chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: LYME
Symptoms: Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included iritis, macular edema and visual disorder. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). This case was reported via medical records forwarded by a lawyer and described the occurrence of unspecified adverse event(s) in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline). On an unspecified date the subject received unspeciifed dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced unspecified adverse event (s). At the time of reporting the outcome of the event (s) was unspecified. Follow up information was received on 13 November 2008 via a statement of injuries. At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, vision loss, hearing loss, eye pain, headache, fatigue, possibly memory loss, and decreased activities of daily life impaired. He also experienced rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX, including but not limited to those set forth above. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Breast cancer, Cardiovascular insufficiency
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). The subject was a former marathon runner. At an unspecified time after vaccination with LYMERIX, the subject experienced arthralgias, myalgias, muscle weakness, loss of stamina, extreme fatigue, pains in her hands, feet, and neck, and difficulty lifting her arms and legs. It was reported that these problems affect her activities of daily life and her ability to participate in physical activities which were an important part of her life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX in April 1999, May 1999, and April 2000. In late-summer  or fall of 1999, the subject developed fatigue, muscle fatigue, joint pain and stiffness, swelling of extremities, water retention, hot sweats, fevers, Raynaud's syndrome, "total lack of circulation", cracks in her fingertips, and "hand bleaching". In January 2004 she developed stage I breast cancer. In the summer of 2006 she developed sciatica. Other events included jaw pain and trouble speaking and swallowing. All of the reported events were attributed to LYMERIX by the subject. Treatment included chemotherapy and radiation therapy, thymus removal, antibiotics, and other unspecified medications. With the exception of breast cancer and sciatica, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed to be medically significant by GSK.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Dysphagia, Fatigue, Fluid retention, Hyperhidrosis, Hypokinesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). The subject was a former marathon runner. At an unspecified time after vaccination with LYMERIX, the subject experienced arthralgias, myalgias, muscle weakness, loss of stamina, extreme fatigue, pains in her hands, feet, and neck, and difficulty lifting her arms and legs. It was reported that these problems affect her activities of daily life and her ability to participate in physical activities which were an important part of her life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX in April 1999, May 1999, and April 2000. In late-summer  or fall of 1999, the subject developed fatigue, muscle fatigue, joint pain and stiffness, swelling of extremities, water retention, hot sweats, fevers, Raynaud's syndrome, "total lack of circulation", cracks in her fingertips, and "hand bleaching". In January 2004 she developed stage I breast cancer. In the summer of 2006 she developed sciatica. Other events included jaw pain and trouble speaking and swallowing. All of the reported events were attributed to LYMERIX by the subject. Treatment included chemotherapy and radiation therapy, thymus removal, antibiotics, and other unspecified medications. With the exception of breast cancer and sciatica, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed to be medically significant by GSK.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Muscle fatigue, Muscular weakness, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). The subject was a former marathon runner. At an unspecified time after vaccination with LYMERIX, the subject experienced arthralgias, myalgias, muscle weakness, loss of stamina, extreme fatigue, pains in her hands, feet, and neck, and difficulty lifting her arms and legs. It was reported that these problems affect her activities of daily life and her ability to participate in physical activities which were an important part of her life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX in April 1999, May 1999, and April 2000. In late-summer  or fall of 1999, the subject developed fatigue, muscle fatigue, joint pain and stiffness, swelling of extremities, water retention, hot sweats, fevers, Raynaud's syndrome, "total lack of circulation", cracks in her fingertips, and "hand bleaching". In January 2004 she developed stage I breast cancer. In the summer of 2006 she developed sciatica. Other events included jaw pain and trouble speaking and swallowing. All of the reported events were attributed to LYMERIX by the subject. Treatment included chemotherapy and radiation therapy, thymus removal, antibiotics, and other unspecified medications. With the exception of breast cancer and sciatica, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed to be medically significant by GSK.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Pain in extremity, Pain in jaw, Pyrexia, Raynaud's phenomenon, Sciatica
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). The subject was a former marathon runner. At an unspecified time after vaccination with LYMERIX, the subject experienced arthralgias, myalgias, muscle weakness, loss of stamina, extreme fatigue, pains in her hands, feet, and neck, and difficulty lifting her arms and legs. It was reported that these problems affect her activities of daily life and her ability to participate in physical activities which were an important part of her life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX in April 1999, May 1999, and April 2000. In late-summer  or fall of 1999, the subject developed fatigue, muscle fatigue, joint pain and stiffness, swelling of extremities, water retention, hot sweats, fevers, Raynaud's syndrome, "total lack of circulation", cracks in her fingertips, and "hand bleaching". In January 2004 she developed stage I breast cancer. In the summer of 2006 she developed sciatica. Other events included jaw pain and trouble speaking and swallowing. All of the reported events were attributed to LYMERIX by the subject. Treatment included chemotherapy and radiation therapy, thymus removal, antibiotics, and other unspecified medications. With the exception of breast cancer and sciatica, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed to be medically significant by GSK.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Skin discolouration, Skin disorder, Swelling
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). The subject was a former marathon runner. At an unspecified time after vaccination with LYMERIX, the subject experienced arthralgias, myalgias, muscle weakness, loss of stamina, extreme fatigue, pains in her hands, feet, and neck, and difficulty lifting her arms and legs. It was reported that these problems affect her activities of daily life and her ability to participate in physical activities which were an important part of her life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX in April 1999, May 1999, and April 2000. In late-summer  or fall of 1999, the subject developed fatigue, muscle fatigue, joint pain and stiffness, swelling of extremities, water retention, hot sweats, fevers, Raynaud's syndrome, "total lack of circulation", cracks in her fingertips, and "hand bleaching". In January 2004 she developed stage I breast cancer. In the summer of 2006 she developed sciatica. Other events included jaw pain and trouble speaking and swallowing. All of the reported events were attributed to LYMERIX by the subject. Treatment included chemotherapy and radiation therapy, thymus removal, antibiotics, and other unspecified medications. With the exception of breast cancer and sciatica, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed to be medically significant by GSK.
Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Arthralgia, Asthma, Autoimmune disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, possible autoimmune disease, activities of daily living impaired, stiffness, debilitating knee pain, debilitating back pain, headaches, nausea, memory loss and possible neurological problems. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX on 15 May 1999. On the same day, 15 May 1999, she developed flu-like symptoms, fatigue and joint aches and pains. In approximately 2001 she developed asthma and allergies. She also reported gynecological complaints. All events were attributed to LYMERIX by the subject. The case was assessed to be medically significant by GSK based on follow up. Treatment included Syndisc injections and anti-inflammatories. With the exception of flu-like symptoms and fatigue, the events were unresolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Back pain, Fatigue, Headache, Hypersensitivity, Influenza like illness
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, possible autoimmune disease, activities of daily living impaired, stiffness, debilitating knee pain, debilitating back pain, headaches, nausea, memory loss and possible neurological problems. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX on 15 May 1999. On the same day, 15 May 1999, she developed flu-like symptoms, fatigue and joint aches and pains. In approximately 2001 she developed asthma and allergies. She also reported gynecological complaints. All events were attributed to LYMERIX by the subject. The case was assessed to be medically significant by GSK based on follow up. Treatment included Syndisc injections and anti-inflammatories. With the exception of flu-like symptoms and fatigue, the events were unresolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Musculoskeletal stiffness, Nausea, Neurological symptom
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, possible autoimmune disease, activities of daily living impaired, stiffness, debilitating knee pain, debilitating back pain, headaches, nausea, memory loss and possible neurological problems. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX on 15 May 1999. On the same day, 15 May 1999, she developed flu-like symptoms, fatigue and joint aches and pains. In approximately 2001 she developed asthma and allergies. She also reported gynecological complaints. All events were attributed to LYMERIX by the subject. The case was assessed to be medically significant by GSK based on follow up. Treatment included Syndisc injections and anti-inflammatories. With the exception of flu-like symptoms and fatigue, the events were unresolved at the time of this report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oxygen saturation normal, Throat tightness
Clinical narrative: Trouble breathing, feelings of throat closing. Occurred hours after vaccine given. Treatment Benadryl 100mg IM and Decadron 10mg IM.
Age: 3.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Expired drug administered
Clinical narrative: Gave pediatric does of Hepatitis A to this patient after shot gave was when the expiration was noted to be 6 days old. I checked the expiration date prior to shot it did not register as being 6 days expired before I gave the shot. Child is fine, no reaction from shot at all.
Age: 31.0
Sex: U
Vaccine: ANTH
Symptoms: Injection site discomfort, Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: SM developed redness, swelling, itching, discomfort at ANTHRAX vaccination site within 24 hrs of the shot. Symptoms: Edema at injection site 50-120mm, Erythema, Pruritus, Swelling, Tenderness
Age: 31.0
Sex: U
Vaccine: ANTH
Symptoms: Injection site swelling
Clinical narrative: SM developed redness, swelling, itching, discomfort at ANTHRAX vaccination site within 24 hrs of the shot. Symptoms: Edema at injection site 50-120mm, Erythema, Pruritus, Swelling, Tenderness
Age: 35.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: Hepatitis A #1 given 5/08, Hepatitis A #2 given 6/26/08. Pt. has been informed that they need to have the Hep A #2 vaccine given again in Dec, 08.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: On November 7th, 2008 Pt. was brought in to our health unit by his mother and father for his MMR vaccine. I got the vaccine and check the expiration date on the vial which was 01/09 after mixing the vaccine I then proceeded to give pt. the vaccine in his left thigh. The next day an opened box of MMR vaccines that were expired was found in our medication refrigerator with 4 vaccines left, there was also an unopened box of MMR vaccines tat had the expiration date of 10/09 on them. It was thought by the other Nurse here that I gave one of the MMR's from the expired lot which I did not because I can see the vial that I was drawing the medication from in my mind even now and I know with out a doubt that it had the expiration date of 01/09. I am filling out this form because I was asked to by my supervisor, even though I know I did not make a mistake when giving this vaccine.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Fatigue, Headache, Hypophagia, Loss of consciousness
Clinical narrative: Pt received flu vaccination at approx. 0930.  Between 1130-1230 pt reports "passing out" in front of computer.  No witnesses around.  Reports a headache pain of 8/10, pressure at top and sides of head.  Pt also reports fatigue and upper body aches.  Pt took 650mg Tylenol at 1440.  Pt recently returned from R&R about 1.5 weeks ago, still not on regular sleep cycle, reports working out, decreased appetite, and decreased water intake.  Reports no caffeine intake except for an energy drink prior to working out, and taking supplements/vitamins.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt received flu vaccination at approx. 0930.  Between 1130-1230 pt reports "passing out" in front of computer.  No witnesses around.  Reports a headache pain of 8/10, pressure at top and sides of head.  Pt also reports fatigue and upper body aches.  Pt took 650mg Tylenol at 1440.  Pt recently returned from R&R about 1.5 weeks ago, still not on regular sleep cycle, reports working out, decreased appetite, and decreased water intake.  Reports no caffeine intake except for an energy drink prior to working out, and taking supplements/vitamins.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Limb discomfort
Clinical narrative: Fluzone administered on 11/07/08.  On 11/14, patient reported that her arm was achy and she has difficulty in lifting the affected arm, especially early in the AM.  No tenderness upon palpation, no induration or swelling at site.  Writer recommended hot packing, acet/ibuprofen and report back to our office in several days.  On 11/19, patient reported still having weakness.  She will consult a physician.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site rash
Clinical narrative: Receieved vaccine in left deltoid.  Within 20 minutes, 2x2 red rash around injection site.  Pt. states burns/itches.  Rated 5 on pain scale.  B/P 130/70, ice applied, arm elevated.  Called physician/physician ordered 2 benadryl PO stat & to apply ice & elevate.  They stated it was a local reaction.  Pt. states my whole body feels hot.  administered 50 mg (2 capsules) Diphenhydramine Hydrochloride PO.  Pt states Pain is better now.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Enlarged uvula
Clinical narrative: swollen uvula with a "clear film over it" Occurred am after vaccine administered.  Slight sore throat on morning of vaccination.  No fever at all during that day or the day after.  this has happened before. Pt feeling better 11/20/08 and feels sx not related to flu vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Hodgkin's disease
Clinical narrative: Patient dx'd with Hodgkins Lymphoma following the vaccine 1/20/09-records received for DOS 9/13/08-Hodgkin's Disease, nodular sclerosis of intrathoracic lymph nodes. Office notes for GYN visit 3/5/06 C/O left calf cramping. Subsequent visit 11/13/06 received first Gardasil vaccine C/O heavy and cramping periods. 8/5/08-sports physical exam enlarged group of cervical lymph nodes. Contact dermatitis and other eczema on visit 7/30/07. 1/8/08 C/O shoulder pain for 4 weeks. 2/14/08 presented with cough, chest tight, sinus congestion, hoarseness, runny nose, sore throat. 3/26/08 blood in BMs times 1 month. 4/22/08-insidious onset cervical pain referred to shoulder. 1/30/09-records received oncology records indicate date of diagnosis 8/20/08 Hodgkin's after routine physical exam 8/5/08 when large right cervical lymphnode discovered. Receiving chemotherapy.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Swelling, redness, below arm approximately 3 inches where shot was given rt. arm  Went to Md. Thursday stated infected-physician gave antibiotics.  Pain, body aches and arm pain. Went to MD receieved antibiotic Levaquin 500 mg. q day.  Started 10/16/08. Put cool compress, rest sore arm, Tylenol if needed.  Physician ordered IV anibiotics.  Physician concerned it may be Staph infection, referred to Dr.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy skin, Pruritus, Rash
Clinical narrative: Rash accompanied by itching.  First appeared in groin area on 10/24/08.  Applied topical ointment.  Began to subside after 4-5 days.  Resurfaced in navel and both ankles on 10/30/08.  Applied topical ointment.  Began to subside after 4-5 days.  Resurfaced on both forearms, upper arms, underarms, scrotum and anus on 11/6/08.  Visited family physician and dermatologist on 11/7/08 and 11/10/08 respectively.  Unable to readily determine cause.  Continued applying topical ointment.  Rash showed little signs of improvement and resurfaced on left ankle.  Returned to dermatologist on 11/14/08.  Took biopsy from left arm (results pending).  Administered Prednisone 20 mg. for 8 days.  Treatment not yet completed.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Computerised tomogram, Endoscopy, Endoscopy upper gastrointestinal tract, Muscle spasms, Nausea
Clinical narrative: Severe swollen arm and four days later neck spasms started from neck down to swollen arm.  Nausea.  Spasms have not stopped and continue in roof of mouth, lower head and neck, both front and back, also in esophagus and chest.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Oedema peripheral, Oesophageal spasm
Clinical narrative: Severe swollen arm and four days later neck spasms started from neck down to swollen arm.  Nausea.  Spasms have not stopped and continue in roof of mouth, lower head and neck, both front and back, also in esophagus and chest.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Eye pruritus, Eye swelling, Headache, Ocular hyperaemia
Clinical narrative: Pt. reported she started experiencing symptoms approximately four hours after receiving the vaccination. Symptoms included wheezing, eyes - burning, itching, redness and swelling, swelling of the throat, fever, and headache. Stated she took Advil and went to bed. Called the Health Department and made the report the next day.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pyrexia, Wheezing
Clinical narrative: Pt. reported she started experiencing symptoms approximately four hours after receiving the vaccination. Symptoms included wheezing, eyes - burning, itching, redness and swelling, swelling of the throat, fever, and headache. Stated she took Advil and went to bed. Called the Health Department and made the report the next day.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Sore, slightly swollen right arm.  Approximately 3-4 hours later.  Put cool compresses in evening then warm this a.m.  Coordinator advised to continue cool compresses, Tylenol if able and needed.  If feel the need you can call your physician.  Patient stated she will be calling her physician or going to Emergency room is problem persists..
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 4 inch red edematous area over left tricept. Warm to touch and no pruritus. First appeared as small welt 24hrs after administration. Increased in diameter at 36hrs. Benadryl given. Site continues to appear warm, red, and slightly edematous after 48hrs. Client remains afebrile.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Swelling, Tenderness
Clinical narrative: Red, sore, swollen, temperature of 100, don't feel sick just arm hurts.  Patient took Tylenol. Coordinator recommended applying a ice-pack, take Tylenol, no lifting per that arm, elevate arm at rest, phone MD if problems persist. Patient went to physician....antibiotics were ordered ...at this time everything resolved....
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Patient reported having a local reaction at the site of injection. No medical attention requested.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Dizziness, Nausea
Clinical narrative: after administration pt felt light headed. sat pt down, pt requested to lay down.  had pt sit on floor and emt was called. pt conplained of stomach pain and "a little nausea." emt responded within 15 minutes.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Headache, Hypoaesthesia, Hypoaesthesia facial, Pain in extremity
Clinical narrative: Patient given vaccine about 4:30 pm, some pain in arm, otherwise ok until about 1:30 am awoke with numbness and tingling in her legs, severe headache, and abdominal pain.  She also developed tingling and numbness in the arms and face.  No visable swelling or redness at injection site.  Mother treated her with ibuprofen and bedrest.  Symptoms resolved after about 24 hrs.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Patient given vaccine about 4:30 pm, some pain in arm, otherwise ok until about 1:30 am awoke with numbness and tingling in her legs, severe headache, and abdominal pain.  She also developed tingling and numbness in the arms and face.  No visable swelling or redness at injection site.  Mother treated her with ibuprofen and bedrest.  Symptoms resolved after about 24 hrs.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: Patient had pain in her arm. It radiated up to her neck and made it painful to put on a sweater, drive her car, or lie down. Sometimes she got headaches. Tylenol didn't seem to help.
Age: 1.25
Sex: F
Vaccine: DTAPH, FLU3, PNC
Symptoms: Irritability, Rash
Clinical narrative: rash & irritability
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Tenderness
Clinical narrative: diffused light erthema over 50% of lateral upper arm ,tender to touch ,limited ROM at shoulder.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, House dust allergy, Immediate post-injection reaction, Throat irritation
Clinical narrative: felt chest heaviness, funny sensation in throat almost immediately after injection. checked blood pressure, monitored for 30 minutes with resolution of symptoms.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture, Delirium, Laboratory test, Pyrexia
Clinical narrative: Fever and delirium for several hours starting 3-4 hrs post vaccines. Resolved spontaneously. 11/24/08 D/C summ received for DOS 11/12-15/2008 with D/C DX:  Pituitary Cystic Adneoma.  Episodic fever-resolved.  Incontinence-resolved.  Altered mental status-resolved. Hyperlipidemia.  HTN. Acute kidney failure-resolving.  Anemia. Pt presented to ER with fever, delium, confusion and urinary incontinence which began several hours after receiving flu and pneumonia vaccines. Pt admitted an by the following morning sx had resoved with abx.  The evaluation revealed other medical problems: Acute renal failure, blood pressure elevation, anemia and a Pituitary adenoma which will be followed as an outpatient.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site atrophy, Injection site erythema, Tenderness
Clinical narrative: 3 weeks post vaccination patient had red indented area size of quarter at site of injection.  Tender to touch and turned bright red after showering. Was not improving and was going to see physician.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles rash noted 10/31/2008.  No fever or other symptoms.  Self resolved.
Age: 32.0
Sex: M
Vaccine: ANTH, MNQ, SMALL
Symptoms: Chest discomfort, Dyspnoea, Pyrexia, Tachycardia
Clinical narrative: Patient received Smallpox vaccine on 06Sep08 and was seen at the emergency room on 14Sep08 for tachycardia, fever, shortness of breath and pressure in chest.  12/8/08 ER record received for DOS 9/14/08 with DX: Adverse effect to smallpox vaccine. Pt presented with tachycardia, fever, shortness of breath and chest pressure 8 days s/p smallpox vaccination. PE (+) for tachycardia, anxiety and ulceration at the smallpox vaccination site on the LUE.  Tx with Toradol and Indocin.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Decreased appetite, Dizziness, Malaise, Tenderness
Clinical narrative: This nurse realized she gave (2) flu shots to (1) person vs giving a flu and pneumonia as intended.  She indicated there were (2) people in line and that she drew up (2) syringes with flu vaccine.  While patient was filling out consent form the client decided to get a pneumonia shot so nurse drew up a pneumonia shot and laid it by glove to know that is what it was.  She then gave flu shot and when she was supposed to grab the pneumonia she accidently grabbed the other syringe with the flu vaccine and administered.  Nurse stated that she did not notice this error until serving the next client.  Nurse noticed that the syringe was still sitting by the glove and she knew that is where she sat the pneumonia vaccine filled syringe. Flu coordinator notified patient of possible side effects.  Flu coordinator verified possible side effects with flu manufacturer.  Flu coordinator notified patient physician...no orders given  Right arm sore.  Patient complained of chills, sick to stomach, lack of hunger, vomited, dizziness.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting, Wrong drug administered
Clinical narrative: This nurse realized she gave (2) flu shots to (1) person vs giving a flu and pneumonia as intended.  She indicated there were (2) people in line and that she drew up (2) syringes with flu vaccine.  While patient was filling out consent form the client decided to get a pneumonia shot so nurse drew up a pneumonia shot and laid it by glove to know that is what it was.  She then gave flu shot and when she was supposed to grab the pneumonia she accidently grabbed the other syringe with the flu vaccine and administered.  Nurse stated that she did not notice this error until serving the next client.  Nurse noticed that the syringe was still sitting by the glove and she knew that is where she sat the pneumonia vaccine filled syringe. Flu coordinator notified patient of possible side effects.  Flu coordinator verified possible side effects with flu manufacturer.  Flu coordinator notified patient physician...no orders given  Right arm sore.  Patient complained of chills, sick to stomach, lack of hunger, vomited, dizziness.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: On 10/27/08 a 70 y/o female was vaccinated with influenza and pneumococcal vaccine at a senior citizen community walk-in vaccination clinic.  The vaccines were provided by the agency and administered by the nursing staff. Pneumo and Flu vaccine were administered at the same time in different sites.  Patient notified the Health Department Vaccine Safety Officer to report the following event:  Aprox. 24 hours post vaccination the pt. c/o Lt. deltoid redness, extending to under armpit, with accompanying pain lasting 7 days.  Pneumo  vaccine documented was administered Lt. deltoid.   Pt saw Pvt. MD on 10/29/08 was evaluated no Tx or therapies given.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Pain in extremity
Clinical narrative: 10/14/08: patient received Fluvirin in left deltoid 10/30/08: patient went to see physician for complaint of pain in left arm. Pain started 2 days after receiving injection. Physician reported no obvious lesion, no erythema or warm of shoulder; and patient has full range of motion. Physician concluded "probably reaction to flu injection and prescribed Celebrex. 11/04/08: Patient came in to store and reported her complaint. Patient stated to me that she still have pain in left shoulder that seems to move to different areas of her left arm such as to shoulder and arm pit, but no where else. Patient said that pain is not getting worse but decreasing at a very slow rate. Patient also stated that she has "hematoma". However, her physician's report did not indicate "hematoma". Upon examining of her arm, I did see any bruising, skin discoloration, or any other physical signs that would indicate "hematoma" or pain. 11/18/08: I called patient so check on her current condition. Patient stated that her pain has decreased, but it is still there and has not completely returned to pre-vaccination state.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site erythema
Clinical narrative: NUMBNESS IN HANDS AND ARMS, REDNESS AT SITE OF INJECTION
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site pain, Injection site pruritus
Clinical narrative: Received vaccine on the 14th, on the 17th, the redness began, and this morning, pt noticed a red ring around the redness.  C/o itching and pain at site.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site infection, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Right axillary and cervical gland swollen and painful.  Low grade fever.  Infected wound around small pox innoculation site.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient received first immunization in series and within 15 minutes of administration, had syncopal episode
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Received vaccine on 11/4.  On 11/5, developed fever of less than 102 degrees, which lasted for two days, along with body aches.  also developed cellulitis at injection site on left upper thigh.  Site became swollen, red, very sore and made mucsle ache and leg weak when attempting to stand.  Fever resolved in two days, but cellulitis covered a patch of skin 3" by 7" across top of thigh, then going down side of outer thigh another 3" by 7" down.  Area was very tender to touch, swollen, itchy, and sore.  The redness and swelling and itch lasted until 11/10, and soreness until 11/14.  Redness gradually faded.  I did return to my doctor for consultation regarding the cellulitis to see if medical intervention was necessary.  He decided to hold off on antibiotics to see if condition resolved on its own.  It is now okay, with only slight soreness, but no redness or itch as of 11/20
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Muscular weakness, Myalgia, Pain, Pyrexia
Clinical narrative: Received vaccine on 11/4.  On 11/5, developed fever of less than 102 degrees, which lasted for two days, along with body aches.  also developed cellulitis at injection site on left upper thigh.  Site became swollen, red, very sore and made mucsle ache and leg weak when attempting to stand.  Fever resolved in two days, but cellulitis covered a patch of skin 3" by 7" across top of thigh, then going down side of outer thigh another 3" by 7" down.  Area was very tender to touch, swollen, itchy, and sore.  The redness and swelling and itch lasted until 11/10, and soreness until 11/14.  Redness gradually faded.  I did return to my doctor for consultation regarding the cellulitis to see if medical intervention was necessary.  He decided to hold off on antibiotics to see if condition resolved on its own.  It is now okay, with only slight soreness, but no redness or itch as of 11/20
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Anaemia, Arthralgia, Blood test abnormal, C-reactive protein increased, Insomnia
Clinical narrative: Debilitating joint pain, joint aches, that began within one hour and a half after injection was given. Pain resulted in loss of sleep for several days. Self treatment with Tylenol accomplished no relief. Visited Urgent Care on 11/16 and was seen by Dr. Blood tests were done. The doctor prescribed 600 mg ibuprofen 3 x daily which resulted in some relief. Advised to follow up in two days with primary care doctor who diagnosed arthralgia, and unspecified anemia. Pain still exists at this date. Blood tests to follow to determine further treatment.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Debilitating joint pain, joint aches, that began within one hour and a half after injection was given. Pain resulted in loss of sleep for several days. Self treatment with Tylenol accomplished no relief. Visited Urgent Care on 11/16 and was seen by Dr. Blood tests were done. The doctor prescribed 600 mg ibuprofen 3 x daily which resulted in some relief. Advised to follow up in two days with primary care doctor who diagnosed arthralgia, and unspecified anemia. Pain still exists at this date. Blood tests to follow to determine further treatment.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: PAIN AND WEAKNESS AT INJECTION SITE SINCE VACCINE ADMINISTRATION ON 10/14/2008
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Joint swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: PAIN AND WEAKNESS AT INJECTION SITE SINCE VACCINE ADMINISTRATION ON 10/14/2008
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: arm red, swollen, itchy
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Epilepsy
Clinical narrative: "Irregular" epileptic seizure in patient with previous history of medication-controlled epilepsy.
Age: 1.92
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given immunizations 2 weeks early, should have been given at 12 months. Patient will be re-immunized after birtdate.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red and warm rash on left arm for the past 1 day.Treatment plan: Cephlexin 250 mg 2 tsps po Tid x days. Otc benadryl Q 4 to 6 hours until clear. Cool compress and ibuprofen prn.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling hot, Headache, Oropharyngeal pain
Clinical narrative: After 3 hours  of get the vaccination,  I felt  my throat like stuck and I felt  pain in my throat too.The next day  I felt  headache and felt   heat in some parts of my body.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Within 30-45 minutes of receiving vaccine I experienced mild dizziness which lasted continually for about 4 hours.  I have had numerous flu vaccines in years past and never experienced any reaction.
Age: 49.0
Sex: M
Vaccine: FLUN3
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Nurse Administered the FLUMIST as directed to each nostril. Immediately the patient became pale he complained of nausea, light headed and he began to sweat. Nurse took his blood pressure and it was 80/60. We then made him comfortable and watched him for about 10 minutes and then called 911. An ambulance arrived and took him to the hospital.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pharyngeal hypoaesthesia, Swelling, Tachycardia paroxysmal, Tenderness
Clinical narrative: 38 year old received the FLUARIX on the rt. deltoid area IM on 11/4/08. 3 days later she returned to the health department c/o Rt. deltoid area pain (8 on 1-10 scale), local tenderness, mild swelling, numbness throat radiated distally and ROM, and paroxysmal tachycardia. Pt was advised to cont. taking Ibuprofen, warm compresses, and see her primary care provider for further evaluation. Pt. returned on 11-10-08 c/o minor changes and improvement. Referred to PCP.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Swelling
Clinical narrative: Received Flu vaccine at Wellness fair around 1330. Noticed lip tingling and swelling at around 8PM. Took Benadryl 50mg tablet to relieve symptoms.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy
Clinical narrative: FLUVIRIN was administered to a pregnant women. On 11/08/08 this patient should have received FLUARIX (thimerosal free) vaccine Per follow-up: Box 11 - There is no adverse event. Customer is fine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt has red, raised, warm area of 80mm X 60mm. Pt advised to take Benadryl at home & monitor breathing. If breathing difficulties arise call EMS or physician.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Area to right upper arm anterior deltoid of approximately 20 cm in length going distally from deltoid towards anticubital joint but not involving joint, and 16cm in width at widest point lateral to medial with irregular demarcated borders pink/erythematous in color, with warmth to touch, superficial edema.
Age: 52.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Headache, Presyncope, Pyrexia
Clinical narrative: Received Imming globulin & RABAVERT on 11/15/08 late pm?  Developed slight HA next couple of days.  On 11/18/08 = 23:30 HA increased, fever 10 degrees, pre-syncope episode. Tylenol taken at home s/s improved.  HA remained.  Seen 11/19/08 for 2nd series RABAVERT.  Dose given = 16:00.  Will determine if RX reoccurs if vaccine caused or immune globulin or other.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis like in (L) upper arm.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Influenza like illness, Pain
Clinical narrative: ! day after receiving vaccine, had symptoms of achiness, flu-like symptoms, temperature 100.1(1 hour after TYLENOL) dry hackey cough. Put on antibiotics, ZITHROMAX 250mg by mouth times 7 days( 5days after vaccine administered. Patients brother had similar reaction).
Age: 4.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Adenotonsillectomy, Condition aggravated, Pain, Sleep apnoea syndrome, Tonsillitis
Clinical narrative: A serious study report of tonsillitis and obstructive sleep apnea was received from a study investigator, concerning a four year-old female patient (patient 56398710) enrolled in post marketing study. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FLUMIST. Medical history includes tonsillitis and obstructive sleep apnea diagnosed on 14-Aug-2007. The patient also has a history of urticaria. Patient was not on any concomitant medication and has no known allergies. The subject is in daycare and gets frequent colds. The patient received FLUMIST on 12-Nov-2007 for influenza immunization. The patient was hospitalized on 26-Nov-2007 for tonsillitis and obstructive sleep apnea. Tonsillectomy and adenoidectomy were performed and were well tolerated. The patient recovered and was discharged on 27-Nov-2007. The events were considered mild. The patient reported pain a week after procedure and subsequently the pain medication was increased and was advised to increase fluid intake. The investigator assessed the events as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Sleep apnoea syndrome, Tonsillitis
Clinical narrative: A serious study report of tonsillitis and obstructive sleep apnea was received from a study investigator, concerning a four year-old female patient (patient 56398710) enrolled in post marketing study. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FLUMIST. Medical history includes tonsillitis and obstructive sleep apnea diagnosed on 14-Aug-2007. The patient also has a history of urticaria. Patient was not on any concomitant medication and has no known allergies. The subject is in daycare and gets frequent colds. The patient received FLUMIST on 12-Nov-2007 for influenza immunization. The patient was hospitalized on 26-Nov-2007 for tonsillitis and obstructive sleep apnea. Tonsillectomy and adenoidectomy were performed and were well tolerated. The patient recovered and was discharged on 27-Nov-2007. The events were considered mild. The patient reported pain a week after procedure and subsequently the pain medication was increased and was advised to increase fluid intake. The investigator assessed the events as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Adenotonsillectomy, Condition aggravated, Pain, Sleep apnoea syndrome, Tonsillitis
Clinical narrative: A serious post-marketed study report of tonsillitis and obstructive sleep apnea has been received from a study investigator concerning a four-year old female subject, patient ID 56398610, participating in a post-marketing study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this subject. The subject received FLUMIST on 12-Nov-2007. On 26-Nov-2007, the subject was hospitalized for tonsillitis and obstructive sleep apnea. The subject's length of hospital stay was one day. The outcome is unknown. The investigator assessed the events of tonsillitis and obstructive sleep apnea as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST.