chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a "16 or 17 year old" female patient. The patient's concurrent conditions included an undiagnosed allergy (also reported as no drug/reactions allergies), medical history and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided). On 30-JUL-2015, the patient was vaccinated with the second dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided), immediately, the patient experienced dizziness and "10 or 15 minutes" following the vaccination, she could not see or hear, so her blood pressure was immediately measured and it was elevated an unspecified value. The patient was sent to the emergency department of an unspecified hospital, but she was not admitted as a patient. The patient reported, after she fully recovered and regained consciousness, that she experienced similar symptoms after she received the first dose of GARDASIL on an unspecified date. The outcome of the following events that the patient experienced with the first dose of GARDASIL: deafness transitory, dizziness, loss of consciousness, hypertension and blindness transient was reported as recovered/resolved on an unspecified date. The outcome of the following events that the patient experienced with the second dose of GARDASIL: deafness transitory, dizziness, loss of consciousness, hypertension and blindness transient was reported as recovered/resolved on 30-JUL-2015. The reporter did not assess the relatedness of deafness transitory, dizziness, loss of consciousness, hypertension and blindness transient with GARDASIL. The reporting physician believed that those symptoms could be related with an undiagnosed allergy. The patient's mother did not want her daughter to receive any additional doses of GARDASIL. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Lip swelling, Throat tightness
Clinical narrative: Dizziness, weakness, throat tihgt, lips swelling. Onset approx. 15-20 min after injection. Given BAYCADRON, EPI, BENADRYL, Diazepam, IVNS.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site about quarter size, came back 10/04 size had grown to 2x3 inches.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Pain, Paraesthesia, Pruritus
Clinical narrative: Severe Headache, Dizziness, itchy, achy, felt like pins and needle were on her skin. Denies fever.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: 101.9-degree fever, chills, and headache; fever continued for 24 hours and declined with periodic administration of Tylenol.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Hyperhidrosis, Influenza like illness, Nausea
Clinical narrative: Chills, aches and coughing.  Also sweating and queasy stomach. Recorded a temperature of 99.2 on Sunday, 10/04/2015.  Generally flu-like symptoms for 2.5 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Chills, aches and coughing.  Also sweating and queasy stomach. Recorded a temperature of 99.2 on Sunday, 10/04/2015.  Generally flu-like symptoms for 2.5 days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Hyperhidrosis, Muscular weakness, Paraesthesia
Clinical narrative: Within 2 minutes of vaccine administration patient had facial flushing with diaphoresis, paraesthesia of face and arms, leg weakness.  Treated with Benadryl, Solumedrol and Pepcid.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Contusion, Pain in extremity
Clinical narrative: Pain in entire arm - large, dark bruise that is still there 5 days later.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Patient given live vaccine (MMR) while he is HIV positive.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Began with a pruritic macular papular rash on legs.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Arthralgia, Blood test, Exposure during pregnancy, Haemorrhage
Clinical narrative: Stiffness and pain in thumb joint and shoulder, cramping and bleeding and miscarriage. Treated for miscarriage at ER on 9/26/2015.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Joint stiffness, Muscle spasms, Musculoskeletal pain, Musculoskeletal stiffness, Ultrasound scan
Clinical narrative: Stiffness and pain in thumb joint and shoulder, cramping and bleeding and miscarriage. Treated for miscarriage at ER on 9/26/2015.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Guillain-Barre syndrome, Lumbar puncture, Muscle contractions involuntary
Clinical narrative: Woke up to extreme back pain a week later loss control of muscles and ascending paralysis and diagnosed with Guillain-Barre Syndrome resulting from the recent vaccination.
Age: 18.0
Sex: M
Vaccine: MEN, UNK
Symptoms: Muscle contracture, Pain in extremity
Clinical narrative: Pt developed pain throughout right arm (deltoid injection) and contracture of right hand muscles at MCP and PIP joints.
Age: 1.25
Sex: M
Vaccine: FLU3, PNC
Symptoms: Aggression, Bacterial test negative, Blister, Constipation, Crying
Clinical narrative: 3 hours after his shot - uncontrollable crying which continued for rest of night and hysterical trying to put him to bed. Slept in our bed- very unpeacefully all night (he has slept in own bed save a few occasions (around vaccinations) since birth). Friday- crying all morning - fever 102 started around 3pm - first vomit at 5pm, second multi projectile vomit at 7pm, uncontrollable crying all night. This same child has had multiple sicknesses (double ear infections, fevers, viral meningitis) and has never acted that way.   Sat morning- 3 hives appeared on legs, fever went away, loss of interest in normal food- no chicken anymore, texture issues.  Constipated Sunday- loss of interest in bottle- tough feeding bottle, tantrums- 4 in one day (compared about two his whole life) Monday, loss interest in bottle completely- must stimmy in order to drink.  Huge welt appeared on arm. 5 days later, diarrhea began and continued for 2 weeks (had testing for many types of stomach virus/bacteria which it wasn't). Relief seemed to come from an aggressive dosing of pro-biotics and removing all milk. In general he no longer wanted to be comforted- crying when trying to kiss him; crying in crib- used to stand up and lean in on me - now just sits there and cries- this continued for a couple weeks and while it's better he is still much more prone to aggression and impatience then he was prior to this.
Age: 1.25
Sex: M
Vaccine: FLU3, PNC
Symptoms: Diarrhoea, Emotional distress, Feeding disorder, Pyrexia, Urticaria
Clinical narrative: 3 hours after his shot - uncontrollable crying which continued for rest of night and hysterical trying to put him to bed. Slept in our bed- very unpeacefully all night (he has slept in own bed save a few occasions (around vaccinations) since birth). Friday- crying all morning - fever 102 started around 3pm - first vomit at 5pm, second multi projectile vomit at 7pm, uncontrollable crying all night. This same child has had multiple sicknesses (double ear infections, fevers, viral meningitis) and has never acted that way.   Sat morning- 3 hives appeared on legs, fever went away, loss of interest in normal food- no chicken anymore, texture issues.  Constipated Sunday- loss of interest in bottle- tough feeding bottle, tantrums- 4 in one day (compared about two his whole life) Monday, loss interest in bottle completely- must stimmy in order to drink.  Huge welt appeared on arm. 5 days later, diarrhea began and continued for 2 weeks (had testing for many types of stomach virus/bacteria which it wasn't). Relief seemed to come from an aggressive dosing of pro-biotics and removing all milk. In general he no longer wanted to be comforted- crying when trying to kiss him; crying in crib- used to stand up and lean in on me - now just sits there and cries- this continued for a couple weeks and while it's better he is still much more prone to aggression and impatience then he was prior to this.
Age: 1.25
Sex: M
Vaccine: FLU3, PNC
Symptoms: Viral test negative, Vomiting projectile
Clinical narrative: 3 hours after his shot - uncontrollable crying which continued for rest of night and hysterical trying to put him to bed. Slept in our bed- very unpeacefully all night (he has slept in own bed save a few occasions (around vaccinations) since birth). Friday- crying all morning - fever 102 started around 3pm - first vomit at 5pm, second multi projectile vomit at 7pm, uncontrollable crying all night. This same child has had multiple sicknesses (double ear infections, fevers, viral meningitis) and has never acted that way.   Sat morning- 3 hives appeared on legs, fever went away, loss of interest in normal food- no chicken anymore, texture issues.  Constipated Sunday- loss of interest in bottle- tough feeding bottle, tantrums- 4 in one day (compared about two his whole life) Monday, loss interest in bottle completely- must stimmy in order to drink.  Huge welt appeared on arm. 5 days later, diarrhea began and continued for 2 weeks (had testing for many types of stomach virus/bacteria which it wasn't). Relief seemed to come from an aggressive dosing of pro-biotics and removing all milk. In general he no longer wanted to be comforted- crying when trying to kiss him; crying in crib- used to stand up and lean in on me - now just sits there and cries- this continued for a couple weeks and while it's better he is still much more prone to aggression and impatience then he was prior to this.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling abnormal, Gait disturbance, Grip strength decreased, Hypoaesthesia, Mobility decreased
Clinical narrative: My son says he began to feel wierd. His legs, arms, and his head felt funny. When he arrived home at 210 PM his walk was wierd. He walked on the tips of his toes and stumbled. He could not really move his arms. He looked sick. I asked him what was wrong and he said his arms and legs were numb and that they hurt. So he laid in my bed for the rest of the day. I called his Dr. and described what was going on and they stated it wasnt vaccine related, they had me check his grip and his right side grip was weaker. They told me to give him ibuprofen. I kept checking him for fevers and asking him how he felt the rest of the day. By Sat morning all symptoms had gone away slowly.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Pain in extremity, Toe walking
Clinical narrative: My son says he began to feel wierd. His legs, arms, and his head felt funny. When he arrived home at 210 PM his walk was wierd. He walked on the tips of his toes and stumbled. He could not really move his arms. He looked sick. I asked him what was wrong and he said his arms and legs were numb and that they hurt. So he laid in my bed for the rest of the day. I called his Dr. and described what was going on and they stated it wasnt vaccine related, they had me check his grip and his right side grip was weaker. They told me to give him ibuprofen. I kept checking him for fevers and asking him how he felt the rest of the day. By Sat morning all symptoms had gone away slowly.
Age: 28.0
Sex: M
Vaccine: FLUN4
Symptoms: Immediate post-injection reaction, Influenza like illness
Clinical narrative: As a pharmacist immunizer, I chose to administer and receive Flumist for myself this flu season. I developed severe flu-like symptoms immediately after receiving the vaccine, and now five days later I am continuing to experience worsening symptoms. I have received this vaccine without any issues in previous years. I wanted to report this event in case there is a problem with this season's Flumist vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eczema
Clinical narrative: Acute Eczematous Reaction on Left Lower Leg, anterior; Left forearm; posterior neck.  Seen today, Oct 5, 2015 in the office and was prescribed Triamcinolone Acetonide 0.1% Cream, apply to affected area BID.
Age: 1.26
Sex: M
Vaccine: HIBV
Symptoms: Abnormal behaviour, Childhood disintegrative disorder, Crying, Decreased appetite, Decreased eye contact
Clinical narrative: Fever started 8 days later on 4/29. The fever started on 4/29/13, with no other symptoms, and was around 101F. It progressed the next day to 102.8F on 4/30/2013, by 5/1/13 it was 104.5F. I believe we went to the ER on 5/3 and he had a temp on 105F with a full dose of Advil already. He barely ate and was extremely lethargic (mostly sleeping in my arms) during the day the entire week, and at night he would often cry, scream, and thrash around, as if in pain, and would arch his back.  It was after this fever that we observed loss of developmental skills such as loss of eye contact, he would not respond when we called his name, he became obsessed with watching the wheels on his car/trains roll, stopped eating all types of foods except soft refried beans and smoothies. He started to scream in settings that seem to overstimulate him (such as the grocery stores and restaurants). He stopped singing and we notice a regression in verbal language, and developed unique self regulating features like flapping his hands and rubbing his fingers together repeatedly. He was also not able to sit for more than a minute after this week of fever, without getting distracted. He would start laying on friends and seem to be unaware of his body proximity to others. He often tries to dart into the street if he sees something of interest there. We have been successful at keeping him from doing that. Often sick due to mitochondrial dysfunction.
Age: 1.26
Sex: M
Vaccine: HIBV
Symptoms: Dyskinesia, Encephalopathy, Lethargy, Mitochondrial cytopathy, Nervous system disorder
Clinical narrative: Fever started 8 days later on 4/29. The fever started on 4/29/13, with no other symptoms, and was around 101F. It progressed the next day to 102.8F on 4/30/2013, by 5/1/13 it was 104.5F. I believe we went to the ER on 5/3 and he had a temp on 105F with a full dose of Advil already. He barely ate and was extremely lethargic (mostly sleeping in my arms) during the day the entire week, and at night he would often cry, scream, and thrash around, as if in pain, and would arch his back.  It was after this fever that we observed loss of developmental skills such as loss of eye contact, he would not respond when we called his name, he became obsessed with watching the wheels on his car/trains roll, stopped eating all types of foods except soft refried beans and smoothies. He started to scream in settings that seem to overstimulate him (such as the grocery stores and restaurants). He stopped singing and we notice a regression in verbal language, and developed unique self regulating features like flapping his hands and rubbing his fingers together repeatedly. He was also not able to sit for more than a minute after this week of fever, without getting distracted. He would start laying on friends and seem to be unaware of his body proximity to others. He often tries to dart into the street if he sees something of interest there. We have been successful at keeping him from doing that. Often sick due to mitochondrial dysfunction.
Age: 1.26
Sex: M
Vaccine: HIBV
Symptoms: Opisthotonus, Pain, Pyrexia, Restlessness, Screaming
Clinical narrative: Fever started 8 days later on 4/29. The fever started on 4/29/13, with no other symptoms, and was around 101F. It progressed the next day to 102.8F on 4/30/2013, by 5/1/13 it was 104.5F. I believe we went to the ER on 5/3 and he had a temp on 105F with a full dose of Advil already. He barely ate and was extremely lethargic (mostly sleeping in my arms) during the day the entire week, and at night he would often cry, scream, and thrash around, as if in pain, and would arch his back.  It was after this fever that we observed loss of developmental skills such as loss of eye contact, he would not respond when we called his name, he became obsessed with watching the wheels on his car/trains roll, stopped eating all types of foods except soft refried beans and smoothies. He started to scream in settings that seem to overstimulate him (such as the grocery stores and restaurants). He stopped singing and we notice a regression in verbal language, and developed unique self regulating features like flapping his hands and rubbing his fingers together repeatedly. He was also not able to sit for more than a minute after this week of fever, without getting distracted. He would start laying on friends and seem to be unaware of his body proximity to others. He often tries to dart into the street if he sees something of interest there. We have been successful at keeping him from doing that. Often sick due to mitochondrial dysfunction.
Age: 1.26
Sex: M
Vaccine: HIBV
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: Fever started 8 days later on 4/29. The fever started on 4/29/13, with no other symptoms, and was around 101F. It progressed the next day to 102.8F on 4/30/2013, by 5/1/13 it was 104.5F. I believe we went to the ER on 5/3 and he had a temp on 105F with a full dose of Advil already. He barely ate and was extremely lethargic (mostly sleeping in my arms) during the day the entire week, and at night he would often cry, scream, and thrash around, as if in pain, and would arch his back.  It was after this fever that we observed loss of developmental skills such as loss of eye contact, he would not respond when we called his name, he became obsessed with watching the wheels on his car/trains roll, stopped eating all types of foods except soft refried beans and smoothies. He started to scream in settings that seem to overstimulate him (such as the grocery stores and restaurants). He stopped singing and we notice a regression in verbal language, and developed unique self regulating features like flapping his hands and rubbing his fingers together repeatedly. He was also not able to sit for more than a minute after this week of fever, without getting distracted. He would start laying on friends and seem to be unaware of his body proximity to others. He often tries to dart into the street if he sees something of interest there. We have been successful at keeping him from doing that. Often sick due to mitochondrial dysfunction.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 2 x 4 inch area red and painful to touch at injection site.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Redness from elbow to top of shoulder, of right arm some itching.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported soreness and redness at injection site.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient was nauseous and lightheaded. After 15 minutes patient felt better and left pharmacy. Feels well. Next day - patient follow up - said she is well. Possible anxiety driven symptoms.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Redness and swelling, itching with a few blisters on 3/4 of upper left arm - onset approximately 24 hrs after Flu vaccine and spreading down arm towards elbow - some relief at 24 hrs after BENADRYL 125mg PO Q 4 hrs and hydrocortisone cream.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: About 2 hours after vaccine administration, patient experienced a throbbing pain around the injection site that woke her up in the middle of the night for about 2 days. She took MOTRIN and ALEVE for pain. The throbbing subsided after 2 days but she now has pain in the shoulder joint (sharp pain when moves her arm certain ways). She has not seen her doctor yet but will make appt if pain persists after a few more days.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Hyperhidrosis, Peripheral swelling
Clinical narrative: Approximately 2 hours after receiving flu vaccine, reported to school nurse at facility diaphoretic, arm swollen, flushed.  Then reporting sensation going up arm into chest and back.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Eczema
Clinical narrative: Eczematous Rash Left Axilla, Intereior Left and Right Lower Legs, Posterior Left Knee.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT WAS GIVEN AN EXPIRED PREVNAR 13 VACCINE - NO ADVERSE REACTION.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: Employee states numbness and tingling to tongue and getting worse, going down throat.  Epi pen 3mg administered sub cutaneous per Dr. standing orders.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: Numbness and tingling in tongue worsened and was "going down her throat". Given Epi pen, ambulance to ER.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Miller Fisher syndrome, Paraesthesia, Sensory loss
Clinical narrative: Patient experienced tingling/loss of feeling in her arm(s).  Was admitted to hospital and diagnosed with Miller-Fisher Syndrome and has been receiving immunoglobulin.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Insomnia, Pain in extremity
Clinical narrative: Bruising in arm, pain in arm, trouble sleeping due to pain in arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Headache, Myalgia, Neuralgia, Pain of skin
Clinical narrative: Horrible headache, neck tender and nerve pain just below ears and above ears - very sharp/piercing (felt like trigimenal nerve pain. Skin hurt and muscle/joint aches all over. Low fever later about 100.1; Sun. am 100.4. Mon. 99.4. - feel a bit better. Will see my PC Dr. Tues. morning.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Tenderness, Trigeminal neuralgia
Clinical narrative: Horrible headache, neck tender and nerve pain just below ears and above ears - very sharp/piercing (felt like trigimenal nerve pain. Skin hurt and muscle/joint aches all over. Low fever later about 100.1; Sun. am 100.4. Mon. 99.4. - feel a bit better. Will see my PC Dr. Tues. morning.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L thigh: local golf ball sized swelling with redness than spread and became less swollen and less warm without antibiotics. Benadryl given.
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Back pain, Chest pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain started in one arm and then slowly radiated across chest to the other arm, back, and shoulder.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 48 hours after vaccination, developed a 2 inch by 1 inch red, raised, warm area at injection site.  It was itchy.  She used topical and oral Benadryl.  Symptoms did not progress and were completely gone within 1 week.
Age: 66.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Injection site is sore with a red streak originating from injection site one and one half inches in length.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling hot, Panic reaction, Pruritus generalised
Clinical narrative: 10 minutes after vaccination, became itchy and hot all over, felt SOB and panicky. Went to work wellness center where they administered an Epi-pen.  They sent her to the ER where they gave her oral Benadryl and prednisone.  She states she felt fine after that except for some generalized itching.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain
Clinical narrative: Intense pain began in arm at injection site within an hour of receiving the vaccination. Shot was given very high on the arm.  No redness or bruising.  Pain is so bad it hurts to lift arm above head for a week after shot.  Taking anti-inflammatory medications.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Extremely hot around injection site. Pain, swelling, redness. The swelling and redness expanded over the course of 7 days so that the entire upper arm was affected, then started to recede. Itchiness and soreness in the muscles and bones followed for the next 5 days. Currently, there is a patch about 4 inches long near the injection site where new, raised and itchy bumps have formed.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Rash pruritic
Clinical narrative: Extremely hot around injection site. Pain, swelling, redness. The swelling and redness expanded over the course of 7 days so that the entire upper arm was affected, then started to recede. Itchiness and soreness in the muscles and bones followed for the next 5 days. Currently, there is a patch about 4 inches long near the injection site where new, raised and itchy bumps have formed.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Injection site pruritus, Injection site swelling
Clinical narrative: The patient reported that the day after she had the flu injection she had a small bump on the left arm the size of a mosquito bite at the site of injection. She stated the area got larger and she went to a doctor on 9/30/15 who prescribed antibiotics. The site started itching and was still visible on 10/1/15 so she went to the State Wellness Center. The doctor there prescribed some topical cream and had drawn blood for labs.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Injection site erythema, Injection site mass, Ocular hyperaemia, Pain
Clinical narrative: Agitation, fever of 101.6 degrees fareinheit, ache, red injection site, lump at infection site, tingling lips, eye redness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Pyrexia
Clinical narrative: Agitation, fever of 101.6 degrees fareinheit, ache, red injection site, lump at infection site, tingling lips, eye redness.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Arthralgia, Dysphagia, Joint stiffness, Musculoskeletal stiffness, Odynophagia
Clinical narrative: Hives, swelling of face, tongue, and throat, pain and stiffness in hands/wrists and feet/ankles, painful and difficulty swallowing. Treated with Benadryl, Zyrtec, and Motrin during first 48 hours.  Started oral steroids at 36 hours for residual facial swelling.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Pain in extremity, Pharyngeal oedema, Swelling face, Swollen tongue, Urticaria
Clinical narrative: Hives, swelling of face, tongue, and throat, pain and stiffness in hands/wrists and feet/ankles, painful and difficulty swallowing. Treated with Benadryl, Zyrtec, and Motrin during first 48 hours.  Started oral steroids at 36 hours for residual facial swelling.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypersensitivity, Pyrexia, Sepsis, Vaccination site cellulitis, White blood cell count increased
Clinical narrative: HIGH FEVER 104.1, CELLULITIS ON SITE OF VACCINATION. HOSPITALIZED ON OCT 1-3 FOR SEPSIS VERSUS ALLERGIC REACTION. WAS ON IV ANTIBIOTICS.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Redness and swelling of left leg at the site of Pentacel and Hep B vaccinations which were given at 1:15pm. Inconsolable fussiness. Symptoms resolved after antihistamine was administered orally.
Age: 75.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Rash
Clinical narrative: RASH ON ONE SIDE OF FACE.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient came few days after she got a Fluzone High dose vaccine and said that She has itchiness on her face and she thinks it is because of vaccine. We are in touch with patient to see how is she doing.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Oedema
Clinical narrative: Erythema and edema 2 inch center spread to aprox 5-6 inches.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: States arm got very sore to move, had limited range of motion.  She called Employee Health on 10/01/2015 and was still having pain and limited range of motion of left shoulder, pain and range of motion had improved but was still having problems.  She was seen at Occupational Health.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching, noticed upon awakening morning after day vaccinated.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Patient reported mild itching about 10 minutes after flu shot administration.  There were no signs of redness or swelling for the next 30 minutes.  Pt went home with daughter, I called her later that night (~5 hours later) and she said that the itching subsided and there was no itching.  For the past week, off and on she has had redness and warmth in the flu shot injection site.  A cold compress and APAP has helped.  No signs of infection and it site is improving all week.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Eye movement disorder, Fatigue, Seizure, Tremor
Clinical narrative: On 10/1/2015 at about 1:04PM, Mother of patient reported that patient had a seizure that lasted about a minute. The shaking was slow and her eyes rolled up. She was unsure of her temperature at the time of the incident. EMS evaluated her and determined to call her PCP for follow up, but did not warrant a trip to the ER. She mentioned that patient is still tired, but alert and oriented. "She should be active and playing now because she just woke up, but she is tired".
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 11x 6 cm area of erythema with warmth and swelling on right arm at site of vaccination.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: 5 DAYS POST VACCINATION, PEA SIZED RED SPOT ON ARM. 7 DAYS POST VACCINATION, RED SPOT SIZE OF LEMON, TENDER TO TOUCH, NOT ITCHY, NOT PAINFUL WHEN RAISING ARM. REFERRED HER TO PHYSICIAN FOR FURTHER EVALUATION.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Nausea, Skin lesion, Vaccination site reaction
Clinical narrative: PATIENT NOTICED RAISED RED LESION ON THE SITE OF VACCINATION, PATIENT FELT TIRED AND NAUSEOUS, CAME TO PHARMACY, WAS TOLD TO GO URGENT CARE WHERE SHE WAS GIVE KEFLEX 500MG 1 THREE TIMES A DAY FOR 10 DAYS.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site swelling
Clinical narrative: PATIENT NOTICED RAISED RED LESION ON THE SITE OF VACCINATION, PATIENT FELT TIRED AND NAUSEOUS, CAME TO PHARMACY, WAS TOLD TO GO URGENT CARE WHERE SHE WAS GIVE KEFLEX 500MG 1 THREE TIMES A DAY FOR 10 DAYS.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red colored Rash on the arm near and sorrounding area of injection site.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Feeling cold, Mobility decreased, Musculoskeletal pain, Rash erythematous
Clinical narrative: Pt felt freezing cold could not get warm.  Joints ached. Excruciating pain in shoulder.  Pt could not lift arm above shoulder due to the pain. Red swollen rash looked like an intense sun burn.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Dyspnoea, Feeling cold, Musculoskeletal pain, Rash
Clinical narrative: Pt felt freezing cold could not get warm.  Joints ached. Excruciating pain in shoulder.  Pt could not lift arm above shoulder due to the pain. Red swollen rash looked like an intense sun burn.
Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Upper extremity mass, Urticaria, Wheezing
Clinical narrative: Pt felt freezing cold could not get warm.  Joints ached. Excruciating pain in shoulder.  Pt could not lift arm above shoulder due to the pain. Red swollen rash looked like an intense sun burn.
Age: 47.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Pain and swelling at injection site. Tingling in jaw area.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Hypoaesthesia, Pain, Pain in extremity, Pyrexia
Clinical narrative: (L) arm pain and numbness, felt like "my throat was closing" "my chest was tight." Flushed face and (L) arm. Used ice pack to treat (L) arm pain. Reported to ER on 9/25/15 at 730pm w/c/o "fever (99.8) shaking" and pain all over." Treated with albuterol nebulizer and then sent home. 9/26/15 "felt sore from shaking from fever" had taken TYLENOL x3 (325,g) by mouth.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Tremor
Clinical narrative: (L) arm pain and numbness, felt like "my throat was closing" "my chest was tight." Flushed face and (L) arm. Used ice pack to treat (L) arm pain. Reported to ER on 9/25/15 at 730pm w/c/o "fever (99.8) shaking" and pain all over." Treated with albuterol nebulizer and then sent home. 9/26/15 "felt sore from shaking from fever" had taken TYLENOL x3 (325,g) by mouth.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia
Clinical narrative: Flu shot administered rt deltoid IM 9/28/2015. No side effects from 9/28-10/2/2015. Noticed rt deltoid numbness at 10AM on 6/3/2015. No pain, no swelling, no tingling, no redness at injection site and rt arm. Numbness noted 7 cm above and below injection site, 4 cm to right of injection site and 1 cm to left of injection site.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen area at site of administration.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Skin lesion
Clinical narrative: Patient developed an exanthem to extremities, and abdomen 6 hours after influenza vaccine receipt. Lesions are flat, pruritis, erythematous and a paired 6x8 cm symmetric fixed patches to anterior medial thighs.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: She received inactivated influenza vaccine at medical center on Sept 29, 2014; injection into her left upper deltoid (vaccine has not yet been recorded in immunization history). She stated the site was high; she immediately experienced a sharp pain at the injection site, which has never resolved. She has been treating with self-directed range of motion, she already takes NSAIDs routinely for her DJD of her knee, and has been using heat and ice. MRI was done which demonstrated a small fluid collection most consistent with subdeltoid/subacromial bursitis. She received steroid injection which was helpful for several months, but symptoms returned in April 2015 and have continued intermittently.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a 66 year old male patent. Pre-existing diagnosed allergies, illness at time of vaccination or medical conditions were not provided. On 17-SEP-2015, the patient was administered pursuant for a physician with the first dose of ZOSTAVAX subcutaneous injection in the right deltoid (lot # L016283; dose and expiration date were not provided). There was no concomitant medication described. On 29-SEP-2015, the patient was diagnosed with shingles on back. At the time of the report, the outcome of herpes zoster was unknown. The relatedness between the event to ZOSTAVAX was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: (R) arm redness and pain.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. received MENACTRA and Tdap in (R) deltoid area became red, swollen, warm 2 days later 5 x 8 cm area of moderate erythema.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and burning at injection site and left arm. Intensely red and swollen. Entire arm to wrist. Prescribed prednisone and ZYRTEC.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling and burning at injection site and left arm. Intensely red and swollen. Entire arm to wrist. Prescribed prednisone and ZYRTEC.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Swelling on the administration site - Rt arm also noted reddish discoloration swelling size 55 x 60.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Eye movement disorder, Loss of consciousness, Nausea, Syncope, Tremor
Clinical narrative: Syncope rxn as nausea, eye rolling, shaking, loss of consciousness. Supportive care, pt was seated, held him preventing falling.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Day 12 post vaccination: pt developed fussiness, low grade fevers around approximately 100 F. Noted rash over neck and trunk. Few areas on face and arms involved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Crying, Injection site movement impairment, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: 104-105 degree fever intermittently for 5 (five) days. Inability to raise arms for 10 (ten) days above the shoulder. Severe swelling at injection points grapefruit-sized swelling! Could not touch arms above elbows or would induce screaming and crying. Lethargy and trouble sleeping.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Lethargy, Pyrexia, Screaming
Clinical narrative: 104-105 degree fever intermittently for 5 (five) days. Inability to raise arms for 10 (ten) days above the shoulder. Severe swelling at injection points grapefruit-sized swelling! Could not touch arms above elbows or would induce screaming and crying. Lethargy and trouble sleeping.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Rash, Urticaria
Clinical narrative: Rash, hives, - legs, face, back, arms.
Age: 1.11
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash, Rash vesicular
Clinical narrative: Vesicular lesions forehead, chest, arms <20.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash two days after shot administered on 9/21/15. Rash did not spread and was itchy. Rash only surrounding site of injection. No other symptoms. Treated with ice and antihistamines.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Ultrasound scan normal, X-ray limb normal
Clinical narrative: Initial soreness inj site as was informed as potential. No erythema, edema, induration, bruising or signs of infection. Continued pain which has increased becoming constant and worse with arm use.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Imm. given 9/23/15 with no reaction. On 9/24/15 mother called stating child had low grade fever and rash. Was seen and given steroid injection. Pt waited in office x4 hrs. Regularly checked on. Rash disappeared. Pt went home with parent and apt to be seen 9/25/15.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Rash, blistering.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 4 week 4 day old patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 25-SEP-2015, the patient was inadvertently given an unspecified dose of VAQTA, injection, lot number reported as L022259 and expiration date 06-APR-2017, (route of administration and anatomical location were not reported) instead of RECOMBIVAX HB. There were no concomitant medications reported. No adverse effects and no product confusion were reported. There was no product quality issue involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions described. The reporter stated that from 29-SEP-2015 through 30-SEP-2015, the patients received improperly stored doses of M-M-R II injection (lot # L000458 with expiration date 06-JAN-2017 and lot # L009212 with expiration date 17-MAR-2017 and lot # L012481 with expiration date 10-APR-2017; dose and route were not provided. There was no concomitant medication. Product quality complaint was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a other health professional refers to a 21 year old male patient. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient as a child was vaccinated with hepatitis B vaccine (manufacturer unknown) series (dose, lot number, expiration and date were not reported). The nurse stated that the unspecified patient "has negative titers" at the time of the report. The outcome of the event was unknown. The relatedness between the event and hepatitis B vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored of GARDASIL (lot# K010215 with expiration date 05-MAY-2017 and lot# K011562 with expiration date 08-APR-2017, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 6 year old patient of unknown gender. No information regarding patient's concurrent conditions and medical history was provided. On 28-SEP-2015, the patient was inadvertently vaccinated with ZOSTAVAX (dose and route were not reported, lot # L015416, expiration date: 01-AUG-2016). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Age: 1.74
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 20 month old patient of unknown gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. On 25-SEP-2015, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose, site of administration were not reported) subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients might have been vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date 17-SEP-2016) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, C-reactive protein, Chest X-ray normal, Chest pain
Clinical narrative: Previously well 19 y/o who on 29 Sep; presented with acute chest pain and shortness of breath x 24 hours that started with exertion. Pain worse with exertion and lying down and better with rest and leaning forward, w/o dyspnea, lightheadedness, or history of trauma. No cardiac risk factors. Also has a rash on trunk (probably NVP or heat rash). CP described as sharp, worse with inspiration. Located over center chest with left more prominent than right. Difficult to breath when chest pain severe. Robust take of smallpox vaccination site on RUE.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Dyspnoea, Electrocardiogram ST segment elevation, Rash, Troponin normal
Clinical narrative: Previously well 19 y/o who on 29 Sep; presented with acute chest pain and shortness of breath x 24 hours that started with exertion. Pain worse with exertion and lying down and better with rest and leaning forward, w/o dyspnea, lightheadedness, or history of trauma. No cardiac risk factors. Also has a rash on trunk (probably NVP or heat rash). CP described as sharp, worse with inspiration. Located over center chest with left more prominent than right. Difficult to breath when chest pain severe. Robust take of smallpox vaccination site on RUE.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to 3 unspecified patients of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL (lot # J003727, expiry date: 07-NOV-2015). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified number of patients whose demographics were unknown. The pertinent medical histories and concurrent conditions of patients were unknown. On an unknown date in SEP-2015 unspecified number of patients were vaccinated with unspecified number of improperly stored doses of RECOMBIVAX HB (lot #L009445, expiry date 01-JUN-2017; lot # K026666, expiry date 22-OCT-2017; L004754, expiry date 10-NOV-2017) through unknown route. Concomitant medications were not reported. No adverse events were reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.