chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Nasal congestion, Opisthotonus, Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: Patient seen in Emergency room 03/05/19 with fever, abnormal movement episode, cough and congestion. The primary encounter diagnosis was Febrile seizure. Mother reported mild dry cough and nasal congestion over the previous 1-2 days; woke that AM with tactile fever. Pt was reported to have arched her back and became stiff with arms stretched out. No eye rolling noted. Unsure if arms stiffened. Entire episode lasted 3-4 seconds. No LOC. No SOB noted. No obvious color change reported during event. Child appeared to have less energy afterwards. Measured temp 101.5F at home after the event. Parents attempted to give Tylenol, but child vomited the med. 4 episodes of NBNB emesis between episode and when seen in the ED. Also reported to ED staff to have recent flu-like illness for about 1-2 weeks at the time seen in the ED.
Age: 27.0
Sex: F
Vaccine: JEV1
Symptoms: Abdominal pain, Nausea, Pain in extremity
Clinical narrative: Nausea, abdominal pain, arm soreness
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient was administered improperly stored PROQUAD; No adverse effects; A patient was administered improperly stored PROQUAD; This spontaneous report has been received from a nurse practitioner referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reaction or allergies, concurrent conditions and concomitant medications was not provided.   On 07-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R011802 with expiration date of 21-OCT-2019, (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis.    The vaccine was exposed to temperature frames between 6°F to 14°F (13°F) for 7 hours, and between 15°F to 46°F (34°F) during 1 hour. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered improperly stored VARIVAX; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 14-MAY-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R023513 with an expiration date in 16-UAG-2020), for prophylaxis (strength, dose, frequency and route were not provided), that underwent multiples temperature excursions, from 6 degrees Fahrenheit to 14  degrees Fahrenheit during a time frame of 7 hours; from 15 degrees Fahrenheit to 46  degrees Fahrenheit during a time frame of 1 hour. Digital data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; one patient received one dose of VARIVAX that was improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No pertinent details regarding the patient's medical history, concurrent conditions and drug reactions or allergies were reported. On an unknown date, the patient received one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot # R030610, expiration date 23-OCT-2020 (exact dose, strength, dose number, route and site of administration were not reported) for prophylaxis. The dose was reconstituted with a properly stored sterile diluent. The vaccine was exposed to the temperature excursion of 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) for 30 minutes. No previous temperature excursions were reported. The call was because of digital data logger. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; a patient was administered an improperly stored ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. No pertinent details regarding the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 06-JUN-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R022223, expiration date 24-MAY-2019, orally (dose, strength and dose number were not reported) for prophylaxis. The vaccine was exposed to the temperature above 47 degrees Fahrenheit / 9 degrees Celsius (8.8 degrees Celsius) for 15 minutes and to the temperature below 36 degrees Fahrenheit / 2 degrees Celsius (-1.4 degrees Celsius) for 3 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was not involved. No adverse effects were reported.
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site nodule, Pain
Clinical narrative: Pain; small, pea size nodule under skin; induration approx. 3 cm; This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   In May 2019, the patient received Bexsero. On an unknown date, less than a month after receiving Bexsero, the patient experienced pain, injection site induration and injection site nodule. On an unknown date, the outcome of the pain and injection site induration were recovered/resolved and the outcome of the injection site nodule was unknown.   It was unknown if the reporter considered the pain, injection site induration and injection site nodule to be related to Bexsero.  Additional details were provided as follows: This case was reported by the family nurse practitioner (FNP). The patient received Bexsero 3 weeks before on an unknown arm from the date of reporting. The patient had pain that awakened from sleep and induration approximately 3 cm for 2 days. The patient had small pea size nodule under skin. The Patient was planning for 2nd injection on other arm. The reporter agreed to followup from GlaxoSmithKline.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced pain at the injection site for a couple of days. The reporter did not consent to follow up. The reporter was unable to obtain additional information. For tolerance of 2nd dose, refer case US2019101618.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Feeling abnormal
Clinical narrative: discomfort; misery; This case was reported by a consumer via call center representative and described the occurrence of discomfort in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced discomfort and feeling miserable. On an unknown date, the outcome of the discomfort and feeling miserable were unknown.   It was unknown if the reporter considered the discomfort and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that, people were suffering a great deal of discomfort and misery and to hold on before having injection. No further information was provided. This case has been linked with case US2019100249, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Feeling hot
Clinical narrative: discomfort; misery; This case was reported by a consumer via call center representative and described the occurrence of discomfort in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced discomfort and feeling miserable. On an unknown date, the outcome of the discomfort and feeling miserable were unknown.   It was unknown if the reporter considered the discomfort and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that, people were suffering a great deal of discomfort and misery and to hold on before having injection. No further information was provided. This case has been linked with case US2019100249, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Feeling abnormal
Clinical narrative: shivering/whole body shivering; feeling hot; felt like he was underwater out of it; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shivering, feeling hot and feeling abnormal. On an unknown date, the outcome of the shivering, feeling hot and feeling abnormal were unknown.   It was unknown if the reporter considered the shivering, feeling hot and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. About 2 to 3 months ago in the morning, the patient received shingrix injection. The next day and night he had whole body shivering, he was awakened in the middle of the night shivering and felt like he was underwater and out of it. The reporter feeling this way until at least 4 days.  The reporter reported he put a freezer pack on his head when he was hot and was not aware he would had such a reaction and wishes that he would had been warned that this could occur. The reporter that he had heard that the 2nd dose was worse than the 1st dose and was calling to find out if he should get the 2nd dose and if there was anything that he could pre-medicate with before having 2nd dose.  The reporter also reported that a friend of his in his early 60's was told by his the health care professional to not have the Shingrix until all the wrinkles had been ironed out". His friend went on to say that the health care professional stated people were suffering a great deal of discomfort and misery and to hold on before having injection. No further information was provided as to the health care professional that said this.  The reporter did not consent to follow up. This case has been linked with case US2019GSK106485, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Feeling hot
Clinical narrative: shivering/whole body shivering; feeling hot; felt like he was underwater out of it; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shivering, feeling hot and feeling abnormal. On an unknown date, the outcome of the shivering, feeling hot and feeling abnormal were unknown.   It was unknown if the reporter considered the shivering, feeling hot and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. About 2 to 3 months ago in the morning, the patient received shingrix injection. The next day and night he had whole body shivering, he was awakened in the middle of the night shivering and felt like he was underwater and out of it. The reporter feeling this way until at least 4 days.  The reporter reported he put a freezer pack on his head when he was hot and was not aware he would had such a reaction and wishes that he would had been warned that this could occur. The reporter that he had heard that the 2nd dose was worse than the 1st dose and was calling to find out if he should get the 2nd dose and if there was anything that he could pre-medicate with before having 2nd dose.  The reporter also reported that a friend of his in his early 60's was told by his the health care professional to not have the Shingrix until all the wrinkles had been ironed out". His friend went on to say that the health care professional stated people were suffering a great deal of discomfort and misery and to hold on before having injection. No further information was provided as to the health care professional that said this.  The reporter did not consent to follow up. This case has been linked with case US2019GSK106485, reported by the same reporter.
Age: 86.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 86-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In May 2019, the patient received Boostrix. On 20th May 2019, less than a month after receiving Boostrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Boostrix.  Additional details were provided as follows: The healthcare professional stated that the patient was vaccinated with Boostrix 2 weeks ago, from the date of reporting and was experiencing pain in the arm. There was no redness or swelling. There was not red to the touch. There was only pain around the injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dry skin, Eczema, Hypersensitivity, Injection site pain
Clinical narrative: Allergic reaction; itchy rash on legs that started above the knees/both arms on the outside of the arm; Burn; Dry skin; Eczema; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 18th April 2018, refer case US2019GSK104673).   On 12th June 2018, the patient received the 2nd dose of Shingrix (intramuscular). In August 2018, less than a year after receiving Shingrix, the patient experienced allergic reaction, itchy rash, burning sensation, dry skin and eczema. The patient was treated with medication unknown (Cream (Medication Unknown)). On an unknown date, the outcome of the allergic reaction, itchy rash, burning sensation, dry skin and eczema were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, itchy rash, burning sensation, dry skin and eczema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix dose and she developed a itchy rash on both legs that started above the knees and went into the inner thighs. At the same time, she also had an itchy rash that extended the length of both arms on the outside of the arm.   She describes that the rash runs along a nerve line. She saw a physician at a free clinic and was told she had an allergic reaction with some dry skin and eczema. The rash resolved and then restarted again. She said that she still has it but now it was getting worse. She has tried multiple creams and they only make it worse, causing the rash to itch more and burn. She said the rash on her legs looks horrible. The reporter did not consent to follow up. The reporter was unable to obtain additional information.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Allergic reaction; itchy rash on legs that started above the knees/both arms on the outside of the arm; Burn; Dry skin; Eczema; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 18th April 2018, refer case US2019GSK104673).   On 12th June 2018, the patient received the 2nd dose of Shingrix (intramuscular). In August 2018, less than a year after receiving Shingrix, the patient experienced allergic reaction, itchy rash, burning sensation, dry skin and eczema. The patient was treated with medication unknown (Cream (Medication Unknown)). On an unknown date, the outcome of the allergic reaction, itchy rash, burning sensation, dry skin and eczema were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, itchy rash, burning sensation, dry skin and eczema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix dose and she developed a itchy rash on both legs that started above the knees and went into the inner thighs. At the same time, she also had an itchy rash that extended the length of both arms on the outside of the arm.   She describes that the rash runs along a nerve line. She saw a physician at a free clinic and was told she had an allergic reaction with some dry skin and eczema. The rash resolved and then restarted again. She said that she still has it but now it was getting worse. She has tried multiple creams and they only make it worse, causing the rash to itch more and burn. She said the rash on her legs looks horrible. The reporter did not consent to follow up. The reporter was unable to obtain additional information.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling hot, Insomnia, Neuralgia
Clinical narrative: hot; tired; weakness; difficulty sleeping; bilateral nerve pain legs; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a day after receiving Shingrix, the patient experienced nerve pain, feeling hot, tiredness, weakness and difficulty sleeping. The patient was treated with ibuprofen (Advil). In May 2019, the outcome of the nerve pain, feeling hot, tiredness, weakness and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the nerve pain, feeling hot, tiredness, weakness and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: In the 1st week of May 2019, the patinet received Shingrix on left arm. The patient stated she felt hot and tired within a few hours of receiving the vaccine and then woke up in the night with feeling nerve pain running up and down the sides of both legs. The patient had trouble in sleeping, took some Advil and went back to bed. The patient all symptoms lasted no longer than 24 hours and resolved. The reporter did not consent to follow-up. The patient declines healthcare professional (HCP) follow up, does not had vaccine information for this adverse event (AE).
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dysphagia, Guillain-Barre syndrome, Headache, Loss of personal independence in daily activities, Monoplegia
Clinical narrative: Guillain-Barre syndrome; Lost use of her arms and she had to be fed; weakness in legs; difficulty swallowing; headache; nausea; leg swelling; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On 27th May 2019, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), arm paralysis (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), swelling of legs, headache and nausea. On 31st May 2019, the patient experienced swallowing difficult. On an unknown date, the outcome of the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The patient expereinced weakness and swelling in her legs. On 28th May 2019, the weakness was so severe, and the patient was carried to the restroom. Within 24 to 36 hours, the patient lost use her arms and had to be fed. On 29th May 2019, the patient was admitted to the hospital. On 31st May 2019, 13 days after vaccination, the patient expereinced difficulty in swallowing. The patient had MRI and other scans and was diagnosed with Guillain barre syndrome. The reporter gave consent for follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscular weakness, Musculoskeletal disorder, Nausea, Nuclear magnetic resonance imaging abnormal, Peripheral swelling
Clinical narrative: Guillain-Barre syndrome; Lost use of her arms and she had to be fed; weakness in legs; difficulty swallowing; headache; nausea; leg swelling; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On 27th May 2019, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), arm paralysis (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), swelling of legs, headache and nausea. On 31st May 2019, the patient experienced swallowing difficult. On an unknown date, the outcome of the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The patient expereinced weakness and swelling in her legs. On 28th May 2019, the weakness was so severe, and the patient was carried to the restroom. Within 24 to 36 hours, the patient lost use her arms and had to be fed. On 29th May 2019, the patient was admitted to the hospital. On 31st May 2019, 13 days after vaccination, the patient expereinced difficulty in swallowing. The patient had MRI and other scans and was diagnosed with Guillain barre syndrome. The reporter gave consent for follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scan abnormal
Clinical narrative: Guillain-Barre syndrome; Lost use of her arms and she had to be fed; weakness in legs; difficulty swallowing; headache; nausea; leg swelling; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On 27th May 2019, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), arm paralysis (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), swelling of legs, headache and nausea. On 31st May 2019, the patient experienced swallowing difficult. On an unknown date, the outcome of the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The patient expereinced weakness and swelling in her legs. On 28th May 2019, the weakness was so severe, and the patient was carried to the restroom. Within 24 to 36 hours, the patient lost use her arms and had to be fed. On 29th May 2019, the patient was admitted to the hospital. On 31st May 2019, 13 days after vaccination, the patient expereinced difficulty in swallowing. The patient had MRI and other scans and was diagnosed with Guillain barre syndrome. The reporter gave consent for follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Aspiration, Balance disorder, Blood test abnormal, Chest discomfort, Chest pain
Clinical narrative: Guillain-Barre syndrome; Lost use of her arms and she had to be fed; weakness in legs; difficulty swallowing; headache; nausea; leg swelling; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On 27th May 2019, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), arm paralysis (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), swelling of legs, headache and nausea. On 31st May 2019, the patient experienced swallowing difficult. On an unknown date, the outcome of the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The patient expereinced weakness and swelling in her legs. On 28th May 2019, the weakness was so severe, and the patient was carried to the restroom. Within 24 to 36 hours, the patient lost use her arms and had to be fed. On 29th May 2019, the patient was admitted to the hospital. On 31st May 2019, 13 days after vaccination, the patient expereinced difficulty in swallowing. The patient had MRI and other scans and was diagnosed with Guillain barre syndrome. The reporter gave consent for follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dysphagia, Dyspnoea, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: Guillain-Barre syndrome; Lost use of her arms and she had to be fed; weakness in legs; difficulty swallowing; headache; nausea; leg swelling; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On 27th May 2019, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), arm paralysis (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), swelling of legs, headache and nausea. On 31st May 2019, the patient experienced swallowing difficult. On an unknown date, the outcome of the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The patient expereinced weakness and swelling in her legs. On 28th May 2019, the weakness was so severe, and the patient was carried to the restroom. Within 24 to 36 hours, the patient lost use her arms and had to be fed. On 29th May 2019, the patient was admitted to the hospital. On 31st May 2019, 13 days after vaccination, the patient expereinced difficulty in swallowing. The patient had MRI and other scans and was diagnosed with Guillain barre syndrome. The reporter gave consent for follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Gastrointestinal haemorrhage, Guillain-Barre syndrome, Intensive care, Loss of control of legs
Clinical narrative: Guillain-Barre syndrome; Lost use of her arms and she had to be fed; weakness in legs; difficulty swallowing; headache; nausea; leg swelling; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On 27th May 2019, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), arm paralysis (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), swelling of legs, headache and nausea. On 31st May 2019, the patient experienced swallowing difficult. On an unknown date, the outcome of the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The patient expereinced weakness and swelling in her legs. On 28th May 2019, the weakness was so severe, and the patient was carried to the restroom. Within 24 to 36 hours, the patient lost use her arms and had to be fed. On 29th May 2019, the patient was admitted to the hospital. On 31st May 2019, 13 days after vaccination, the patient expereinced difficulty in swallowing. The patient had MRI and other scans and was diagnosed with Guillain barre syndrome. The reporter gave consent for follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Packed red blood cell transfusion, Pain, Respiratory failure, Wheelchair user
Clinical narrative: Guillain-Barre syndrome; Lost use of her arms and she had to be fed; weakness in legs; difficulty swallowing; headache; nausea; leg swelling; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On 27th May 2019, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), arm paralysis (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), swelling of legs, headache and nausea. On 31st May 2019, the patient experienced swallowing difficult. On an unknown date, the outcome of the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The patient expereinced weakness and swelling in her legs. On 28th May 2019, the weakness was so severe, and the patient was carried to the restroom. Within 24 to 36 hours, the patient lost use her arms and had to be fed. On 29th May 2019, the patient was admitted to the hospital. On 31st May 2019, 13 days after vaccination, the patient expereinced difficulty in swallowing. The patient had MRI and other scans and was diagnosed with Guillain barre syndrome. The reporter gave consent for follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; Lost use of her arms and she had to be fed; weakness in legs; difficulty swallowing; headache; nausea; leg swelling; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 18th May 2019, the patient received the 1st dose of Shingrix. On 27th May 2019, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), arm paralysis (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), swelling of legs, headache and nausea. On 31st May 2019, the patient experienced swallowing difficult. On an unknown date, the outcome of the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, arm paralysis, lower extremities weakness of, swelling of legs, swallowing difficult, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The patient expereinced weakness and swelling in her legs. On 28th May 2019, the weakness was so severe, and the patient was carried to the restroom. Within 24 to 36 hours, the patient lost use her arms and had to be fed. On 29th May 2019, the patient was admitted to the hospital. On 31st May 2019, 13 days after vaccination, the patient expereinced difficulty in swallowing. The patient had MRI and other scans and was diagnosed with Guillain barre syndrome. The reporter gave consent for follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: syncope; This case was reported by a physician via call center representative and described the occurrence of syncope in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABX751AA, expiry date 29th February 2020) for prophylaxis.   On 5th June 2019, the patient received Bexsero. On an unknown date, less than a week after receiving Bexsero, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Bexsero.  The additional details were provided as follows: In June 2019,the patient experienced an episode of syncope. This case is one of 4 cases, reported by same reporter. The vaccination date for Bexsero was discrepantly reported as 23rd June 2019 which was future date and it was updated to 5th June 2019 as per the adverse event description
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: syncope; This case was reported by a physician via call center representative and described the occurrence of syncope in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABX751AA, expiry date 29th February 2020) for prophylaxis.   On 5th June 2019, the patient received Bexsero. On an unknown date, less than a week after receiving Bexsero, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Bexsero.  Additional details were provided as follows: In Jun 2019, the patient experienced an episode of syncope. This case is one of 4 cases, reported by same reporter.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: light-headed; This case was reported by a physician via call center representative and described the occurrence of light headedness in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABX751AA, expiry date 29th February 2020) for prophylaxis.   On 6th June 2019, the patient received Bexsero. On 6th June 2019, less than a day after receiving Bexsero, the patient experienced light headedness. On an unknown date, the outcome of the light headedness was unknown.   It was unknown if the reporter considered the light headedness to be related to Bexsero.  Additional details were provided as follows: The doctor reported that the patient felt light-headed. This was 3 of 4 cases, reported by same reporter. In XML start date given as 20th July 2019 and in narrative 6th June 2019 as XML date is future date so captured as per narrative.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: light-headed; This case was reported by a physician via call center representative and described the occurrence of light headedness in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX751AA, expiry date 29th February 2020) for prophylaxis.   On 6th June 2019, the patient received Bexsero. On 6th June 2019, less than a day after receiving Bexsero, the patient experienced light headedness. On an unknown date, the outcome of the light headedness was unknown.   It was unknown if the reporter considered the light headedness to be related to Bexsero.  Additional details were provided as follows: The doctor reported that the patient felt light-headed. This was 4 of 4 cases, reported by same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Low grade fever (100.2F), flu-like symptoms, headache started early morning (2am) 6/12/2019 resolved by 8am 6/13/2019 Injection site reaction including swelling, itching and redness started evening 6/11/2019 (3'' diameter by 6/13/2019) continuing at this time. Ibuprofen prn
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Low grade fever (100.2F), flu-like symptoms, headache started early morning (2am) 6/12/2019 resolved by 8am 6/13/2019 Injection site reaction including swelling, itching and redness started evening 6/11/2019 (3'' diameter by 6/13/2019) continuing at this time. Ibuprofen prn
Age: 16.0
Sex: F
Vaccine: HEPA, MMRV, MNQ
Symptoms: Loss of consciousness, Pallor
Clinical narrative: After receiving vaccines, patient appeared pale and lost consciousness for about 3 seconds. Patient was laid back on exam table. Patient became responsive and alert and oriented. Vitals were obtained, BP 108/71, HR 98. Cold compress was applied. Patient was given juice and lollipop. Patient was monitored for additional 25 minutes. Vitals were rechecked, BP 108/74, HR 84. Her color returned to normal and she stated she felt better. Patient left office with mom in stable condition.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Malaise, Peripheral swelling
Clinical narrative: Patient reported bruising and swelling of arm, along with extreme malaise.
Age: 5.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Small pinpoint raised areas on face/neck/abdomen/back.. Our MD assessed sites. Instructed mom to give OTC Tylenol as needed/Benadryl before bed. This nurse instructed to use OTC hydrocortisone cream to raised areas. MD informed any respiratory issues 911.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Pain, Pyrexia
Clinical narrative: Symptoms- fever, fatigue, body aches, cough
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Unknown-Received a call that patient died 6/12/2019 @ Hospital
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Pain
Clinical narrative: patient states that his ribs hurt really bad and it hurts when he moves his diaphragm
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Irritated site with a bump and site colored red.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Headache, Impaired work ability, Insomnia
Clinical narrative: I got the vaccine and the pharmacist said to take Tylenol for any headache, arm soreness or Fever. I pictured symptoms consistent with other shots I have had. My arm is in so much pain it kept me awake all night even with Tylenol.  More importantly I am running 101 fever, have chills, can't eat, cant go to work. I  am afraid to get the second shot since this one made me this sick. I have never had problems with vaccines in the past. I saw that this is a higher incidence of side effects but I didn't think being this sick would be considered just a side effect. I feel too bad to get up and go to the doctor but I may have to get someone to take me if I don't start to get better.  Evidently this is not that unusual which is scary to me for the elderly who get this shot.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I got the vaccine and the pharmacist said to take Tylenol for any headache, arm soreness or Fever. I pictured symptoms consistent with other shots I have had. My arm is in so much pain it kept me awake all night even with Tylenol.  More importantly I am running 101 fever, have chills, can't eat, cant go to work. I  am afraid to get the second shot since this one made me this sick. I have never had problems with vaccines in the past. I saw that this is a higher incidence of side effects but I didn't think being this sick would be considered just a side effect. I feel too bad to get up and go to the doctor but I may have to get someone to take me if I don't start to get better.  Evidently this is not that unusual which is scary to me for the elderly who get this shot.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Bedridden, Pyrexia
Clinical narrative: I got the vaccine and the pharmacist said to take Tylenol for any headache, arm soreness or Fever. I pictured symptoms consistent with other shots I have had. My arm is in so much pain it kept me awake all night even with Tylenol.  More importantly I am running 101 fever, have chills, can't eat, cant go to work. I  am afraid to get the second shot since this one made me this sick. I have never had problems with vaccines in the past. I saw that this is a higher incidence of side effects but I didn't think being this sick would be considered just a side effect. I feel too bad to get up and go to the doctor but I may have to get someone to take me if I don't start to get better.  Evidently this is not that unusual which is scary to me for the elderly who get this shot.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: I got the vaccine and the pharmacist said to take Tylenol for any headache, arm soreness or Fever. I pictured symptoms consistent with other shots I have had. My arm is in so much pain it kept me awake all night even with Tylenol.  More importantly I am running 101 fever, have chills, can't eat, cant go to work. I  am afraid to get the second shot since this one made me this sick. I have never had problems with vaccines in the past. I saw that this is a higher incidence of side effects but I didn't think being this sick would be considered just a side effect. I feel too bad to get up and go to the doctor but I may have to get someone to take me if I don't start to get better.  Evidently this is not that unusual which is scary to me for the elderly who get this shot.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling and soreness around the site on her Rt arm. No weakness, headache, fatigue or problems breathing.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest pain, Diarrhoea
Clinical narrative: Patient experienced chest pain, stomach ache, and diarrhea the afternoon after the vaccine was administered.  The patient has no history of chest pain and believed that the symptoms were due to the shot, which was given earlier in the day.  The symptoms continued for 2 days.  The patient appeared to have fully recovered after two days, and no longer experienced the previously described symptoms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site urticaria, Nausea, Vomiting
Clinical narrative: Pain in right leg continuing on day 3. Hives around injection site. Nausea and vomiting. Symptoms resolved day 4.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B, Laboratory test
Clinical narrative: Hep B given before working at hospital I have look for records at hospital but unable to recovey. I have Heb B since I was given the live virus. On a routine visit to OB/Gyn Doctor 3/19 found out I have been exposed to virus but never had any symptoms. Or been exposed I feel I was given a live virus of the shot because my antibodies are normal
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; the patient received one dose of MMR-II inadvertently by the intramuscular route; This spontaneous report was received from a pharmacist referred to a male patient of an unknown age.    The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the pharmacist reported that "one week ago", on approximately 05-JUN-2019, the patient received one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(lot number and expiration date was unknown) inadvertently by the intramuscular instead of subcutaneous and no adverse effects was reported(incorrect route of product administration and no adverse event). No additional information provided and no PQC found.