIL (0.5 ml, lot number not provided) intramuscularly. The patient's had no concomitant medication. On 30-JUN-2015, the patient experienced an elevated temperature, hypotension, sweating and tingling in her hands and feet. The patient sought medical attention via seeing her doctor. Blood pressure and glucose was tested as lab diagnostics studies (result not provided). MOTRIN was given as a treatment for the events. The outcome of the events were reported as recovered on 01-JUL-2015. The reporter did not assess the causality between the events to GARDASIL. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Blood glucose, Body temperature increased, Hyperhidrosis, Hypotension, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician via a field representative referring to a 16 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On 13-DEC-2013, the patient start the vaccination of GARDASIL. On 30-JUN-2015 the patient was vaccinated with the third dose of GARDASIL (0.5 ml, lot number not provided) intramuscularly. The patient's had no concomitant medication. On 30-JUN-2015, the patient experienced an elevated temperature, hypotension, sweating and tingling in her hands and feet. The patient sought medical attention via seeing her doctor. Blood pressure and glucose was tested as lab diagnostics studies (result not provided). MOTRIN was given as a treatment for the events. The outcome of the events were reported as recovered on 01-JUL-2015. The reporter did not assess the causality between the events to GARDASIL. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician via a field representative referring to a 16 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On 13-DEC-2013, the patient start the vaccination of GARDASIL. On 30-JUN-2015 the patient was vaccinated with the third dose of GARDASIL (0.5 ml, lot number not provided) intramuscularly. The patient's had no concomitant medication. On 30-JUN-2015, the patient experienced an elevated temperature, hypotension, sweating and tingling in her hands and feet. The patient sought medical attention via seeing her doctor. Blood pressure and glucose was tested as lab diagnostics studies (result not provided). MOTRIN was given as a treatment for the events. The outcome of the events were reported as recovered on 01-JUL-2015. The reporter did not assess the causality between the events to GARDASIL. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Cellulitis, Pruritus
Clinical narrative: Immediate itching at site-> redness, swelling warmth-> blistering, weakness, achy, HA & nausea -> urgency room-> KEFLEX x 10 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Immediate itching at site-> redness, swelling warmth-> blistering, weakness, achy, HA & nausea -> urgency room-> KEFLEX x 10 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles, Injection site warmth, Nausea, Pain
Clinical narrative: Immediate itching at site-> redness, swelling warmth-> blistering, weakness, achy, HA & nausea -> urgency room-> KEFLEX x 10 days.
Age: 68.0
Sex: M
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Asthenia, Discomfort, Erythema, Headache, Malaise
Clinical narrative: Patient presented Monday after vaccination with "bug bite" type mark on arm. Represented on Friday 6/26 with extensive marks on his legs resembling a skin reaction or pox. He was directed to seek treatment at facility. He was diagnosed with a viral reaction probably due to vaccine. Patient has fully recovered - spoke to him 7/28/15.
Age: 68.0
Sex: M
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Pruritus, Rash, Rash macular, Rash pustular, Vaccination complication
Clinical narrative: Patient presented Monday after vaccination with "bug bite" type mark on arm. Represented on Friday 6/26 with extensive marks on his legs resembling a skin reaction or pox. He was directed to seek treatment at facility. He was diagnosed with a viral reaction probably due to vaccine. Patient has fully recovered - spoke to him 7/28/15.
Age: 68.0
Sex: M
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Rash pustular, Skin reaction, Viral infection
Clinical narrative: Patient presented Monday after vaccination with "bug bite" type mark on arm. Represented on Friday 6/26 with extensive marks on his legs resembling a skin reaction or pox. He was directed to seek treatment at facility. He was diagnosed with a viral reaction probably due to vaccine. Patient has fully recovered - spoke to him 7/28/15.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Pt states he has body aches, fatigue redness and swelling at the site. Pt requested an appointment with primary care provider after being instructed that the side effects are normal for Anthrax. Primary care provider stated they were normal side effects, prescribed Tylenol for symptoms and excused pt from work for the day.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site.
Age: 31.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: RASH.
Age: 84.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Death, Local reaction, Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a 84 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route of administered was not reported) and PREVNAR. On an unknown date the patient experienced "local reaction which was not specified" and swelling in her feet. The patient did not seek medical attention. On an unknown date the patient passed away. Relatedness between therapy and adverse event was not reported. Additional information is not expected, physician refused to contact to him.