chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site nerve damage, Injection site pain
Clinical narrative: Client states that she yelled when flu shot administered.  "It hurt more than usual."  Was immediately sore and progessively became more sore overtime.  Presently client cannot pick up anything with affected arm.  Client called Family doctor who feels Flu shot was administered too high and hit a nerve.  She will be seeing her MD today.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, redness, severe pain, area hot, itching.
Age: 0.77
Sex: M
Vaccine: HIBV
Symptoms: Abnormal behaviour, Irritability, Nasal congestion
Clinical narrative: Developed congestion/stuffy nose the evening of the vaccination, irritable, not himself.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Stridor
Clinical narrative: Difficuly breathing, stridor, coughing.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash macular
Clinical narrative: Systemic rash, red spotches on arms, face, legs.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Wrong technique in drug usage process
Clinical narrative: Gave soldier the small vaccination. After soldier left the nurses station another nurse told me that the smallpox vaccine that I had used had to much dilutent in it. I checked with the person who made it and she said that she had put 1ml more dilutent in it than it was supposed to have. Found patient in P.A.'s office and let the patient and P.A. know what had happened. I was told P.A. would find out what was to be done about it, patient was watched for 15 minutes and P.A. Patient was asked to come back in 10 days so that we can check on smallpox reaction. If there is none we will revaccinate. and was let go. Then P.A. came and told me that they had let patient go and he was coming back to get reaction checked.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Skin discolouration
Clinical narrative: Arm swelling to size of football and purple.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, redness and itching.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cardiomyopathy, Catheterisation cardiac normal, Cellulitis, Chest X-ray
Clinical narrative: Cellulitis started same day of injection.  Arm became extremely sore on day two; started running fever of 104.0 degrees.  Redness became visible on day three (11/24); pain became worse and redness increased/spread throughout the day.  On 11/25/11 patient rushed to ER with heart attack/myocarditis/cardiomyopathy.  No obstructions of heart as determined by catheterization.  Decreased ejection fraction 45%.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram thorax, Ejection fraction decreased, Erythema, Myocardial infarction, Myocarditis
Clinical narrative: Cellulitis started same day of injection.  Arm became extremely sore on day two; started running fever of 104.0 degrees.  Redness became visible on day three (11/24); pain became worse and redness increased/spread throughout the day.  On 11/25/11 patient rushed to ER with heart attack/myocarditis/cardiomyopathy.  No obstructions of heart as determined by catheterization.  Decreased ejection fraction 45%.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Ultrasound scan
Clinical narrative: Cellulitis started same day of injection.  Arm became extremely sore on day two; started running fever of 104.0 degrees.  Redness became visible on day three (11/24); pain became worse and redness increased/spread throughout the day.  On 11/25/11 patient rushed to ER with heart attack/myocarditis/cardiomyopathy.  No obstructions of heart as determined by catheterization.  Decreased ejection fraction 45%.
Age: 29.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever for 4-5 days; swelling, redness and pain at injection site; flu-like symptoms.
Age: 0.77
Sex: M
Vaccine: HIBV, PNC
Symptoms: Eye swelling, Pyrexia, Swelling face
Clinical narrative: Swelling of the face, ESP around the eyes and fever of 102.0 rectally.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: RED 35X40MM SPOT ON RT ARM.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Staphylococcal infection
Clinical narrative: Mild pain, moderate swelling at site, fever 101. Saw Dr twice. Treated for Staph Infection.
Age: 0.99
Sex: M
Vaccine: FLU3, HIBV, IPV, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt woke up with high fever and vomited twice within 15 min.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, FLUN3, HEPA
Symptoms: Abasia, Injection site pain, Injection site swelling
Clinical narrative: Child complained of pain in left leg and did not want to bear weight (i.e., walk). Mother noted left leg swollen even down to the foot. Left thigh much bigger than R thigh. Stated not reddened and denied fever.  "Just painful, it hurt him and he wouldn't walk." Acetaminophen reportedly administered about 2 hrs after administration of vaccines and about every 4 hours, but not during sleep hours at night. When father called about 1:00 p.m. on 11/30/11, was advised to repeat analgesic if time and also try a warm (or cold) compress to toleration of child.  Mother stated he liked the frozen sponge they gave him and he held it to his thigh himself.  It did not worsen so they elected to not visit a healthcare provider. Next morning (today), leg was noticeably better but still swollen at thigh. Child is now walking and wanted to go to daycare today.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 6 HOURS POST GETTING VACCINE - DEVELOPED HIGH FEVER, CHILLS AND BODY ACHES.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Swelling face, Urticaria
Clinical narrative: Pt. broke out in hives on neck and legs and had facial swelling approximately 4 1/2 hours after receiving FluMist vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin disorder, Swelling
Clinical narrative: Redness, swelling and streaks.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Flushing, Nausea, Oedema peripheral
Clinical narrative: Pt. c/o nausea, feeling flushed, and swelling of both hands approximately 1 hour after receiving FluMist vaccine.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, hot, swollen, painful around injection site.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Flushing, Nausea, Oedema peripheral
Clinical narrative: Pt. with nausea, feeling flushed, and swelling in both hands approximately 1 hour after FluMist vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Oropharyngeal pain
Clinical narrative: 2 weeks after felt sore throat, one ankle swelling.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Mononucleosis heterophile test negative, Oropharyngeal pain, Rash macular, Streptococcus test negative, White blood cell count normal
Clinical narrative: Pt states 3 hrs after getting HPV shot, got sore throat, blotchy rash which largely resolved by 11/29/11.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site infection
Clinical narrative: Patient's right upper arm became infected shortly after I gave ADACEL shot on 11/27/11. She came to pharmacy to show me on 11/30/11. I thought it was adverse reaction, but she went to the hospital & was diagnosed with bad infection.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Urticaria
Clinical narrative: After 2 yr well check & shots, he developed hives - treated with BENADRYL but still present following day.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Patient is stating that the vaccination lead to bursitis of the shoulder.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus, Rash morbilliform
Clinical narrative: Facial flushing and fine, measles-like rash appeared about 1 hour after vaccination, responded to BENADRYL - at 2pm 12/01/11 rash is fading, severe itching noted.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Paraesthesia
Clinical narrative: Pt describes tingling sensation - swelling of arm she had her flu shot in. Pt visited doctor - he prescribed MOTRIN.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Initial report was received 13 September 2011 from a health care professional. A 56-year-old female patient who had known allergies to seafood, penicillin and statin drugs, had received a first dose intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number UH459AC on 12 September 2011, and on the day of vaccination she developed a stiff neck, fever of 103F and a headache. The patient called her physician's office to report the symptoms and was instructed to go to the emergency room. She had not received any other vaccines during the four weeks prior to vaccination and she had no concurrent illness at the time of vaccination. Additional past medical history was not reported; however, the patient had been taking 15 concomitant medications which were unknown by the reporter. Outcome was not recovered. Documents held by sender: None.
Age: 0.19
Sex: M
Vaccine: PNC
Symptoms: Apnoea, Blood culture, Bradycardia, Endotracheal intubation, Full blood count
Clinical narrative: Severe apneic and bradycardic episodes requiring bag and mask. Intubated infant and now on a ventilator.
Age: 0.19
Sex: M
Vaccine: PNC
Symptoms: Mechanical ventilation
Clinical narrative: Severe apneic and bradycardic episodes requiring bag and mask. Intubated infant and now on a ventilator.
Age: 69.0
Sex: F
Vaccine: DTAP
Symptoms: Herpes zoster
Clinical narrative: Patient came down with shingles after receiving a DTAP vaccine. Felt that perhaps because patient had whooping cough as a child and was over 65 that they should not have received it. Patient does not know for sure if it cause shingles, but their immune system is usually strong.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Flushing, Headache, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: ARM "SO SORE COULD NOT LIFT IT UP" FEVER HEADACHE AND "FELT FLUISH".
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient had redness and swelling from mid-forearm to deltoid region.  There was a raised red are at the injection site that remained hard and warm for several days.  The patient denies any fever.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Patient had redness and swelling from mid-forearm to deltoid region.  There was a raised red are at the injection site that remained hard and warm for several days.  The patient denies any fever.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Child told mother to look at her arm around 6:30 PM on Wednesday, November 30, 2011 because it was itching her. Left arm was red in color and not hot. Child had no fever or pain. Mom took child to the ER. Child is currently taking antibiotics and Benadryl. The redness has reduced and child still continues to state that it does not hurt her. Fever has not occurred.
Age: 0.77
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site induration, Injection site nodule, Irritability, Pyrexia
Clinical narrative: Fever and fussiness, hard nodule in left thigh muscle.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Pain
Clinical narrative: Pain, lemon sized knot.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Breast swelling, Erythema, Fatigue
Clinical narrative: LEFT ARM SWOLLEN AND RED, SPREAD TO WHOLE ARM FROM FINGER TO SHOULDERS AND SWOLLEN LEFT ARMPIT AND BREAST, VERY PAINFUL.  BODY ACHES, FEVER, FATIGUE.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral, Pain, Pyrexia
Clinical narrative: LEFT ARM SWOLLEN AND RED, SPREAD TO WHOLE ARM FROM FINGER TO SHOULDERS AND SWOLLEN LEFT ARMPIT AND BREAST, VERY PAINFUL.  BODY ACHES, FEVER, FATIGUE.
Age: 1.14
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Mother states that at 10pm daughter had a seizure and called an amublance. Arrived at ER at 11:35 pm alert and no seizure activity noted per ER records at Hospital. Fever 103.6 rectal. Client given Tylenol and discharged from ER at 2:08 am. Mother informed us or this at 11/28/11 visit for flu shot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Received injection at 4:50 PM and then went to lab.  Lab called patient at 4:55 Pm to come to the lab to check on patients arm.  Red area the size of a grapefruit without itching.  Dr. notified and checked area at 5:00 PM.  No difficult breathing, no increase in redness and no further itching.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Throat tightness, Tremor
Clinical narrative: Throat tightness, chills, uncontrollable shaking, & nausea.  Went to bed and woke up without any symptoms the following morning.  Denied previous reaction to flu vaccine, egg allergy or intolerance, or any new foods, sushi, or foods with MSG.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Vaccination complication
Clinical narrative: Patient came in to have flu shot reaction examined on left arm. Spot is 3 cm x 3 cm and is mildly red and warm.  Patient can move arm full range and does not have any other symptoms, denied fever.  Patient informed to watch spot, if it gets bigger, redder, or a fever develops to go to ER.  Patient informed to put ice on arm to help swelling. Patient has never had a flu shot before.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Itching. Next day severe headache, itch pin prick and swelling ovals down her arem from both injection sites to her elbow.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Diarrhoea, Nausea, Pain, Pain in extremity
Clinical narrative: Diarrhea, nausea, fever, aching and chills for 3 and a half days. Left arm so sore he could barely move it.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Diarrhea, nausea, fever, aching and chills for 3 and a half days. Left arm so sore he could barely move it.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Right arm very red, swollen and sore. Left arm red and sore.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Symptoms started with joint pain, headache, and redness with swelling at immunization site. Progressed with addition of fever in evening. Patient took ibuprofen. Fever, aches and joint pain gone by 12/1/11 but redness and swelling of site is spreading. Patient went to urgent care afternoon of 12/1/11 and received rx for prednisone and OTC diphenhydramine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Symptoms started with joint pain, headache, and redness with swelling at immunization site. Progressed with addition of fever in evening. Patient took ibuprofen. Fever, aches and joint pain gone by 12/1/11 but redness and swelling of site is spreading. Patient went to urgent care afternoon of 12/1/11 and received rx for prednisone and OTC diphenhydramine.
Age: 2.0
Sex: F
Vaccine: FLUX, HEPA, HIBV, PNC13
Symptoms: Abdominal pain upper, Fatigue, Pyrexia, Vomiting
Clinical narrative: Fever, tired, and stomach ache.  Vomited at 7:30 PM.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: My arm was reasonably sore same day of injection. The next day, around the injection site, it was red, hot and swollen.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Nausea, Rash
Clinical narrative: Headache and nausea started day of vaccine.  Improved, then on 11/30/11 started with rash seen today, which was thought was shingles.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Antinuclear antibody, Biopsy, Blood albumin, Blood lactate dehydrogenase, Electrophoresis protein
Clinical narrative: 3-4 days later developed a rash around flu shot site, about lemon sized. He applied topical hydrocortisone cream - it gradually improved. The 1.5 wk after flu shot, rash broke out on both legs. He tool OTC allergy pills (? BENADRYL). On 11/21/11 was seen at office with extensive crop of petechial palpable lesions both legs - thighs, knees, calves, front & back.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Full blood count, Hepatitis B virus test, Injection site rash, Metabolic function test, Petechiae
Clinical narrative: 3-4 days later developed a rash around flu shot site, about lemon sized. He applied topical hydrocortisone cream - it gradually improved. The 1.5 wk after flu shot, rash broke out on both legs. He tool OTC allergy pills (? BENADRYL). On 11/21/11 was seen at office with extensive crop of petechial palpable lesions both legs - thighs, knees, calves, front & back.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Rheumatoid factor, Streptococcus test, Urine analysis
Clinical narrative: 3-4 days later developed a rash around flu shot site, about lemon sized. He applied topical hydrocortisone cream - it gradually improved. The 1.5 wk after flu shot, rash broke out on both legs. He tool OTC allergy pills (? BENADRYL). On 11/21/11 was seen at office with extensive crop of petechial palpable lesions both legs - thighs, knees, calves, front & back.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Vaccine rx (MMR & KINRIX - (DTAP & IPV) 9.0 cm x 9.5 cm (L) thigh.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Full blood count normal, Metabolic function test normal, Staring, Unresponsive to stimuli
Clinical narrative: The day after the patient received vaccines he had an episode of staring and unresponsiveness for 2 minutes. Went to ED, fully recovered 8-10 minutes after event.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood gases, CSF culture, Chest X-ray, Computerised tomogram head, Endotracheal intubation
Clinical narrative: 10:00 am 11/28/11 - 15 mo immunizations received PM 11/28/11 - clonic tonic seizure activity = 911. Admitted to PICU & intubation, fever and seizure activity.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Full blood count, Grand mal convulsion, Intensive care, Metabolic function test, Pyrexia
Clinical narrative: 10:00 am 11/28/11 - 15 mo immunizations received PM 11/28/11 - clonic tonic seizure activity = 911. Admitted to PICU & intubation, fever and seizure activity.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urine analysis
Clinical narrative: 10:00 am 11/28/11 - 15 mo immunizations received PM 11/28/11 - clonic tonic seizure activity = 911. Admitted to PICU & intubation, fever and seizure activity.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (R) arm swelling - sore - itchy reddened deltoid & in near armpit all over muscles.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed a hard lump (baseball size) that was warm to the touch, red, swollen at vaccine injection site, which was very itchy the next day. Symptoms lasted 4-5 days.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Pt developed a hard lump (baseball size) that was warm to the touch, red, swollen at vaccine injection site, which was very itchy the next day. Symptoms lasted 4-5 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pruritus
Clinical narrative: Pt complained of itching. Arm turned red, hot, started to swell. Treated w/BENADRYL, prednisone and OMNICEF.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Red, hard inflamed area at injection site raised and about 1 1/2 inches diameter. Was painful and itchy for 7 days after injection. Took BENADRYL and MOTRIN.
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Red, hard inflamed area at injection site raised and about 1 1/2 inches diameter. Was painful and itchy for 7 days after injection. Took BENADRYL and MOTRIN.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed a red raised area at site of inj.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient complained of pain when lifting left arm above head. Started when she received flu shot one week later, no treatment. She is not sure if she just injured it before flu vaccine.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pt. noticed burning when vaccine was injected. There was a lump at injection site. Site became red and swollen and warm to the touch.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Pt. noticed burning when vaccine was injected. There was a lump at injection site. Site became red and swollen and warm to the touch.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Slight redness.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Complex regional pain syndrome, Injection site pain, Pain in extremity
Clinical narrative: Severe regional pain syndrome of distal ipsilateral area (left arm) from above elbow to hand. Occurred 15-16 hours following flu vaccine.
Age: 58.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Arthralgia, Feeling hot, Myalgia, Pain, Pain in extremity
Clinical narrative: Arthralgias, myalgias > intermittent sharp shooting "almost cramping" worst in (R) bicep and (L) calf. Followed by warm feeling same area.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Flu vaccine given on 9/28/2011. Notified today 12/1/11 that he had received a previous Flu vaccine mid-September.
Age: 11.0
Sex: F
Vaccine: FLUN3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity, Puncture site induration
Clinical narrative: 6 cm x 8 cm red, warm, indurated punctate site; (R) arm deltoid. (+) tender to touch. C/O arm with pain (not severe). Able to move arm. Vaccine given 11/30/11; S/S same P.M. Tx = MOTRIN 800 mg Q6 - 8 hours; Rtn to PCP with increased pain > 48 hours; LROM.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Urticaria
Clinical narrative: Dollar size hive, painful. Came into clinic where she was given BENADRYL.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Oedema
Clinical narrative: Moderate edema left arm, erythema, warmth & pain post PNEUMOVAX injection at (L) deltoid. Streaking noted (L) anterior axillary region. Moderate edema starts at clavicle ends just above elbow. Referral to PCP ASAP.
Age: 1.66
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: 12-1-11 woke up with left thigh red and swollen - swelling decreased - has bumps only - was given BENADRYL.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain
Clinical narrative: Site of injection reddened & painful. Elevated temp (101 degrees).
Age: 0.17
Sex: M
Vaccine: HEP, PNC13, RV5
Symptoms: Irritability, Pyrexia, Vomiting
Clinical narrative: Fever, irritability, vomiting for 48 hours.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying
Clinical narrative: Prolonged crying.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, C-reactive protein increased, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: Raised painful blotchy rash at injection site and extending down arm. Pain radiating into clavicle. Fever x 3 days.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, White blood cell count increased
Clinical narrative: Raised painful blotchy rash at injection site and extending down arm. Pain radiating into clavicle. Fever x 3 days.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Muscle soreness at injection site, has persisted since vaccine administration.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site erythema, Injection site reaction, Skin disorder
Clinical narrative: Left deltoid area has approximately 2" diameter are of redness around injection site and also in areas where band-aid applied with 1/2" area of skin breakdown approximately 2.5" away from injection site (on right side) which appears to have been from band-aid. Oozing a little, afebrile.
Age: 20.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area to back of Lt upper arm - red, swollen and warm to touch. Approx 7 cm x 6 cm and pt voices that it "aches and that it hurts."
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Loss of consciousness, Vomiting
Clinical narrative: Severe vomiting and diarrhea lasted 12 hrs. Passed out on floor.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash macular
Clinical narrative: 9 x 7 macular erythematus rash surrounding injection site.
Age: 0.24
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Culture urine, Dermatitis diaper, Diarrhoea, Hypersomnia, Mucous stools
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included acid reflux. Concurrent vaccination included PENTACEL (Sanofi) and PREVNAR (Wyeth Labs) both given on 22 November 2011. Concurrent medications included ZANTAC. On 22 November 2011 at 15:30 the subject received 1st dose of ROTARIX at 1.0 ml, orally. On 25 November 2011, 3 days after vaccination with ROTARIX, the subject experienced diarrhea (12 to 15 times daily), increased sleep, diaper rash and mucus in stool (no blood). These events resolved on an unspecified date and were considered possibly related to vaccination with ROTARIX. Fever (99.4 to 100.9) was also reported with onset 25 November 2011. Resolution of fever and attribution to ROTARIX was not reported. The subject had been taken to the emergency room on 26 November 2011, but was not admitted. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). It was reported that a urine bag was used so the reporter assumed that a urinalysis and culture was performed, but results were not available.
Age: 0.24
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Pyrexia, Somnolence, Urine analysis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included acid reflux. Concurrent vaccination included PENTACEL (Sanofi) and PREVNAR (Wyeth Labs) both given on 22 November 2011. Concurrent medications included ZANTAC. On 22 November 2011 at 15:30 the subject received 1st dose of ROTARIX at 1.0 ml, orally. On 25 November 2011, 3 days after vaccination with ROTARIX, the subject experienced diarrhea (12 to 15 times daily), increased sleep, diaper rash and mucus in stool (no blood). These events resolved on an unspecified date and were considered possibly related to vaccination with ROTARIX. Fever (99.4 to 100.9) was also reported with onset 25 November 2011. Resolution of fever and attribution to ROTARIX was not reported. The subject had been taken to the emergency room on 26 November 2011, but was not admitted. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). It was reported that a urine bag was used so the reporter assumed that a urinalysis and culture was performed, but results were not available.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pt received FLUZONE 2011-2012 multidose vaccine at 3PM on 11/7/11. At 6 PM on 11/8/11 Pt experienced constant, severe, pain, numbness and tingling in joints and the whole arm down to wrist and fingers for 6-8 hours. After this symptoms improved but still sore (couldn't lay on arm) for 3 days.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 2" raised, red, itchy patch at site of injection, symptoms improved by 11/20 but not completely resolved.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC
Symptoms: Decreased appetite, Febrile convulsion, Haemoglobin normal, Irritability, Polymerase chain reaction
Clinical narrative: 11/23/11 Pt seen in office for fever elevated 105, irritable, decreased appetite and runny nose. While in office T 101.7 ET at 355P and at 4P increased 103.6 ET. Pt had acute febrile seizure. Had Ibuprofen last at 1200.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC
Symptoms: Pyrexia, Rhinorrhoea, Streptococcus test negative, White blood cell count normal
Clinical narrative: 11/23/11 Pt seen in office for fever elevated 105, irritable, decreased appetite and runny nose. While in office T 101.7 ET at 355P and at 4P increased 103.6 ET. Pt had acute febrile seizure. Had Ibuprofen last at 1200.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Irritability, Local reaction, Pain, Swelling
Clinical narrative: Localized reaction pain, swelling, irritable 1 hour after injection.
Age: 34.0
Sex: M
Vaccine: HEP, JEV1
Symptoms: Body temperature increased, Nausea, Vomiting
Clinical narrative: 3 hours after receiving dose 2 of ENGERIX Hep B on accelerated scheduled (0, 7d, 21d, 1 yr) and dose 1 of IXIARO client experienced nausea, vomiting, temp less than or equal to 104 degrees (-) diarrhea (-) rash (-) airway swelling. Symptoms relieved by taking ALEVE.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fall, Feeling abnormal, Hyperhidrosis, Loss of consciousness
Clinical narrative: Pale skin color, sweating. Patient passed out and fell on floor. He said he felt dizzy ("didn't feel good"). He was conscious within seconds and slowly felt better (within 10 min).
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: Pale skin color, sweating. Patient passed out and fell on floor. He said he felt dizzy ("didn't feel good"). He was conscious within seconds and slowly felt better (within 10 min).
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Patient was treated in the emergency room twice for severe pain/swelling and cellulitis at the injection site.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Croup infectious, Gait disturbance, Headache, Injected limb mobility decreased
Clinical narrative: Left shoulder extreme pain. Could hardly move arm 2 days after shot, then legs hurt could hardly walk - 3 days after shot. Lasted for 3 weeks. Headache, then turned into cough which turned into croup. Still have a lot of mucus still ill. I never was sick before the shot.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Left shoulder extreme pain. Could hardly move arm 2 days after shot, then legs hurt could hardly walk - 3 days after shot. Lasted for 3 weeks. Headache, then turned into cough which turned into croup. Still have a lot of mucus still ill. I never was sick before the shot.
Age: 0.56
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Pt. was given Rotavirus at 6 mo visit. It was Rota #4.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Blood culture negative, Computerised tomogram normal, Fatigue, Joint range of motion decreased, Laboratory test normal
Clinical narrative: Onset of extreme pain in (L) shoulder/scapula and (L) neck approx. 30 min after injection. Inability to raise arm especially with abduction and decreased range of motion for about 6 weeks. Unable to sleep on (L) side due to pain and soreness. Generalized tiredness. Noted some grating and popping sounds (L) shoulder. Tx with NSAIDS.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Neck pain, Pain, Tenderness
Clinical narrative: Onset of extreme pain in (L) shoulder/scapula and (L) neck approx. 30 min after injection. Inability to raise arm especially with abduction and decreased range of motion for about 6 weeks. Unable to sleep on (L) side due to pain and soreness. Generalized tiredness. Noted some grating and popping sounds (L) shoulder. Tx with NSAIDS.
Age: 44.0
Sex: F
Vaccine: YF
Symptoms: Headache, Hypoaesthesia, Injection site mass, Tenderness
Clinical narrative: Pt. called to complain of H/A, tenderness and lump at injection site (LA) 3 days after injection. Also c/o numbness down entire arm to fingers. Saw MD (neurologist) for eval. Sx subsided next day.
Age: 37.0
Sex: F
Vaccine: MM, TDAP
Symptoms: Abasia, Dizziness, Limb discomfort, Nausea, Pain in extremity
Clinical narrative: Left leg was under extreme pressure, could not walk, fever, whole arm was sore. Red blotches on wrist. Dizziness, nauseousness.
Age: 37.0
Sex: F
Vaccine: MM, TDAP
Symptoms: Pyrexia, Rash macular
Clinical narrative: Left leg was under extreme pressure, could not walk, fever, whole arm was sore. Red blotches on wrist. Dizziness, nauseousness.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Injection site vesicles, Joint swelling, Pyrexia
Clinical narrative: Shot given at same time PPD skin test placed. Around 6 hours following vaccination, client felt "feverish". She also experienced chills and sweating. The client expressed a strong sensitivity to band-aids. On (R) deltoid she got a blister where the band-aid was. The client woke up today 11/18 and noticed a bump on (R) wrist and at joint of right of right pointer finger/hand.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 34-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 27 January 2011 the subject received 2nd dose of TWINRIX (1 ml, unknown, left arm). On 27 January 2011, immediately after vaccination with TWINRIX, the subject experienced swelling injection site and injection site redness. On 27 January 2011, immediately after vaccination with TWINRIX, the subject experienced swelling, injection site redness; the size was described as a fourth to half a dollar size. Intervention to prevent further swelling was performed at the physician's office and included application of ice. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Ice pack. One day later on 28 January 2011, the swelling injection site and injection site redness were resolved. This is the second of two cases by the healthcare professional; for the first case see A0910755A. Follow-up information was received on 16 February 2011. It was reported that TWINRIX was administered intramuscularly. The events began immediately after vaccination on 27 January 2011 and resolved the following day on 28 January 2011. In the reporter's opinion, the events were considered probably related to treatment with TWINRIX.
Sex: U
Vaccine: HEPAB
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling arm in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). In 2011 the subject received unspecified dose of TWINRIX in the left arm. At an unspecified time after vaccination with TWINRIX (starting about a week ago following vaccination), the subject experienced swelling arm, arms redness and arm pain. At the time of reporting the events were unresolved. Attribution of events to TWINRIX was not reported. No additional information was known.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Condition aggravated, Headache, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 54-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included Atenolol, Spironolactone and LEXAPRO. On 28 April 2011 the subject received 2nd dose of TWINRIX. On 28 April 2011 (a couple of hours after administration of TWINRIX) the subject experienced headache. The healthcare professional considered the event was disabling. At the time of reporting the event was resolved and probably attributable to TWINRIX vaccination. It was also reported that the subject experienced a headache following the 1st administration of TWINRIX. The outcome of this event was not indicated. It was noted that the headache following the 2nd dose of TWINRIX was worse and lasted a couple of days. Follow-up information was received on 24 May 2011. It was reported that the first event of headache occurred at an unspecified time following 1st dose of TWINRIX administration. Headache onset was on 31 March 2011 and ended on 02 April 2011. On 28 April 2011, the subject received a 2nd dose of TWINRIX and one day later on 29 April 2011 the subject again developed a headache. The event ended on 01 May 2011. In the reporter's opinion, both events of headache were probably related to treatment with TWINRIX. On follow-up, the events were not considered to be serious/disabling.
Sex: M
Vaccine: HEPAB
Symptoms: VIIth nerve paralysis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of Bell's palsy in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included TWINRIX; GlaxoSmithKline given on an unspecified date. On an unspecified date the subject received 2nd dose of TWINRIX (unknown). One day after vaccination with TWINRIX, the subject experienced Bell's palsy. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved.
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Transient global amnesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of transient global amnesia in a 63-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 16 June 2011 the subject received 2nd dose of TWINRIX at 1.0 ml. At an unspecified time after vaccination with TWINRIX, the subject experienced transient global amnesia. At the time of reporting the event was unresolved. The healthcare professional considered the event was probably related to vaccination with TWINRIX.
Age: 27.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody positive, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, No therapeutic response, Serology test
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of hepatitis b antibody negative in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On October 2010 the subject completed the TWINRIX series (1st dose, 2nd dose and 3rd dose). Serological testing performed on 19 June 2011 showed antibodies to to hepatitis A vaccine, but was non-reactive for hepatitis B vaccine (hepatitis b antibody negative). The subject had not responded to therapy. No additional details were provided. Follow-up information was received via a nurse on 15 August 2011. It was reported that the subject was a 29 year old male. He received intramuscular TWINRIX on 09 September 2009, 09 October 2009 and a third dose on 09 March 2010. The subject was tested on 19 July 2011, 16 months after completion of the TWINRIX series, and was found to have not responded to the hepatitis B component of the TWINRIX vaccine. The subject was hepatitis B antigen and antibody non reactive. Medical history of hepatitis C virus and allergy to penicillin were reported.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 49-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st dose of TWINRIX given on 3 June 2011. The subject had no adverse events following that vaccination. On 1 July 2011 at 14:00 the subject received 2nd dose of TWINRIX (unknown route, right arm). On an unspecified date, less than one year after vaccination with TWINRIX, the subject experienced diarrhea. At the time of reporting the event was unresolved. The subject had not contacted her physician and had left a voice mail which was collected by the reporter. The healthcare professional noted that the subject had received the vaccination for travel prophylaxis and that the subject could have picked up an illness while travelling.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Activities of daily living impaired, Fatigue, Headache, Lacrimation increased, Nasopharyngitis
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of headache in a 48-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st and 2nd doses of TWINRIX (GlaxoSmithKline) given on 23 June 2011 and 30 June 2011. Concurrent medications included PREMARIN and SYNTHROID. On 19 July 2011 at 16:30 the subject received 3rd dose of TWINRIX at 0.5 ml in the left arm. On 20 July 2011, 1 day after vaccination with TWINRIX, the subject experienced severe headaches, soreness, fatigue, fever, watery eyes and sore throat. Watery eyes was self treated with unspecified drops and sore throat was treated with MUCINEX. It was reported that the subject missed a couple weeks of work (impaired work ability). At the time of reporting the events were unresolved except for fever which had resolved. A note was made that it sounded like the subject had a cold. It was noted that the subject had no history of previous such reactions. The next (4th - booster) dose of TWINRIX was planned for 12 months after the 1st dose.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of headache in a 48-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st and 2nd doses of TWINRIX (GlaxoSmithKline) given on 23 June 2011 and 30 June 2011. Concurrent medications included PREMARIN and SYNTHROID. On 19 July 2011 at 16:30 the subject received 3rd dose of TWINRIX at 0.5 ml in the left arm. On 20 July 2011, 1 day after vaccination with TWINRIX, the subject experienced severe headaches, soreness, fatigue, fever, watery eyes and sore throat. Watery eyes was self treated with unspecified drops and sore throat was treated with MUCINEX. It was reported that the subject missed a couple weeks of work (impaired work ability). At the time of reporting the events were unresolved except for fever which had resolved. A note was made that it sounded like the subject had a cold. It was noted that the subject had no history of previous such reactions. The next (4th - booster) dose of TWINRIX was planned for 12 months after the 1st dose.
Sex: U
Vaccine: HEPAB
Symptoms: Erythema, Hyperaesthesia, Rash, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of skin sensitivity in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included itchy skin. Concurrent vaccination included TWINRIX (GlaxoSmithKline) given on an unspecified date approximately one month following administration of the first dose of TWINRIX. On an unspecified date the subject received 1st dose of TWINRIX (unknown). Within a few days of vaccination with TWINRIX, the subject skin sensitivity. It was described as the skin being very sensitive to ribbing and even light abrasion. The example was given that after shaving (with an electric razor) the subject noticed several welts on the skin similar to hives. These went away after an hour or so. Since the TWINRIX vaccination, the subject noted several instances where his/her skin at any location would become very red when it rubbed or again raise welts if rubbed hard enough. Again, these persisted for a short duration and then went away. The subject noted that both rash and hives are side effects of TWINRIX and now questions these events as attributable to the TWINRIX vaccination. The symptoms of rash and hives were reported to have started three days after the 1st injection with TWINRIX and have persisted to date (for 3 months). The subject reported taking antihistamines which help with itching, but the skin sensitivity was still present at the time of reporting. It was reported that the skin sensitivity was "perhaps toned down a little." Two doses of TWINRIX were received a month apart and the events continued. It was noted that there were no discernible side effects immediately after either shot (no local soreness or redness).
Sex: F
Vaccine: HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown), and experienced not responding to therapy. At an unknown time after completing the vaccination series with TWINRIX, the subject was tested for hepatitis A antibody and the physician reported that the subject was "not immune" (not responding to therapy).
Sex: F
Vaccine: HEPAB
Symptoms: Bedridden
Clinical narrative: This case was reported by a consumer and described the occurrence of bedridden in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 1 April 2011 the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject was bedridden for at least two days at the time of reporting. No additional details were reported. At the time of reporting the outcome of the event was unspecified.