chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient arm started to swell and was told to put ice on it. The ice helped but the redness and swelling continued onto the underside of the arm from the top of the arm to the elbow. She came in on a Friday night after her doctors office was closed. I recommended to keep icing and add on BENADRYL. If no better or worse she should seek medical attention at an urgent care. Saturday she stated that it did look a lot better.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia
Clinical narrative: Patient developed a fever starting at 7pm that went up to 101.3 degrees F at 9pm. She also experienced a slight headache the following day.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Pain, Paraesthesia, Pruritus
Clinical narrative: Patient reported red spot approximately 2 inches in diameter, pain, itching. Right arm tingling - body full of electrical impulses, random itching that hurts when scratched. Patient went to see physician 10/19 and told her reflexes and strength were fine and prescribed MEDROL DOSEPAK. Followed up with patient 10/21 and patient reports improvement, tingling is better and itching gone.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient removed bandage one day after vaccination. Area was red, slightly swollen and slightly itchy, about the size of a silver dollar when observed on 10/21/17.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Asthenia, Decreased appetite, Dizziness, Lymphadenopathy, Nausea
Clinical narrative: Arm above elbow very sore, lymph nodes came up a bit, onset within hours. Next morning, experienced sustained racing heartbeat, dizziness, weakness, slight nausea. Felt achy, weak, little appetite that day and night. Had to sleep with pillow under arm to be comfortable.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pain, Pain in extremity, Palpitations
Clinical narrative: Arm above elbow very sore, lymph nodes came up a bit, onset within hours. Next morning, experienced sustained racing heartbeat, dizziness, weakness, slight nausea. Felt achy, weak, little appetite that day and night. Had to sleep with pillow under arm to be comfortable.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Chest discomfort, Computerised tomogram, Dizziness
Clinical narrative: I had a fainting episode approximately 3 hours after receiving the Tdap shot. My arms went stone cold, and my chest felt tight, was dizzy, and my head shut down. I was taken home by my husband. I developed pain all over my body-muscles and joints, Taken to hospital by ambulance on 10/5/17. Pain in back, could not feel legs or move them or lift arms or sit up.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Lumbar puncture, Mobility decreased, Myalgia
Clinical narrative: I had a fainting episode approximately 3 hours after receiving the Tdap shot. My arms went stone cold, and my chest felt tight, was dizzy, and my head shut down. I was taken home by my husband. I developed pain all over my body-muscles and joints, Taken to hospital by ambulance on 10/5/17. Pain in back, could not feel legs or move them or lift arms or sit up.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain, Peripheral coldness, Syncope
Clinical narrative: I had a fainting episode approximately 3 hours after receiving the Tdap shot. My arms went stone cold, and my chest felt tight, was dizzy, and my head shut down. I was taken home by my husband. I developed pain all over my body-muscles and joints, Taken to hospital by ambulance on 10/5/17. Pain in back, could not feel legs or move them or lift arms or sit up.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Apnoea, Base excess decreased, Blood bicarbonate decreased, Blood pH decreased, Bradycardia
Clinical narrative: Apnea and Bradycardia, seizure, Hypoxic brain injury, Death. Full Resuscitation. Ventilator support. Epinephrine, Dopamine, Insulin, hydrocortisone, Antibiotics. VERSED x1 dose, Phenobarbital Loading dose.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Brain injury, Death, Electroencephalogram abnormal, Mechanical ventilation, PCO2 increased
Clinical narrative: Apnea and Bradycardia, seizure, Hypoxic brain injury, Death. Full Resuscitation. Ventilator support. Epinephrine, Dopamine, Insulin, hydrocortisone, Antibiotics. VERSED x1 dose, Phenobarbital Loading dose.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Resuscitation, Seizure
Clinical narrative: Apnea and Bradycardia, seizure, Hypoxic brain injury, Death. Full Resuscitation. Ventilator support. Epinephrine, Dopamine, Insulin, hydrocortisone, Antibiotics. VERSED x1 dose, Phenobarbital Loading dose.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient stated that 5 days after receiving PREVNAR 13 her right arm became red, swollen and warm to the touch.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Arthritis, Loss of consciousness, Pain in extremity
Clinical narrative: Patient experience severe pain in the left arm and passed out twice and was taken by ambulance to the hospital, patient was told possible reaction to PREVNAR 13, patient known to have had arthritis in the shoulder, patient was advised by MD at the hospital to excercise arm and take ADVIL.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, 4 x 3 inch red, hard and significantly swollen site on upper left deltoid. Swelling is so severe that arm cannot be lifted lift past 90° to vertical.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Dystonia
Clinical narrative: Patient in emergency room, asymptomatic at this time, had dystonic reactions after flu shot and family is unsure if related.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Influenza like illness, Nausea, Pain, Vomiting
Clinical narrative: Significant nausea, vomiting approximately 12 hours after HPV vaccine was administered. Child reports aches/pains and flu-like symptoms, as well.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt. Reported next day that after receiving the flu inj. (on 10/12/17 around 1105AM) that early (10/12) evening she developed shoulder, back legs, and hips aches. 1030 That evening had chills and a headache and some vomiting. Much better when reported 10/13/17 at 10:30A. Feeling good 10/13/17 at 4:45p. T98.3
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Oropharyngeal pain, Swollen tongue
Clinical narrative: Patient call in complaining of a swollen tongue with a dry mouth/sore throat. She self-medicated with ibuprofen, APAP, salt water gargles, and BENADRYL.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot
Clinical narrative: Patient felt a warm sensation in her arm for 7 days.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema of eyelid, Eyelid irritation, Nausea, Pyrexia
Clinical narrative: Patient stated nausea shortly after vaccines administer, fever later that evening 10/13/17 eyelids red/irritated.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Feeling abnormal, Lacrimation increased, Paraesthesia
Clinical narrative: 10 minutes after vaccination, patient stated "I feel my body is rejecting the vaccine." Symptoms included watering of eyes, paresthesia of fingers, mild angioedema involving tongue. Denied symptoms of shortness of breath, swelling of throat, or chest pain. VSS. Patient was observed for an hour. Symptoms resolved. Called the evening of event. No new symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Pt developed presumably vaccine-related herpes zoster on right thigh and superior buttock starting about 6 months after receiving the varicella vaccine (rash first noted 10/17/17). He has no known Hx of wild type varicella.
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Pyrexia
Clinical narrative: At each of the following times, gave 3 tsp of Advil: 10/20/17: 10:30 PM - fever of 102.5 and headache; 10/21/17: 7:30 AM - fever 100.5; 3:00 PM - fever 101; 9:00 PM - fever 102.5; 10/22/17: 5:30 AM - fever 100.8
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The evening of the IMZ the patient had pain, redness and swelling that was uncomfortable and keep her awake. The next day she called and asked about reaction, she described as red, swollen and painful from injection's site to above elbow. No problems with arm movement. She decided to go to ER for evaluation. The ER discharge summary diagnosed localized allergic reaction with skin rash to IM drug. The discharge summary recommended antihistamine and cool compresses. Loratadine was selected to minimize sedation.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia
Clinical narrative: The evening of the IMZ the patient had pain, redness and swelling that was uncomfortable and keep her awake. The next day she called and asked about reaction, she described as red, swollen and painful from injection's site to above elbow. No problems with arm movement. She decided to go to ER for evaluation. The ER discharge summary diagnosed localized allergic reaction with skin rash to IM drug. The discharge summary recommended antihistamine and cool compresses. Loratadine was selected to minimize sedation.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient report itching aroun neck.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Lethargy, Lung disorder, Oropharyngeal pain
Clinical narrative: Flu-like cough, day and night, continues (5 days as of 10/22/17). Lethargy, continues (5 days as of 10/22/17). Raw lungs (mild) two days. Sore throat, mild, one day. Fever and sore skin, mild, 1 day.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain of skin, Pyrexia
Clinical narrative: Flu-like cough, day and night, continues (5 days as of 10/22/17). Lethargy, continues (5 days as of 10/22/17). Raw lungs (mild) two days. Sore throat, mild, one day. Fever and sore skin, mild, 1 day.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Muscular weakness, Pyrexia, Vomiting
Clinical narrative: Fever 103. Vomiting. Leg weakness. Fatique.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling
Clinical narrative: Tissue swelling around left elbow, 12 inches approx from vaccine site.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: Diarrhea starting 14 hours after shot. Started early this morning, so not sure how long it will last.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Computerised tomogram head, Electroencephalogram, Laboratory test, Seizure
Clinical narrative: Patient had a first time seizure starting at 0445 the morning after her 6 mo vaccines. Seizures have continued since resulting in two ER visits, and additional testing on multiple occasions.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Chest X-ray normal, Crying, Electroencephalogram normal, Eye movement disorder
Clinical narrative: Patient had a first time seizure starting at 0445 the morning after her 6 mo vaccines. Seizures have continued since resulting in two ER visits, and additional testing on multiple occasions.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Febrile convulsion, Head injury, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Opisthotonus
Clinical narrative: Patient had a first time seizure starting at 0445 the morning after her 6 mo vaccines. Seizures have continued since resulting in two ER visits, and additional testing on multiple occasions.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming, Seizure, Urine analysis
Clinical narrative: Patient had a first time seizure starting at 0445 the morning after her 6 mo vaccines. Seizures have continued since resulting in two ER visits, and additional testing on multiple occasions.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Angiogram, Echocardiogram, Electrocardiogram, Electroencephalogram, Hypoaesthesia
Clinical narrative: Facial numbness (paresthesia) complete left side, including tongue.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Nuclear magnetic resonance imaging brain, Paraesthesia, Venogram
Clinical narrative: Facial numbness (paresthesia) complete left side, including tongue.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Anger, Blood glucose normal, Confusional state, Electrocardiogram normal, Eye movement disorder
Clinical narrative: Pt received shot and then I asked her a few questions about what hurt the most, was it cold, and did it hurt at all....while she was still sitting in chair. She got up and stood just outside the booth while I proceeded to give her brother a flu shot. 2 minutes later she hit the floor, her father rushed to her side and called her name several times with no response. I saw her eyes rolling around in her head for 10 seconds, then she came to. She was confused and started to get upset. She said her head hurt and she hit her head. 911 was called upon her hitting the floor. Father denied transportation to hospital, but took her the ER himself.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Headache, Unresponsive to stimuli
Clinical narrative: Pt received shot and then I asked her a few questions about what hurt the most, was it cold, and did it hurt at all....while she was still sitting in chair. She got up and stood just outside the booth while I proceeded to give her brother a flu shot. 2 minutes later she hit the floor, her father rushed to her side and called her name several times with no response. I saw her eyes rolling around in her head for 10 seconds, then she came to. She was confused and started to get upset. She said her head hurt and she hit her head. 911 was called upon her hitting the floor. Father denied transportation to hospital, but took her the ER himself.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: Customer called two days after the vaccination complaining about the pain at the site of vaccination, could not sleep on that side due to unbearable pain. No prior history of any pain related to vaccinations. Came back today (10/22), almost six week later and still complaining of soreness at the site and thinks it might be a muscle damage caused from the vaccine. No visible signs of any damage that could be reported. But insisted I do a reporting on this situation. I have advised her to check with her primary physician and also recommended OTC remedies.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Patient called pharmacy and reported a grapefruit sized rash two inches below injections site that was warm to touch with slight swelling. Patient did not feel sick.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pyrexia, Rash, Rash erythematous
Clinical narrative: PATIENT COMPLAINS OF BRIGHT RED RASH FROM SHOULDER TO ELBOW, FEVER OF 104 THAT HAS RESOLVED WITH TYLENOL, TENDERNESS OF THE ARM, ARM STIFFNESS THAT CAUSES DIFFICULTY WITH MOVEMENT.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: PATIENT COMPLAINS OF BRIGHT RED RASH FROM SHOULDER TO ELBOW, FEVER OF 104 THAT HAS RESOLVED WITH TYLENOL, TENDERNESS OF THE ARM, ARM STIFFNESS THAT CAUSES DIFFICULTY WITH MOVEMENT.
Age: 64.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt received a FLUAD shot instead of a FLUARIX shot...no known adverse outcomes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Localized area swelling, induration 15 cm long by 14 cm wide oval shaped left lateral thigh.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13, RV1, DTAPHEPBIP, PNC13, RV5
Symptoms: Fontanelle bulging, Swelling, Ultrasound skull abnormal
Clinical narrative: The following morning at 5:00 AM, patient was drinking his bottle when I noticed a large lump on the top of his head right over his soft spot. I called the triage nurse who did not immediately answer the phone. I left a message, but then decided to take patient to the emergency room. The nurse called back while we were waiting at the ER and said to immediately take patient to the ER. The ER physician stated he has a "bulging fontanelle" but appeared alert, responsive, and in no distress. He recommended a visit to patient's pediatrician. We then went to his pediatrician's office where they also confirmed him to have a "bulging fontanelle." They ordered a head ultrasound scan of his brain. The findings indicated, a build-up of cerebral spinal fluid over the fontanelle. They classified it as idiopathic. The radiologist recommended a possible MRI for further analysis. The pediatrician scheduled a follow up appointment on 10/26/2017.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13, RV1, DTAPHEPBIP, PNC13, RV5
Symptoms: Fontanelle bulging, Intracranial pressure increased, Ultrasound skull
Clinical narrative: The following morning at 5:00 AM, patient was drinking his bottle when I noticed a large lump on the top of his head right over his soft spot. I called the triage nurse who did not immediately answer the phone. I left a message, but then decided to take patient to the emergency room. The nurse called back while we were waiting at the ER and said to immediately take patient to the ER. The ER physician stated he has a "bulging fontanelle" but appeared alert, responsive, and in no distress. He recommended a visit to patient's pediatrician. We then went to his pediatrician's office where they also confirmed him to have a "bulging fontanelle." They ordered a head ultrasound scan of his brain. The findings indicated, a build-up of cerebral spinal fluid over the fontanelle. They classified it as idiopathic. The radiologist recommended a possible MRI for further analysis. The pediatrician scheduled a follow up appointment on 10/26/2017.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool for over a month.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling, swelling at injection site and approximately 5 inches downward.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Tenderness
Clinical narrative: Marked mild erythema 15-20cm, mild tenderness.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local reaction, Pain, Pruritus, Skin warm
Clinical narrative: Circle about 10 cm in diameter of Red, Warm, Itching and painful area. Recommended to patient to use cold compress since it is a local reaction 2 days after the Vaccine and seek medical assistance and let me know if it get worse or other symptoms develops.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Malaise, Visual impairment
Clinical narrative: Received flu vaccination; about nine hours later, experienced sudden vision change and dizziness, horizon was moving while standing and sitting still; symptoms last for at least a couple of hours, still felt unwell the next morning but with improved vision and no dizziness; took until about midday to feel like myself again.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Limb mass, Nasopharyngitis, Pain
Clinical narrative: Patient complains of extreme soreness, a lump in arm, fever, loss of appetite, cold/shiver.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after administration - said it was due to fear of needles, has happened before but he did not tell the pharmacist. Patient regained quickly, got some ice for his head and gave him water, ambulance was called.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling covering majority of upper arm, severe pain, heat from injection site. Patient took BENADRYL and applied ice to site. Reaction resolved within 24 hours of treatment.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Gait inability, Mobility decreased, Nausea
Clinical narrative: Patient complaining about whole body ache and tired. He feels horrible, he is unable to bend or walk because of the pain. Does not have any fever and no reaction at injection site. Friday morning he called his PCP and was prescribed TAMIFLU. He did not get this filled until 10/21 (9.09am). He went to ER the same afternoon (4.20pm) and said he collapsed as he was so nauseated. Was prescribed ZOFRAN and ZANTAC.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Syncope
Clinical narrative: Patient complaining about whole body ache and tired. He feels horrible, he is unable to bend or walk because of the pain. Does not have any fever and no reaction at injection site. Friday morning he called his PCP and was prescribed TAMIFLU. He did not get this filled until 10/21 (9.09am). He went to ER the same afternoon (4.20pm) and said he collapsed as he was so nauseated. Was prescribed ZOFRAN and ZANTAC.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Nerve injury, Pain, X-ray
Clinical narrative: After 3 weeks of not being able to move my arm and constantly feeling like I was being stabbed by a knife in my anterior deltoid, an Orthopedic Surgeon confirmed that my nerve was hit when the injection was given. It will take 8-10 weeks for my nerve to regenerate, I hope.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Abnormal behaviour, Asthenia, Cold sweat, Dyspnoea
Clinical narrative: A few minutes after receiving vaccine patient said he did not feel well. He was very pale, cool to the touch, clammy on his face. He felt nauseous and weak, Dad held him up as he spit in the toilet. He was quiet and not himself, when questioned said his stomach hurt, he didn't feel well, and eventually stated he felt like "there wasn't a big space to take a breath." I called 911 and we put a cool cloth on his head and had him rest on the bench with his dad, monitored his breathing which was normal, but he was still pale. After a few minutes he got some color back in his face and was more responsive, even smiling occasionally. Rescue squad assessed him and said his heart rate was elevated but otherwise he was fine.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Heart rate increased, Malaise, Nausea, Pallor, Peripheral coldness
Clinical narrative: A few minutes after receiving vaccine patient said he did not feel well. He was very pale, cool to the touch, clammy on his face. He felt nauseous and weak, Dad held him up as he spit in the toilet. He was quiet and not himself, when questioned said his stomach hurt, he didn't feel well, and eventually stated he felt like "there wasn't a big space to take a breath." I called 911 and we put a cool cloth on his head and had him rest on the bench with his dad, monitored his breathing which was normal, but he was still pale. After a few minutes he got some color back in his face and was more responsive, even smiling occasionally. Rescue squad assessed him and said his heart rate was elevated but otherwise he was fine.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Joint crepitation
Clinical narrative: Popping sensation and immediate pain and decreased range of motion in right arm following administration of vaccine on 9/21. Flu shot was placed very high on arm and into shoulder joint. Patient self-treated with rest and MOTRIN at home; pain worsened over the following week. Severe pain with numbness and tingling in right palm was noted, which is what caused patient to seek medical treatment. Patient seen by corporate care on 10/2 and was evaluated and an ultrasound was performed. At follow up visit on 10/3, patient was diagnosed with SIRVA and given a prescription for prednisone oral. At follow-up appointment on 10/6, pain was still present but range of motion was improved. Patient was instructed to finish oral steroids and to ice area and take ALEVE as needed.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Limb injury, Pain, Pain in extremity, Paraesthesia, Ultrasound scan
Clinical narrative: Popping sensation and immediate pain and decreased range of motion in right arm following administration of vaccine on 9/21. Flu shot was placed very high on arm and into shoulder joint. Patient self-treated with rest and MOTRIN at home; pain worsened over the following week. Severe pain with numbness and tingling in right palm was noted, which is what caused patient to seek medical treatment. Patient seen by corporate care on 10/2 and was evaluated and an ultrasound was performed. At follow up visit on 10/3, patient was diagnosed with SIRVA and given a prescription for prednisone oral. At follow-up appointment on 10/6, pain was still present but range of motion was improved. Patient was instructed to finish oral steroids and to ice area and take ALEVE as needed.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was given the two vaccinations above in the left arm on 10/17. She presented to the pharmacy on 10/18 with an injection site reaction that included redness, pain and swelling. Called patient on 10/20 and she stated it was subsiding but still present.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Sleep disorder
Clinical narrative: Continued stiffness running up through the deltoid into the neck and trapezius, prolonged and irritating, pt unable to sleep on that side, began 10/01/17, the morning after the shot, pt thought the initial soreness would subside, but it lingered.
Age: 18.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Hypoaesthesia
Clinical narrative: Severe swelling in the right arm, numbness, rash that spread from arm all the way up to shoulder and chest, tightness in chest, difficulty breathing, feeling faint and this all happened within 5 hours of getting the shots. Had to go to the emergency room at 5:30 PM on 10/19/2017 where they diagnosed her with having a severe allergic reaction that resulted in her getting 3 shots to counteract the reaction. She is still not any better.
Age: 18.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Peripheral swelling, Rash
Clinical narrative: Severe swelling in the right arm, numbness, rash that spread from arm all the way up to shoulder and chest, tightness in chest, difficulty breathing, feeling faint and this all happened within 5 hours of getting the shots. Had to go to the emergency room at 5:30 PM on 10/19/2017 where they diagnosed her with having a severe allergic reaction that resulted in her getting 3 shots to counteract the reaction. She is still not any better.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Aphonia, Dysphonia, Lacrimation increased, Throat tightness
Clinical narrative: Patient states that after the imz she went home and slept she woke up at 11:30pm with tightness in the throat and very little voice, she had no voice the next day and called in sick to work, she worked the next day and lost her voice again on Friday. Additionally her eyes have been watering.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site joint pain, Injection site pain, Weight bearing difficulty
Clinical narrative: Within 12 hours of injection severe pain in shoulder. Unable to move arm or put weight on it. Paper stated that it may happen. Still 3 weeks later arm does not have full motion and severe pain at joint. Injection given to high on deltoid possible in bursa.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling and Redness in arms.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: MOTHER OF CHILD INFORMED PHARMACIST PT EXPERIENCED A RED ITCHY RASH ALLOVER HER TORSO AFTER RECEIVING VACCINE. RASH SPREAD TO LEGS AND LEFT SIDE OF FACE. SHE ALSO HAS A LOW GRADE FEVER.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Headache, Induration, Nausea, Oropharyngeal pain
Clinical narrative: Approximately 6 hours after 2 vaccination in left arm  I experienced pain and soreness. The following day my arm became bright red from shoulder to almost my elbow, raised up, hard and hot with spot by red edges. I also experienced headache, mild nausea and discomfort in throat (similar to congestion/cold). Swollen, hot, red, painful arm persisted for 4 days. Arm is now back to normal at 5 days. (Note: I likely have the Inflenza shot type inncorrect. The sheet I was given says Flu H.D. Also, I received PCV 13 12/10/15 with no adverse effects.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Approximately 6 hours after 2 vaccination in left arm  I experienced pain and soreness. The following day my arm became bright red from shoulder to almost my elbow, raised up, hard and hot with spot by red edges. I also experienced headache, mild nausea and discomfort in throat (similar to congestion/cold). Swollen, hot, red, painful arm persisted for 4 days. Arm is now back to normal at 5 days. (Note: I likely have the Inflenza shot type inncorrect. The sheet I was given says Flu H.D. Also, I received PCV 13 12/10/15 with no adverse effects.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site rash, Pruritus, Swelling
Clinical narrative: Patient came into the pharmacy on Sunday 10/22/17 and reported red rash appeared at the injection site on Saturday 10/21/17. Patient was informed to put cold compress (iced) to rash for approximately 15minutes and take Benadryl for the itching, redness, and swelling. Patient also need to go to the emergency room If symptom worsen. Prescriber was informed and confirmed treatment on 10/22/17.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Red streak running from site of injection medially, approximately 4" long, red, warm to the touch, very sensitive, and swollen. Patient noticed the red streak and tenderness the morning of 10/21/2017.  She applied heat to the area and the redness has subsided somewhat (per patient) but the site is still very tender, warm to the touch, and somewhat swollen. She did not come back to the pharmacy until today about 4:00pm. She did not contact the pharmacy prior to coming in. I examined the site and informed her that I would make a report. She will continue to apply heat and I will follow up with her again 10/23/2017.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Swelling
Clinical narrative: Major bruise, bump that just is subsiding a week later.
Age: 16.0
Sex: F
Vaccine: FLUX, MEN, MNQ
Symptoms: Vertigo
Clinical narrative: Severe vertigo 10/07/17 - 10/20/17.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin abnormal, Cellulitis, Central venous catheterisation, Erythema, Erythema nodosum
Clinical narrative: I went to urgent care on 9/28 with bilateral foot swelling and redness. I was then sent to the ER at  Hospital. They diagnosed me with cellulitis and sent me home with antibiotics. Over the weekend the swelling and redness moved up my legs and to my arms and hands. I went to Medical Center ED and was admitted on Oct. 3-4. A central line was placed and a biopsy taken of my arm. I was discharged on prednisone. On Oct 12 I followed up with dermatology and had another biopsy taken in my doctor's office. My pain and swelling had spread. On Oct. 17, I passed out with a high fever, increased redness, swelling and pain. I was again admitted to Hospital 17-18.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: I went to urgent care on 9/28 with bilateral foot swelling and redness. I was then sent to the ER at  Hospital. They diagnosed me with cellulitis and sent me home with antibiotics. Over the weekend the swelling and redness moved up my legs and to my arms and hands. I went to Medical Center ED and was admitted on Oct. 3-4. A central line was placed and a biopsy taken of my arm. I was discharged on prednisone. On Oct 12 I followed up with dermatology and had another biopsy taken in my doctor's office. My pain and swelling had spread. On Oct. 17, I passed out with a high fever, increased redness, swelling and pain. I was again admitted to Hospital 17-18.
Age: 46.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hyperaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: I am a teacher and received a flu shot and also a pneumonia shot on that day. A few hours later I developed pain in the arm where the injections took place. Both injections were place very high up on my left arm. The pain traveled all the way to to my hand and by the time I went to bed I was in severe pain and could barely move my arm. I have never been allergic to anything and have never had a reaction to a vaccine. I could not even touch the skin of that arm without being in tears. The severe pain lasted until the morning of October 22nd. It is still painful today but bearable. However, I have developed fairly large red marks on my upper arm that are very sensitive and hot to the touch. I am now taking a steroid and have been cooling the area with ice packs. I looks as if my skin in that area was burned.
Age: 46.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: I am a teacher and received a flu shot and also a pneumonia shot on that day. A few hours later I developed pain in the arm where the injections took place. Both injections were place very high up on my left arm. The pain traveled all the way to to my hand and by the time I went to bed I was in severe pain and could barely move my arm. I have never been allergic to anything and have never had a reaction to a vaccine. I could not even touch the skin of that arm without being in tears. The severe pain lasted until the morning of October 22nd. It is still painful today but bearable. However, I have developed fairly large red marks on my upper arm that are very sensitive and hot to the touch. I am now taking a steroid and have been cooling the area with ice packs. I looks as if my skin in that area was burned.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: High fever 104.5, 2 silent seizures. Went to ER. Gave Motrin and Tylenol around the clock every 3 hours, luke warm bath, skin to skin, breastfeeding. Fever lasted 24 hours.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Strep throat like sore throat, runny nose.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Nausea, Pain, Peripheral swelling
Clinical narrative: Swollen red and hot arm, fever x 3 days, pain (excessive), nausea, light-headedness. Not resolved as of 10/20/17 from shots 10/16/17.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Swollen red and hot arm, fever x 3 days, pain (excessive), nausea, light-headedness. Not resolved as of 10/20/17 from shots 10/16/17.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: At 8 pm pt noticed she had a golf ball sized swelling at her injection site.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Headache, Malaise
Clinical narrative: Feeling sick, headache, loss of appetite.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Pt. has had prolonged pain in the muscle that extends both above and below the elbow. One day had a shooting pain down to thumb, but only happened once. Currently experiencing an aching pain right above elbow. Can't lift anything without pain.
Age: 78.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Lethargy, Musculoskeletal pain, Neck pain, Pruritus
Clinical narrative: Shot given on Thursday, itch Friday morning, Saturday redness, inner arm and extend 3 inches past elbow feels like "smirked", lousy shoulder/neck aching, lethargic.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling around injection site, arm is "tight". Area is warm to touch even 3 days post administration. Pt. is complaining of feeling low in energy.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin tightness
Clinical narrative: Redness and swelling around injection site, arm is "tight". Area is warm to touch even 3 days post administration. Pt. is complaining of feeling low in energy.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Hyperhidrosis, Pruritus, Pyrexia, Rash
Clinical narrative: Pt. came to pharmacy 10/21/17 and said her back had a rash on both sides and was very itchy. She stated that she woke up sweating and believes she has a slight fever. She was using hydrocortisone cream on rash. I recommended BENADRYL tabs at night and the cream during the day and to follow up w/PCP.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Couldn't lift arm, swelling in arm and soreness after.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site vesicles, Pain in extremity
Clinical narrative: Developed rash (itching), big bump on arm at site of injection and redness around 2 inch area, and small blisters; severe pain at arm.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Developed rash (itching), big bump on arm at site of injection and redness around 2 inch area, and small blisters; severe pain at arm.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Left arm injection: extreme soreness (patient rated 7/8). Knot, redness, bruise at injection site. Injection administered 10/17/2017, reported adverse effects on 10/20/17. Still bruised, soreness improved but still present.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pt. called 10/22/17 at 11:40 AM - said she wanted to let us know she had a bad reaction at injection site. Said it wasn't immediately after the shot but about 1 AM it woke her up with pain in her arm radiating to shoulder. It did not require a Doctor call or visit or hospitalization. Said it's still tender today - just wanted to let us know.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Immediate post-injection reaction, Peripheral swelling, Rash erythematous, Rash generalised
Clinical narrative: Initial unsolicited report received from a consumer on 29-Sep-2017. This case involves a female patient (age not reported) who was vaccinated with a single dose of INFLUENZA VACCINE (batch number, expiry date and site of administration were not reported) via intramuscular route on unspecified date in 2014. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2014, immediately following the vaccination, the patient's legs swelled up and had hives and a red rash all over. The patient's laboratory data was not reported. Patient treated for an allergic reaction. On an unknown date patient was recovered. It was reported that patient filed a VAERS in 2014 about this issue. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a consumer on 29-Sep-2017. This case involves a female patient (age not reported) who was vaccinated with a single dose of INFLUENZA VACCINE (batch number, expiry date and site of administration were not reported) via intramuscular route on unspecified date in 2014. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2014, immediately following the vaccination, the patient's legs swelled up and had hives and a red rash all over. The patient's laboratory data was not reported. Patient treated for an allergic reaction. On an unknown date patient was recovered. It was reported that patient filed a VAERS in 2014 about this issue. List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: After the vaccine my shoulder hurt but I thought it is normal to hurt for a day or two. But then it didn't stop. It was painful on its own. After 4 month it got better to the point it didn't hurt on its own but only when I reach with my arm back or lay on it. Still does.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: After the vaccine my shoulder hurt but I thought it is normal to hurt for a day or two. But then it didn't stop. It was painful on its own. After 4 month it got better to the point it didn't hurt on its own but only when I reach with my arm back or lay on it. Still does.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: Kidney-Calyceal dilation enlarged due to rapid progression /baby has to much fluid around kidney/only one funtional kidney; the patient received GARDASIL 9 prior to pregnancy/vaccinated on 20-SEP-2016 and last menstrual period (LMP) was on 05-OCT-2016; Surgery ureterocele; Ultrasound Kidney-Calyceal dilation enlarged due to rapid progression early delivery recommended.; This spontaneous report was received from a physician referring to a male patient of unknown age. The patient's medical history, concurrent conditions, and historical drugs were not reported. Concomitant therapies included betamethasone acetate (+) betamethasone sodium phosphate(CELESTONE SOLUSPAN) and vitamins (unspecified) via transplacental.  The patients' mother was  vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for abnormal Papanicolaou (PAP) smears. She became pregnant with Last Menstrual Period (LMP) of 05-OCT-2016 and Estimated Date of Delivery (EDD) of 12-JUL-2017. The mother's history included  4 previous pregnancies and 1 live birth(s). Her concurrent conditions included mild cervical dysplasia.   On 16-JUN-2017, an ultrasound was performed to the mother of the patient and the results were that the patient had a Kidney-Calyceal dilation enlarged due to rapid progression (ultrasound kidney abnormal ) and that an early delivery was recommended. It was also reported that the patient had only one funtional kidney(renal impairment neonatal) and that at week 36 of pregancy he had too much fluid around kidneys.  The patient was born weighing 7kg 7ozs. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Subsequently, on 18-JUL-2017, the new born had his first surgery on ureterocele(ureterocelectom).  At the time of the report the outcome of renal impairment neonatal, ultrasound kidney abnormal and ureterocelectomy was unknown.  The physician did not mention the causality assesment beteen the events of renal impairment neonatal, ultrasound kidney abnormal and ureterocelectomy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1612USA011465:
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby, Renal impairment neonatal, Single functional kidney
Clinical narrative: Kidney-Calyceal dilation enlarged due to rapid progression /baby has to much fluid around kidney/only one funtional kidney; the patient received GARDASIL 9 prior to pregnancy/vaccinated on 20-SEP-2016 and last menstrual period (LMP) was on 05-OCT-2016; Surgery ureterocele; Ultrasound Kidney-Calyceal dilation enlarged due to rapid progression early delivery recommended.; This spontaneous report was received from a physician referring to a male patient of unknown age. The patient's medical history, concurrent conditions, and historical drugs were not reported. Concomitant therapies included betamethasone acetate (+) betamethasone sodium phosphate(CELESTONE SOLUSPAN) and vitamins (unspecified) via transplacental.  The patients' mother was  vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for abnormal Papanicolaou (PAP) smears. She became pregnant with Last Menstrual Period (LMP) of 05-OCT-2016 and Estimated Date of Delivery (EDD) of 12-JUL-2017. The mother's history included  4 previous pregnancies and 1 live birth(s). Her concurrent conditions included mild cervical dysplasia.   On 16-JUN-2017, an ultrasound was performed to the mother of the patient and the results were that the patient had a Kidney-Calyceal dilation enlarged due to rapid progression (ultrasound kidney abnormal ) and that an early delivery was recommended. It was also reported that the patient had only one funtional kidney(renal impairment neonatal) and that at week 36 of pregancy he had too much fluid around kidneys.  The patient was born weighing 7kg 7ozs. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Subsequently, on 18-JUL-2017, the new born had his first surgery on ureterocele(ureterocelectom).  At the time of the report the outcome of renal impairment neonatal, ultrasound kidney abnormal and ureterocelectomy was unknown.  The physician did not mention the causality assesment beteen the events of renal impairment neonatal, ultrasound kidney abnormal and ureterocelectomy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1612USA011465: