chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: This case was reported by a physician and described the occurrence of injection site redness in a 59-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included DTAP;GlaxoSmithKline;right arm given on an unspecified date. On an unspecified date, the subject received an unspecified dose of HAVRIX (route unknown, left arm). At an unspecified time after vaccination with HAVRIX, the subject experienced injection site redness and extensive swelling of vaccinated limb (quarter-size area of his left lateral arm). At the time of reporting, the outcome of the events was unspecified.
Age: 4.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a 4-year-old patient who received ENGERIX B pediatric (batch number AHBVC190AA, expiry date 24th January 2015). On an unknown date, the patient received ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. No adverse event reported.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient said she has aches and pain around the shoulder area in the arm she had the Zostavax shot.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose increased, Pollakiuria
Clinical narrative: Frequent Urination.
Age: 1.18
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Apnoeic attack, Bacterial test positive, Blood glucose normal, Blood urine present, Convulsion
Clinical narrative: Sudden onset fever, headache, seizures (5 minute status epilepticus, apneic episode).
Age: 1.18
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Glucose urine absent, Headache, Nitrite urine absent, Protein urine absent, Pyrexia
Clinical narrative: Sudden onset fever, headache, seizures (5 minute status epilepticus, apneic episode).
Age: 1.18
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Red blood cells urine positive, Status epilepticus, Urine analysis abnormal, Urine ketone body absent, Urine leukocyte esterase
Clinical narrative: Sudden onset fever, headache, seizures (5 minute status epilepticus, apneic episode).
Age: 1.18
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Urobilinogen urine decreased, White blood cells urine negative
Clinical narrative: Sudden onset fever, headache, seizures (5 minute status epilepticus, apneic episode).
Age: 49.0
Sex: M
Vaccine: MMR, TYP
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia
Clinical narrative: Joint pain, fever, chills, fatigue x 1 month.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Already described above.  Basically soreness of arm and shoulder which increased throughout evening and made sleep very uncomfortable.  Continued for a couple of days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: Patient states a large 2 inch lump under at the injecction site which was pruritic.  Reported on 02/07/2015 by patient.
Age: 1.31
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Lethargy, Pyrexia, Vomiting
Clinical narrative: Diarrhea, vomiting, fever, lethargy.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Staring
Clinical narrative: Child was given ibuprofen an hour before MMR vaccination was given (9:00 AM). At 5:00 PM (once ibuprofen wore off) a fever started.  It spiked to 102.6 by 9:00 PM and another dose of ibuprofen was given at that time.  At 9:00 PM, right after patient's temperature was taken, she began staring around at the walls as if she was seeing something.  This continued until her second dose of ibuprofen took affect (about 15 minutes).  Patient was calm during the 15 minutes she was staring around the room.  She was not making eye-contact and seemed to be entertained by whatever it was she was seeing.
Age: 49.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Hypoaesthesia, Injection site pain, Pain, Paraesthesia
Clinical narrative: R facial numbness and tingling 3-4 weeks following vaccination, "I thought I was having a stroke". L deltoid pain: rates from 3-5 in pain, described as "deep aching" and sometimes "sharp/shooting", no limited range of motion, "hurts to lay on left arm".
Age: 49.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: R facial numbness and tingling 3-4 weeks following vaccination, "I thought I was having a stroke". L deltoid pain: rates from 3-5 in pain, described as "deep aching" and sometimes "sharp/shooting", no limited range of motion, "hurts to lay on left arm".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Child was complaining of itching of left leg, mom noted big red area around where the Kinrix had been given - following day was seen in the clinic with measurements of 10cm x 17cm of erythema/induration and warmth, no tenderness, no itching at time of visit.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Lymph node pain, Rash, Rash erythematous
Clinical narrative: I had a painful lymph node in right armpit that I thought was an ingrown hair and a pink rash on chest by arm pit. Ten days later I noticed a whole bunch of raised rash areas on my chest and neck and that it resembled Shingles. My physician confirmed it was shingles on Feb. 5th and it was too late to receive the anti viral drug. I've never had Shingles before and I thought it was important to make people aware that the vaccine can cause you to have shingles. I heard of two other people from friends that it happened to them, also. My doctor assured me the good news is that it will lessen the pain of shingles having had the vaccine. Please present this in your handouts for people to be aware of before taking the vaccine. Thank you.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: EXCESSIVE SWELLING OF RIGHT DELTOID MUSCLE AND RIGHT SHOULDER AREA (VACCINE INJECTED INTO RIGHT DELTOID), EXTREME PAIN, WARM TO TOUCH, RIGHT DELTOID AND SHOULDER AREA PINK IN COLOR, PAIN AND TENDERNESS AT INJECTION SITE, VERY LIMITED RANGE OF MOTION IN RIGHT ARM.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Syncopal episode, lightheadedness, dizziness. Patient was unresponsive for approximately 30 seconds to 1 minute. She became responsive and was alert and oriented x 3.  Her vital signs remained stable. EMT was called and she was taken to the emergency department.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Asthma, Condition aggravated, Fatigue, Headache
Clinical narrative: Extreme Pain, redness, swelling at injection site and up to 6 inches away.  Increasing over next 4 days.  Joint pain, body aches , increasing over next 3 days.  Headache, 4 days.  Asthma symptoms.  Slight fever day 1 -3.  Exhaustion.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Extreme Pain, redness, swelling at injection site and up to 6 inches away.  Increasing over next 4 days.  Joint pain, body aches , increasing over next 3 days.  Headache, 4 days.  Asthma symptoms.  Slight fever day 1 -3.  Exhaustion.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Body temperature increased, Fatigue, Headache, Injection site erythema
Clinical narrative: Extreme pain, redness, swelling up to 7" away from injection sites. Increasing pain and redness over next 4 days. Joint pain, body aches, inc. over next 3 days.  Headache, exhaustion. 102.3 temp day 4 in evening.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site infection, Injection site pain, Injection site swelling, Pain
Clinical narrative: Extreme pain, redness, swelling up to 7" away from injection sites. Increasing pain and redness over next 4 days. Joint pain, body aches, inc. over next 3 days.  Headache, exhaustion. 102.3 temp day 4 in evening.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autism, Dyskinesia, Pyrexia, Regressive behaviour, Social avoidant behaviour
Clinical narrative: Fever of 104 after every single vaccine up to 15 months shots,  Autism symptoms and jerky movements, delayed speech, staring spells, social withdrawal, regression.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Speech disorder developmental, Staring
Clinical narrative: Fever of 104 after every single vaccine up to 15 months shots,  Autism symptoms and jerky movements, delayed speech, staring spells, social withdrawal, regression.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Computerised tomogram, Electrocardiogram, Electroencephalogram, Endometrial ablation, Menorrhagia
Clinical narrative: Menorrhagia began in 2003 and became extreme in 2011--leading to uterine ablation.  Chronic Migraines began 2011.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Migraine, Nerve conduction studies, Sinoscopy
Clinical narrative: Menorrhagia began in 2003 and became extreme in 2011--leading to uterine ablation.  Chronic Migraines began 2011.
Age: 1.52
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Abnormal behaviour, Bed sharing, Constipation, Crying, Decreased appetite
Clinical narrative: Extreme fussiness, behaving very ill and abnormal. I expected this to go away anf it never did. Patient has acted very out of character and began screaming or crying unconsolably frequently. This has been a nightmare. Her sleeping patterns have also been significantly affected. Almost three weeks later she suddenly acquired a fever of 101-103 for over twenty four hours. After that period (in which I was told to keep her home for monitoring) we resolved to get her to the doctor the following morning. Over this time she slept in our bed with us and was vlosely monitored. The following morning her temperature had dropped so we did not end up going into the doctor. However, hours later after the doctor's offices had closed her fever returned, lasted about 4 more hours, and finally subsided for good. Then about four or five days later (tonight; almost a full month since vaccination) my daughter developed visible bumps that had the appearance of chickenpox all over her torso. When I saw this I recalled prior odd behavior that in hindsight was obviously her rubbing against things to scratch herself...so I am inferring she is also itchy. And still highly irritable, unconsolable fits (not in her character), extreme lethargy and desire to sleep, decreased appetite, and abnormal bowel movements ranging from constipation to mild diarrhea.
Age: 1.52
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Diarrhoea, Irritability, Lethargy, Pruritus, Pyrexia
Clinical narrative: Extreme fussiness, behaving very ill and abnormal. I expected this to go away anf it never did. Patient has acted very out of character and began screaming or crying unconsolably frequently. This has been a nightmare. Her sleeping patterns have also been significantly affected. Almost three weeks later she suddenly acquired a fever of 101-103 for over twenty four hours. After that period (in which I was told to keep her home for monitoring) we resolved to get her to the doctor the following morning. Over this time she slept in our bed with us and was vlosely monitored. The following morning her temperature had dropped so we did not end up going into the doctor. However, hours later after the doctor's offices had closed her fever returned, lasted about 4 more hours, and finally subsided for good. Then about four or five days later (tonight; almost a full month since vaccination) my daughter developed visible bumps that had the appearance of chickenpox all over her torso. When I saw this I recalled prior odd behavior that in hindsight was obviously her rubbing against things to scratch herself...so I am inferring she is also itchy. And still highly irritable, unconsolable fits (not in her character), extreme lethargy and desire to sleep, decreased appetite, and abnormal bowel movements ranging from constipation to mild diarrhea.
Age: 1.52
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Rash vesicular, Screaming, Sleep disorder, Somnolence
Clinical narrative: Extreme fussiness, behaving very ill and abnormal. I expected this to go away anf it never did. Patient has acted very out of character and began screaming or crying unconsolably frequently. This has been a nightmare. Her sleeping patterns have also been significantly affected. Almost three weeks later she suddenly acquired a fever of 101-103 for over twenty four hours. After that period (in which I was told to keep her home for monitoring) we resolved to get her to the doctor the following morning. Over this time she slept in our bed with us and was vlosely monitored. The following morning her temperature had dropped so we did not end up going into the doctor. However, hours later after the doctor's offices had closed her fever returned, lasted about 4 more hours, and finally subsided for good. Then about four or five days later (tonight; almost a full month since vaccination) my daughter developed visible bumps that had the appearance of chickenpox all over her torso. When I saw this I recalled prior odd behavior that in hindsight was obviously her rubbing against things to scratch herself...so I am inferring she is also itchy. And still highly irritable, unconsolable fits (not in her character), extreme lethargy and desire to sleep, decreased appetite, and abnormal bowel movements ranging from constipation to mild diarrhea.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Induration, Pain, Skin warm, Swelling
Clinical narrative: 2/5/15 patient noticed area looked bruised and sore. 2/6/15 patient reports area bruised look, sore, tender to touch, warm to touch, raised area and hard to touch. Area approx size (4 x 6 inches).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: 2/5/15 patient noticed area looked bruised and sore. 2/6/15 patient reports area bruised look, sore, tender to touch, warm to touch, raised area and hard to touch. Area approx size (4 x 6 inches).
Sex: U
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a patient's mother refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (also reported as unspecified vaccine) (dose, dose no., lot no. unknown). No concomitant medication was reported. On an unknown date the patient experienced unspecified adverse reaction. The outcome of unspecified adverse reaction was unknown. The causality of unspecified adverse reaction was not reported. Product quality complaint was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Blood test, Chest X-ray, Fall, Headache
Clinical narrative: First GARDASIL shot given 7/21/14. Second shot 10/22/14. 6 weeks she had full blown symptoms of neck, head all over body pain, falling down. Have done blood, MRI, chest X-ray etc. Saw doctor almost daily saw a pediatric neurologist. Diagnosis: Autoimmune reaction.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: First GARDASIL shot given 7/21/14. Second shot 10/22/14. 6 weeks she had full blown symptoms of neck, head all over body pain, falling down. Have done blood, MRI, chest X-ray etc. Saw doctor almost daily saw a pediatric neurologist. Diagnosis: Autoimmune reaction.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Aggression, Pallor
Clinical narrative: Patient came home very combative with wife who reported adverse event. Patient was "white faced" and complained of upset stomach. Pt symptoms have improved since then but still complaining of upset stomach.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Heart rate decreased, Somnolence
Clinical narrative: Patient began to "feel sleepy" and leaned forward as if to fall for about 10 seconds after adminstr. of MCV-4 and HPV #1 dose. Heart rate fell to 67 and returned to baseline (100-107) in approx. 20 min.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of arm soreness at injection site in a 63-year-old female subject who was vaccinated with Influenza vaccine trivalent or quadrivalent unspecified 2013-2014 season (Influenza vaccine unspecified 2013-2014 season, GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions, included depression, high blood pressure and high cholesterol. Concurrent medications included SYNTHROID, Blood pressure medication, Anti-hypercholesterolaemic, Vitamins, and Antidepressant (unspecified). On 5 November 2013 at 17:30 the subject received a dose of Influenza vaccine unspecified 2013-2014 season (unknown, left arm). On an unspecified date in 2013, within months of vaccination with Influenza vaccine unspecified 2013-2014 season, the subject experienced arm soreness at injection site. The subject reported she received the flu vaccine a few weeks ago; brand name and manufacturer were unknown. She reported she did not know when she first started experiencing arm soreness, but that the soreness is not going away. At the time of reporting the event was unresolved. Follow up received from consumer on 19 December 2013. The consumer (subject) confirmed that she was vaccinated with FLULAVAL TRIVALENT (GlaxoSmithKline), previously the subject did not know which manufacturer or brand name. Follow up information was received on 27 March 2014 via healthcare professional. Concurrent medications were clarified as SYNTHROID, Atenolol, Atorvastatin, Vitamins and Citalopram. The healthcare professional reported an additional event of shoulder/arm pain at injection site and attributed to post injection arm pain aggravating shoulder. The events started in November 2013. The outcome was unknown. No action was taken with FLULAVAL; the patient had previously received flu vaccines.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Delivery, Exposure during pregnancy, Pain in extremity
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of sore arm in a 30-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. The current pregnancy was by normal conception and the subject was not using contraception. There was no evidence of a defect on prenatal testing. There was no maternal or paternal history which may have an impact on the outcome of the pregnancy. The subject had no concomitant medications. On 11 September 2013 the subject received a dose of FLULAVAL (unknown, left arm) and experienced vaccine exposure during the second trimester of pregnancy. The gestational age was calculated as 22 5/7 weeks at the time of vaccination. The date of last menstrual period was 05 April 2013 and the estimated delivery date was 10 January 2014. On 11 September 2013, less than one day after vaccination with FLULAVAL, the subject experienced sore arm. At the time of reporting the event was resolved. The subject considered the event related to the vaccination. At the time of the report, the pregnancy was ongoing. 28 April 2014 - No further information was provided; patient lost to follow-up. Follow-up information was received on 20 May 2014 via physician who gave discrepant information regarding the pregnancy end date. The report noted two dates as the pregnancy end date, 04 January 2014 and 10 January 2014. At 40 weeks gestation age, the subject have birth to a male live infant wit no apparent congenital anomaly, who was considered full term. The infant was delivered by normal spontaneous vaginal delivery with forceps due to rotation. The infant weight 4.02 kilograms; 31 3/4 inches in length; 13 3/4 inches head circumference an APGAR score of 8/9. The delivery was noted to have had "no complications". The subject was noted to have a post partum visit on 04 March 2014 which was "well". At the time of the report no other information was provided.
Age: 0.51
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Decreased appetite, Irritability, Pyrexia, Screaming
Clinical narrative: She began running a fever two hours after getting the vaccine. By 5p her temp was up to 104.5 I took her to the hospital. They said alternate Tylenol and Motrin. She continued running high fevers for three days was vomiting couldn't eat much and was very fussy. I took her back to hospital they said continue Motrin and ibuprofen gave her antibiotic and said bring her back if need be. She continued to run high temps as high as 104.5 for three weeks. She was also fussy had no energy she just wanted to sleep. She was on Pedalyte because she couldn't keep anything down. She would wake up screaming and nothing seemed to sooth her. The site of the vaccination became bruised. She was seen at the hospital 3 times.
Age: 0.51
Sex: F
Vaccine: MMR
Symptoms: Somnolence, Vaccination site bruising, Vomiting
Clinical narrative: She began running a fever two hours after getting the vaccine. By 5p her temp was up to 104.5 I took her to the hospital. They said alternate Tylenol and Motrin. She continued running high fevers for three days was vomiting couldn't eat much and was very fussy. I took her back to hospital they said continue Motrin and ibuprofen gave her antibiotic and said bring her back if need be. She continued to run high temps as high as 104.5 for three weeks. She was also fussy had no energy she just wanted to sleep. She was on Pedalyte because she couldn't keep anything down. She would wake up screaming and nothing seemed to sooth her. The site of the vaccination became bruised. She was seen at the hospital 3 times.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Autoimmune hepatitis, Biopsy liver, Hepatic enzyme
Clinical narrative: Auto-immune hepatitis, lifetime use of immuran, azathioprine, steroids as needed.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure fluctuation, Blood test, Cardiac stress test, Cough, Dizziness
Clinical narrative: Started with a cough, as the day progressed I started getting stiff, cramp like feelings at the injection site and upper back, Day 2 admitted to hospital emergency room cramping in legs, dizzy, difficulty breathing, radiating pain all over, Blood pressure all over the place, high pulse rate.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Electrocardiogram, Heart rate increased, Injection site reaction, Muscle spasms
Clinical narrative: Started with a cough, as the day progressed I started getting stiff, cramp like feelings at the injection site and upper back, Day 2 admitted to hospital emergency room cramping in legs, dizzy, difficulty breathing, radiating pain all over, Blood pressure all over the place, high pulse rate.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic, Pain, Ultrasound scan
Clinical narrative: Started with a cough, as the day progressed I started getting stiff, cramp like feelings at the injection site and upper back, Day 2 admitted to hospital emergency room cramping in legs, dizzy, difficulty breathing, radiating pain all over, Blood pressure all over the place, high pulse rate.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Started with a cough, as the day progressed I started getting stiff, cramp like feelings at the injection site and upper back, Day 2 admitted to hospital emergency room cramping in legs, dizzy, difficulty breathing, radiating pain all over, Blood pressure all over the place, high pulse rate.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Pharyngeal oedema, Urticaria
Clinical narrative: Allergic reaction- pt reports hives in throat with throat swelling.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac fibrillation, Differential white blood cell count, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Difficulty breathing. Erratic and rapid heart, dizziness, swelling of throat. Went to the ER. Was placed on gurney and given EKG. Heart rate was 179. They administered Cardizem also did Basic Metabolic Panel, CBC with Differential, ECG 12 Lead, Troponin 1. My heart was in Aortal Fibrillation and took over two hours to get back to normal heart beat. Spent 3 hours there.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Heart rate increased, Heart rate irregular, Metabolic function test, Pharyngeal oedema
Clinical narrative: Difficulty breathing. Erratic and rapid heart, dizziness, swelling of throat. Went to the ER. Was placed on gurney and given EKG. Heart rate was 179. They administered Cardizem also did Basic Metabolic Panel, CBC with Differential, ECG 12 Lead, Troponin 1. My heart was in Aortal Fibrillation and took over two hours to get back to normal heart beat. Spent 3 hours there.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Troponin I
Clinical narrative: Difficulty breathing. Erratic and rapid heart, dizziness, swelling of throat. Went to the ER. Was placed on gurney and given EKG. Heart rate was 179. They administered Cardizem also did Basic Metabolic Panel, CBC with Differential, ECG 12 Lead, Troponin 1. My heart was in Aortal Fibrillation and took over two hours to get back to normal heart beat. Spent 3 hours there.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Bursitis, Injected limb mobility decreased, Injection site pain, Tendonitis
Clinical narrative: Muscular/Shoulder pain on administered arm, lack of strength and flexibility resulting in tendonitis/bursitis. Physical therapy prescribed by physician.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Bursitis, Injected limb mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Muscular/Shoulder pain on administered arm, lack of strength and flexibility resulting in tendonitis/bursitis. Physical therapy prescribed by physician.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tendonitis
Clinical narrative: Muscular/Shoulder pain on administered arm, lack of strength and flexibility resulting in tendonitis/bursitis. Physical therapy prescribed by physician.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Acupuncture, Arthralgia, Body temperature increased, Decreased appetite
Clinical narrative: Time of injection 2:30, painful.  Approx. 3:30 pm left arm injection site began throbbing, then unable to move arm comfortably.  Followed by onset of malaise, fatigue, localized pain, redness, swelling.  Moved into total body muscle/joint pain.  Inability to weight bear - Thursday 2.05.15.  Fatigue, flu-like symptoms, no appetite.  Injection site increase redness/swelling/pain. Headache.  Temp 100.5 (typical baseline 97.1). No appetite.  Total body ache.  Treated with local ice to hips.  NSAIDs.  Oxycodone 5 mg (Rx for chronic pain fibromyalgia), fluids.  None to minimal relief.  Acupuncture treatment to local injection site 02/06/16; suggested reporting.  Phoned PCP office, spoke with tech/nurse described symptoms/tx.  Told me I'd done everything they would have suggested.  If persist swelling/redness seek medical attention urgent care with concern for cellulitis locally; local site resolving at time of this report.  Other symptoms continue with less intensity but extreme fatigue, head congestion, inability to do normal daily living activities due to lethargy/fatigue/pain.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Injected limb mobility decreased
Clinical narrative: Time of injection 2:30, painful.  Approx. 3:30 pm left arm injection site began throbbing, then unable to move arm comfortably.  Followed by onset of malaise, fatigue, localized pain, redness, swelling.  Moved into total body muscle/joint pain.  Inability to weight bear - Thursday 2.05.15.  Fatigue, flu-like symptoms, no appetite.  Injection site increase redness/swelling/pain. Headache.  Temp 100.5 (typical baseline 97.1). No appetite.  Total body ache.  Treated with local ice to hips.  NSAIDs.  Oxycodone 5 mg (Rx for chronic pain fibromyalgia), fluids.  None to minimal relief.  Acupuncture treatment to local injection site 02/06/16; suggested reporting.  Phoned PCP office, spoke with tech/nurse described symptoms/tx.  Told me I'd done everything they would have suggested.  If persist swelling/redness seek medical attention urgent care with concern for cellulitis locally; local site resolving at time of this report.  Other symptoms continue with less intensity but extreme fatigue, head congestion, inability to do normal daily living activities due to lethargy/fatigue/pain.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy, Local swelling
Clinical narrative: Time of injection 2:30, painful.  Approx. 3:30 pm left arm injection site began throbbing, then unable to move arm comfortably.  Followed by onset of malaise, fatigue, localized pain, redness, swelling.  Moved into total body muscle/joint pain.  Inability to weight bear - Thursday 2.05.15.  Fatigue, flu-like symptoms, no appetite.  Injection site increase redness/swelling/pain. Headache.  Temp 100.5 (typical baseline 97.1). No appetite.  Total body ache.  Treated with local ice to hips.  NSAIDs.  Oxycodone 5 mg (Rx for chronic pain fibromyalgia), fluids.  None to minimal relief.  Acupuncture treatment to local injection site 02/06/16; suggested reporting.  Phoned PCP office, spoke with tech/nurse described symptoms/tx.  Told me I'd done everything they would have suggested.  If persist swelling/redness seek medical attention urgent care with concern for cellulitis locally; local site resolving at time of this report.  Other symptoms continue with less intensity but extreme fatigue, head congestion, inability to do normal daily living activities due to lethargy/fatigue/pain.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Myalgia, Pain, Upper respiratory tract congestion, Weight bearing difficulty
Clinical narrative: Time of injection 2:30, painful.  Approx. 3:30 pm left arm injection site began throbbing, then unable to move arm comfortably.  Followed by onset of malaise, fatigue, localized pain, redness, swelling.  Moved into total body muscle/joint pain.  Inability to weight bear - Thursday 2.05.15.  Fatigue, flu-like symptoms, no appetite.  Injection site increase redness/swelling/pain. Headache.  Temp 100.5 (typical baseline 97.1). No appetite.  Total body ache.  Treated with local ice to hips.  NSAIDs.  Oxycodone 5 mg (Rx for chronic pain fibromyalgia), fluids.  None to minimal relief.  Acupuncture treatment to local injection site 02/06/16; suggested reporting.  Phoned PCP office, spoke with tech/nurse described symptoms/tx.  Told me I'd done everything they would have suggested.  If persist swelling/redness seek medical attention urgent care with concern for cellulitis locally; local site resolving at time of this report.  Other symptoms continue with less intensity but extreme fatigue, head congestion, inability to do normal daily living activities due to lethargy/fatigue/pain.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea, Fontanelle depressed
Clinical narrative: Diarrhea several times a day (up to 6). Sunken fontanel and fear of dehydration. Visit at emergency. It took more than a month for the diarrhea to stop. Baby was 100% breastfed.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Dysphagia, Paraesthesia oral
Clinical narrative: His tongue "felt weird" and had trouble swallowing.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling and redness about the right deltoid.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Blood glucose increased, Glycosylated haemoglobin increased
Clinical narrative: Elevated A1C levels, elevated blood glucose levels. Possible Diabetes type 1 diagnosis.
Age: 14.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Chest discomfort, Headache, Injection site swelling, Injection site warmth
Clinical narrative: Site of inject swollen and hot.  Fever muscle weakness, sore joints, headache, tightness in chest.
Age: 14.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Site of inject swollen and hot.  Fever muscle weakness, sore joints, headache, tightness in chest.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Visited Dr. 02/06/2015. Swollen, red and painful area of injection site about the size of a baseball. Dr. office concluded cellulitis and prescribed prednisone and BACTRIM.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site warmth, Pain in extremity
Clinical narrative: The left arm was very swollen and sore and there was a 1.5 inch knot and heat and redness where the vaccine was administered.  It was difficult to move the arm without moderate pain for secure days.  On Sunday, Feb. 8, the knot has grown 2.5 inches.  The redness around the injection site has grown and is spreading down in an oval shape.  There continues to be soreness and swelling.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: The left arm was very swollen and sore and there was a 1.5 inch knot and heat and redness where the vaccine was administered.  It was difficult to move the arm without moderate pain for secure days.  On Sunday, Feb. 8, the knot has grown 2.5 inches.  The redness around the injection site has grown and is spreading down in an oval shape.  There continues to be soreness and swelling.
Age: 43.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Fatigue, Headache, Pruritus
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of fatigue in a 43-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 16 October 2013 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On an unspecified date the subject received unspecified dose of influenza vaccine unspecified (unknown details). On an unknown date, less than one day after vaccination with influenza vaccine unspecified, the subject experienced fatigue, headache, cough and itching. At the time of reporting the events were resolved. Per the nurse, "the [subject] has had same symptoms in the past with other flu vaccine; however, they usually go away within a week of the vaccine being given" and "never lasted this long." The subject was treated with TYLENOL and ADVIL. On 16 October 2013, less than one day after vaccination with FLULAVAL, the subject experienced fatigue, headache, cough and itching. At the time of reporting the events were unresolved.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Alpha 1 foetoprotein normal, Cytogenetic analysis, Exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of vaccine exposure during pregnancy in a 42-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included anemia during pregnancy, live birth and pregnancy. Concurrent medical conditions included pregnancy with advanced maternal age. The subject had 3 previous full-term pregnancies that resulted in 3 normal live births. The mother was not using contraception and the type of conception was normal. The subject had advanced maternal age for the current pregnancy. The subject experienced anemia with her last pregnancy in 2011. The maternal grandmother has diabetes and the subject's father had a myocardial infarct. There was no paternal history which may have an impact on the outcome of this pregnancy. On 15 October 2013 the subject received a dose of FLULAVAL (.5 ml, intramuscular, right deltoid) and experienced vaccine exposure during the 2nd trimester of pregnancy. The gestational age was calculated to be 18 weeks. The date of last menstrual period was reported as 5 June 2013. The estimated date of delivery was reported as 12 March 2014 per the nurse. There were no adverse events reported. There was evidence of defect from prenatal testing. The nurse documented that there was evidence of defect from prenatal testing. The ultrasound results from "both ultrasounds showed evidence of increased nuchal thickness". The results of the "verified test (type of detailed genetic test)" (cytogenic analysis) were not yet available at the time of reporting. At the time of reporting the pregnancy was ongoing. The nurse reported 3 other cases with FLULAVAL. See A1050106A, A1050110A, and A1050111A for details on the other cases. Follow up was received from the nurse on 25 February 2014. The subject was pregnant with one fetus. The type of conception was normal and no in-vitro fertilization was used. The FLULAVAL was administered intramuscularly. Concurrent medications included prenatal vitamins. There were no adverse events reported. Relevant diagnostic tests included an "AFP tetra screen" (Alpha-fetoprotein tetra screen) and results were negative. At the time of reporting, the subject had "not yet delivered". 17 June 2014 - No further information was provided; patient lost to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 01 December 2013 the subject received a dose of FLULAVAL TETRA (unknown). At an unspecified time after vaccination with FLULAVAL TETRA, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of allergic reaction in a 55-year-old female subject who was vaccinated with FLULAVAL, (GlaxoSmithKline). Concurrent medical conditions included asthma. Historic vaccination included FLULAVAL (GlaxoSmithKline) given on an unspecified date. Concurrent medications included PROAIR HFA. On 4 December 2013 the subject received a dose of FLULAVAL (.5 ml, intramuscular, left deltoid). On 4 December 2013, 90 minutes after vaccination with FLULAVAL, the subject experienced allergic reaction, injection site redness, injection site pruritus, swelling injection site and injection site warmth. Per the medical assistant, the subject contacted the physician's office on 9 December 2013. Per the medical assistant, the subject reported that "within 90 minutes of the vaccination she had redness, itching and swelling of the site and also warmness at the site down to her elbow." The subject was treated with BENADRYL. Per the medical assistant, the subject was advised to use over the counter BENADRYL pills or cream for the itching, redness and swelling. The subject was advised by the physician's office to "seek medical attention if swelling of the tongue or airway occurred." At the time of reporting the outcome of the events were unknown. There has been no further contact from the subject to the physician's office; therefore, the outcome was unknown. Follow-up information received on 08 January 2014 via healthcare professional who reported the subject previously received FLULAVAL on 16 January 2013. No action was taken with FLULAVAL administered on 04 December 2013 via intramuscular injection. The events resolved on 07 December 2013. The reporting healthcare professional did not consider the events to be serious. At the time of the report no other information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via claims management company and described the occurrence of adverse event(s) in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 October 2013 the subject received a dose of FLULAVAL (unknown details). On an unspecified date in 2013, within months of vaccination with FLULAVAL, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Patient said had shingles rash at site for 7 days. Resolved on its own.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Oropharyngeal pain, Pain
Clinical narrative: Case number PHHY2013US117396 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 487742) website on 15 Oct 2013. This report refers to a 03-year-old female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 19 Mar 2013. On 21 Mar 2013, she experienced tiredness, sleeping all the time, body pain, fever, runny nose, sore throat and loss of appetite. Outcome of the events was reported as not recovered as of 21 Mar 2013. No seriousness and causality was reported for the events.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Case number PHHY2013US117396 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 487742) website on 15 Oct 2013. This report refers to a 03-year-old female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 19 Mar 2013. On 21 Mar 2013, she experienced tiredness, sleeping all the time, body pain, fever, runny nose, sore throat and loss of appetite. Outcome of the events was reported as not recovered as of 21 Mar 2013. No seriousness and causality was reported for the events.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US010574 is an initial spontaneous report received from a pharmacist on 02 May 2013 with a follow up information received from vaccine adverse event reporting system (VAERS reference number: 491440) web site on 06 Aug 2013. This report refers to a 24-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with expired MENVEO (batch number: A10047/X10047 and expiry date: Dec 2012) intramuscularly in the left arm 01 May 2013. No adverse reaction was reported following this administration error. Follow up information received from vaccine adverse event reporting system web site on 06 Aug 2013: Updated reporter and route and site of vaccination.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US012286, is an initial spontaneous report received from a nurse on 03 Jun 2013, with a follow-up received on 28 Jun 2013 and a non-significant follow up report from the vaccine adverse event reporting system (Vaers ID: 493530) received on 05 Se2013. This report refers to a 13-year-old female patient. Her medical history was not reported. Her concomitant medication included BOOSTRIX (batch number: AC52B07BBA) at a dose of 0.5 ml into right deltoid and GARDASIL (batch number: H016238) at a dose of 0.5 ml into left deltoid on 09 May 2013. She inadvertently received only liquid conjugate component of MENVEO vaccine, (batch number: X11076) at a dose of 0.5 ml, intramuscularly into left deltoid, without being reconstituted with Men A component on 09 May 2013 (in the afternoon). She did not reat the vaccine as per instructions and the patient was doing well at the time of report. The patient did not experience any event following medication error. Follow-up was received on 28 Jun 2013: Patient demographics, concomitant medication, vaccination site and information that patient experienced no adverse event were updated. Non-significant follow-up report from the vaccine adverse event reporting system received on 05 Sep 2013: Vaers ID and batch numbers of concomitant vaccines were updated.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Crying, Injection site erythema
Clinical narrative: Initial report received from a healthcare professional on 23 October 2013. A 2-month-old male patient who had no illness at the time of vaccination, medical history and concomitant medications, had received an intramuscular first dose of PENTACEL (lot number: C4557AA) in the left thigh, received an intramuscular first dose of PREVNAR 13 vaccine (Manufacturer: Pfizer, lot number was not reported) in the right thigh, received an oral first dose of ROTATEQ vaccine (Manufacturer: MSD, lot number was not reported) all of 22 October 2013. On 22 October 2013, after vaccination, the patient experienced redness at left thigh and patient cried 4 hours. Laboratory investigations were not reported and the patient had received Ibuprofen as corrective medications. On an unspecified date, the patient had recovered from events. Documents held by sender: None. Additional information reported by healthcare professional on 22-Nov-2013: Previous medication was added. Corresponding fields and narrative updated accordingly.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Patient is worked in today because of an adverse reaction to the intradermal flu shot that she had a month ago.  She is right-handed.  She had it about four weeks ago and has had some itching, redness, swelling, tenderness and is having difficulty moving the left arm.  The itching is improved and she has used over-the-counter cream. PHYSICAL EXAMINATION: EXTREMITIES:  Examination of the left triceps region reveals some erythema, warmth and redness.   There is diminished range of motion of the left shoulder.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tenderness
Clinical narrative: Patient is worked in today because of an adverse reaction to the intradermal flu shot that she had a month ago.  She is right-handed.  She had it about four weeks ago and has had some itching, redness, swelling, tenderness and is having difficulty moving the left arm.  The itching is improved and she has used over-the-counter cream. PHYSICAL EXAMINATION: EXTREMITIES:  Examination of the left triceps region reveals some erythema, warmth and redness.   There is diminished range of motion of the left shoulder.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling hot, Hypoaesthesia, Muscular weakness, Paraesthesia, Restless legs syndrome
Clinical narrative: After few days, restless, numbness on feet to upper body. First trip to emergency after falling a couple times. Second trip to emergency with Bell's Palsy. Third trip to emergency with weak legs and very strong symptoms. Diagnosed with Guillain-Barre Syndrome and acute inflammatory demyelinating polyneuropathy.
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Fall, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: After few days, restless, numbness on feet to upper body. First trip to emergency after falling a couple times. Second trip to emergency with Bell's Palsy. Third trip to emergency with weak legs and very strong symptoms. Diagnosed with Guillain-Barre Syndrome and acute inflammatory demyelinating polyneuropathy.