chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Neutrophil count increased
Clinical narrative: Early a.m., pt c/o dizziness and "hot", crawling to BR; agitated disoriented, delirious, questionable rt sided lip droop. To ER - Brain and Neck CT and Brain/Neck MRI completed to r/o TIA or stroke. All negative. During a.m pt spiked temp to 38.6; and continued delirious with temp spikes;  blood cultures, lab, chest X Ray, Urine cultures drawn all negative;  During nite 09/21/2013, continued to have temps over 38 intermittently despite Tylenol 650 mg q 4 hours.  BP dec to 89/systolic;  IV fluid bolus given. Pt continued to c.o rt upper arm soreness.  Noted approx 3 inch induration around injection site rt deltoid which expanded over next 24 hours to a 4 inch x 8 in area of redness, hot to touch and extreme tenderness.   Additional CBC and Blood cultures drawn. Cultures all negative.  WBC inc to 16,000, with inc neutrophils, inc ESR and inc CRP.  IV antibiotics initiated and IV fluids.   Temp to normal on 9/22/13 and cognition back to baseline.  Discharge early evening 9/22/13 on po cefpodoxime 200 mg q 12 hours and will repeat CBC and CMP in one week.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Early a.m., pt c/o dizziness and "hot", crawling to BR; agitated disoriented, delirious, questionable rt sided lip droop. To ER - Brain and Neck CT and Brain/Neck MRI completed to r/o TIA or stroke. All negative. During a.m pt spiked temp to 38.6; and continued delirious with temp spikes;  blood cultures, lab, chest X Ray, Urine cultures drawn all negative;  During nite 09/21/2013, continued to have temps over 38 intermittently despite Tylenol 650 mg q 4 hours.  BP dec to 89/systolic;  IV fluid bolus given. Pt continued to c.o rt upper arm soreness.  Noted approx 3 inch induration around injection site rt deltoid which expanded over next 24 hours to a 4 inch x 8 in area of redness, hot to touch and extreme tenderness.   Additional CBC and Blood cultures drawn. Cultures all negative.  WBC inc to 16,000, with inc neutrophils, inc ESR and inc CRP.  IV antibiotics initiated and IV fluids.   Temp to normal on 9/22/13 and cognition back to baseline.  Discharge early evening 9/22/13 on po cefpodoxime 200 mg q 12 hours and will repeat CBC and CMP in one week.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Vomiting
Clinical narrative: Chills and head ache + diarrhea + vomiting.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Insomnia, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain
Clinical narrative: Immediate shooting pain, shoulder pain ever since unable to rotate shoulder, lift arm can't sleep from the pain, aspirin, heat, cold, MRI 9/24/2013.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: Immediate shooting pain, shoulder pain ever since unable to rotate shoulder, lift arm can't sleep from the pain, aspirin, heat, cold, MRI 9/24/2013.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Vaccine administered and patient began having shortness of breath.  Epi administered and 911 called.
Age: 0.34
Sex: F
Vaccine: HIBV
Symptoms: Vaccination site rash
Clinical narrative: Rash on vaccine site, left thigh.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood glucose decreased, Blood glucose normal, Dizziness, Hyperhidrosis, Sleep study normal
Clinical narrative: Severe shaking, sweating, dizziness and low blood sugar as low as 69... she was given juice and sent home from school on the first day. Next day patient suffered same symptoms. Has been tested for diabetes and sleep apnea, thyroid..all tests are normal.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Thyroid function test normal, Tremor
Clinical narrative: Severe shaking, sweating, dizziness and low blood sugar as low as 69... she was given juice and sent home from school on the first day. Next day patient suffered same symptoms. Has been tested for diabetes and sleep apnea, thyroid..all tests are normal.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Convulsion, Gaze palsy, Skin discolouration, Syncope
Clinical narrative: Was fine at time of shot. A few seconds after shot was administered eyes rolled back in head and fell back on table (fainted) then began to convulse for maybe 10 seconds...nurse put her legs up in the air and I held fan in her face while beating on the wall for help. She then began to open her eyes and then close them again like she could not stay awake. After a few minutes color back and awake. Other nurse brought fluids and crakers for her to eat. Patient had had a big lunch around 1:30 and plenty of juice to drink before going to Health Dept.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Pain, Pain in extremity
Clinical narrative: Left arm pain with touch and movement.  Patient unable to move arm out from body more than 20 degrees.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Insomnia
Clinical narrative: Fluzone HD injection.  Moderate pain in muscle at sight of injection.  Enough to cause difficulty sleeping.  Eased over night and better 24 hours later.  Slight headache.  No prior issues with flu shots. Similar issue for my 96 year old mother getting shot at same time except hers extended to arm and side. Both had restless night's sleep.  No fever or other issues so far (24 hours later).  First time for both of us having the HD version of the flu shot.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Local swelling, Pain, Pyrexia
Clinical narrative: Redness and swelling of right arm with hives, fever 101, fatigue, pain.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Redness and swelling of right arm with hives, fever 101, fatigue, pain.
Age: 1.02
Sex: F
Vaccine: FLU4, HIBV, MMR, PNC13, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: 1 year old received Zostavax instead of varicella vaccine.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Swelling face
Clinical narrative: SEVERE HEADACHE; SEVERE SWELLING OF FACE; WAS TREATED IN EMERGENCY ROOM; RECIEVED BENADRYL--PREDNISONE MORPHINE-FAMOTIDINE-DIPHENHYDRAMINE-HYDROCODONE.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Aphasia, Chills, Cough, Malaise
Clinical narrative: SICK AS A DAMN DOG!!!! NON-STOP RACKING COUGH TILL MY THROAT WAS SORE AND RAW, UNABLE TO TALK AT ALL DUE TO SEVERE SORE THROAT, LOW GRADE FEVER, CHILLS, BODY ACHES, RUNNY NOSE. NON-STOP ILLNESS FOR 4-5 DAYS. UNABLE TO CONTINUE WITH DAILY ACTIVITIES OF WORK, HOUSE CLEANING, ETC. JUST LAID IN BED CONTINUOUSLY SICK AND REGRETTING THE DAY I EVER GOT THIS STINKING FLU SHOT!!!!
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: SICK AS A DAMN DOG!!!! NON-STOP RACKING COUGH TILL MY THROAT WAS SORE AND RAW, UNABLE TO TALK AT ALL DUE TO SEVERE SORE THROAT, LOW GRADE FEVER, CHILLS, BODY ACHES, RUNNY NOSE. NON-STOP ILLNESS FOR 4-5 DAYS. UNABLE TO CONTINUE WITH DAILY ACTIVITIES OF WORK, HOUSE CLEANING, ETC. JUST LAID IN BED CONTINUOUSLY SICK AND REGRETTING THE DAY I EVER GOT THIS STINKING FLU SHOT!!!!
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Incoherent
Clinical narrative: Slightly confused and incoherent...went to bed for a couple of hours...called doc and doc told her plenty of fluids.  No true black out.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at site day 1. By next day. Increased redness (3" X 2""). Warm to touch.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Malaise, Myalgia, Pyrexia
Clinical narrative: 104 degree fever, coughing, aching muscles, sick feeling.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: REDNESS AT SITE OF INJECTION.  AREA 3-4 INCHES IN DIAMETER.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Sore, red, itchy at injection site.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever spike to 103F, left deltoid arm red and swollen. Vancomycin iv started empirically for left arm cellulitis. After 2 days of iv vancomycin, redness and swelling diminished and patient was stable for discharge.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Lip blister, Pyrexia, Vomiting
Clinical narrative: Mother states the child developed a fever a few hours after the immunizations were given.  She started "vomiting uncontrollably" around 2:00 AM on 9/24/2013 and her fever reached approximately 103 degrees F.  Advil was given but the fever did not respond.  Mother also reports that there are blisters on the child's lips.  Food and beverages are not tolerated well at this time.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal discomfort, Blood test, Chapped lips, Crying, Kawasaki's disease
Clinical narrative: My daughter began screaming and crying about a sore mouth a few hours after the Flumist vaccine was administered.  The evening of the 19th she began to run a low grade fever and seemed puny.  The next morning on the 20th she had a stuffy nose and watery eyes with no fever.  She returned from school that day (5:00 PM on the 20th) and she was running a fever again.  She still complained about her mouth being sore and now her stomach started bothering her.  On Saturday the 21st her lips began swelling and cracking and her tongue was red with raised taste buds.  These symptoms persisted but the fever seemed to be getting better.  Then on Monday the 30th her face had completely broken out in sores around her eyes, mouth and chin.  We took her to see Dr. who had blood work drawn.  The blood work was inconclusive so we took her back on Tuesday the 24th when they diagnosed her with Kawasaki's disease as a direct result of the FluMist vaccine.  Her trunk and bottom are now peeling like a sunburn.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Lacrimation increased, Lip swelling, Nasal congestion, Oral pain, Pyrexia
Clinical narrative: My daughter began screaming and crying about a sore mouth a few hours after the Flumist vaccine was administered.  The evening of the 19th she began to run a low grade fever and seemed puny.  The next morning on the 20th she had a stuffy nose and watery eyes with no fever.  She returned from school that day (5:00 PM on the 20th) and she was running a fever again.  She still complained about her mouth being sore and now her stomach started bothering her.  On Saturday the 21st her lips began swelling and cracking and her tongue was red with raised taste buds.  These symptoms persisted but the fever seemed to be getting better.  Then on Monday the 30th her face had completely broken out in sores around her eyes, mouth and chin.  We took her to see Dr. who had blood work drawn.  The blood work was inconclusive so we took her back on Tuesday the 24th when they diagnosed her with Kawasaki's disease as a direct result of the FluMist vaccine.  Her trunk and bottom are now peeling like a sunburn.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Screaming, Skin exfoliation, Skin lesion, Tongue disorder
Clinical narrative: My daughter began screaming and crying about a sore mouth a few hours after the Flumist vaccine was administered.  The evening of the 19th she began to run a low grade fever and seemed puny.  The next morning on the 20th she had a stuffy nose and watery eyes with no fever.  She returned from school that day (5:00 PM on the 20th) and she was running a fever again.  She still complained about her mouth being sore and now her stomach started bothering her.  On Saturday the 21st her lips began swelling and cracking and her tongue was red with raised taste buds.  These symptoms persisted but the fever seemed to be getting better.  Then on Monday the 30th her face had completely broken out in sores around her eyes, mouth and chin.  We took her to see Dr. who had blood work drawn.  The blood work was inconclusive so we took her back on Tuesday the 24th when they diagnosed her with Kawasaki's disease as a direct result of the FluMist vaccine.  Her trunk and bottom are now peeling like a sunburn.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Arm is swollen, red and painful.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Muscle spasms
Clinical narrative: Pt called from store reporting muscle spasm and diffuculty breathing after 6 hours of flu vaccine administration.  Instructed pt to call 911.  Pt was contacted same day and next and told me that this kind of episode happened to him about 3 times before.  Not sure if flu vaccine triggered this episode.  MD at ER gave him robaxin and naprosyn on discharge.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Muscular weakness, Peripheral coldness
Clinical narrative: Profound swelling starting at injection site and involving large portion of upper arm, redness, warmth, arm weakness. Pain level 8 out of 10. Coldness in hand of the vaccinated arm. Patient went to the emergency room for treatment with Cleocin, Medrol Dosepak and naprosyn.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Fatigue, Paraesthesia, Pyrexia
Clinical narrative: Chills, fever of 100.4, skin burning, prickly feeling all over body, groggy, fatigue, SOB.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation, Somnolence
Clinical narrative: Chills, fever of 100.4, skin burning, prickly feeling all over body, groggy, fatigue, SOB.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache
Clinical narrative: Acute onset of severe headache and still persisting 4 days after.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Bedridden, Diarrhoea, Dizziness, Injection site erythema, Injection site pruritus
Clinical narrative: Felt sick to stomach, diarrhea I became bedridden for two days feeling light headed fever at that time I became aware arm had swollen and injection sight was red ring and itching. it was then I realized it was from vaccination.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Local swelling, Nausea, Pyrexia
Clinical narrative: Felt sick to stomach, diarrhea I became bedridden for two days feeling light headed fever at that time I became aware arm had swollen and injection sight was red ring and itching. it was then I realized it was from vaccination.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Said she woke up with burning and aching of every muscle and joint in her body.  States this continued through Saturday 9/21, but had lessened by then.  Denies had any fever.  States all of pain was gone by Saturday night.  States she took Tramadol Wednesday night and Ibuprofen on Wednesday morning.  States she didn't take anything on Thursday, Friday or Saturday.  Did not go to physician either.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Throat irritation, Urticaria
Clinical narrative: Hives all over body, throat swelling and itching.  Benadryl 50mg given.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest discomfort, Heart rate abnormal, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, elevated heart rate, elevated blood pressure, chest pressure. Symptoms worsened throughout the day - peaked at approx. 2:30PM.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, redness, warm to touch at injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Facial paresis
Clinical narrative: Pt. reported having symptoms of unilateral facial weakening at 9:30 pm after receiving Gardasil and Menactra vaccinations at appointment earlier that day.  Patient went to the ER the next day.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A large (app 3 ") red warm feeling circular area appeared about 2 inches BELOW the injection site.  It has stayed there, somewhat less red, but the nurses would not give me my normal allergy injection when they saw it today, 3 days after the extra strength flu Fluzone HD 2013-14 PFS SANO was given me.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood pressure immeasurable, Cold sweat, Dizziness, Unresponsive to stimuli
Clinical narrative: After drawing pt blood and given pt 3 vaccines and DEPO-PROVERA 5 min later pt became dizzy. After 10 min pt then became unresponsive. She was cold and clammy. Unable to get a BP. IV was given. After given IV fluid we were able to get a BP reading. We then called EMS and pt was transported to the ER.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: After receiving 3 vaccines pt felt dizzy. Cool compress applied sucker given. Pt waited 15 min then left without incident.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Headache, Hyperhidrosis, Hypoaesthesia oral, Local swelling
Clinical narrative: Severe headache, aching arm, numb lips, pain in neck, swollen arm, chest pains, sweating.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Severe headache, aching arm, numb lips, pain in neck, swollen arm, chest pains, sweating.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Pruritus, Throat irritation, Urticaria
Clinical narrative: Itching, hoarseness, throat itching, hives.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling, redness, small blisters stretching over a large area surrounding the injection site...told to try Benadryl and possible an ice pack...doctor out of town today.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Swelling, redness, small blisters stretching over a large area surrounding the injection site...told to try Benadryl and possible an ice pack...doctor out of town today.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Within an hour after receiving Fluzone patient experienced numbness of her left hand...tingling in her lower arm and worse towards the hand.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: Fever (100.4), chills, violent muscle shaking for 2 hours, severe headache. Duration of event was seven hours but headache continued for another 8 hours.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV, TDAP, VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Swelling and redness of left arm.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: PATIENT STATES THAT SHE WAS AWAKEN WITH A STIFF AND/OR NUMBNESS IN THE ARM OF VACCINATION FROM THE NECK DOWN TO THE ARM. ADVISED PATIENT TO TAKE AN ALEVE. HOWEVER AFTER 3 HOURS PT. STATED NO RELIEF.
Age: 88.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting. Pt was treated @ ER.
Age: 88.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Body temperature increased, Chills, Feeling cold, Laboratory test, Vomiting
Clinical narrative: Fever, nausea, vomiting. Pt was treated @ ER.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Pain in arm, headache, itchy eyes, body aches, sore throat, running nose, tired.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Pain in arm, headache, itchy eyes, body aches, sore throat, running nose, tired.
Age: 0.71
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site swelling, Pyrexia, Respiratory tract infection viral, Swelling
Clinical narrative: Fever, swelling, respiratory virus.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Urticaria
Clinical narrative: Headache. 11:00 PM hives on neck, chest, arms. Took Benadryl.  Hives gone by midnight. Headache lasted all day, 9/24/2013.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Mom contacted the clinic on 9/20/2013 stating pt has red and swelling on (R) arm pt came to clinic for visual pt applying ice pack. Large area on (R) arm no other symptoms.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt fainted after receiving 2 vaccines. Pt stood up then fainted recovered quickly waited 15 min in clinic.
Age: 1.09
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Developed herpes zoster on right trunk.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5 cm red indurated spot around KINRIX injection site.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Local reaction, Vaccination site discolouration
Clinical narrative: DTap vaccine was administered in the LVL at 4:00 PM. Father of patient informed staff that the patient's leg was "black" at 4:0a PM. MD examined the leg and ordered Benadryl 4ml stat. Impression: Localized reaction.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5cm red indurated spot around KINRIX injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2 in red indurated spot around injection site of KINRIX.
Age: 89.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Got PNEUMOVAX and FLUVIRIN on same arm. Developed swelling and redness in left arm about 5-7 inches.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Pt stated she had a giant hive from shoulder to her elbow. Swollen and itchy. Still itches 1 week later.
Age: 77.0
Sex: U
Vaccine: FLU3, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Got redness/swelling started day after shot. Spread down center of arm to elbow. Felt sore for several days and nights.
Age: 77.0
Sex: U
Vaccine: FLU3, FLU3, PPV
Symptoms: Chills, Local swelling, Pyrexia
Clinical narrative: Got redness/swelling started day after shot. Spread down center of arm to elbow. Felt sore for several days and nights.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Influenza like illness, Local swelling, Urticaria
Clinical narrative: Significant swelling and redness "welt-like" 3 inch area on inside area of L arm - not at injection site. Flu-like symptoms 30 min. after vaccine; treated area w/ice pack - saw MD 9/23/13.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Deafness, Dizziness, Ear discomfort, Nausea
Clinical narrative: This spontaneous report as received from a physician via agency refers to her 71 year old mother with high blood pressure and heart burn. She had no relevant medical history. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # unknown), 0.65 ml, subcutaneous. Concomitant therapies included hydrochlorothiazide, triamterene, aspirin (low dose) and vitamins (unspecified). On 20-SEP-2013 24 hours after vaccinated with ZOSTAVAX, the patient experienced fullness in the right ear with some tinnitus. On 21-SEP-2013, the patient experienced lightheadedness, mild hearing loss, vomiting, nausea and loss of balance. There is no relevant lab data. The reporter suspects that her mother may be developing shingles. As of 21-SEP-2013, it was unknown if she would continue ZOSTAVAX and she was still experiencing fullness in the ear, mild hearing loss, loss of balance, and lightheadedness. The tinnitus was worsening. The out come of nausea and vomiting was unknown. The reporter would taking her mother to the emergency room. Upon internal review, mild hearing loss was considered to be medically significant. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Vomiting
Clinical narrative: This spontaneous report as received from a physician via agency refers to her 71 year old mother with high blood pressure and heart burn. She had no relevant medical history. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # unknown), 0.65 ml, subcutaneous. Concomitant therapies included hydrochlorothiazide, triamterene, aspirin (low dose) and vitamins (unspecified). On 20-SEP-2013 24 hours after vaccinated with ZOSTAVAX, the patient experienced fullness in the right ear with some tinnitus. On 21-SEP-2013, the patient experienced lightheadedness, mild hearing loss, vomiting, nausea and loss of balance. There is no relevant lab data. The reporter suspects that her mother may be developing shingles. As of 21-SEP-2013, it was unknown if she would continue ZOSTAVAX and she was still experiencing fullness in the ear, mild hearing loss, loss of balance, and lightheadedness. The tinnitus was worsening. The out come of nausea and vomiting was unknown. The reporter would taking her mother to the emergency room. Upon internal review, mild hearing loss was considered to be medically significant. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient called pharmacy c/o severe arm pain/stiffness. I recommended ibuprofen and an ice pack. I told patient that is she didn't get better or if it get worse to contact PCP. Patient's arm started to get better, never contacted doctor.
Age: 78.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pain in arm, erythema down to hands, patient states whole arm is very sore.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Blood electrolytes, Computerised tomogram, Convulsion
Clinical narrative: After 6 month vaccination - had seizure within 24 hours (afebrile). No other seizures since occurred.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on left arm, left wrist and left elbow. MD gave cortisone cream and it got better.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Tremor
Clinical narrative: Pt felt dizzy. Pt shaking and weak after 3 vaccines given. Sucker and water given. Pt examined by nurse practitioner then released.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Pt reported a generalized rash that began at injection site, spread to her elbow and up to her shoulder. She went to her physician who confirmed a reaction. Pt experienced these symptoms for several days. She was treated with Augmentin 875 two times per day for 7 days.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient experienced rash/bumps all over body the day after administration. Between fingers, toes, breast etc., about 3-4 dozen spots. Chickenpox when very young and didn't have more than 2-3 spots then.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient experienced rash/bumps all over body the day after administration. Between fingers, toes, breast etc., about 3-4 dozen spots. Chickenpox when very young and didn't have more than 2-3 spots then.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt reported getting shingles after being administered shot.
Age: 12.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL, HEP, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Pt feeling dizzy after receiving 4 vaccines. Cool compress applied sucker given. Pt recovered 15 min later then left.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Mon. 8-26-13 vaccine given. Tues. 8-27-13 - small red area. Wed. 8-28-13 - larger red area patient went to her doctor and was given antibiotic and Benadryl.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Exposure during pregnancy, No adverse event, Ultrasound antenatal screen
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with hearing loss (had hearing aid) and myopia and a history of migraine convulsion and bipolar disorder who in February 2011, was vaccinated with the first dose of GARDASIL (lot number, dose and site of administration not reported). In April 2011, the patient was vaccinated with the second dose of GARDASIL. In September 2011, the patient was vaccinated with the third dose of GARDASIL. No adverse events were  reported and no other information was provided from the nurse practitioner. No treatment was given for the adverse event. The patient sought unspecified medical attention. The LMP was on 15-JUN-2011 and EDD was on 21-MAR-2012. Additional information was received from a nurse practitioner  regarding pregnancy outcomes. The patient gave birth to a full term healthy baby girl on 11-MAY-2012 with no congenital anomalies reported. Her corrected EDD determined by ultrasound was 15-MAY-2012. LMP was on 09-AUG-2011. The baby weighed 6 pounds (lbs) 11 ounces (oz). The infant's APGAR scores were 8 at one minute and 9 at five minutes. Upon delivery, the infant was noted to be a normal, healthy newborn. The patient delivered vaginally without complications. The patient was exposed to GARDASIL during trimester 1. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received as apart of Varivax pregnancy registry from a physician via medical records concerning a 23 year old female who on 04-NOV-2011 was vaccinated with the first dose of VARIVAX (Merck). Concomitant therapy incuded a first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient's priior vaccination inclujded: four doses of diphtheria toxoid  (+) pertussis acellular Biken vaccine (+) tetanus toixoid (on 13-MAR-1989, 01-AUG-1989, 16-OCT-1989 and 06-MAY-1991), one dose of Hib conj vaccine (unspecified carrier) (on 06-MAY-1991), three doses of polio virus vaccine and diphtheria toxoid (+) pertussis acellulr vaccine (unspecified) (+) tetanus toxoid (on 13-MAR-1989, 01-ASUG-1989 and 06-MAY-1991). On 04-NOV-2011 the patient was given the VARIVAX (Merck). At the time of vaccination the patient was 5 months gestation, she did not information nurse that she was pregnancy at the time. At the time of reporting the patient's otucome was unknown. Health care professional contacted during the followup-up could not supply the information about the patient's pregnancy otucome and had no knowledge where she might have had her baby. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse and the patient's mother for GARDASIL, a Pregnancy Registry product, concerning a 14 year old female patient with no pertinent medical history or drug reactions/allergies who at the "sometime in the beginning of the year" was vaccinated with the first dose of GARDASIL. On 30-JUN-2011, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot # 666596/0766Z) into her left arm. There were no concomitant medications. Subsequently, on 06-JUL-2011, the patient found out that she was "almost 8 weeks pregnant". No adverse effect was reported. Follow-up information of prospective pregnancy report was received from licensed practical nurse. The patient's history of previous pregnancies and live births is not known. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient's estimated delivery date (EDD) was on 20-FEB-12 and based on that the last menstrual period (LMP) was calculated as of 16-MAY-2011. The patient was exposed to GARDASIL during the first and second and third trimester. It was reported that on 06-FEB-12, the patient delivered a male infant via vaginal delivery without complications. The infant's APGAR scores are not available. Upon delivery, the infant was noted to be a normal, healthy newborn. The infant weight 7lbs and 8 oz, length 20 inches. No congenital anomalies reported. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: Information has been received from a 20 year old female consumer for GARDASIL, Pregnancy Registry product, concerning herself with no drug reactions or allergies and no pertinent medical history who on 23-JUN-2011 was intramuscularly vaccinated with a dose of GARDASIL (Lot# and expiration not reported). There was no concomitant medication. Consumer reported that she became pregnant after received GARDASIL. The consumer stated she was pregnant since "six weeks ago", approximately on 24-MAY-2011, EDD approximately on 28-FEB-2012. Patient did not seek medical attention. No laboratories were performed. Follow-up information has been received from the registered nurse via a completed pregnancy questionnaire concerning the female patient. The patient has a history of 2 previous pregnancies and 2 pre-term deliveries and the last baby had heart murmur. The patient was intramuscularly vaccinated with the first dose of 0.5 ml GARDASIL (lot # 666595/0096Z) on 23-JUN-2011. Then the patient became pregnancy. The LMP was 24-MAY-2011, and the estimated delivery date was 28-FEB-2012 (also reported as 06-MAR-2012. It was reported that on 17-FEB-2012 the patient delivered a viable normal male baby. The patient's due date was 06-MAR-2012. The baby weighted 7 pounds 4 1/2 ounces, length 19 1/2 inch. The infant's APGAR score was unknown. There were no complication during pregnancy or delivery and had no congenital anomalies. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Alpha 1 foetoprotein normal, Delivery, Exposure during pregnancy, No adverse event, Ultrasound scan normal
Clinical narrative: Information has been received from a 33 year old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies, for VARIVAX (Merck), a Pregnancy Registry product, who on 01-SEP-2010 was vaccinated subcutaneously, 0.5 ml dose of VARIVAX (Merck) (lot # unknown). There was no concomitant medication. The consumer stated that "a couple of weeks after" receiving a booster of VARIVAX, she found out she was pregnant. She had 7 weeks of gestation. Her last menstrual period was in approximately 15-AUG-2010 and estimate delivery date is on 24-MAY-2011. Patient did not report an adverse effect. The consumer also stated that on an unspecified date "a number of lab tests" were performed (results not provided. Follow up information has been received from a physician concerning a 32 years old (also reported as 33 years old) female patient who on 01-SEP-2010 was vaccinated with the first dose of VARIVAX (Merck) intramuscularly in right arm at 7:30 AM. Other medication used during pregnancy included metamucil for constipation and OTC prenatal vitamins. It was reported that the patient had no complication with the vaccination. No adverse events was reported. The patient had 4 previous pregnancy (2 full-term deliveries, 1 pre-term births, 1 still birth or miscarriage). No birth defect occurred in previous pregnancies. The patient was not tested for varicella antibodies before vaccination, on 03-DEC-2010, a MSAFP (serum alpha-fetoprotein test) revealed negative for ONTD (open neural tube defects). On 06-JAN-2011, an ultrasound revealed a normal result. On 16-MAY-2011 (40.2 weeks from LMP) the patient delivered a normal female baby weighing 7 pound and 5 ounce. There was no complication during pregnancy or delivery. Follow up information has been received from the physician's office who reported that this was not their patient. This was a pediatric practice. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient with drug hypersensitivity to VICODIN and with no pertinent medical history who on 07-FEB-2012, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. The registered nurse reported that on 29-FEB-2012 a urine pregnancy test was performed and the patient tested positive. The estimated last menstrual period was on 06-FEB-2012 and the EDD was on 05-NOV-2012. The patient sought unspecified medical attention. At the time of the report no adverse effect was reported. All attempts to obtain follow up information have been unsuccessful. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with no drug reactions or allergies and no pertinent medical history who on 24-FEB-2012, was vaccinated with a first dose of GARDASIL 0.5 ml, intramuscular (lot number reported as 1668AA, expiration date 15-AUG-2014). Concomitant therapy included ALLEGRA-D 12 hour. There was no treatment given for receiving the first dose of GARDASIL and being pregnant by the patient. It was reported that the patient was pregnant. On an unknown date, home pregnancy test was performed with positive result. The patient's last menstrual period was on 31-JAN-2012. Estimated delivery date would be 06-NOV-2012. Follow-up information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with a history of one previous pregnancies and one full term deliveries and unknown obstetric history of birth defects or infant complications in previous pregnancies, who on 24-FEB-2012, was vaccinated with a first dose of GARDASIL. Concomitant therapy included ALLEGRA-D 12 hour for the treatment of allergies, and reporter was unsure it was taken afternoon (PM) by the patient. Ultrasound test was scheduled on 09-MAR-2012 to reassurance patient's GARDASIL exposure. It was not completed at the time of the report. A follow-up information has been received from a nurse, who reported that the patient was no longer with the practice. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Feeling hot, Insomnia, Vomiting
Clinical narrative: Said he rec'd the flu shot yesterday. At supper he vomited. At 6P he developed chills, put a sweater on. At bedtime he felt hot, did not take temp. He developed all over joint achiness. At 3A he woke, could not go back to sleep. Denies any urinary sx. States sx have gone completely away, is back to baseline at present wants to know if sx could be caused by flu shot.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Rash and pruritic macular rash on chest, upper neck/back, axillae and. Diphenhydramine 25mg once, hydrocortisone 1 dab once.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Client's shingles shot is red and swollen, 3 inches across her right arm. The area is painless. There was no triage for this reaction, but, education was provided, with documentation and note to the provider. Client will call if any additional symptoms. The concern was: Zone of redness around the site that is over 2 inches in diameter, persists for more than 2 days, Client does not have a traveling red streak from the injection site. Please not that the time of onset is unknown. Patient was educated to use warm compresses and acetaminophen as needed (exact dose unknown). Follow up phone call with patient on 9/23: Spoke with patient and she reports that she continues with some redness at the injection site. It is significantly smaller in size down to about 1/2 from approx 3, she denies any fever or other adverse effects from the injection.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. Or an unknown date, the patient was vaccinated with M-M-R II (dose route and lot # were not reported). On an unspecified date, the patient was receiving M-M-R II when she was pregnant (LMP and EDD was not mentioned). The primary reporter nurse stated that the patient would be visiting the clinic on 07-SEP-2012 for a medical visit. The outcome of the event was unknown. Follow up information has been received from the registered nurse referring the female patient. The patient who was receiving a TB test and reported that she was pregnant and had recently received M-M-R II vaccine before she found out she was pregnant. The reporter did not give the vaccine at agency. The patient's physician was reporting this. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: ABO incompatibility, Delivery, Exposure during pregnancy, Glycosylated haemoglobin, No adverse event
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning an approximately 17 year old female with none drug reactions/allergies and pertinent medical history who on 26-JAN-2012 was vaccinated with the first dose of GARDASIL (lot # 670048/0963AA, exp on 09-NOV-2013), 0.5 ml, IM on left arm. There was no concomitant medication. The nurse reported that the patient contacted the office on 16-FEB-2012 and informed them that she did a home pregnancy test and the result was positive. The patient's LMP was 02-JAN-2012 and estimated delivery date 08-OCT-2012. No adverse event reported. No treatment was given. Nurse stated that the patient would be following up with an Obstetrics and Gynecology (OB/GYN) physician in March 2012 (doctor unspecified). Follow up information has been received from a registered nurse which reported that the patient had a single pregnancy, estimated delivery date 14-SEP-2012 (previously reported as 08-OCT-2012). On 25-JUN-2012, ABO/Rh test and glucose A1C were performed at 25 weeks. The pregnancy outcome was live birth, no complications during the delivery. Neonate was normal female length 20", weight: 6 lb 3 ozs, head circumference 13" 3/4 without congenital anomalies. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test urine positive
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning an approximately 17 year old female with none drug reactions/allergies and pertinent medical history who on 26-JAN-2012 was vaccinated with the first dose of GARDASIL (lot # 670048/0963AA, exp on 09-NOV-2013), 0.5 ml, IM on left arm. There was no concomitant medication. The nurse reported that the patient contacted the office on 16-FEB-2012 and informed them that she did a home pregnancy test and the result was positive. The patient's LMP was 02-JAN-2012 and estimated delivery date 08-OCT-2012. No adverse event reported. No treatment was given. Nurse stated that the patient would be following up with an Obstetrics and Gynecology (OB/GYN) physician in March 2012 (doctor unspecified). Follow up information has been received from a registered nurse which reported that the patient had a single pregnancy, estimated delivery date 14-SEP-2012 (previously reported as 08-OCT-2012). On 25-JUN-2012, ABO/Rh test and glucose A1C were performed at 25 weeks. The pregnancy outcome was live birth, no complications during the delivery. Neonate was normal female length 20", weight: 6 lb 3 ozs, head circumference 13" 3/4 without congenital anomalies. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer referred to her 15 years old daughter. The patient's history of previous pregnancies and live births was unknown. The patient had no pertinent medical history or drug reactions/allergies. The patient was vaccinated with dose 1, 0.5 ml GARDASIL during the middle of March 2012, before discovering that she was currently pregnant. No other co-suspects were reported. No concomitant medications were reported. The patient was exposed to GARDASIL during trimester 2. The patient did not seek medical attention. No treatment information was reported. On an unspecified date, pregnancy related  blood work laboratory was taken to determine risk for diabetes and sickle cell trait (results not provided). GARDASIL was discontinued and postponed until completed pregnancy. The outcome of patient was unknown. The event was not related to GARDASIL. Follow up information has been received from a other health professional on 26-FEB-2013. It was reported that the patient's demographic information was added and that at the time of this report the patient's age was 16 years old. Also, it was mentioned that GARDASIL (Lot number 1229AA, expiration date 12-NOV-2013, intramuscular route) was applied on 21-FEB-2012 (previously reported as 15-MAR-2012). Although, it was reported that the patient's last visit in office was on 20-APR-2012 for menstrual disorder, and at that time a pregnancy test (urine) was performed resulting positive. Patient was then referred to an Obstretical Gynecologist. Also, it was mentioned that on 20-APR-2012, the patient started to intake a prenatal therapy (30-0975, 200mg, daily, oral route). At the time of the report the pregnancy outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female who "several months ago" (in approximately 2010) was vaccinated with the second dose of GARDASIL (route and lot # unspecified). The physician reported the patient "just discovered" (on 01-MAR-2011) she was "2 weeks pregnant" (estimated last menstrual period on 17-FEB-2011 and estimated delivery date on 24-NOV-2011). Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with a dose (lot # 1404AA, expiration date 13-SEP-2013) of M-M-R II (dose and route not reported) on 25-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient received the vaccines when she was 3-4 weeks pregnant. The LMP was approximately in April 2012 and an EDD of approximately February 2013. Initial exposure to M-M-R II was at 3-4 weeks during trimester 1. The patient experienced no adverse symptoms. No treatment information was reported. At the time of the report the outcome of pregnancy was unknown. Additional information has been requested.