chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Electrocardiogram, Feeling cold, Fluid retention, Intensive care, Joint swelling
Clinical narrative: Information has been received from a consumer concerning an 86 (also reported as 88) year old male who in approximately 2007 "about 2-3 years ago" was vaccinated with a first dose of PNEUMOVAX 23 (route and lot # invalid). On 06-OCT-2010 the patient went to his HCP for a respiratory illness and was placed on amoxicillin. On 10-OCT-2010 the patient received a flu shot at church (manufacturer unknown). On 21-OCT-2010 the patient received a chest x-ray and electrocardiogram from HCP (result unknown) and received a second dose of PNEUMOVAX 23 (route and lot # invalid). On 22-OCT-2010 the patient had trouble breathing, felt cold, no fever reported. On 23-OCT-2010 to 24-OCT-2010 the patient experienced foot and joint swelling. On 21-OCT-2010 to 25-OCT-2010 the patient reported 8-10 pound weight gain. On 25-OCT-2010 nurse practitioner sent patient to the emergency room. The patient was admitted to the ICU with diagnoses of congestive heart failure and fluid retention. On 29-OCT-2010 to 30-OCT-2010 was further diagnosed with pneumonia. The patient was discharged to home with medications for asthma, diuretics and antibiotics. On 04-NOV-2010 the patient continued with persistent cough labored breathing and wheezing. Fluid retention resolved. At the time of this report, the patient's outcome was not recovered. Congestive heart failure, pneumonia and fluid retention were considered to be other important medical events by the reporter. Additional information has been requested. The patient was hospitalized.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pneumonia, Respiratory disorder, Weight increased, Wheezing
Clinical narrative: Information has been received from a consumer concerning an 86 (also reported as 88) year old male who in approximately 2007 "about 2-3 years ago" was vaccinated with a first dose of PNEUMOVAX 23 (route and lot # invalid). On 06-OCT-2010 the patient went to his HCP for a respiratory illness and was placed on amoxicillin. On 10-OCT-2010 the patient received a flu shot at church (manufacturer unknown). On 21-OCT-2010 the patient received a chest x-ray and electrocardiogram from HCP (result unknown) and received a second dose of PNEUMOVAX 23 (route and lot # invalid). On 22-OCT-2010 the patient had trouble breathing, felt cold, no fever reported. On 23-OCT-2010 to 24-OCT-2010 the patient experienced foot and joint swelling. On 21-OCT-2010 to 25-OCT-2010 the patient reported 8-10 pound weight gain. On 25-OCT-2010 nurse practitioner sent patient to the emergency room. The patient was admitted to the ICU with diagnoses of congestive heart failure and fluid retention. On 29-OCT-2010 to 30-OCT-2010 was further diagnosed with pneumonia. The patient was discharged to home with medications for asthma, diuretics and antibiotics. On 04-NOV-2010 the patient continued with persistent cough labored breathing and wheezing. Fluid retention resolved. At the time of this report, the patient's outcome was not recovered. Congestive heart failure, pneumonia and fluid retention were considered to be other important medical events by the reporter. Additional information has been requested. The patient was hospitalized.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Arthritis allergic, Asthma, Axillary pain, Back pain
Clinical narrative: Information has been received from a 43 year old female with sulfa, penicillin and erythromycin allergies and asthma, allergic rhinitis and depression who on 04-NOV-2010 was vaccinated IM with a first dose of PNEUMOVAX 23 (lot# not reported). Concomitant therapy included cetirizine hydrochloride, LEXAPRO and ESTRACE. On 05-NOV-2010 "about 25 hours later" the patient began to have back pain which spreaded to the sternum. She had pain in the arm, armpit and chest. Also, she had neck stiffness. A 6 inch by 5 inch area of induration developed at the injection site. The skin was red, painful and hot in that area. She also developed malaise, nausea, headache and loss of appetite. At the time of report, the patient was recovering. No diagnostic laboratory tests were performed. The patient sought unspecified medical attention. It was reported that these adverse effects had kept her in bed and in her house for 4 days. They were considered to be disabling. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Decreased appetite, Depression, Headache, Injection site erythema
Clinical narrative: Information has been received from a 43 year old female with sulfa, penicillin and erythromycin allergies and asthma, allergic rhinitis and depression who on 04-NOV-2010 was vaccinated IM with a first dose of PNEUMOVAX 23 (lot# not reported). Concomitant therapy included cetirizine hydrochloride, LEXAPRO and ESTRACE. On 05-NOV-2010 "about 25 hours later" the patient began to have back pain which spreaded to the sternum. She had pain in the arm, armpit and chest. Also, she had neck stiffness. A 6 inch by 5 inch area of induration developed at the injection site. The skin was red, painful and hot in that area. She also developed malaise, nausea, headache and loss of appetite. At the time of report, the patient was recovering. No diagnostic laboratory tests were performed. The patient sought unspecified medical attention. It was reported that these adverse effects had kept her in bed and in her house for 4 days. They were considered to be disabling. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Malaise, Musculoskeletal stiffness
Clinical narrative: Information has been received from a 43 year old female with sulfa, penicillin and erythromycin allergies and asthma, allergic rhinitis and depression who on 04-NOV-2010 was vaccinated IM with a first dose of PNEUMOVAX 23 (lot# not reported). Concomitant therapy included cetirizine hydrochloride, LEXAPRO and ESTRACE. On 05-NOV-2010 "about 25 hours later" the patient began to have back pain which spreaded to the sternum. She had pain in the arm, armpit and chest. Also, she had neck stiffness. A 6 inch by 5 inch area of induration developed at the injection site. The skin was red, painful and hot in that area. She also developed malaise, nausea, headache and loss of appetite. At the time of report, the patient was recovering. No diagnostic laboratory tests were performed. The patient sought unspecified medical attention. It was reported that these adverse effects had kept her in bed and in her house for 4 days. They were considered to be disabling. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity
Clinical narrative: Information has been received from a 43 year old female with sulfa, penicillin and erythromycin allergies and asthma, allergic rhinitis and depression who on 04-NOV-2010 was vaccinated IM with a first dose of PNEUMOVAX 23 (lot# not reported). Concomitant therapy included cetirizine hydrochloride, LEXAPRO and ESTRACE. On 05-NOV-2010 "about 25 hours later" the patient began to have back pain which spreaded to the sternum. She had pain in the arm, armpit and chest. Also, she had neck stiffness. A 6 inch by 5 inch area of induration developed at the injection site. The skin was red, painful and hot in that area. She also developed malaise, nausea, headache and loss of appetite. At the time of report, the patient was recovering. No diagnostic laboratory tests were performed. The patient sought unspecified medical attention. It was reported that these adverse effects had kept her in bed and in her house for 4 days. They were considered to be disabling. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Heaviness, extreme redness and swelling appox. 5" vertically and the complete circumference of the arm. Soreness - pain - difficulty lifting the arm - condition continued for 4 days - slightly elevated body temperature for 2 days - still today sensitive and itching but no rash.
Age: 80.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Sensation of heaviness
Clinical narrative: Heaviness, extreme redness and swelling appox. 5" vertically and the complete circumference of the arm. Soreness - pain - difficulty lifting the arm - condition continued for 4 days - slightly elevated body temperature for 2 days - still today sensitive and itching but no rash.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria, Rash, Urticaria
Clinical narrative: Patient presented with rash/hives on injection arm from wrist to deltoid. Phoned approx. 6 hours after vaccination. I informed patient to take BENADRYL and seek treatment if worsens.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Right upper arm swollen, warm to touch, pain with movement (deltoid muscle injection site to elbow).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt called complaining of arm still being tender & sore at injection site after 2 wks.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Blood human chorionic gonadotropin, Drug exposure during pregnancy
Clinical narrative: Information has been received from a Health care worker, for GARDASIL a pregnancy registry product, concerning a 16 year old female with no reported drug reactions/allergies and medical history who on 30-JUL-2007 and 18-JUN-2008 was vaccinated with a first and third dose respectively of GARDASIL (route, dose and lot number of the first dose was not reported) (route IM, 0.5ml and lot number: 660555/0279X for the third dose). There was no concomitant medication. The health care coworker stated that after the third dose of GARDASIL shot was given (on 18-JUN-2008), the reporter found out that the patient was 14 weeks pregnant (approximately LMP: 11-MAR-2008, EDD:17?-DEC-2008 date approximately) at the time she received the third vaccination. Also the Health care worker reported, the patient was not pregnant at the time of the first and second shots. The baby was given up for adoption so they did not have access to any additional information on the baby. The patient had not been in the office since "June 2008" so they did not know the present status. A pregnancy test was performed. No adverse effects reported. The patient sought medical attention at the physician's office. Follow-up information has been received via telephone call from an other health professional on 05-NOV-2010 regarding pregnancy outcome information of the patient. Patient's mother was called to find out the outcome and she reported that they decided to terminate the pregnancy (date not provided). The patient and her family did not have the pregnancy terminated due to GARDASIL, rather because the patient was so young. Upon internal review termination of pregnancy was determined to be an other important medical event. No further information is available.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Muscular weakness, Myositis, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Arm hurts, can't lift arm above shoulders or push open door with that arm. Dr diagnosed inflammation of the muscle. Is taking Ibu 600 qid.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Arm hurts, can't lift arm above shoulders or push open door with that arm. Dr diagnosed inflammation of the muscle. Is taking Ibu 600 qid.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Arm hurts, can't lift arm above shoulders or push open door with that arm. Dr diagnosed inflammation of the muscle. Is taking Ibu 600 qid.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Feeling hot, Flushing
Clinical narrative: 10:15 PM (10-25-2010) - cough and tightness in throat. Within minutes, progressed into wheezing and difficulty breathing. Tightness could be felt further down wind pipe. At this point, I did not connect any of this to the flu shot. No hives, no heart palpitations, no dizziness, no fever. I had no noticeable problem at the injection site. 11:00 PM (10-25-2010) - Took 4 tsp of liquid DIMATAPP (which is what I take for my seasonal allergies) prior to going to bed, hoping it would ease the difficulty in breathing. I don't think it helped. 2-3 AM (10-26-2010) - awoke with inside of upper mouth swollen, still had difficulty breathing, had chills and all-over body aches, felt feverish. I realized that all of these symptoms may be a reaction to the flu shot. 7-8 AM (10-26-2010) - awoke, still with body aches. Swelling in mouth subsided, but still a bit swollen. No difficulty breathing. Still felt flushed and feverish. Took oral temperature - did not register above 98 degrees. I took my normal daily medication (including low dosage aspirin). I took no other pain relief medication. By the evening of 10-26-10 - I was back to normal, no difficulty breathing, no swelling in mouth, no body aches, no flushed feeling.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema mouth, Pain, Throat tightness, Wheezing
Clinical narrative: 10:15 PM (10-25-2010) - cough and tightness in throat. Within minutes, progressed into wheezing and difficulty breathing. Tightness could be felt further down wind pipe. At this point, I did not connect any of this to the flu shot. No hives, no heart palpitations, no dizziness, no fever. I had no noticeable problem at the injection site. 11:00 PM (10-25-2010) - Took 4 tsp of liquid DIMATAPP (which is what I take for my seasonal allergies) prior to going to bed, hoping it would ease the difficulty in breathing. I don't think it helped. 2-3 AM (10-26-2010) - awoke with inside of upper mouth swollen, still had difficulty breathing, had chills and all-over body aches, felt feverish. I realized that all of these symptoms may be a reaction to the flu shot. 7-8 AM (10-26-2010) - awoke, still with body aches. Swelling in mouth subsided, but still a bit swollen. No difficulty breathing. Still felt flushed and feverish. Took oral temperature - did not register above 98 degrees. I took my normal daily medication (including low dosage aspirin). I took no other pain relief medication. By the evening of 10-26-10 - I was back to normal, no difficulty breathing, no swelling in mouth, no body aches, no flushed feeling.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Insomnia
Clinical narrative: Had PNEUMOVAX in right arm 11-2-10. Had pain at site - wakes him at night. No redness or edema at site. Called on 11-4-10 with adverse event. Using one ALEVE at bedtime with minimal pain relief. I asked him to review the PNEUMOVAX vis. May try over the counter ALEVE two times a day, 12 hours apart if tolerated. May use ice pack prn to site.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Burning sensation when vaccine given with immediate right arm pain stiffness in right side neck 5-6 hours following vaccination lasted 2 days. Used ice pack on right arm, heat pack on neck, used TYLENOL, too.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: 1.75 in x 1.25 in area of erythema no fever no pain.
Age: 29.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Headache, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: Congestion, headache, nausea, complained of feeling cold, sweaty these symptoms lasted approx. 30 hours also complained of numbness/tingling left hand this lasted approx. 12 hours. All symptoms started 11/4/10 at 2:30 AM.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Respiratory tract congestion
Clinical narrative: Congestion, headache, nausea, complained of feeling cold, sweaty these symptoms lasted approx. 30 hours also complained of numbness/tingling left hand this lasted approx. 12 hours. All symptoms started 11/4/10 at 2:30 AM.
Age: 1.07
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Allergy test negative, Full blood count normal, Gait disturbance, Injection site erythema, Injection site pain
Clinical narrative: Mom stated pt awoke on 11-04-10 the right thigh was red, swollen and warm to touch. On 11-05-10 leg was even more red, swollen and painful to walk. Mom brought pt to office.
Age: 1.07
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mom stated pt awoke on 11-04-10 the right thigh was red, swollen and warm to touch. On 11-05-10 leg was even more red, swollen and painful to walk. Mom brought pt to office.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cough, Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat, weakness, tired, cough, stuffy nose, aches, symptoms would come & go for about 2 full weeks
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Sore throat, weakness, tired, cough, stuffy nose, aches, symptoms would come & go for about 2 full weeks
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Patient reported intense pain in joints.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgias fatigue, beginning 6 hours-after vaccine. As of 11-8-10 symptoms persist.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 22-OCT-2010 was intramuscularly vaccinated with a second dose of GARDASIL (lot # "10172"). After receiving vaccine, the patient reported that her arm was sore and swollen. The physician had prescribed the patient BENADRYL. On 02-NOV-2010, the patient called the doctor's office stating that the diphenhydramine hydrochloride did not work and that her arm hurt even worse, with pain extending from her shoulder to her finger. The patient stated that she was not able to use her arm. She was then sent to urgent care (location and duration unspecified) and was given ibuprofen and a muscle relaxer. No diagnostic laboratory tests were performed. On 03-NOV-2010 the patient called said she was slightly better but not recovered. According to the reporter the patient's arm sore and swollen were considered to be disabling. The reporter also considered that the events were other important medical event since the patient "was treated with diphenhydramine hcl and a muscle relaxer." Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at site since receiving injection until now.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Activities of daily living impaired, Arthralgia, Arthritis infective, Blood test
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 08-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot # 662304/1013Y). Concomitant therapy included VAQTA (Lot # 667827/0416Z), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and MENACTRA. On 09-JUN-2010 the patient experienced severe stomach ache, constipation, pain on the right side and joint pain after receiving GARDASIL. The patient went to ER and the final diagnosis was mesenteric adenitis with post infectious arthritis and was hospitalized. The patient had some blood tests performed (results not provided). At the time of the report, the patient's arthritis continued and the outcome for mesenteric adenitis was unknown. The physician said that experience was considered to be disabling as it had kept the patient from participating in sports. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Constipation, Flank pain, Lymphadenitis, Pain
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 08-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot # 662304/1013Y). Concomitant therapy included VAQTA (Lot # 667827/0416Z), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and MENACTRA. On 09-JUN-2010 the patient experienced severe stomach ache, constipation, pain on the right side and joint pain after receiving GARDASIL. The patient went to ER and the final diagnosis was mesenteric adenitis with post infectious arthritis and was hospitalized. The patient had some blood tests performed (results not provided). At the time of the report, the patient's arthritis continued and the outcome for mesenteric adenitis was unknown. The physician said that experience was considered to be disabling as it had kept the patient from participating in sports. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site warmth, Insomnia, Limb discomfort
Clinical narrative: "No pain from needle but instant hot as medication dispensed. Within 10 minutes arm became sore. By nightfall, could not raise right arm above head. Dull ache - constant". Neck became stiff by 2nd night - very stiff by morning - seems to loosen up by morning (mid-am). Not sore to touch. "Used TYLENOL, rubbed area, stretched". 11-10-10 Right arm discomfort persists. Limited ability to raise right arm overhead. Poor sleeping ability due to pain rated 7-8 - uses anti-inflammatory meds. Use of warm moist compresses, anti-inflammatory meds, gentle stretching right arm encouraged.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: "No pain from needle but instant hot as medication dispensed. Within 10 minutes arm became sore. By nightfall, could not raise right arm above head. Dull ache - constant". Neck became stiff by 2nd night - very stiff by morning - seems to loosen up by morning (mid-am). Not sore to touch. "Used TYLENOL, rubbed area, stretched". 11-10-10 Right arm discomfort persists. Limited ability to raise right arm overhead. Poor sleeping ability due to pain rated 7-8 - uses anti-inflammatory meds. Use of warm moist compresses, anti-inflammatory meds, gentle stretching right arm encouraged.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pain and severe soreness in right arm that radiated down arm to hand, up to right shoulder and neck. Pain NOT easily relieved with MOTRIN or TYLENOL. Started 1 hour after injection, lasted 48 hours.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Pain, Retching
Clinical narrative: Saturday 9/18/10 a.m. stomach ache, dry heaves, headache "all over" used TYLENOL and ice pack with final relief 9-21-10. No fever. "Wonders if swine flu vaccine caused a problem". Started day after flu shot given 9-17-10. Used light-foods and fluids to prevent dehydration. No new medications prescribed by MD before or after flu shot.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Hypersensitivity, Lip swelling, Pruritus, Rash
Clinical narrative: 10-20-10 received flu shot. On 10-22-10 patient c/o itching, rash, 3 small blisters lower hip with lip puffiness. No c/o sore throat. Used hydrocortisone cream topically with minimal itch relief. (Rash on rib cage under both breasts and on legs. Went to E.R. -Received Prednisone prescription to take "10 days". ER doctor told her she may have had reaction to the "binders used in the flu shot".
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Herpes zoster, Immediate post-injection reaction, Injection site pain
Clinical narrative: Painful right arm same day she had flu shot. Swollen, red blemishes with watery blisters started 9-8-10. Went to doctor 9-13-10 got medication for shingles diagnosis. C/o itching on whole right arm - and "immediately after getting the shot she had pain and burning at site. On my follow-up telephone call to her 9-20-10 she reported she was "doing much better".
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Painful right arm same day she had flu shot. Swollen, red blemishes with watery blisters started 9-8-10. Went to doctor 9-13-10 got medication for shingles diagnosis. C/o itching on whole right arm - and "immediately after getting the shot she had pain and burning at site. On my follow-up telephone call to her 9-20-10 she reported she was "doing much better".
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Felt tired, ached all over, upset stomach without vomiting, frontal headache left arm injection site tenderness radiated to left neck and shoulder blade - dizzy at times, per 10-11-10 report. Used ice to forehead, over the counter pain meds. On 10-13-10 she called our office - stated she went to see her doctor - but he had not given any instructions to relieve fatigue, arm soreness that persists. I suggested use of Preservative free flu shot next year.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Felt tired, ached all over, upset stomach without vomiting, frontal headache left arm injection site tenderness radiated to left neck and shoulder blade - dizzy at times, per 10-11-10 report. Used ice to forehead, over the counter pain meds. On 10-13-10 she called our office - stated she went to see her doctor - but he had not given any instructions to relieve fatigue, arm soreness that persists. I suggested use of Preservative free flu shot next year.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pharyngitis streptococcal, Pyrexia, Vomiting
Clinical narrative: 30 minutes after receiving injection, had sweating, lightheadedness and vomiting. Daughter had strep throat and fever since 10/8/10. "Too lightheaded to walk - is sweating though is just sitting". Directed to take TYLENOL or other OTC analgesic/bottle directions take temperature, call physician if not improved in 24/48 hrs. or immediately if condition worsens.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Pt. reported pain at injection site x 2-3 days that resolved then within week (L) shoulder pain began and has not resolved in 3-4 weeks.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Malaise, Nausea, Pain
Clinical narrative: 4 hrs after vaccine - Malaise, chills, faint, nausea severe body ache fever 102.4F oral headache. Seen 5:44pm on same day at Urgent Care clinic temp 102.7 - No focal infection. Dx: Febrile vaccine reaction. Rx: NSAID's.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Syncope
Clinical narrative: 4 hrs after vaccine - Malaise, chills, faint, nausea severe body ache fever 102.4F oral headache. Seen 5:44pm on same day at Urgent Care clinic temp 102.7 - No focal infection. Dx: Febrile vaccine reaction. Rx: NSAID's.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: After receiving flu shot, pt reports "pins and needles" plus swelling sensation of hands. This lasted 3 hours and stopped.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling, warm, no fever.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Leg cramps at night one week after vaccine was given.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Immunization hurt upon receiving vaccine pain persisted; 2 days later unable to lift left arm; pain is persisting 2 weeks and 2 days later. No previous adverse events to vaccinations.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Fall
Clinical narrative: Equilibrium disturbed about 1 week after vaccine was given , falls.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Neoplasm
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 12 month old female who on approximately 25-OCT-2010 ("about two weeks ago") was vaccinated with a dose of VARIVAX (Merck) (lot# , dose and route not reported) without the knowledge of presence of unspecified neoplasm. It was reported that sometime after vaccination, patient was diagnosed with neoplasm and pharmacist inquired when to start chemo therapy when VARIVAX was administered "about two weeks ago". It was unknown if the patient sought medical attention. At the time of report, the outcome of neoplasm was unknown. Upon internal review, neoplasm was determined to be an other important medical event. Additional information has been requested.
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 16 week old male patient with no pertinent medical history, drug reactions or allergies who on 20-SEP-2010 was vaccinated orally with a first dose of ROTATEQ (Lot# 668264/0854Z) (Expiration date 07-APR-2012). Second dose of ROTATEQ (Lot# 668336/0518Z) (Expiration date 23-APR-2012) was given on 01-NOV-2010 and concomitantly received on the same date a dose of PENTACEL (Lot# C3748AB) and a dose of PREVNAR 13 (Lot# 914506). The medical assistant reported that on 01-NOV-2010, the patient began to have bloody stools. On 02-NOV-2010, the patient had also fever and was seen by the physician. The patient's fecal occult blood test was positive. The patient was sent to the Emergency Room to rule-out intussusception and intussusception was ruled out. The patient was not admitted to the hospital. On 03-NOV-2010, the patient was seen by the physician. The patient had mucus and blood in his stools. The patient was referred to a Gastroenterologist to rule out milk allergy (results not provided). The patient did not have any other symptoms besides mucus and blood in his stools. At the time of the report, the patient had not recovered. Upon internal review blood in stools was considered to be an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Pyrexia
Clinical narrative: A serious spontaneous report of fever and non-serious report of H1N1 LAIV was administered to 13 weeks pregnant female was received from a non-health professional concerning a 20-year-old female, subsequent to H1N1, Intranasal. The patient's past medical history is unknown. The patient had no concomitant medications. The patient's obstetrical history included gravida one, para one. The date of last menstrual period was 02-Sep-2009, estimated date of delivery was approximately 09-Jun-2010. The patient was 11 weeks pregnant at the time of vaccination. On 02-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. The patient has remained healthy, never developed side-effects and never developed flu-like symptoms since vaccination. The patient delivered a baby girl without complications. The only complication was that, 12 hours prior to delivery, the patient experienced a fever. She was admitted to the hospital and treated with antibiotics. Twelve hours after the fever, she delivered vaginally. The birth occurred just a few days under 40 weeks in Jun-2010. Both the mom and baby were healthy after delivery and they were released from the hospital 48 hours after delivery. The outcome of fever was unknown and the outcome of H1N1 LAIV was administered to 13 weeks pregnant female was resolved. Additional information was received on 17-Dec-2009 and incorporated into the narrative: The patient's obstetrical history, LMP, EDD was added. Additional information was received on 12-Jul-2010 and incorporated into the narrative: Pregnancy Outcome was added. Additional information was received on 06-Aug-2010 and incorporated into the narrative: Adverse event, gestation age of child and mode of delivery.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Nasopharyngitis, Sinusitis, Sputum discoloured
Clinical narrative: A non-serious spontaneous report of green sputum, common cold and sinus infection has been received from a mother/consumer concerning a five-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a total of two doses before onset of the event with the last dose given in Nov-2009 and first dose was given on 26-Oct-2009. In late Nov-2009, the child experienced clear dry cough every 2-3 mins almost continually with no fever. In Dec-2009, patient went to the physician who diagnosed common cold but no fever and no bacterial infection. In Jan-2010, coughing got worse and sinus infection was diagnosed. The patient received amoxicillin and clavulanate potassium, amoxicillin, mometasone furoate monohydrate and saline nasal drops at different times over four to five months. The patient experienced an increase in cough severity. On 19-May-2010, the patient was taken to the doctor with a cough that produced a green sputum and was prescribed amoxicillin and clavulanate potassium for ten days. The outcome of all reported events was unknown.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning a 77 year old female who in 2006 was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneous injection (lot# and dose not reported). In May 2010, the patient developed ophthalmic shingles even though she had a vaccination. Medical attention was sought. At the time of report, the patient's ophthalmic shingles was not recovered. The patient's ophthalmic shingles was considered to be disabling by the physician. Additional information has been requested.
Age: 1.68
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given 2nd Hep A 5 months early.  Will need another Hep A 4/22/11
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Diarrhoea, Dizziness, Dysgeusia
Clinical narrative: 36 hours with fever, dizziness, diarrhea, cramps, chills, difficulty breathing, tightness in throat, bad taste in mouth, head congestion, coughing, bloody nose
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Epistaxis, Muscle spasms, Pyrexia, Sinus congestion
Clinical narrative: 36 hours with fever, dizziness, diarrhea, cramps, chills, difficulty breathing, tightness in throat, bad taste in mouth, head congestion, coughing, bloody nose
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: 36 hours with fever, dizziness, diarrhea, cramps, chills, difficulty breathing, tightness in throat, bad taste in mouth, head congestion, coughing, bloody nose
Age: 32.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Oral herpes
Clinical narrative: Multiple Cold Sores on bottom lip grew. I have had one on occasion- maybe 2-3 times a year. But 2 days after shot I felt multiple breaking out at same time. Wound up with 3 spaced across bottom lip.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Chills, Myalgia
Clinical narrative: Joint aches, myalgias, fevers/chills that began 11/10/10; erythematous rash over entire body that began 11/12/10 and all above are persisting 8 days after vaccine.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Neutropenia, Pyrexia, Rash erythematous, Thrombocytopenia
Clinical narrative: Joint aches, myalgias, fevers/chills that began 11/10/10; erythematous rash over entire body that began 11/12/10 and all above are persisting 8 days after vaccine.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient was suppose to receive HPV vaccine, instead received Hep A vaccine.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1), HPV4
Symptoms: Fall, Head injury, Joint injury, Syncope
Clinical narrative: PATIENT HAD A SYNCOPAL EPISODE 2-3 MINUTES AFTER RECEVING HER GARDASIL AND FLU SHOTS.  SHE WAS ON HER WAY TO THE LOBBY TO WAIT FOR 20 MINUTES BUT FELL TO THE FLOOR BEFORE SHE COULD LEAVE THE ROOM.  SHE HIT HER HEAD, RIGHT HIP, AND RIGHT KNEE.  SHE WAS EVALUATED BY THE MD ON CALL.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: After receiving the seasonal influenza shot, she and her friend (both nurses) were walking through the store and she started feeling very flushed and felt as if she was going to faint.  She sat down. She became diaphoretic and began to vomit.  Her pulse was 90.  She described the feeling in her chest as similar to when she had a heart cath. and at the time the dye was injected.  She stated that her heart was pounding. After approximately 30 min. she was able to get to her car with help from her friend.  Her friend took her blood pressure and it was 138/83 at that time. Talked to her the next day and she stated that she had a very restless night and was still queasy all the next day and felt very weak. She reported that her upper GI distress continued throughout the day.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Restlessness, Vomiting
Clinical narrative: After receiving the seasonal influenza shot, she and her friend (both nurses) were walking through the store and she started feeling very flushed and felt as if she was going to faint.  She sat down. She became diaphoretic and began to vomit.  Her pulse was 90.  She described the feeling in her chest as similar to when she had a heart cath. and at the time the dye was injected.  She stated that her heart was pounding. After approximately 30 min. she was able to get to her car with help from her friend.  Her friend took her blood pressure and it was 138/83 at that time. Talked to her the next day and she stated that she had a very restless night and was still queasy all the next day and felt very weak. She reported that her upper GI distress continued throughout the day.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous
Clinical narrative: sudden miscarriage at 9 weeks pregnant
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Contusion, Immediate post-injection reaction, Swelling, Vomiting
Clinical narrative: Bruised immediately, swelled up. On the way home patient vomited, and had an anaphylactic reaction. Co-worker took patient to the ER. Patient recieved 3 Benadryl injections, IV fluids, given Rx for Benadryl and phenegran for vomiting. Doing well now.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Within 1 minute of receiving vaccine, patient felt extremely dizzy and starting to blackout.  Patient was sitting down with his head between his knees.  He began to perspire.  His first blood pressure reading was 83/38 & pulse of 40.  Patient was instructed to remain seating and after 5 minutes a second reading of 88/42 & pulse of 45 but patient was still very dizzy.  A third reading after another 5 minutes, see improvement to 95/48 & pulse of 50.  Patient begin to feel less dizzy and perspiration stop.  A fourth reading after another 5 minutes, reading was high at 170/110 & pulse of 105.  A fifth and sixth reading (17-20  minutes after incidence), see vital sign stabilized at 140/88, P:80 and then 120/77, P:70.  Patient fully recovered after 20 minutes after incidence.  Vital signs returned to normal and no longer feel dizzy.  No treatment needed.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: Small itchy bumps on ears, neck and head, then disappeared in 2 days. New larger eruptions that are reddish and itchy appeared in other parts of the body (chest, back, hips, arms, legs) in the following days.
Age: 21.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainting episode immediately following IM injection of Tdap
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: DEVELOPED HIVES, TREATED WITH ANTIHISTAMINE
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Chest discomfort, Dyspnoea, Injection site erythema
Clinical narrative: Heat & redness at injection site at noon.  At 1 p.m. experienced shortness of breath, wheezing, chest tightness, back ache and weakness.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Wheezing
Clinical narrative: Heat & redness at injection site at noon.  At 1 p.m. experienced shortness of breath, wheezing, chest tightness, back ache and weakness.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Abdominal pain, Aphasia, Bowel movement irregularity, Dysphagia
Clinical narrative: Started having shortness of breath, hard to swallow, then about 6 o'clock was rushed to the emergency room high fever 103 shaking my whole body started cramping couldnt use my muscles could not urinate or have a bowel movement couldnt speak or walk..pain on a scale from 1-10 was 9..throbbing headache neck pain abdominal pain kidney pain had ibuprofen, Tylenol, Benadryl and a shot of Toradol was feeling better about 3 hrs later it is now 7 days later and still not feeling 100% better.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Dysuria, Headache, Muscle disorder, Muscle spasms
Clinical narrative: Started having shortness of breath, hard to swallow, then about 6 o'clock was rushed to the emergency room high fever 103 shaking my whole body started cramping couldnt use my muscles could not urinate or have a bowel movement couldnt speak or walk..pain on a scale from 1-10 was 9..throbbing headache neck pain abdominal pain kidney pain had ibuprofen, Tylenol, Benadryl and a shot of Toradol was feeling better about 3 hrs later it is now 7 days later and still not feeling 100% better.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pyrexia, Renal pain, Tremor
Clinical narrative: Started having shortness of breath, hard to swallow, then about 6 o'clock was rushed to the emergency room high fever 103 shaking my whole body started cramping couldnt use my muscles could not urinate or have a bowel movement couldnt speak or walk..pain on a scale from 1-10 was 9..throbbing headache neck pain abdominal pain kidney pain had ibuprofen, Tylenol, Benadryl and a shot of Toradol was feeling better about 3 hrs later it is now 7 days later and still not feeling 100% better.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Eye swelling, Swelling face
Clinical narrative: periorbital and peribuccal swelling, mom gave Benadryl 25 mgm and Pepcid 10 mgm took her to ER and was given 0.3 Epi.IM, Benadryl 25 mgm IM, Solumedrol 50 mgm IM Pepcid 20 mgm PO
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dry throat, Headache, Sinus congestion
Clinical narrative: Dry throat, stuffy sinuses, headache from Friday evening through following Monday.  Dry throat continuing through Tuesday (today).
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Herpes zoster, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Started to experience unusual symptoms that I attributed to the flu vac--numbness, tingling, in addition to extreme soreness which began the day of the vaccine as expected; rash appeared Friday; sought treatment in ER Saturday & was diagnosed with shingles; still suffering & not able to work as of today, 11/16/2010; extremely severe case with intense pain; started on antivirals within 24 hours of rash appearance; on Vicodin and now am trying gabapentin.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Started to experience unusual symptoms that I attributed to the flu vac--numbness, tingling, in addition to extreme soreness which began the day of the vaccine as expected; rash appeared Friday; sought treatment in ER Saturday & was diagnosed with shingles; still suffering & not able to work as of today, 11/16/2010; extremely severe case with intense pain; started on antivirals within 24 hours of rash appearance; on Vicodin and now am trying gabapentin.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Headache, Malaise
Clinical narrative: Started feeling ill the evening after receiving the seasonal flu shot.  Was sick in bed from Mon.-Fri.  Was too weak to dress until the 22nd of Oct.  Was sick to stomach and had a severe headache.  Said the headache moved around her head.  Stated that one baby aspirin usually would relieve her headaches but that week she took a whole bottle.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: After the vaccine he started to feel lightheaded afterwards, and he walked back in to the clinic for drinking water and passed out.  He was pale.  After a couple of minutes of lying down with a wet washcloth on his forehead, he again felt well.  Oxygen saturation was 100%, pulse rate in the 60s, had good color.  He is able to sit up and walk out of building without problems afterwards.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Itchy Rash
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Nausea
Clinical narrative: Muscles started to ache, nausea, chills. Leg muscles are still aching.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Rash, Tinnitus
Clinical narrative: Rash on hand, ringing in ear, muscle pain in legs, knee, lower back
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Asterixis, Dysphonia
Clinical narrative: He began flapping left arm and making vocalizations such as "ah, ah, ah" while flapping arm.
Age: 57.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Initial case was received on 05 November 2010 from a healthcare professional. A 57 year old female patient received on 11 July 2010, the second of a series of injections of IMOVAX with lot number D0869-1, for "possible rabies exposure." The first in the series of injections of IMOVAX with lot number D0792, had previously been given on 08 July 2010. One week after the IMOVAX vaccination received on 11 July 2010, the patient experienced numbness and tingling of left side of face, body tingling and as of this report experienced numbness and tingling of both arms. She was being treated by a healthcare professional and a neurologist. The patient had "several" prior IMOVAX vaccinations for past history of "possible rabies exposures" (no dates provided). No pre-existing medical conditions, allergies or concomitant medications were reported. The outcome was not recovered. List of documents held by sender: None.
Sex: F
Vaccine: TTOX
Symptoms: Anaphylactic reaction, Throat tightness
Clinical narrative: Initial report received from a consumer who is the patient's daughter on 05 November 2010. A female patient had received a Tetanus Toxoid vaccination on an unknown date in 1950 while in the second grade for an injury she had sustained. It was reported the patient had a bad reaction of "anaphylactic reaction" in which her throat closed up. Recovery status was not reported. The reporter declined to provide any further information. No further information is expected. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Swelling face, Urticaria
Clinical narrative: On 9/16/10 in afternoon pt. stated her face and neck became red and itchy and her face swelled. Pt. stated she also felt hives in the same area. Pt. called her family physician who prescribed a cream. Pt. reports by 9/17/10 in the AM it had resolved.