chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Nausea, Rash generalised
Clinical narrative: After the fact, Mom reports that within 15 minutes of receiving the vaccination, child developed a rash all over - this started on her fingers but spread to entire body. Child also became nauseated. No measured fever. Mom did not contact medical services. Child went to bed and when she woke next morning rash was gone and child was better. Mom declines for child to receive shot #3.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Rash, Red blood cell abnormality
Clinical narrative: Patient experienced a rash that caused his red corpusles to explode. Also, his blood sugars increased to 500-600.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Skin warm
Clinical narrative: Patient came into the clinic on 10/01/18 to report a rash on his left arm. Patient stated the rash started out small, but then continued to spread two days after receiving the PREVNAR-13 vaccine. Patient stated the rash continued to worsen and was warm to the touch.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, bruising, and pain on the inner bicep/elbow region. No reaction around the site of injection.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Chills, Migraine, Myalgia, Pyrexia
Clinical narrative: The patient they experienced fever, muscle pain, migraine headache, shivering, and that he couldn't up the whole day on Saturday.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Amnesia, Blood test normal, Catatonia, Dizziness, Drooling
Clinical narrative: 8/27/2018 Patient fainted after vaccine and became pale, drooling, and motionless for several minutes before waking up. Drank Gatorade at doctors office and waited 30mins. before left office. Patient did not feel well after leaving and has become worse with several symptoms; Dizziness, headaches, extreme tiredness, brain fog, memory loss, blurry vision, tingling in hands and feet, pale color to skin, sleep issues, and mini catatonic seizures. The symptoms have occurred for 5 weeks and others symptoms have gotten worse, now with siezures. This still continues today 10/1/2018.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Mobility decreased
Clinical narrative: 8/27/2018 Patient fainted after vaccine and became pale, drooling, and motionless for several minutes before waking up. Drank Gatorade at doctors office and waited 30mins. before left office. Patient did not feel well after leaving and has become worse with several symptoms; Dizziness, headaches, extreme tiredness, brain fog, memory loss, blurry vision, tingling in hands and feet, pale color to skin, sleep issues, and mini catatonic seizures. The symptoms have occurred for 5 weeks and others symptoms have gotten worse, now with siezures. This still continues today 10/1/2018.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Paraesthesia, Seizure, Sleep apnoea syndrome, Syncope
Clinical narrative: 8/27/2018 Patient fainted after vaccine and became pale, drooling, and motionless for several minutes before waking up. Drank Gatorade at doctors office and waited 30mins. before left office. Patient did not feel well after leaving and has become worse with several symptoms; Dizziness, headaches, extreme tiredness, brain fog, memory loss, blurry vision, tingling in hands and feet, pale color to skin, sleep issues, and mini catatonic seizures. The symptoms have occurred for 5 weeks and others symptoms have gotten worse, now with siezures. This still continues today 10/1/2018.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vision blurred
Clinical narrative: 8/27/2018 Patient fainted after vaccine and became pale, drooling, and motionless for several minutes before waking up. Drank Gatorade at doctors office and waited 30mins. before left office. Patient did not feel well after leaving and has become worse with several symptoms; Dizziness, headaches, extreme tiredness, brain fog, memory loss, blurry vision, tingling in hands and feet, pale color to skin, sleep issues, and mini catatonic seizures. The symptoms have occurred for 5 weeks and others symptoms have gotten worse, now with siezures. This still continues today 10/1/2018.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Pt reported to pharmacy to get flu shot and stated her arm has been terribly bruised since she received the second SHINGRIX shot. Showed me her arm and it is still very bruised, yellow, and purple.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cervicogenic vertigo, Vertigo positional
Clinical narrative: Vertigo when getting up/down.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Inflammation, Injection site erythema, Injection site swelling, Ultrasound scan
Clinical narrative: Swelling and redness of the thigh and knee are a localized inflammatory reaction to the flue vaccine on 9/28/18 (reported by Hospital). TYLENOL should be effective for pain, and BENADRYL will be helpful if your child develops itching (hospital treatment).
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Muscle spasms, Nausea
Clinical narrative: Patient reported nausea, some cramping and diarrhea (no blood) after receiving the vaccine. Symptoms lasted throughout the day for several days.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Pt had redness and swollen on left arm. Pt came to pharmacy today 10/1/18. Pt is doing ok, just little pain. Pt has been taking TYLENOL for the pain. Advised pt to take IBU or TYLENOL and put ice.
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Patient experienced flu-like symptoms, low grade fever, chills within 9 hrs of vaccination, which resolved after 24 hours. She also experienced a non-itchy, blotchy rash over entire body (chest, torso, back, arms and legs) within 12 hours of vaccination. Rash gradually subsided, but was not completely resolved when she reported adverse event to pharmacy after 72 hours of vaccination.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Pt had redness and swollen on left arm. Pt came to pharmacy today 10/1/18. Pt is doing ok and just have little pain now. Pt has been taking TYLENOL for the pain. Advise pt to take IBU or TYLENOL and put ice for inflammation/pain. Consult PCP if getting worse.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Pt's husband said she experienced some muscle pain, fever, headache, dizziness. Her husband said she couldn't get up the whole day.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Mild rash, swelling and redness.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Erythema, Fatigue, Pruritus
Clinical narrative: Patient reports feeling chills and fatigue starting the night on the same day of receiving the SHINGRIX. The next day, the patient started having redness and itchiness on her abdomen and back for the next 4-5 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: From one inch below the injection site down to the elbow, swelling and redness. Patient was seen at an urgent care facility one day after symptoms began (2 days after the injection), and started doxycycline as prescribed by the urgent care facility 3 days after the vaccination.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Flu shot was given in left arm on Saturday 9/29/18 and a few hours later mom noticed the left arm was becoming swollen, warm to touch, and red. Symptoms have persisted since then.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Aching muscles and joints, shivering, slight headache, extreme fatigue, soreness at injection site but that much was expected. Took Ibuprofen, 400-600 mgs per dose, sleep. Symptoms started Sat night(injection day), it's now Monday. Most symptoms have subsided. Still some muscle soreness and fatigue. I had the same reaction after the first dose. Was hoping after the first dose my body would handle the 2nd dose ok.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Muscle fatigue, Myalgia, Vaccine positive rechallenge
Clinical narrative: Aching muscles and joints, shivering, slight headache, extreme fatigue, soreness at injection site but that much was expected. Took Ibuprofen, 400-600 mgs per dose, sleep. Symptoms started Sat night(injection day), it's now Monday. Most symptoms have subsided. Still some muscle soreness and fatigue. I had the same reaction after the first dose. Was hoping after the first dose my body would handle the 2nd dose ok.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swollen at injection site, patient states feels like bee sting, symptoms started per patient after 48 hours. Advised patient to apply ice and take acetaminophen or NSAID. Advised patient if persists to contact primary care provider.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Lethargy, Pyrexia, Swelling face
Clinical narrative: Within 10 minutes, severe headache and fatigue. Treated with ibuprofen. Later, that evening,  fever and lethargy and swollen face. Treated with ibuprofen, ZYRTEC, BENADRYL. All but swollen face resolved by next am, and swollen face resolved by following day.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Bump on her arm (about 1/4 inch high with diameter 1 1/2 inches), hot to the touch noticed on 09.27.18. Discomfort on the first few days and itchiness starting 09/30/2018, then improving now.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient complained of a rash that spread across the chest area.
Age: 49.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient did not have an adverse event but she did experience a med error. She came to us to get a Tdap shot and we had done so many flu shots we made an assumption she was her to get a flu shot. The error was discovered after administration when patient said she had a grandchild on the way. I apologized for the mix up and gave her a Tdap in her other arm. Patient had not yet received a flu shot for this season. Patient has not reported any adverse reactions to either vaccination.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Malaise, Syncope
Clinical narrative: Shortly after shot given patient did not feel well and put his head between knees while seated. Shortly after this he fainted. Helped to floor and regained consciousness shortly after. Stayed on floor a few minutes with feet elevated, then was seated, and went on to recover fully.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Patient had sore arm and swelling around the injection site within 24 hours of vaccination. Then bruising started to show up approximately 7 days later (Sept. 23, 2018). Bruise started in Upper Left Arm and then it moved down to his elbow area. He went to his Primary Care Physician on Tuesday Sept. 25, 2018 and Dr. examined his Left arm with bruises and the swelling at the injection site. Dr. told patient that he haven't seen something like this before. Dr. told patient to buy ice pack to apply it to his arm to decrease the swelling at the injection site. On October 1, 2018, the bruise is getting a bit lighter but the swelling at the injection site and sore arm still exist.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nasal congestion, Papule, Pyrexia, Rash
Clinical narrative: 8/27/2018-onset of rash, left lower thoracic area, crossed midline across left flank, some papules on abdomen, small area of left shoulder, also (R) glute. 8/18/18-pain, fever up to 100.3 a few d later, noticeable fatigue; nasal congestion. No pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood creatine phosphokinase, C-reactive protein, Differential white blood cell count, Erythema
Clinical narrative: Had erythema, swelling and pain into (R) chest that started night of administration. The progressively developed severe myalgias and arthralgias that prevented her from sleeping. Saw her on 9/25 stating it had not resolved and not getting better.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Metabolic function test, Myalgia, Pain, Red blood cell sedimentation rate
Clinical narrative: Had erythema, swelling and pain into (R) chest that started night of administration. The progressively developed severe myalgias and arthralgias that prevented her from sleeping. Saw her on 9/25 stating it had not resolved and not getting better.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Had erythema, swelling and pain into (R) chest that started night of administration. The progressively developed severe myalgias and arthralgias that prevented her from sleeping. Saw her on 9/25 stating it had not resolved and not getting better.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, warm to the touch. Pt received TDaP 8/28/18 as part of wellness visit. Called 8/30/18 to report vaccine site warm and swollen. She did not see need for visit at that time. Assume resoled.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dizziness, Dyspnoea, Injection site swelling, Local reaction
Clinical narrative: 9-19-18 Noticed swelling at injection site and felt dizzy at 6 pm. 9-19-18 9pm felt dizzy, difficulty breathing so took a BENADRYL. 9-20-18 went to an urgent care for fever, cough, swelling at injection site where she got her flu shot. The urgent care told her to put ice to her arm, BENADRYL, ADVIL and rest. Discharge instruction stated localized reaction to flu shot. D/c to home.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: 9-19-18 Noticed swelling at injection site and felt dizzy at 6 pm. 9-19-18 9pm felt dizzy, difficulty breathing so took a BENADRYL. 9-20-18 went to an urgent care for fever, cough, swelling at injection site where she got her flu shot. The urgent care told her to put ice to her arm, BENADRYL, ADVIL and rest. Discharge instruction stated localized reaction to flu shot. D/c to home.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, swelling (about 3 inch diameter) mild pain. Minor itching appeared 24 hrs after shots.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (Day 2) Cellulitis like symptoms - redness entire arm to elbow starting at injections location - swelling and extremely sore and hot to touch, spreading around arm. Day 3 spread around arm. Dr. prescribed 3 day dose of cephalexin 500 mg 4 times a day. Slight fever off and on.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: (Day 2) Cellulitis like symptoms - redness entire arm to elbow starting at injections location - swelling and extremely sore and hot to touch, spreading around arm. Day 3 spread around arm. Dr. prescribed 3 day dose of cephalexin 500 mg 4 times a day. Slight fever off and on.
Age: 1.08
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Injection site warmth, Rash
Clinical narrative: Reaction started 9/22/18 right leg started with a lump, red and hot. Parent applied cold compresses. Then rash stated on right leg then spread to the left leg and abdominal area.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed redness at injection site.
Age: 49.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Arm swelling, headache, fever, chills, fatigue, pain, redness.
Age: 49.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Arm swelling, headache, fever, chills, fatigue, pain, redness.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Lump in left deltoid since receiving HPV on 8/30/18 only painful if area is palpated.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Difficulty breathing, tight chest, gave 1 EPIPEN, 50mg Diphenhydramine IM. EMT came and Pt refused to go to hospital. Appears to be resolved.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Angiogram normal, Nuclear magnetic resonance imaging brain normal, Strabismus
Clinical narrative: Mom noticed eyes crossed 4 hours after receiving 12mos vaccines on 6-27-18. She got Hep A, MMR, Varicella and PREVNAR. She was instructed to go to the ER. Brain MRI and MRA were normal. Neck MRA was normal. She was instructed to follow up with ophthalmology.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Patient called clinic today, 8/31/18. Stated that for 2 days after receiving the SHINGRIX vaccine she was on the couch with a "terrible headache". Patient states that she took aspirin with only temporary relief for approximately one hour. Denies any shortness of breath, rash or fever. States that she is better now with only an occasional twinge of a headache. Denies any history of migraine headaches. Advised to follow up with her primary care physician if headaches continue or worsen. Patient verbalized understanding.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Headache, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Entire arm extremely painful, unable to lift arm, headaches and discomfort, pain radiating to neck and shoulder and body aches all over. Tried using OTC ibuprofen, ice, heat without relief.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Entire arm extremely painful, unable to lift arm, headaches and discomfort, pain radiating to neck and shoulder and body aches all over. Tried using OTC ibuprofen, ice, heat without relief.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt given KINRIX. KINRIX is licensed for greater than 4 years.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Redness at the site, gradually increasing, warm to touch discomfort locally -> SHINGRIX #2.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt given KINRIX, KINRIX is licensed for greater than 4 years.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Fever, shortness of breath, headache at back of head, sweating, extreme cold feeling, dizziness, muscle fatigue (2 days).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle fatigue, Pyrexia
Clinical narrative: Fever, shortness of breath, headache at back of head, sweating, extreme cold feeling, dizziness, muscle fatigue (2 days).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: Patient visited pharmacy on 09/28/18 to report bruising and redness on arm.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No adverse reactions were noted.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient complains of pain in arm where vaccine was given. Followed up with MD on 8-30-18 per patient. "He told me that it may be an abscess under the skin in the muscle". "They gave me antibiotic shot and some to take at home". States that she will follow up with MD on 9-3-18 if area has not improved. Patient denies any visual signs of abscess or drainage.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Amblyopia, Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Vision blurred
Clinical narrative: Lazy (Half closed) right eye, blurred vision - 2 days numbness right side of face from corner of mouth to outside right eye area about the width of index finger - 5 days. (Symptoms possibility included in paperwork provided).
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt given adult Hep A.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Body temperature increased, Decreased appetite, Gait inability, Injection site movement impairment, Synovitis
Clinical narrative: Mother reports won't walk or let you move her legs. Low grade temps since yesterday. Poor appetite, is drinking and voiding. Fine when sitting still. Received flu, MMR and QUADRECEL 9/21/18. Of note, had similar episode in the spring when dad had influenza. Seen at express care and DX with toxic synovitis. SX resolved. No known injury. Temp 100.8.
Age: 77.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: No adverse event
Clinical narrative: No adverse events were reported or additional treatments were needed.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse reactions were noted.
Age: 12.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain entire upper arm of injection site.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Spoke on 9/27, red, swollen to 1 1/2 to 2 inches wide around injection site. Warm to touch. As of 10/1/18, redness and size are decreasing in size and improving.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Pt. was given MMRV and Varicella, no treatment necessary at this time. Spoke with mom today and asked how the inj. sites look. She says the RT is red and swollen on the injection site. She has been instructed to give BENADRYL for the swelling and TYLENOL or MOTRIN for discomfort.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Pallor, Urinary incontinence
Clinical narrative: Patient ambulating out of room and states to mother "I don't feel good". Patient immediately became pale and urinated on herself. Pt RR even and unlabored, eyes closed; ammonia used; pt immediately aroused and assisted to bed; during episode pt urinated on herself. VS WNL.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Red, swollen and painful to touch on injection site (L) deltoid. Nausea 2 days. No vomiting, patient received prescription for promethazine 25 mg po every 8 hr and ibuprofen 800 mg q8hr. Follow up apt 11-21-18 with dr.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort, Pruritus, Rash
Clinical narrative: Pt c/o itching on scalp, hands, soles of feet that evening. Next morning presence of rashes and more itching on neckline and arms. Went to urgent care and received prednisone x 3 days. No significant improvement. Went to see primary MD and got BENADRYL and Pred. Currently her rashes and itching comes and goes.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Pt developed redness and swelling over most of upper arm where SHINGRIX had been administered. She was seen by a physician who diagnosed it as a "severe allergic reaction" and prescribed a 4 day course of steroids to treat. Pt reported this to me, and still had a slight residual redness on the left upper arm.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Abdominal pain, Abnormal dreams, Blood test normal, Chills, Computerised tomogram normal
Clinical narrative: Patient reports experiencing his first Seizure on 8/4/18. He became unconscious, lost bladder control and had rhythmic, jerking and grunting sounds. Was admitted to the hospital via paramedics and after observation was released the following day. In addition to the seizure He developed a fever above 102 degrees. His arm was swollen, painful, red and warm.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Dyskinesia, Electrocardiogram normal, Erythema, Fatigue, Grunting
Clinical narrative: Patient reports experiencing his first Seizure on 8/4/18. He became unconscious, lost bladder control and had rhythmic, jerking and grunting sounds. Was admitted to the hospital via paramedics and after observation was released the following day. In addition to the seizure He developed a fever above 102 degrees. His arm was swollen, painful, red and warm.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Myalgia, Pain
Clinical narrative: Patient reports experiencing his first Seizure on 8/4/18. He became unconscious, lost bladder control and had rhythmic, jerking and grunting sounds. Was admitted to the hospital via paramedics and after observation was released the following day. In addition to the seizure He developed a fever above 102 degrees. His arm was swollen, painful, red and warm.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia, Seizure, Skin warm, Somnolence
Clinical narrative: Patient reports experiencing his first Seizure on 8/4/18. He became unconscious, lost bladder control and had rhythmic, jerking and grunting sounds. Was admitted to the hospital via paramedics and after observation was released the following day. In addition to the seizure He developed a fever above 102 degrees. His arm was swollen, painful, red and warm.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Urinary incontinence, X-ray normal
Clinical narrative: Patient reports experiencing his first Seizure on 8/4/18. He became unconscious, lost bladder control and had rhythmic, jerking and grunting sounds. Was admitted to the hospital via paramedics and after observation was released the following day. In addition to the seizure He developed a fever above 102 degrees. His arm was swollen, painful, red and warm.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Computerised tomogram normal, Dyskinesia, Electroencephalogram normal, Erythema, Grunting
Clinical narrative: Patient reports experiencing his first Seizure on 8/4/18. He became unconscious, lost bladder control and had rhythmic, jerking and grunting sounds. Was admitted to the hospital via paramedics and after observation was released the following day. In addition to the seizure He developed a fever above 102 degrees. His arm was swollen, painful, red and warm.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Loss of consciousness, Nuclear magnetic resonance imaging normal, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient reports experiencing his first Seizure on 8/4/18. He became unconscious, lost bladder control and had rhythmic, jerking and grunting sounds. Was admitted to the hospital via paramedics and after observation was released the following day. In addition to the seizure He developed a fever above 102 degrees. His arm was swollen, painful, red and warm.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Seizure, Skin warm, Urinary incontinence
Clinical narrative: Patient reports experiencing his first Seizure on 8/4/18. He became unconscious, lost bladder control and had rhythmic, jerking and grunting sounds. Was admitted to the hospital via paramedics and after observation was released the following day. In addition to the seizure He developed a fever above 102 degrees. His arm was swollen, painful, red and warm.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3
Symptoms: Dyspnoea, Pain in extremity, Vomiting
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 65 years old female patient who experienced aching in her right arm on a 10 out of 10 on a scale and she was vomiting so much that she pulled a muscle in her right side of her back, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication include an unspecified Pneumonia Vaccine. On 05-Sep-2018, the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot number not reported via intramuscular route in the right deltoid (reported as in her right upper arm). On an unknown date, the patient developed a non-serious the patient's right arm was aching on a 10 out of 10 on a scale (pain in extremity) 1 hour following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. On an unknown date, the patient developed a non-serious she was vomiting so much that she pulled a muscle in her right side of her back (vomiting) 1 hour following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. (Other relevant tests included No lab data.) Final diagnosis was she was vomiting so much that she pulled a muscle in her right side of her back and the patient's right arm was aching on a 10 out of 10 on a scale. Patient received antihistamines and steroids as corrective treatment. The patient outcome is reported as not recovered for the patient's right arm was aching on a 10 out of 10 on a scale and as Not Recovered / Not Resolved on an unknown date for she was vomiting so much that she pulled a muscle in her right side of her back. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3
Symptoms: Muscle strain, Pain in extremity, Vomiting
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 65 years old female patient who experienced aching in her right arm on a 10 out of 10 on a scale and she was vomiting so much that she pulled a muscle in her right side of her back, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication include an unspecified Pneumonia Vaccine. On 05-Sep-2018, the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot number not reported via intramuscular route in the right deltoid (reported as in her right upper arm). On an unknown date, the patient developed a non-serious the patient's right arm was aching on a 10 out of 10 on a scale (pain in extremity) 1 hour following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. On an unknown date, the patient developed a non-serious she was vomiting so much that she pulled a muscle in her right side of her back (vomiting) 1 hour following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. (Other relevant tests included No lab data.) Final diagnosis was she was vomiting so much that she pulled a muscle in her right side of her back and the patient's right arm was aching on a 10 out of 10 on a scale. Patient received antihistamines and steroids as corrective treatment. The patient outcome is reported as not recovered for the patient's right arm was aching on a 10 out of 10 on a scale and as Not Recovered / Not Resolved on an unknown date for she was vomiting so much that she pulled a muscle in her right side of her back. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Body temperature, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Patient reported she was hospitalized 2 to 3 days after the vaccine. She had a fever, shortness of breath and cough. Patient felt she was fatigue and loss of appetite which led to weight loss. She also experience headache. Patient was put on albuterol nebulizer solution, ipratropium nebulizer solution and cipro 250mg tablet. She was also put on augment and promezathine with codeine followed by the other therapy. Patient said she feels a lot better but still feel weak and she is not sure what happen to her body.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pain, Peripheral swelling
Clinical narrative: Patient reported she was hospitalized 2 to 3 days after the vaccine. She had a fever, shortness of breath and cough. Patient felt she was fatigue and loss of appetite which led to weight loss. She also experience headache. Patient was put on albuterol nebulizer solution, ipratropium nebulizer solution and cipro 250mg tablet. She was also put on augment and promezathine with codeine followed by the other therapy. Patient said she feels a lot better but still feel weak and she is not sure what happen to her body.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Asthenia, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Patient reported she was hospitalized 2 to 3 days after the vaccine. She had a fever, shortness of breath and cough. Patient felt she was fatigue and loss of appetite which led to weight loss. She also experience headache. Patient was put on albuterol nebulizer solution, ipratropium nebulizer solution and cipro 250mg tablet. She was also put on augment and promezathine with codeine followed by the other therapy. Patient said she feels a lot better but still feel weak and she is not sure what happen to her body.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Headache, Pyrexia, Weight decreased
Clinical narrative: Patient reported she was hospitalized 2 to 3 days after the vaccine. She had a fever, shortness of breath and cough. Patient felt she was fatigue and loss of appetite which led to weight loss. She also experience headache. Patient was put on albuterol nebulizer solution, ipratropium nebulizer solution and cipro 250mg tablet. She was also put on augment and promezathine with codeine followed by the other therapy. Patient said she feels a lot better but still feel weak and she is not sure what happen to her body.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Pyrexia
Clinical narrative: Patient reported she was hospitalized 2 to 3 days after the vaccine. She had a fever, shortness of breath and cough. Patient felt she was fatigue and loss of appetite which led to weight loss. She also experience headache. Patient was put on albuterol nebulizer solution, ipratropium nebulizer solution and cipro 250mg tablet. She was also put on augment and promezathine with codeine followed by the other therapy. Patient said she feels a lot better but still feel weak and she is not sure what happen to her body.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Weight decreased
Clinical narrative: Patient reported she was hospitalized 2 to 3 days after the vaccine. She had a fever, shortness of breath and cough. Patient felt she was fatigue and loss of appetite which led to weight loss. She also experience headache. Patient was put on albuterol nebulizer solution, ipratropium nebulizer solution and cipro 250mg tablet. She was also put on augment and promezathine with codeine followed by the other therapy. Patient said she feels a lot better but still feel weak and she is not sure what happen to her body.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 52-year-old male patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and enlargement of lymph nodes. On an unknown date, the outcome of the fever and enlargement of lymph nodes were recovered/resolved. It was unknown if the reporter considered the fever and enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever for three days, and a swollen lymph node under their arm. The duration for swollen lymph node was unknown. The exact time of onset of symptoms was unknown.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bed rest, Blood test, Chest X-ray, Deafness unilateral, Ear discomfort
Clinical narrative: This case was reported by a consumer and described the occurrence of sensorineural hearing loss in a female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On 27th March 2018, 1 days after receiving SHINGRIX, the patient experienced sensorineural hearing loss (serious criteria disability and GSK medically significant). On an unknown date, the patient experienced tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged. On an unknown date, the outcome of the sensorineural hearing loss and tinnitus were unknown and the outcome of the intermittent headache, influenza like illness, vomiting and ear feels clogged were recovered/resolved.  It was unknown if the reporter considered the sensorineural hearing loss, tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient recieved vaccine in the left deltoid. The pateint experienced sudden onset idiopathic hearing loss on right ear side only.  Accompanied by tinnitus,headache, flu symptoms (no fever or vertigo though). The patiet remained in bed, vomiting with flu-like sickness for about 3 days, then, tinnitus, hearing loss, aural fullness and headache for last 6 months. The hearing loss was permanent (in lowest register, about 30 percent).  The tinnitus appeared as permanent and headache was intermittent. The patient did not have concrete evidence that the sudden onset episode was triggered by the vaccination, but it was certainly very coincidental. The patient did not get second vaccine for that reason. The patient had been encouraged to report experience to GSK as the vaccine was so new and reaction also, if it was one, so severe.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza, Lumbar puncture, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: This case was reported by a consumer and described the occurrence of sensorineural hearing loss in a female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On 27th March 2018, 1 days after receiving SHINGRIX, the patient experienced sensorineural hearing loss (serious criteria disability and GSK medically significant). On an unknown date, the patient experienced tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged. On an unknown date, the outcome of the sensorineural hearing loss and tinnitus were unknown and the outcome of the intermittent headache, influenza like illness, vomiting and ear feels clogged were recovered/resolved.  It was unknown if the reporter considered the sensorineural hearing loss, tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient recieved vaccine in the left deltoid. The pateint experienced sudden onset idiopathic hearing loss on right ear side only.  Accompanied by tinnitus,headache, flu symptoms (no fever or vertigo though). The patiet remained in bed, vomiting with flu-like sickness for about 3 days, then, tinnitus, hearing loss, aural fullness and headache for last 6 months. The hearing loss was permanent (in lowest register, about 30 percent).  The tinnitus appeared as permanent and headache was intermittent. The patient did not have concrete evidence that the sudden onset episode was triggered by the vaccination, but it was certainly very coincidental. The patient did not get second vaccine for that reason. The patient had been encouraged to report experience to GSK as the vaccine was so new and reaction also, if it was one, so severe.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of sensorineural hearing loss in a female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On 27th March 2018, 1 days after receiving SHINGRIX, the patient experienced sensorineural hearing loss (serious criteria disability and GSK medically significant). On an unknown date, the patient experienced tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged. On an unknown date, the outcome of the sensorineural hearing loss and tinnitus were unknown and the outcome of the intermittent headache, influenza like illness, vomiting and ear feels clogged were recovered/resolved.  It was unknown if the reporter considered the sensorineural hearing loss, tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient recieved vaccine in the left deltoid. The pateint experienced sudden onset idiopathic hearing loss on right ear side only.  Accompanied by tinnitus,headache, flu symptoms (no fever or vertigo though). The patiet remained in bed, vomiting with flu-like sickness for about 3 days, then, tinnitus, hearing loss, aural fullness and headache for last 6 months. The hearing loss was permanent (in lowest register, about 30 percent).  The tinnitus appeared as permanent and headache was intermittent. The patient did not have concrete evidence that the sudden onset episode was triggered by the vaccination, but it was certainly very coincidental. The patient did not get second vaccine for that reason. The patient had been encouraged to report experience to GSK as the vaccine was so new and reaction also, if it was one, so severe.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Ear discomfort, Headache, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer and described the occurrence of sensorineural hearing loss in a female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On 27th March 2018, 1 days after receiving SHINGRIX, the patient experienced sensorineural hearing loss (serious criteria disability and GSK medically significant). On an unknown date, the patient experienced tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged. On an unknown date, the outcome of the sensorineural hearing loss and tinnitus were unknown and the outcome of the intermittent headache, influenza like illness, vomiting and ear feels clogged were recovered/resolved.  It was unknown if the reporter considered the sensorineural hearing loss, tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient recieved vaccine in the left deltoid. The pateint experienced sudden onset idiopathic hearing loss on right ear side only.  Accompanied by tinnitus,headache, flu symptoms (no fever or vertigo though). The patiet remained in bed, vomiting with flu-like sickness for about 3 days, then, tinnitus, hearing loss, aural fullness and headache for last 6 months. The hearing loss was permanent (in lowest register, about 30 percent).  The tinnitus appeared as permanent and headache was intermittent. The patient did not have concrete evidence that the sudden onset episode was triggered by the vaccination, but it was certainly very coincidental. The patient did not get second vaccine for that reason. The patient had been encouraged to report experience to GSK as the vaccine was so new and reaction also, if it was one, so severe.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Tinnitus, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of sensorineural hearing loss in a female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On 27th March 2018, 1 days after receiving SHINGRIX, the patient experienced sensorineural hearing loss (serious criteria disability and GSK medically significant). On an unknown date, the patient experienced tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged. On an unknown date, the outcome of the sensorineural hearing loss and tinnitus were unknown and the outcome of the intermittent headache, influenza like illness, vomiting and ear feels clogged were recovered/resolved.  It was unknown if the reporter considered the sensorineural hearing loss, tinnitus, intermittent headache, influenza like illness, vomiting and ear feels clogged to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient recieved vaccine in the left deltoid. The pateint experienced sudden onset idiopathic hearing loss on right ear side only.  Accompanied by tinnitus,headache, flu symptoms (no fever or vertigo though). The patiet remained in bed, vomiting with flu-like sickness for about 3 days, then, tinnitus, hearing loss, aural fullness and headache for last 6 months. The hearing loss was permanent (in lowest register, about 30 percent).  The tinnitus appeared as permanent and headache was intermittent. The patient did not have concrete evidence that the sudden onset episode was triggered by the vaccination, but it was certainly very coincidental. The patient did not get second vaccine for that reason. The patient had been encouraged to report experience to GSK as the vaccine was so new and reaction also, if it was one, so severe.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Full Body Hives.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Nuclear magnetic resonance imaging brain, Post herpetic neuralgia
Clinical narrative: DEVELOPED PHN (POST HERPETIC NEURALGIA) SECONDARY TO SHINGLES INFECTION IN SCALP. NO RASH OR BLISTERS. PAIN IS ON LEFT SIDE OF HEAD (PARIETAL OCCIPITAL AREA.)
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Post herpetic neuralgia
Clinical narrative: DEVELOPED PHN (POST HERPETIC NEURALGIA) SECONDARY TO SHINGLES INFECTION IN SCALP. NO RASH OR BLISTERS. PAIN IS ON LEFT SIDE OF HEAD (PARIETAL OCCIPITAL AREA.)
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: DEVELOPED PHN (POST HERPETIC NEURALGIA) SECONDARY TO SHINGLES INFECTION IN SCALP. NO RASH OR BLISTERS. PAIN IS ON LEFT SIDE OF HEAD (PARIETAL OCCIPITAL AREA.)
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Erythema, Hyperhidrosis, Liver function test, Pain
Clinical narrative: Shaking, throwing up, chills, aches, pains, fever 102, sweating. I gained 11 lbs in 4 days went to urgent care Dr gave me prednisone 20 mg to remove weight gain which I lost 7 lbs overnight. I got rest and felt better after 7 days and arm was red and swollen for 6 days.
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Peripheral swelling, Pyrexia, Tremor, Urine analysis, Weight increased
Clinical narrative: Shaking, throwing up, chills, aches, pains, fever 102, sweating. I gained 11 lbs in 4 days went to urgent care Dr gave me prednisone 20 mg to remove weight gain which I lost 7 lbs overnight. I got rest and felt better after 7 days and arm was red and swollen for 6 days.