chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Injection site pain, Loss of consciousness, Pallor
Clinical narrative: After administering the final vaccine (given in the order of: MENACTRA, Tdap, HPV), patient noted that the HPV one hurt a little bit more. He then noted he was lightheaded and started to lean forward on the chair he had been sitting on, and fell to the ground. PHN then dialed 911 and patient woke up briefly after (total time unconscious approx. 15-20 seconds). PHN gave patient water and had him remain sitting on the floor and took vital signs: BP was 106/80, HR 100. He was observed for 25 minutes and regained his color as he had been pale. Mother declined emergency services. PHN educated on what signs and symptoms to observe for post syncope.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at injection site noticed a couple days after done, BENADRYL, with cold compresses, could also take naproxen to help with the inflammation and pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain
Clinical narrative: 3.5 inches wide by 4.5 long- redness, pain, hard and painful. Lasted 10 days. Treated with ice and Ibuprofen.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis
Clinical narrative: Myopericarditis.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 49.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Vaccine Hep B was ordered and in error vaccine HIB was given.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever (101.5), body aches, headache, painful injection site w/ 5 inch circle of swelling. Symptoms decreased after 48 hours and gone at 72 hours.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Pallor, Syncope
Clinical narrative: After administration of Tdap vaccine, patient experienced a vasovagal syncopal episode. Patient fell from table to floor and hit the left side of her head. Patient was picked up and was placed flat on floor until conscious and then once conscious placed her in the chair. She gained consciousness within 1-2sec. Vital signs were assessed and were normal. Patient's color returned from pale to pink within 5 minutes. Patient was offered juice and crackers. She had not eaten all day. Nurse practitioner came in to assess patient and patient was responsive and talking with provider. Patient's color was pink and vital signs were repeated and patient was discharged home awake, alert, and oriented x3 into mom's care. Mom was called later to verify child's status and stated child was awake, alert, and drinking fluids.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Myalgia, Nausea
Clinical narrative: Fever, nausea, headache, muscle aches (all over), a very sore and red upper arm at the injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, nausea, headache, muscle aches (all over), a very sore and red upper arm at the injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, nausea, headache, muscle aches (all over), a very sore and red upper arm at the injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Peripheral swelling
Clinical narrative: Patient had swelling in the upper arm. Looks like the vaccine was administered subcutaneously.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Severe headache lasting hours, sustained fever over 101F lasting 24 hours, nausea lasting 24 hours, malaise lasting 24 hours, sore arm lasting 3 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Influenza like illness, Pain
Clinical narrative: Patient reported fever with temperature above 101 F along with flu like symptoms. Patient had a really bad shiver on Friday night. She was in pain, weak, and loss appetite for the whole day. She took ADVIL to relieve pain and fever. She gradually back to normal today.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported fever with temperature above 101 F along with flu like symptoms. Patient had a really bad shiver on Friday night. She was in pain, weak, and loss appetite for the whole day. She took ADVIL to relieve pain and fever. She gradually back to normal today.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Burning sensation, Headache, Muscular weakness, Nausea
Clinical narrative: Left arm pain, headache, lower back pain, nausea, burning both legs and arms, muscle weakness both legs and arms.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Urine analysis
Clinical narrative: Left arm pain, headache, lower back pain, nausea, burning both legs and arms, muscle weakness both legs and arms.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Decreased appetite, Dizziness, Malaise, Nausea
Clinical narrative: Developed nausea, vomiting, abdominal pain, dizziness, fever 101.2 to 102F, generalized bodice, left arm. Every day nausea, generally not feeling well with decreased appetite. Side effect of nausea, vomiting, fever, abdominal pain started after about approximately 16 hour after vaccine injection. Left arm pain soon after injection.Continue to have nausea daily and low grade fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Developed nausea, vomiting, abdominal pain, dizziness, fever 101.2 to 102F, generalized bodice, left arm. Every day nausea, generally not feeling well with decreased appetite. Side effect of nausea, vomiting, fever, abdominal pain started after about approximately 16 hour after vaccine injection. Left arm pain soon after injection.Continue to have nausea daily and low grade fever.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Cerebral infarction, Cerebrovascular accident, Headache, Hemiparesis, Influenza virus test negative
Clinical narrative: Child had 5-7 days of high fever starting on 7/4/18. Seen on 7/9/18 and was strep negative, flu negative, monospot negative. Improved. Had well check by me on 7/13/18 and was fever free with completely normal vital signs. We administered MENVEO number 2 and BEXSERO number 1. On 7/14/18, he developed headache. On 7/16/18, he developed right sided weakness, and was subsequently diagnosed with "stroke" due to thrombosis of the saggital sinus.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Mononucleosis heterophile test negative, Nuclear magnetic resonance imaging brain abnormal, Streptococcus test negative, Superior sagittal sinus thrombosis, Venogram abnormal
Clinical narrative: Child had 5-7 days of high fever starting on 7/4/18. Seen on 7/9/18 and was strep negative, flu negative, monospot negative. Improved. Had well check by me on 7/13/18 and was fever free with completely normal vital signs. We administered MENVEO number 2 and BEXSERO number 1. On 7/14/18, he developed headache. On 7/16/18, he developed right sided weakness, and was subsequently diagnosed with "stroke" due to thrombosis of the saggital sinus.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chapped lips, Erythema, Lip dry, Pain, Pruritus
Clinical narrative: Dry chapped lips which then progressed to swelling, itching, redness and pain. Patient describes it like when your lips are sunburned.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Dry chapped lips which then progressed to swelling, itching, redness and pain. Patient describes it like when your lips are sunburned.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Axillary pain, Back pain, Blepharospasm, Burning sensation
Clinical narrative: Hot burning feet, arms jerking, eyelid twitching. Sharp pain on head, arms, chest, abdomen, feet, toes, hands, fingers, rectum, testicles, face, back, both body sides, under armpits. Vibrating and twitching around whole body as well. Right elbow muscle did tighten up too. Right leg went to sleep and hard to raise up.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Dyskinesia, Facial pain, Feeling hot, Headache
Clinical narrative: Hot burning feet, arms jerking, eyelid twitching. Sharp pain on head, arms, chest, abdomen, feet, toes, hands, fingers, rectum, testicles, face, back, both body sides, under armpits. Vibrating and twitching around whole body as well. Right elbow muscle did tighten up too. Right leg went to sleep and hard to raise up.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Muscle tightness, Muscle twitching, Pain in extremity
Clinical narrative: Hot burning feet, arms jerking, eyelid twitching. Sharp pain on head, arms, chest, abdomen, feet, toes, hands, fingers, rectum, testicles, face, back, both body sides, under armpits. Vibrating and twitching around whole body as well. Right elbow muscle did tighten up too. Right leg went to sleep and hard to raise up.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Proctalgia, Testicular pain, Vibratory sense increased
Clinical narrative: Hot burning feet, arms jerking, eyelid twitching. Sharp pain on head, arms, chest, abdomen, feet, toes, hands, fingers, rectum, testicles, face, back, both body sides, under armpits. Vibrating and twitching around whole body as well. Right elbow muscle did tighten up too. Right leg went to sleep and hard to raise up.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Ileocolectomy, Intussusception, Laboratory test abnormal
Clinical narrative: Patient developed intussusception symptoms 7/17/18. Diagnosed on 7/20/18 at one location; transferred to MC another location; she required ileocecectomy-still currently hospitalized.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Feeling hot, Flushing, Malaise
Clinical narrative: Hives on (R) arm (same side as vaccine) within 10 min; felt hot, flushed, weak; "palpitations", HR 90, BP 122/72, O2 sat 99; lungs CTA; 25 mg BENADRYL p.o.; symptoms resolved within 30 min; d/c'ed in stable condition. Fever, chills during night, not feeling well.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Palpitations, Pyrexia, Urticaria
Clinical narrative: Hives on (R) arm (same side as vaccine) within 10 min; felt hot, flushed, weak; "palpitations", HR 90, BP 122/72, O2 sat 99; lungs CTA; 25 mg BENADRYL p.o.; symptoms resolved within 30 min; d/c'ed in stable condition. Fever, chills during night, not feeling well.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Pruritus, Rash, Skin irritation
Clinical narrative: Rash on left arm-starting at injection site and going down entire arm. Itching and irritation noted.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Pruritus generalised, Rash, Rash pruritic
Clinical narrative: Patient came back to clinic 10:36 am after a meal outside the clinic and c/o generalized itching. The patient had some rash in her right cheek and lateral left thigh where she was scratching. There was no rash and itching at the injection site on both arms noted. Patient denied any difficulty breathing. MD was informed and an order was carried out of BENADRYL 25 mg. IM. given at 10:36am to left deltoid. Patient observed until 11:30am. Patient's mother advised that patient is going to be drowsy and not to be allow to drive or operate machinery and advised to obtain OTC diphenhydramine 12.5 mg p.o. tid x 2 days and 0.5% hydrocortisone cream to the affected skin TID. Mother of patient said that patient already has an existing topical medication for rash because she has eczema. List of ED, Pediatricians, and clinics given to patient. Advised patient to report to ED if symptoms worsen. And given an appointment for patient to RTC 07/26/2018 for reassessment of symptoms.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Rash
Clinical narrative: Developed fevers to 102 about 5 hours following vaccine administration. Had not been ill before, had no other signs of illness. Had fever day of vaccination and for 2 more days, then no more fever. Was completely well for more than one day. Next day (more than 1 day after fever had resolved and 4 days after vaccination) he developed trunk rash with no other signs of illness.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, itchy, 3 inches long, 1 1/2 - 2 in below injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: Generalized urticaria - 4 days after immunization w\Tdap, MENACTRA, GARDASIL 9.
Age: 4.0
Sex: M
Vaccine: MMRV, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Pt received MENACTRA Vaccine instead of KINRIX vaccine. 7/23/18 4:22pm manufacturer notified.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Patient fainted - was advised to stay in she still went outside - fell - got him to stay with knees between his arms - happened few minutes after shot was administered - only lasted few minutes.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: A lot of pain put in and still a lot of pain.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, X-ray
Clinical narrative: A lot of pain put in and still a lot of pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular, Vomiting
Clinical narrative: Patient showed me pictures of a large, blistery rash that appeared on her arm. It has now spread to her scalp. She went to the doctor and they diagnosed her with a case of Shingles. She said about 3 days after the vaccine she experienced vomiting as well.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Eye swelling, Facial pain, Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 25-JUL-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician office by her primary care physician for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed burning, redness, pain, and swelling accompanied by a rash above her left eyebrow and along her forehead. In response to these complaints, on 30-JUL-2016, the patient returned to her primary care physician and was diagnosed as suffering from shingles. Shortly thereafter, the patient developed left eye swelling and reduced vision and presented to the emergency room of a hospital. The patient was diagnosed with shingles surrounding her left eye and along her forehead, which resulted in significant facial scarring and nerve damage. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, including significant facial scarring and nerve damage, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient(s) sustained severe and permanent personal injuries. Further, the patient(s) suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, the event of Developed left eye swelling and reduced vision / diagnosed with shingles surrounding her left eye and along her forehead was determined to be medically significant. The events of Developed left eye swelling and reduced vision / diagnosed with shingles surrounding her left eye and along her forehead, Persistent strain of Herpes zoster/shingles, reduced vision, significant facial scarring, and nerve damage were considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury, Ophthalmic herpes zoster, Rash, Scar, Swelling face
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 25-JUL-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician office by her primary care physician for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed burning, redness, pain, and swelling accompanied by a rash above her left eyebrow and along her forehead. In response to these complaints, on 30-JUL-2016, the patient returned to her primary care physician and was diagnosed as suffering from shingles. Shortly thereafter, the patient developed left eye swelling and reduced vision and presented to the emergency room of a hospital. The patient was diagnosed with shingles surrounding her left eye and along her forehead, which resulted in significant facial scarring and nerve damage. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, including significant facial scarring and nerve damage, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient(s) sustained severe and permanent personal injuries. Further, the patient(s) suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, the event of Developed left eye swelling and reduced vision / diagnosed with shingles surrounding her left eye and along her forehead was determined to be medically significant. The events of Developed left eye swelling and reduced vision / diagnosed with shingles surrounding her left eye and along her forehead, Persistent strain of Herpes zoster/shingles, reduced vision, significant facial scarring, and nerve damage were considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 25-JUL-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician office by her primary care physician for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed burning, redness, pain, and swelling accompanied by a rash above her left eyebrow and along her forehead. In response to these complaints, on 30-JUL-2016, the patient returned to her primary care physician and was diagnosed as suffering from shingles. Shortly thereafter, the patient developed left eye swelling and reduced vision and presented to the emergency room of a hospital. The patient was diagnosed with shingles surrounding her left eye and along her forehead, which resulted in significant facial scarring and nerve damage. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, including significant facial scarring and nerve damage, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient(s) sustained severe and permanent personal injuries. Further, the patient(s) suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, the event of Developed left eye swelling and reduced vision / diagnosed with shingles surrounding her left eye and along her forehead was determined to be medically significant. The events of Developed left eye swelling and reduced vision / diagnosed with shingles surrounding her left eye and along her forehead, Persistent strain of Herpes zoster/shingles, reduced vision, significant facial scarring, and nerve damage were considered disabling. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP
Symptoms: Vaccination complication
Clinical narrative: Intermittent ocular flutter with flutter dysmetria (induced with saccadic movements); overshoot on attempted side gaze fixation and spontaneous micro-flutter like movement in primary gaze.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP
Symptoms: Computerised tomogram abdomen normal, Computerised tomogram head normal, Computerised tomogram pelvis, Electroencephalogram normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Intermittent ocular flutter with flutter dysmetria (induced with saccadic movements); overshoot on attempted side gaze fixation and spontaneous micro-flutter like movement in primary gaze.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP
Symptoms: Ocular dysmetria, Saccadic eye movement, Scan with contrast normal, Urine analysis normal
Clinical narrative: Intermittent ocular flutter with flutter dysmetria (induced with saccadic movements); overshoot on attempted side gaze fixation and spontaneous micro-flutter like movement in primary gaze.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 37-year-old female patient, who refers on herself. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. The patient became pregnant with last menstrual period (LMP) of 23-OCT-2017, calculated based on gestational age of 35 weeks (information reported on 25-JUN-2018). The date of conception was calculated as 06-NOV-2017 and date of delivery was estimated as 30-JUL-2018. On 21-JUN-2018, the patient was supposed to be vaccinated against diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid and was accidentally vaccinated with GARDASIL 9 one dose 0.5 ml, into shoulder area (lot# and expiration date not reported) for prophylaxis. No stress test, ultrasound and urinalysis were performed. On 21-JUN-2018, the patient was excessively tired. The patient sought medical attention by physician obstetrician-gynecologist. Treatment was given for reported adverse event. Therapy was reported to be discontinued. The outcome of fatigue was reported as not recovered/not resolved. The pregnancy outcome was outcome pending and the fetal outcome was unknown. The relatedness between the fatigue and GARDASIL 9 was unknown.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Fatigue, Ultrasound scan, Urine analysis, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a 37-year-old female patient, who refers on herself. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. The patient became pregnant with last menstrual period (LMP) of 23-OCT-2017, calculated based on gestational age of 35 weeks (information reported on 25-JUN-2018). The date of conception was calculated as 06-NOV-2017 and date of delivery was estimated as 30-JUL-2018. On 21-JUN-2018, the patient was supposed to be vaccinated against diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid and was accidentally vaccinated with GARDASIL 9 one dose 0.5 ml, into shoulder area (lot# and expiration date not reported) for prophylaxis. No stress test, ultrasound and urinalysis were performed. On 21-JUN-2018, the patient was excessively tired. The patient sought medical attention by physician obstetrician-gynecologist. Treatment was given for reported adverse event. Therapy was reported to be discontinued. The outcome of fatigue was reported as not recovered/not resolved. The pregnancy outcome was outcome pending and the fetal outcome was unknown. The relatedness between the fatigue and GARDASIL 9 was unknown.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 66-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included chickenpox (at 7 years of age). Previously administered products included ZOSTAVAX (at 60 years of age). Concurrent medical conditions included fruit allergy (Sensitive to honeydew melon). On 5th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th July 2018, 3 days after receiving SHINGRIX, the patient experienced allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash. The patient was treated with Cortisone. On an unknown date, the outcome of the allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash were unknown. It was unknown if the reporter considered the allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. Three days later she started to break out in spots that looked like a pimple trying to emerge with a fluid-filled bubble on top. They were very itchy and were on both arms and legs. On Sunday, 8th July 2018, she went to a walk-in clinic and was told that the presentation was consistent with chickenpox because the breakouts were in pairs. She stayed home from work on Monday, 9th July 2018, and went to see her family physician. This physician told her that it was not chickenpox but rather an allergic reaction and gave her a cortisone shot. She had continued to work since but reports that the spots were still there and they have become inflamed, red, and looking like they were going to leave a scar. One in particular on her right calf was bright red, an inch by 1 by 2 inch, with irregular borders, that had opened up and looks like it was going to scar, too. There were other spots that had opened up. The itching for most of the spots resolved this past Monday, 9th July 2018. However she had a new spot appear yesterday on her left leg and it was very itchy. The ones on her left and right wrists had turned into oval shapes.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Inflammation, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 66-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included chickenpox (at 7 years of age). Previously administered products included ZOSTAVAX (at 60 years of age). Concurrent medical conditions included fruit allergy (Sensitive to honeydew melon). On 5th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th July 2018, 3 days after receiving SHINGRIX, the patient experienced allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash. The patient was treated with Cortisone. On an unknown date, the outcome of the allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash were unknown. It was unknown if the reporter considered the allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. Three days later she started to break out in spots that looked like a pimple trying to emerge with a fluid-filled bubble on top. They were very itchy and were on both arms and legs. On Sunday, 8th July 2018, she went to a walk-in clinic and was told that the presentation was consistent with chickenpox because the breakouts were in pairs. She stayed home from work on Monday, 9th July 2018, and went to see her family physician. This physician told her that it was not chickenpox but rather an allergic reaction and gave her a cortisone shot. She had continued to work since but reports that the spots were still there and they have become inflamed, red, and looking like they were going to leave a scar. One in particular on her right calf was bright red, an inch by 1 by 2 inch, with irregular borders, that had opened up and looks like it was going to scar, too. There were other spots that had opened up. The itching for most of the spots resolved this past Monday, 9th July 2018. However she had a new spot appear yesterday on her left leg and it was very itchy. The ones on her left and right wrists had turned into oval shapes.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 66-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included chickenpox (at 7 years of age). Previously administered products included ZOSTAVAX (at 60 years of age). Concurrent medical conditions included fruit allergy (Sensitive to honeydew melon). On 5th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th July 2018, 3 days after receiving SHINGRIX, the patient experienced allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash. The patient was treated with Cortisone. On an unknown date, the outcome of the allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash were unknown. It was unknown if the reporter considered the allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. Three days later she started to break out in spots that looked like a pimple trying to emerge with a fluid-filled bubble on top. They were very itchy and were on both arms and legs. On Sunday, 8th July 2018, she went to a walk-in clinic and was told that the presentation was consistent with chickenpox because the breakouts were in pairs. She stayed home from work on Monday, 9th July 2018, and went to see her family physician. This physician told her that it was not chickenpox but rather an allergic reaction and gave her a cortisone shot. She had continued to work since but reports that the spots were still there and they have become inflamed, red, and looking like they were going to leave a scar. One in particular on her right calf was bright red, an inch by 1 by 2 inch, with irregular borders, that had opened up and looks like it was going to scar, too. There were other spots that had opened up. The itching for most of the spots resolved this past Monday, 9th July 2018. However she had a new spot appear yesterday on her left leg and it was very itchy. The ones on her left and right wrists had turned into oval shapes.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash papular, Varicella
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 66-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included chickenpox (at 7 years of age). Previously administered products included ZOSTAVAX (at 60 years of age). Concurrent medical conditions included fruit allergy (Sensitive to honeydew melon). On 5th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th July 2018, 3 days after receiving SHINGRIX, the patient experienced allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash. The patient was treated with Cortisone. On an unknown date, the outcome of the allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash were unknown. It was unknown if the reporter considered the allergic reaction, inflammation localized, papulovesicular rash, itchy rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. Three days later she started to break out in spots that looked like a pimple trying to emerge with a fluid-filled bubble on top. They were very itchy and were on both arms and legs. On Sunday, 8th July 2018, she went to a walk-in clinic and was told that the presentation was consistent with chickenpox because the breakouts were in pairs. She stayed home from work on Monday, 9th July 2018, and went to see her family physician. This physician told her that it was not chickenpox but rather an allergic reaction and gave her a cortisone shot. She had continued to work since but reports that the spots were still there and they have become inflamed, red, and looking like they were going to leave a scar. One in particular on her right calf was bright red, an inch by 1 by 2 inch, with irregular borders, that had opened up and looks like it was going to scar, too. There were other spots that had opened up. The itching for most of the spots resolved this past Monday, 9th July 2018. However she had a new spot appear yesterday on her left leg and it was very itchy. The ones on her left and right wrists had turned into oval shapes.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Discoloured vomit, Dysstasia, Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected flu in a 81-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th July 2018, 3 hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and several hours after receiving SHINGRIX, the patient experienced flu, nausea, vomiting, shivering and vertigo. On 10th July 2018, 1 day after receiving SHINGRIX, the patient experienced exhaustion, appetite lost, muscle weakness, black stools, sore throat and throat irritation. On an unknown date, the outcome of the flu, injection site erythema, injection site pain, sore throat and throat irritation were not recovered/not resolved and the outcome of the nausea, appetite lost and black stools were recovering/resolving and the outcome of the vomiting, shivering, vertigo, exhaustion and muscle weakness were recovered/resolved. It was unknown if the reporter considered the influenza and throat irritation to be related to SHINGRIX. The reporter considered the injection site erythema, injection site pain, nausea, vomiting, shivering, vertigo, exhaustion, appetite lost, muscle weakness, black stools and sore throat to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm (the batch number was reported as 29RR4, which was corrected to Z9RR4 as per sales data sheet). The patient stated that 3 hours later she experienced redness and soreness at the injection site. The patient also experienced nausea, vomiting, shivering and vertigo later that evening. The next morning (10th July 2018) she woke up and felt very exhausted and could not eat due to nausea and loss of appetite. The day before reporting (10th July 2018), she experienced muscle weakness and noticed that her stools were black. On 10th July 2018 (last night of the reporting date), she noticed that her throat was sore and raspy and it felt "froggy" and she had to keep clearing her throat. The patient stated that she called her doctor to report her symptoms and her doctor did not think it was related to the vaccine and informed her that she must have the flu or something. The patient however, believes that the symptoms were related to the vaccine and states that she felt fine prior to receiving the vaccine.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Nausea, Somnolence, Tremor, Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected flu in a 81-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th July 2018, 3 hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and several hours after receiving SHINGRIX, the patient experienced flu, nausea, vomiting, shivering and vertigo. On 10th July 2018, 1 day after receiving SHINGRIX, the patient experienced exhaustion, appetite lost, muscle weakness, black stools, sore throat and throat irritation. On an unknown date, the outcome of the flu, injection site erythema, injection site pain, sore throat and throat irritation were not recovered/not resolved and the outcome of the nausea, appetite lost and black stools were recovering/resolving and the outcome of the vomiting, shivering, vertigo, exhaustion and muscle weakness were recovered/resolved. It was unknown if the reporter considered the influenza and throat irritation to be related to SHINGRIX. The reporter considered the injection site erythema, injection site pain, nausea, vomiting, shivering, vertigo, exhaustion, appetite lost, muscle weakness, black stools and sore throat to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm (the batch number was reported as 29RR4, which was corrected to Z9RR4 as per sales data sheet). The patient stated that 3 hours later she experienced redness and soreness at the injection site. The patient also experienced nausea, vomiting, shivering and vertigo later that evening. The next morning (10th July 2018) she woke up and felt very exhausted and could not eat due to nausea and loss of appetite. The day before reporting (10th July 2018), she experienced muscle weakness and noticed that her stools were black. On 10th July 2018 (last night of the reporting date), she noticed that her throat was sore and raspy and it felt "froggy" and she had to keep clearing her throat. The patient stated that she called her doctor to report her symptoms and her doctor did not think it was related to the vaccine and informed her that she must have the flu or something. The patient however, believes that the symptoms were related to the vaccine and states that she felt fine prior to receiving the vaccine.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Faeces discoloured, Fatigue, Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected flu in a 81-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th July 2018, 3 hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and several hours after receiving SHINGRIX, the patient experienced flu, nausea, vomiting, shivering and vertigo. On 10th July 2018, 1 day after receiving SHINGRIX, the patient experienced exhaustion, appetite lost, muscle weakness, black stools, sore throat and throat irritation. On an unknown date, the outcome of the flu, injection site erythema, injection site pain, sore throat and throat irritation were not recovered/not resolved and the outcome of the nausea, appetite lost and black stools were recovering/resolving and the outcome of the vomiting, shivering, vertigo, exhaustion and muscle weakness were recovered/resolved. It was unknown if the reporter considered the influenza and throat irritation to be related to SHINGRIX. The reporter considered the injection site erythema, injection site pain, nausea, vomiting, shivering, vertigo, exhaustion, appetite lost, muscle weakness, black stools and sore throat to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm (the batch number was reported as 29RR4, which was corrected to Z9RR4 as per sales data sheet). The patient stated that 3 hours later she experienced redness and soreness at the injection site. The patient also experienced nausea, vomiting, shivering and vertigo later that evening. The next morning (10th July 2018) she woke up and felt very exhausted and could not eat due to nausea and loss of appetite. The day before reporting (10th July 2018), she experienced muscle weakness and noticed that her stools were black. On 10th July 2018 (last night of the reporting date), she noticed that her throat was sore and raspy and it felt "froggy" and she had to keep clearing her throat. The patient stated that she called her doctor to report her symptoms and her doctor did not think it was related to the vaccine and informed her that she must have the flu or something. The patient however, believes that the symptoms were related to the vaccine and states that she felt fine prior to receiving the vaccine.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Muscular weakness, Nausea, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected flu in a 81-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th July 2018, 3 hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and several hours after receiving SHINGRIX, the patient experienced flu, nausea, vomiting, shivering and vertigo. On 10th July 2018, 1 day after receiving SHINGRIX, the patient experienced exhaustion, appetite lost, muscle weakness, black stools, sore throat and throat irritation. On an unknown date, the outcome of the flu, injection site erythema, injection site pain, sore throat and throat irritation were not recovered/not resolved and the outcome of the nausea, appetite lost and black stools were recovering/resolving and the outcome of the vomiting, shivering, vertigo, exhaustion and muscle weakness were recovered/resolved. It was unknown if the reporter considered the influenza and throat irritation to be related to SHINGRIX. The reporter considered the injection site erythema, injection site pain, nausea, vomiting, shivering, vertigo, exhaustion, appetite lost, muscle weakness, black stools and sore throat to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm (the batch number was reported as 29RR4, which was corrected to Z9RR4 as per sales data sheet). The patient stated that 3 hours later she experienced redness and soreness at the injection site. The patient also experienced nausea, vomiting, shivering and vertigo later that evening. The next morning (10th July 2018) she woke up and felt very exhausted and could not eat due to nausea and loss of appetite. The day before reporting (10th July 2018), she experienced muscle weakness and noticed that her stools were black. On 10th July 2018 (last night of the reporting date), she noticed that her throat was sore and raspy and it felt "froggy" and she had to keep clearing her throat. The patient stated that she called her doctor to report her symptoms and her doctor did not think it was related to the vaccine and informed her that she must have the flu or something. The patient however, believes that the symptoms were related to the vaccine and states that she felt fine prior to receiving the vaccine.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Throat irritation, Vertigo, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected flu in a 81-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th July 2018, 3 hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and several hours after receiving SHINGRIX, the patient experienced flu, nausea, vomiting, shivering and vertigo. On 10th July 2018, 1 day after receiving SHINGRIX, the patient experienced exhaustion, appetite lost, muscle weakness, black stools, sore throat and throat irritation. On an unknown date, the outcome of the flu, injection site erythema, injection site pain, sore throat and throat irritation were not recovered/not resolved and the outcome of the nausea, appetite lost and black stools were recovering/resolving and the outcome of the vomiting, shivering, vertigo, exhaustion and muscle weakness were recovered/resolved. It was unknown if the reporter considered the influenza and throat irritation to be related to SHINGRIX. The reporter considered the injection site erythema, injection site pain, nausea, vomiting, shivering, vertigo, exhaustion, appetite lost, muscle weakness, black stools and sore throat to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm (the batch number was reported as 29RR4, which was corrected to Z9RR4 as per sales data sheet). The patient stated that 3 hours later she experienced redness and soreness at the injection site. The patient also experienced nausea, vomiting, shivering and vertigo later that evening. The next morning (10th July 2018) she woke up and felt very exhausted and could not eat due to nausea and loss of appetite. The day before reporting (10th July 2018), she experienced muscle weakness and noticed that her stools were black. On 10th July 2018 (last night of the reporting date), she noticed that her throat was sore and raspy and it felt "froggy" and she had to keep clearing her throat. The patient stated that she called her doctor to report her symptoms and her doctor did not think it was related to the vaccine and informed her that she must have the flu or something. The patient however, believes that the symptoms were related to the vaccine and states that she felt fine prior to receiving the vaccine.