chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Paraesthesia, Pruritus, Throat tightness
Clinical narrative: Due to prior reaction (itchiness, rash) to another formulation of Hep B vaccine, client went to HCP after HEPLISAV was given and took a medication (unknown) to try to prevent reaction. Client stated that at 11:00 am on 6/6/18 (25h after vaccine admin), she started experiencing flushing, hotness, sweatiness, itchiness, and mild airway constriction. Antihistamines decreased these symptoms and she has only been experiencing a "needles and pins" feeling (through 6/7/18 - ongoing). Injection site remains warm and red (about a 40mm circle) today (53 hours after vaccine admin). Client will visit HCP today for exam and recommendations, as our Health Clinic cannot provide this intervention.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Flushing, Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Due to prior reaction (itchiness, rash) to another formulation of Hep B vaccine, client went to HCP after HEPLISAV was given and took a medication (unknown) to try to prevent reaction. Client stated that at 11:00 am on 6/6/18 (25h after vaccine admin), she started experiencing flushing, hotness, sweatiness, itchiness, and mild airway constriction. Antihistamines decreased these symptoms and she has only been experiencing a "needles and pins" feeling (through 6/7/18 - ongoing). Injection site remains warm and red (about a 40mm circle) today (53 hours after vaccine admin). Client will visit HCP today for exam and recommendations, as our Health Clinic cannot provide this intervention.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site warmth, Paraesthesia, Pruritus generalised, Somnolence
Clinical narrative: Due to prior reaction (itchiness, rash) to another formulation of Hep B vaccine, client went to HCP after HEPLISAV was given and took a medication (unknown) to try to prevent reaction. Client stated that at 11:00 am on 6/6/18 (25h after vaccine admin), she started experiencing flushing, hotness, sweatiness, itchiness, and mild airway constriction. Antihistamines decreased these symptoms and she has only been experiencing a "needles and pins" feeling (through 6/7/18 - ongoing). Injection site remains warm and red (about a 40mm circle) today (53 hours after vaccine admin). Client will visit HCP today for exam and recommendations, as our Health Clinic cannot provide this intervention.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Inflammation, Influenza like illness, Myalgia
Clinical narrative: Right arm swollen twice size, extremely inflamed and painful. Muscles in body sore. Had chills and fever for 16 hours. Muscles in upper back continue to hurt today one week later. Flu like symptom's.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Right arm swollen twice size, extremely inflamed and painful. Muscles in body sore. Had chills and fever for 16 hours. Muscles in upper back continue to hurt today one week later. Flu like symptom's.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Diarrhoea, Lymphadenopathy, Vomiting
Clinical narrative: Began on evening of 6/2/18 with two hours of vomiting for a total of three times. On Wednesday evening (6/6/18) through Thursday morning (6/7/18) four episodes of tan, foamy diarrhea and enlarged lymph nodes behind both ears.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever (104).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: Per patient on the day he received the vaccine he was preparing dinner about 4-5 hours after receiving it. He experienced a tightness in his throat. He called his daughter who happens to be a pharmacist. She recommended he take BENADRYL. After following her advice, he started to feel better about an hour later.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal behaviour, Delirium, Disorientation, Lymphadenopathy, Pain in extremity
Clinical narrative: The night she received vaccine her legs hurt really bad and her husband said she was acting strange. She slept that night and woke disoriented/delirious with a fever of 102 degrees F. She mentioned that as a child she had a history of becoming delirious with a fever. She did not take anything for fever (but did confirm that we went over analgesics were okay to take if needed). Because of the delirium her husband took her to hospital where she was kept overnight for observation. She also developed a large swollen lymph node in her left armpit (no local reaction at injection site). She stated neurologist did say that her reaction was due to SHINGRIX and advised her not to get the second dose. Injection date 5/11/18, admitted to Hospital 5/12/18, discharged 5/13/18 (fever and symptoms were resolved).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: The night she received vaccine her legs hurt really bad and her husband said she was acting strange. She slept that night and woke disoriented/delirious with a fever of 102 degrees F. She mentioned that as a child she had a history of becoming delirious with a fever. She did not take anything for fever (but did confirm that we went over analgesics were okay to take if needed). Because of the delirium her husband took her to hospital where she was kept overnight for observation. She also developed a large swollen lymph node in her left armpit (no local reaction at injection site). She stated neurologist did say that her reaction was due to SHINGRIX and advised her not to get the second dose. Injection date 5/11/18, admitted to Hospital 5/12/18, discharged 5/13/18 (fever and symptoms were resolved).
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: The vaccine was mixed with a sterile water diluent instead of the diluent provided with the vaccine.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Knee arthroplasty, Walking aid user
Clinical narrative: Patient stated that his right knee hurt within 1 hour of vaccination. The pain was severe enough that he had to use a cane. The pain had subsided by 6am the following day. He has had knee replacement done but this was not the knee that surgery was done on. He is sure this was related to vaccine.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Exposure during pregnancy, Feeling hot, Headache
Clinical narrative: Second pregnancy- uncomplicated, due 8/28/18. Vaccine given at 28 wk routine appointment. Got in 2007 prior to med school and then in late 2014 with first pregnancy (both no reaction). Woke next morning with headache, fever, chills, muscle ache, lightheadedness, mild nausea. TYLENOL 500 mg helped symptoms but needed dosing every 4 hours as symptoms returned. Had to skip work and in bed all day. Took TYLENOL 3AM 6/7. At work morning 6/7 had to leave patient room as lightheaded and felt hot (did eat light breakfast). Sat on  floor, had soda, took a last dose of TYLENOL. Able to finish rest of day- afebrile now still and improved.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Myalgia, Nausea, Pyrexia
Clinical narrative: Second pregnancy- uncomplicated, due 8/28/18. Vaccine given at 28 wk routine appointment. Got in 2007 prior to med school and then in late 2014 with first pregnancy (both no reaction). Woke next morning with headache, fever, chills, muscle ache, lightheadedness, mild nausea. TYLENOL 500 mg helped symptoms but needed dosing every 4 hours as symptoms returned. Had to skip work and in bed all day. Took TYLENOL 3AM 6/7. At work morning 6/7 had to leave patient room as lightheaded and felt hot (did eat light breakfast). Sat on  floor, had soda, took a last dose of TYLENOL. Able to finish rest of day- afebrile now still and improved.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on underside of right forearm.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Cough, Headache, Lethargy, Nasal congestion
Clinical narrative: Symptoms began with what seemed to be a very bad cold that did not go away: cough, sore throat,  congestion, sneezing, stuffy/runny nose, cold sweats/low grade fever, headache, lethargy. By December 2017 myself and ten year old daughter were diagnosed with Pertussis (Whooping Cough)
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pertussis, Pyrexia, Respiratory tract congestion
Clinical narrative: Symptoms began with what seemed to be a very bad cold that did not go away: cough, sore throat,  congestion, sneezing, stuffy/runny nose, cold sweats/low grade fever, headache, lethargy. By December 2017 myself and ten year old daughter were diagnosed with Pertussis (Whooping Cough)
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Symptoms began with what seemed to be a very bad cold that did not go away: cough, sore throat,  congestion, sneezing, stuffy/runny nose, cold sweats/low grade fever, headache, lethargy. By December 2017 myself and ten year old daughter were diagnosed with Pertussis (Whooping Cough)
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was administered Tdap, but was ordered to receive HPV.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: MENVEO vaccine was not mixed with diluent. Patient only received diluent intramuscularly. Contacted patient to return for vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient developed rash, pink, raised, bumpy and painful on left upper arm around injection site 12 hrs. Patient told to use ice and ibuprofen when in for evaluation next day, 6/5/19. Received PNEUMOVAX 23. Spoke with patient 6/7/2018, states swelling and redness reduced, still having some mild pain overall improved.
Age: 74.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site rash, Nausea
Clinical narrative: Rash, bumps at injection site. Nausea. According to patient, reaction persisted for 14 days.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site induration, Pyrexia, Swelling
Clinical narrative: Presents at ER 3d. post vaccines with redness and swelling present "today". Had mild fever "yesterday". Exam: 10 cm area of erythema and induration L. thigh.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Fatigue, Peripheral swelling
Clinical narrative: Pt developed swelling and redness in her left arm after the injection on 6/5/18, felt tired and dizzy yesterday 6/6/18, but now improved. Treatment: monitor for increase swelling, pain, fever or blister. RTC if any concerns. Cool compresses and rest arm. Cephalexin 500mg capsule-1 capsule 3x/day PO x 7 days.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pallor, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh - erythema, swelling mild heat and central pallor - 12.5 cm diameter area.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced symptoms following day (6/6/18) at injection site: swelling, redness, hot to the touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Lt arm: 4 mm bruising, 2.5 mm induration with 1 cm erythematous margins. Warm to touch, tender to touch. No SOB, respiratory S/S.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Psychogenic seizure, Syncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fainting in a adult male patient who received HAVRIX 1440 adult (batch number TB995, expiry date 25th October 2020). On an unknown date, the patient received HAVRIX 1440 adult (intramuscular) 1 ml. On an unknown date, 1 min after receiving HAVRIX 1440 adult, the patient experienced fainting and pseudoseizure. On an unknown date, the outcome of the fainting and pseudoseizure were recovered/resolved. The reporter considered the fainting and pseudoseizure to be unrelated to HAVRIX 1440 adult. Additional details were provided as follows: The age at the vaccination was not reported. The patient received HAVRIX 1440 adult in the left deltoid. The patient fainted 1 minute after getting the vaccination and fainted again 6 hours later. The patient was taken to the emergency room where it was determined that it was not related to the vaccination. Follow up was received by a other health professional on 1st June 2018: The patient had not received any medication which was known to reduce the seizure threshold (example metoclopramide, phenothiazine's and antidepressants). The patient did not have a history of seizures including febrile seizures and epilepsy, movement disorders, head injury, other central nervous system conditions. The event was witnessed. The event was not preceded by an aura and headache. One minute, after receiving vaccination, the patient had loss of consciousness. Less than a day after receiving vaccine the patient experienced urine and fecal incontinence. The patient was not disoriented or drowsy upon regaining consciousness. The patient did not remember the event. There was no evidence that the symptoms might had resulted from withdrawal of alcohol or other psychotropic substances. There were no planned follow-up of the event. The patient was not given any driving restrictions. There was no evidence of a neurological lesion or infection (encephalitis, meningitis) which might had been the cause of the seizure. On an unknown date, the serum electrolytes was normal. It was unknown if loss of consciousness, urine and fecal incontinence was related to HAVRIX 1440 adult.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Anal incontinence, Blood electrolytes normal, Loss of consciousness, Psychogenic seizure, Syncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fainting in a adult male patient who received HAVRIX 1440 adult (batch number TB995, expiry date 25th October 2020). On an unknown date, the patient received HAVRIX 1440 adult (intramuscular) 1 ml. On an unknown date, 1 min after receiving HAVRIX 1440 adult, the patient experienced fainting and pseudoseizure. On an unknown date, the outcome of the fainting and pseudoseizure were recovered/resolved. The reporter considered the fainting and pseudoseizure to be unrelated to HAVRIX 1440 adult. Additional details were provided as follows: The age at the vaccination was not reported. The patient received HAVRIX 1440 adult in the left deltoid. The patient fainted 1 minute after getting the vaccination and fainted again 6 hours later. The patient was taken to the emergency room where it was determined that it was not related to the vaccination. Follow up was received by a other health professional on 1st June 2018: The patient had not received any medication which was known to reduce the seizure threshold (example metoclopramide, phenothiazine's and antidepressants). The patient did not have a history of seizures including febrile seizures and epilepsy, movement disorders, head injury, other central nervous system conditions. The event was witnessed. The event was not preceded by an aura and headache. One minute, after receiving vaccination, the patient had loss of consciousness. Less than a day after receiving vaccine the patient experienced urine and fecal incontinence. The patient was not disoriented or drowsy upon regaining consciousness. The patient did not remember the event. There was no evidence that the symptoms might had resulted from withdrawal of alcohol or other psychotropic substances. There were no planned follow-up of the event. The patient was not given any driving restrictions. There was no evidence of a neurological lesion or infection (encephalitis, meningitis) which might had been the cause of the seizure. On an unknown date, the serum electrolytes was normal. It was unknown if loss of consciousness, urine and fecal incontinence was related to HAVRIX 1440 adult.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Urinary incontinence
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fainting in a adult male patient who received HAVRIX 1440 adult (batch number TB995, expiry date 25th October 2020). On an unknown date, the patient received HAVRIX 1440 adult (intramuscular) 1 ml. On an unknown date, 1 min after receiving HAVRIX 1440 adult, the patient experienced fainting and pseudoseizure. On an unknown date, the outcome of the fainting and pseudoseizure were recovered/resolved. The reporter considered the fainting and pseudoseizure to be unrelated to HAVRIX 1440 adult. Additional details were provided as follows: The age at the vaccination was not reported. The patient received HAVRIX 1440 adult in the left deltoid. The patient fainted 1 minute after getting the vaccination and fainted again 6 hours later. The patient was taken to the emergency room where it was determined that it was not related to the vaccination. Follow up was received by a other health professional on 1st June 2018: The patient had not received any medication which was known to reduce the seizure threshold (example metoclopramide, phenothiazine's and antidepressants). The patient did not have a history of seizures including febrile seizures and epilepsy, movement disorders, head injury, other central nervous system conditions. The event was witnessed. The event was not preceded by an aura and headache. One minute, after receiving vaccination, the patient had loss of consciousness. Less than a day after receiving vaccine the patient experienced urine and fecal incontinence. The patient was not disoriented or drowsy upon regaining consciousness. The patient did not remember the event. There was no evidence that the symptoms might had resulted from withdrawal of alcohol or other psychotropic substances. There were no planned follow-up of the event. The patient was not given any driving restrictions. There was no evidence of a neurological lesion or infection (encephalitis, meningitis) which might had been the cause of the seizure. On an unknown date, the serum electrolytes was normal. It was unknown if loss of consciousness, urine and fecal incontinence was related to HAVRIX 1440 adult.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in March 2018 (reported as 2 months ago), the patient was vaccinated at unspecified Physician office with a first dose of GARDASIL 9 injection, in the left upper arm region, intramuscularly,(dose, lot# and expiration date were not reported) for human papilloma virus (HPV) prevention. The patient felt the injection was painful. On an unknown date in March 2018 (reported as few day after after receiving injection), the patient felt a small pebble under her skin at the injection site. On 08-MAY-2018, the patient returned to the pharmacy and was examined by the pharmacist, who palpated, what felt like a small pebble under the skin at injection site. There was no treatment given for the events. The events did not cause any significant disability or incapacity and they were not life threatening. The patient was not hospitalized. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA004354:
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in March 2018 (reported as 2 months ago), the patient was vaccinated at unspecified Physician office with a first dose of GARDASIL 9 injection, in the left upper arm region, intramuscularly,(dose, lot# and expiration date were not reported) for human papilloma virus (HPV) prevention. The patient felt the injection was painful. On an unknown date in March 2018 (reported as few day after after receiving injection), the patient felt a small pebble under her skin at the injection site. On 08-MAY-2018, the patient returned to the pharmacy and was examined by the pharmacist, who palpated, what felt like a small pebble under the skin at injection site. There was no treatment given for the events. The events did not cause any significant disability or incapacity and they were not life threatening. The patient was not hospitalized. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA004354:
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Immediate post-injection reaction, Injection site rash, Injection site vesicles
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vaccination failure in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and rash. The patient was treated with Lidocaine. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and rash to be related to SHINGRIX. The additional details were provided as follows: The age at vaccination was not reported. The patient did lab test which confirmed that the patient experienced shingles. The patient thought she was in the last stages of shingles, but had a burning sensation at the site of the rash that she had to patient put ice on. The patient was also using lidocaine and cortisone. This case was considered as suspected vaccination failure as it was unknown if the full immunization schedule for SHINGRIX was complete and also the time to onset was unknown. The patient received SHINGRIX dose at her physician's office.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash, Viral test
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vaccination failure in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and rash. The patient was treated with Lidocaine. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and rash to be related to SHINGRIX. The additional details were provided as follows: The age at vaccination was not reported. The patient did lab test which confirmed that the patient experienced shingles. The patient thought she was in the last stages of shingles, but had a burning sensation at the site of the rash that she had to patient put ice on. The patient was also using lidocaine and cortisone. This case was considered as suspected vaccination failure as it was unknown if the full immunization schedule for SHINGRIX was complete and also the time to onset was unknown. The patient received SHINGRIX dose at her physician's office.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash, Injection site vesicles, Rash, Tenderness
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vaccination failure in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and rash. The patient was treated with Lidocaine. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and rash to be related to SHINGRIX. The additional details were provided as follows: The age at vaccination was not reported. The patient did lab test which confirmed that the patient experienced shingles. The patient thought she was in the last stages of shingles, but had a burning sensation at the site of the rash that she had to patient put ice on. The patient was also using lidocaine and cortisone. This case was considered as suspected vaccination failure as it was unknown if the full immunization schedule for SHINGRIX was complete and also the time to onset was unknown. The patient received SHINGRIX dose at her physician's office.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Bone pain, Burning sensation, Herpes zoster, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vaccination failure in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and rash. The patient was treated with Lidocaine. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and rash to be related to SHINGRIX. The additional details were provided as follows: The age at vaccination was not reported. The patient did lab test which confirmed that the patient experienced shingles. The patient thought she was in the last stages of shingles, but had a burning sensation at the site of the rash that she had to patient put ice on. The patient was also using lidocaine and cortisone. This case was considered as suspected vaccination failure as it was unknown if the full immunization schedule for SHINGRIX was complete and also the time to onset was unknown. The patient received SHINGRIX dose at her physician's office.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neck pain, Neuralgia, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vaccination failure in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and rash. The patient was treated with Lidocaine. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and rash to be related to SHINGRIX. The additional details were provided as follows: The age at vaccination was not reported. The patient did lab test which confirmed that the patient experienced shingles. The patient thought she was in the last stages of shingles, but had a burning sensation at the site of the rash that she had to patient put ice on. The patient was also using lidocaine and cortisone. This case was considered as suspected vaccination failure as it was unknown if the full immunization schedule for SHINGRIX was complete and also the time to onset was unknown. The patient received SHINGRIX dose at her physician's office.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Vaccination failure, Varicella virus test positive
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vaccination failure in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and rash. The patient was treated with Lidocaine. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and rash to be related to SHINGRIX. The additional details were provided as follows: The age at vaccination was not reported. The patient did lab test which confirmed that the patient experienced shingles. The patient thought she was in the last stages of shingles, but had a burning sensation at the site of the rash that she had to patient put ice on. The patient was also using lidocaine and cortisone. This case was considered as suspected vaccination failure as it was unknown if the full immunization schedule for SHINGRIX was complete and also the time to onset was unknown. The patient received SHINGRIX dose at her physician's office.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Delirium, Influenza like illness, Injection site irritation, Injection site pain
Clinical narrative: Flu like symptoms (shiver).
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: Flu like symptoms (shiver).
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: Flu like symptoms (shiver).
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dizziness, Feeling hot, Flushing
Clinical narrative: This case was reported by a consumer and described the occurrence of skin reaction in a adult female patient who received SHINGRIX. Concurrent medical conditions included allergy to chemicals (nickel, formaldehyde, and arabiatic acid, patient wondered if she had any of these). On 24th May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, less than a day after receiving SHINGRIX, the patient experienced skin reaction and influenza-like symptoms. On an unknown date, the outcome of the skin reaction was not recovered/not resolved and the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the skin reaction and influenza-like symptoms to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient had worked for a laboratory in 1964 to 1965. The patient's husband and she went to local pharmacy to get SHINGRIX vaccination. The patient's husband had no reaction, but the patient had a bad skin reaction along with flu-like symptoms. The skin reaction was still there after five days, on the date of reporting. The patient already filed a side effects report. The patient feared having the second vaccination because her body was already sensitized.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dizziness, Hot flush, Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of skin reaction in a adult female patient who received SHINGRIX. Concurrent medical conditions included allergy to chemicals (nickel, formaldehyde, and arabiatic acid, patient wondered if she had any of these). On 24th May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, less than a day after receiving SHINGRIX, the patient experienced skin reaction and influenza-like symptoms. On an unknown date, the outcome of the skin reaction was not recovered/not resolved and the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the skin reaction and influenza-like symptoms to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient had worked for a laboratory in 1964 to 1965. The patient's husband and she went to local pharmacy to get SHINGRIX vaccination. The patient's husband had no reaction, but the patient had a bad skin reaction along with flu-like symptoms. The skin reaction was still there after five days, on the date of reporting. The patient already filed a side effects report. The patient feared having the second vaccination because her body was already sensitized.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness, Skin reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of skin reaction in a adult female patient who received SHINGRIX. Concurrent medical conditions included allergy to chemicals (nickel, formaldehyde, and arabiatic acid, patient wondered if she had any of these). On 24th May 2018, the patient received the 1st dose of SHINGRIX. On 24th May 2018, less than a day after receiving SHINGRIX, the patient experienced skin reaction and influenza-like symptoms. On an unknown date, the outcome of the skin reaction was not recovered/not resolved and the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the skin reaction and influenza-like symptoms to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient had worked for a laboratory in 1964 to 1965. The patient's husband and she went to local pharmacy to get SHINGRIX vaccination. The patient's husband had no reaction, but the patient had a bad skin reaction along with flu-like symptoms. The skin reaction was still there after five days, on the date of reporting. The patient already filed a side effects report. The patient feared having the second vaccination because her body was already sensitized.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 57-year-old female patient who received SHINGIRX (batch number G47M2, expiry date 11th October 2020). On 22nd May 2018, the patient received SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced erythema and pruritus. On 27th May 2018, the patient experienced rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the rash was recovering/resolving and the outcome of the erythema and pruritus were unknown. The reporter considered the rash to be unrelated to SHINGRIX. It was unknown if the reporter considered the erythema and pruritus to be related to SHINGRIX. Additional details were provided as follows: Five days after vaccination the patient reported a rash that had developed on her torso and continuing to spread outward. On an unknown date, less than a month after receiving SHINGRIX the patient experienced redness and itchiness. Till the time of reporting, the patient did not contact her Primary Care Physician, but she was taking BENADRYL to control the redness and itchiness.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 57-year-old female patient who received SHINGIRX (batch number G47M2, expiry date 11th October 2020). On 22nd May 2018, the patient received SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced erythema and pruritus. On 27th May 2018, the patient experienced rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the rash was recovering/resolving and the outcome of the erythema and pruritus were unknown. The reporter considered the rash to be unrelated to SHINGRIX. It was unknown if the reporter considered the erythema and pruritus to be related to SHINGRIX. Additional details were provided as follows: Five days after vaccination the patient reported a rash that had developed on her torso and continuing to spread outward. On an unknown date, less than a month after receiving SHINGRIX the patient experienced redness and itchiness. Till the time of reporting, the patient did not contact her Primary Care Physician, but she was taking BENADRYL to control the redness and itchiness.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Antibody test negative, Ataxia, Cerebellar ataxia, Immunology test normal, Laboratory test normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neurologic reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced neurologic reaction, cerebellar disorder NOS and vertigo CNS origin. On an unknown date, the outcome of the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin were unknown. It was unknown if the reporter considered the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. The other healthcare professional reported that the patient received SHINGRIX about 5 weeks before the reporting date. The patient experienced an acute neurological reaction as midline cerebellar with vertigo. On 30th April 2018, the other healthcare professional became aware of adverse events. The other healthcare professional would not provide further detailed information.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Viral test negative
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neurologic reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced neurologic reaction, cerebellar disorder NOS and vertigo CNS origin. On an unknown date, the outcome of the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin were unknown. It was unknown if the reporter considered the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. The other healthcare professional reported that the patient received SHINGRIX about 5 weeks before the reporting date. The patient experienced an acute neurological reaction as midline cerebellar with vertigo. On 30th April 2018, the other healthcare professional became aware of adverse events. The other healthcare professional would not provide further detailed information.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Nervous system disorder, Neurological symptom, Vertigo CNS origin
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neurologic reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced neurologic reaction, cerebellar disorder NOS and vertigo CNS origin. On an unknown date, the outcome of the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin were unknown. It was unknown if the reporter considered the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. The other healthcare professional reported that the patient received SHINGRIX about 5 weeks before the reporting date. The patient experienced an acute neurological reaction as midline cerebellar with vertigo. On 30th April 2018, the other healthcare professional became aware of adverse events. The other healthcare professional would not provide further detailed information.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Back pain, Cerebellar ataxia, Gait disturbance, Neuromuscular pain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neurologic reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced neurologic reaction, cerebellar disorder NOS and vertigo CNS origin. On an unknown date, the outcome of the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin were unknown. It was unknown if the reporter considered the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. The other healthcare professional reported that the patient received SHINGRIX about 5 weeks before the reporting date. The patient experienced an acute neurological reaction as midline cerebellar with vertigo. On 30th April 2018, the other healthcare professional became aware of adverse events. The other healthcare professional would not provide further detailed information.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neurologic reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced neurologic reaction, cerebellar disorder NOS and vertigo CNS origin. On an unknown date, the outcome of the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin were unknown. It was unknown if the reporter considered the neurologic reaction, cerebellar disorder NOS and vertigo CNS origin to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. The other healthcare professional reported that the patient received SHINGRIX about 5 weeks before the reporting date. The patient experienced an acute neurological reaction as midline cerebellar with vertigo. On 30th April 2018, the other healthcare professional became aware of adverse events. The other healthcare professional would not provide further detailed information.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal tenderness, Adverse drug reaction, Cellulitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was unknown. It was unknown if the reporter considered the abdominal pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. Few days after receiving SHINGRIX, the patient experienced abdominal pain. The healthcare professional did not have any information about the patient. This case has been linked with case US2018096028, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was unknown. It was unknown if the reporter considered the abdominal pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. Few days after receiving SHINGRIX, the patient experienced abdominal pain. The healthcare professional did not have any information about the patient. This case has been linked with case US2018096028, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was unknown. It was unknown if the reporter considered the abdominal pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. Few days after receiving SHINGRIX, the patient experienced abdominal pain. The healthcare professional did not have any information about the patient. This case has been linked with case US2018096028, reported by same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Large hives spread over entire body, high fever, swollen injection site and redness.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 24-MAY-2018, the patient was vaccinated with an expired dose of VAQTA lot number N005605, expiration date on 08-APR-2018, intramuscularly for prophylaxis (strength, dose number, anatomical location, lot number and expiration date were not reported). No adverse effect was reported.