chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPVX, MENB, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: passing out; fainting; This case was reported by a nurse via sales rep and described the occurrence of passed out in an unspecified number of 16-year-old patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patients received Bexsero at an unknown dose, Menveo at an unknown dose and HPV vaccine at an unknown dose. On an unknown date, unknown after receiving Bexsero, Menveo and HPV vaccine, the patients experienced passed out (serious criteria GSK medically significant) and fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out and fainting were unknown.   It was unknown if the reporter considered the passed out and fainting to be related to Bexsero, Menveo and HPV vaccine.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that there were some patients,(most were 16 years of age) experienced passing out or fainting after receiving either Bexsero and Menveo or Bexsero, Menveo, and HPV vaccine at the same visit. It was unknown whether which group of patients received only Bexsero and Menveo or which group had received Bexsero, Menveo, and HPV vaccine. The reporter noticed that in 2 to 5 patients, but this had not occurred in the majority of patients.  It was reported that they had implemented a protocol to let the parents decide if multiple vaccines could be received and if parents chooses not to have multiple vaccines administered to child then the nurses visit was scheduled for additional vaccines, specifically the Bexsero which was usually rescheduled. If multiple vaccines were administered to the patients then the patient should wait for 20 minutes. The reporter had not agreed to follow up from GSK.
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Influenza like illness
Clinical narrative: flu like symptoms; bedriden; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and bedridden. On an unknown date, the outcome of the influenza-like symptoms and bedridden were recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the bedridden to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient's age at vaccination might be around 57 or 58 years. The patient received his 1st dose of Shingrix 3 months ago of reporting and less than a year after receiving Shingrix, the patient experienced flu like symptoms for a couple of days and spent one entire day in bed. The patient was trying to make a decision on whether to get the 2nd dose but first wanted to know if there was any efficacy after 1st dose and could the side effects be the same with the 2nd dose. The patient did not want to provide any demographics except his first name and did not provide any additional details.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Malaise, Pyrexia
Clinical narrative: sick; fever; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, fever and incomplete course of vaccination. On an unknown date, the outcome of the sickness, fever and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness and fever to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose on unknown deltoid. The patient experienced bad reaction to the first shot, she was sick and had a fever. The patient did not get her second dose of Shingrix within 6 months of the first dose, which led to incomplete course of vaccination. The reporter had consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2021) for prophylaxis.   On 11th June 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife. The reporter only provided her first name.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: shingle like rash on trunk and armpits; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter did not have patient demographics details. On 10th June 2019 or 11th June 2019, the patient received a dose of Shingrix at the pharmacy. On the day of reporting, the patient reported to the pharmacist a shingle like rash on his trunk and armpits. The reporter would call back to provide more details.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Eye swelling, Food allergy, Urticaria
Clinical narrative: Food allergies of some sort - haven't pin pointed the food yet... Hives on face, swelling of eyes, hives on torso.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Injection site pain, Myalgia
Clinical narrative: Pain during shot and after.  Bad night.  Chills. Muscle pain.  General feeling of discomfort, head to foot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Bone pain, Chills, Impaired work ability, Malaise
Clinical narrative: Chills/shivering, low grade fever 100.2, muscle aches, bone pain, severe headache, nausea, dry heaves, general malaise lasting for approximately 24 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Retching
Clinical narrative: Chills/shivering, low grade fever 100.2, muscle aches, bone pain, severe headache, nausea, dry heaves, general malaise lasting for approximately 24 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, body aches, fatigue, chills/shivers. Tylenol 1,000 times two (6/18/19 - 4:00 PM and 6/19/19 - 2:30 AM) All symptoms relieved by 6:00 AM on 6/19/19. Fatigue returned on late night 6/19/19 and stayed on till 6/20/19 AM
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache, body aches
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Father of patient stated that child had a full body rash. Child received the vaccines on a Wednesday and parents noticed rash on Saturday. Child was taken to an ER where she was given benadyrl. Father did not state if child had a fever or not. Only noticable symptom was a rash. Child was fine after ER visit. Rash went away.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Herpes zoster, Myalgia, Pain
Clinical narrative: Extreme muscle pain, chilling, aching, headache , itching .  in 48 hours had a shingles outbreak on right arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Extreme muscle pain, chilling, aching, headache , itching .  in 48 hours had a shingles outbreak on right arm.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Patient developed generalized rash 10 days after the immunization
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash pruritic, Rash vesicular
Clinical narrative: Pt received the vaccine on  May 17th 2019.  This was his second dose. He noticed a rash that started on 5/21/2019. The rash started on his arms and then spread to legs, trunk, and back. They are slightly raised and mildly itchy. The itch increased with pressure or touch.  Pt was seen by NP on  6/3/2019. At that point, over the last 7 days, bilateral palmar redness with vesicles under the skin were presenting.  Pt complaining of burning and itching.  He denied any use of new detergents, soaps, contact with irritants, fever, cough, or other systemic symptoms.  The provider felt like these were two separate rashes. She felt like he had a hypersensitivity rash likely due to shingles.  She felt that the rash on the palms was actually an eruption of shingles. Pt placed on a renal dose of Acyclovir 1gm take one tablet twice a day for 7 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Chills, Diarrhoea
Clinical narrative: 6/6/2019:  10:30 AM vaccine.  11:30 lunch..  return home as the 1st dose 2/11/19 did make me feel a little like lying down.  Th e site of injection was very sore and had a red rash around for days.  pharmacy advised the 2nd dose would not be as bad, but the site would be sore    7:30 PM, I knew I had to throw up.  At that time diarrhea, belly pain, shivering and slight headache started.  I threw up and continued diarrhea til 3:00 AM.  Fever of 100.6 the next day (6//7/2019)  Burping, heartburn.  Heartburn continued for several days after.  I have had heartburn before, but not in a long time.  Was weak and fragile stomach for days later.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia, Eructation, Headache, Injection site discomfort, Injection site erythema
Clinical narrative: 6/6/2019:  10:30 AM vaccine.  11:30 lunch..  return home as the 1st dose 2/11/19 did make me feel a little like lying down.  Th e site of injection was very sore and had a red rash around for days.  pharmacy advised the 2nd dose would not be as bad, but the site would be sore    7:30 PM, I knew I had to throw up.  At that time diarrhea, belly pain, shivering and slight headache started.  I threw up and continued diarrhea til 3:00 AM.  Fever of 100.6 the next day (6//7/2019)  Burping, heartburn.  Heartburn continued for several days after.  I have had heartburn before, but not in a long time.  Was weak and fragile stomach for days later.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pyrexia, Vomiting
Clinical narrative: 6/6/2019:  10:30 AM vaccine.  11:30 lunch..  return home as the 1st dose 2/11/19 did make me feel a little like lying down.  Th e site of injection was very sore and had a red rash around for days.  pharmacy advised the 2nd dose would not be as bad, but the site would be sore    7:30 PM, I knew I had to throw up.  At that time diarrhea, belly pain, shivering and slight headache started.  I threw up and continued diarrhea til 3:00 AM.  Fever of 100.6 the next day (6//7/2019)  Burping, heartburn.  Heartburn continued for several days after.  I have had heartburn before, but not in a long time.  Was weak and fragile stomach for days later.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Developed a fever of 103 for 24 hours
Age: 1.17
Sex: M
Vaccine: DTAP
Symptoms: Hypersomnia, Lethargy, Pyrexia, Screaming, Somnolence
Clinical narrative: Vaccine administered on a Thursday, all day and Friday he seemed fine. Saturday morning he would not wake and was approaching 14-15 hours of straight sleep. I expected my son to be a little drowsy but this was concerning, I called his pediatrician and she said he should not be sleeping like that, to wake him and get fluids in him. Upon waking him he shook uncontrollably and screamed a high pitch scream I have never heard him make before.  His fever peaked at 104 degrees. His lethargy continued for next few days, and fever was controlled via tylenol but remained around 101-102 until Sunday. Each time he woke he would scream that same high pitch scream we initially heard Saturday morning. I brought him back to office Monday and saw PA. She said he seemed to have had a reaction to the vaccine but he was no longer running a fever. When I spoke to pediatrician (6/19) about reporting, she said she did not report it because she considered it a "side effect" and not a reaction.  Therefore, as his parent, I am reporting this event.
Age: 1.17
Sex: M
Vaccine: DTAP
Symptoms: Tremor
Clinical narrative: Vaccine administered on a Thursday, all day and Friday he seemed fine. Saturday morning he would not wake and was approaching 14-15 hours of straight sleep. I expected my son to be a little drowsy but this was concerning, I called his pediatrician and she said he should not be sleeping like that, to wake him and get fluids in him. Upon waking him he shook uncontrollably and screamed a high pitch scream I have never heard him make before.  His fever peaked at 104 degrees. His lethargy continued for next few days, and fever was controlled via tylenol but remained around 101-102 until Sunday. Each time he woke he would scream that same high pitch scream we initially heard Saturday morning. I brought him back to office Monday and saw PA. She said he seemed to have had a reaction to the vaccine but he was no longer running a fever. When I spoke to pediatrician (6/19) about reporting, she said she did not report it because she considered it a "side effect" and not a reaction.  Therefore, as his parent, I am reporting this event.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Asthenia, Cognitive disorder, Epilepsy, Fatigue
Clinical narrative: epilepsy; cognitive problems/cognitive and memory problems; memory problems/cognitive and memory problems; occasional visual disturbances; reduced physical stamina; Fatigue; headaches; Other symptoms; This spontaneous report was received as an online article via company representative refers to a female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was also reported that the patient was a fit and healthy teenager previously. On an unknown date the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, frequency, route, lot# and expiry date were not provided) for prophylaxis. On an unknown date within weeks of second dose of vaccine, the patient developed epilepsy. She had cognitive and memory problems (cognitive disorder; memory impairment), reduced physical stamina (asthenia), fatigue, headaches (headache), occasional visual disturbances (visual impairment) and other symptoms (adverse event). The patient's mother told that the conditions were debilitating. The studying, writing, and recalling facts all suddenly had become difficult. The patient's mother found that dealing with patient's bi­monthly seizures had curtailed her independence and her social life dramatically. As a family they had to alter their lives to make sure the patient was never alone and to get her to the medical appointments. Currently the patient was coping with life at university and managing her studies with support. The patient's mother was angry and frustrated with the fact that there were no investigations and the sadness about what had happened was always on their minds. Four years later the epilepsy was still uncontrolled. The outcome of events cognitive disorder, memory impairment, asthenia, fatigue, headache, visual impairment and adverse event was unknown. The causality assessment was not provided by the reporter.  Upon internal review, the event epilepsy was determined to be serious (medically significant).  This is one of the multiple reports received from the same reporter.; Sender's Comments:  1906CAN005269:
Sex: F
Vaccine: HPV4
Symptoms: Headache, Loss of personal independence in daily activities, Memory impairment, Seizure, Visual impairment
Clinical narrative: epilepsy; cognitive problems/cognitive and memory problems; memory problems/cognitive and memory problems; occasional visual disturbances; reduced physical stamina; Fatigue; headaches; Other symptoms; This spontaneous report was received as an online article via company representative refers to a female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was also reported that the patient was a fit and healthy teenager previously. On an unknown date the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, frequency, route, lot# and expiry date were not provided) for prophylaxis. On an unknown date within weeks of second dose of vaccine, the patient developed epilepsy. She had cognitive and memory problems (cognitive disorder; memory impairment), reduced physical stamina (asthenia), fatigue, headaches (headache), occasional visual disturbances (visual impairment) and other symptoms (adverse event). The patient's mother told that the conditions were debilitating. The studying, writing, and recalling facts all suddenly had become difficult. The patient's mother found that dealing with patient's bi­monthly seizures had curtailed her independence and her social life dramatically. As a family they had to alter their lives to make sure the patient was never alone and to get her to the medical appointments. Currently the patient was coping with life at university and managing her studies with support. The patient's mother was angry and frustrated with the fact that there were no investigations and the sadness about what had happened was always on their minds. Four years later the epilepsy was still uncontrolled. The outcome of events cognitive disorder, memory impairment, asthenia, fatigue, headache, visual impairment and adverse event was unknown. The causality assessment was not provided by the reporter.  Upon internal review, the event epilepsy was determined to be serious (medically significant).  This is one of the multiple reports received from the same reporter.; Sender's Comments:  1906CAN005269:
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Herpes zoster
Clinical narrative: Back pain; Joint pain; Shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 25-APR-2017, the patient was inoculated the zoster vaccine live (ZOSTAVAX)(lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2017 [reported as "shortly after" receiving the zoster vaccine live (ZOSTAVAX)], the patient suffered from severe joint pain and severe back pain. The patient was also diagnosed with shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered.  Joint pain, back pain, and shingles were considered to be disabling.
Sex: F
Vaccine: HPV4
Symptoms: Autopsy, Death, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: patient died; tested post mortem blood samples and found fragments of foreign DNA in her spleen and these were positive for human papilloma virus; This spontaneous report has been received from a physician as a social media post referring to a female patient of unknown age.Information on patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with third dose Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, anatomical location, route, lot# and expiry date was not reported) for prophylaxis. On an unknown date, the patient died in her sleep six months after her third Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection due to unknown reason. On an unknown date, the autopsy (reported as post-martem blood test) was performed which showed fragments of foreign deoxyribose nucleic acid (DNA) in patient's blood and spleen and those samples were positive for human papilloma virus (HPV) (Human papilloma virus test positive). Physician also reported that it was not the result of natural HPV infection, most likely the DNA was bound to aluminum, which was also found in the patient. The physician further mentioned that HPV gene was foreign DNA and its detection six months after the injection was not normal. The physician also tested five samples of the vaccine sent from somewhere else and found HPV vaccine in each. Causality assessment between the events and the suspect therapy was unknown.; Reported Cause(s) of Death: unknown cause of death.
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, Papule, Pruritus, Rash pustular, Varicella post vaccine
Clinical narrative: The patient received her first dose of VARIVAX, at approximately 12 months of age, and received the second dose of VARIVAX, at approximately, four years of age; Patient experienced breakthrough chickenpox, described as approximately 30 papular lesions, some slightly pustular, on trunk and neck, with mild itching, but was afebrile; This spontaneous report was received from a consumer regarding his 9 year old female daughter. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were no reported.   Approximately in 2010 (reported as "approximately 12 months of age), the patient received her first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). Approximately in 2013 (reported as "four years of age) she received the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (inappropriate schedule of product administration) for routine vaccination (prophylaxis) (strength, dosage, frequency, route of administration, lot number and expiration date were not reported).  On 17-JUN-2019, the patient experienced breakthrough chickenpox, described as approximately 30 papular lesions, some slightly pustular, on trunk and neck, with mild itching, but was afebrile (Varicella). No treatment was given for the event. Also, no lab diagnostics or studies were performed.  The action taken of the event Varicella was not reported. The causal relationship between the event and vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; Improperly stored doses of MMR II and VARIVAX were administered to the same patient; Improperly stored doses of MMR II and VARIVAX were administered to the same patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 21-JUN-2018, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) , 0.5 milliliter, subcutaneously (invalid lot# reported as N045101, expiration date 10-NOV-2018), and varicella virus vaccine live (oka/merck) (VARIVAX) (the dosage regimen was not reported) lot# N012132 (expiration date: 17-APR-2019), both of them for prophylaxis. No adverse effects were reported.  The vaccines were exposed to a temperature of 55.7 Fahrenheit degrees for a timeframe of 8 hours and 30 minutes. It was found because of a digital data logger.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; The patient received her fist dose of the vaccine on 01-JUL-2015 and she was in the office "today" for her second dose; This spontaneous report has been received from a nurse prescriber concerning to a 23-year-old female patient.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 01-JUL-2015, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unspecified day in June 2019 (also reported as today), the patient was in the nurse's office for her second dose (inappropriate schedule of product administration). No adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; inadvertently received an expired dose of VAQTA; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported. On 13-JUN-2019, the patient was vaccinated inadvertently with an expired dose (1 dosage form) of hepatitis a vaccine, inactivated (VAQTA), lot # R013515 and expiry date: 30-MAY-2019 for prophylaxis (strength, route and anatomical location were not reported) (expired product administered). No adverse effects were reported. The outcome of expired product administered was unknown. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness; injection site swelling; injection site warmth to touch; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patent experienced redness, swelling and site is warm to the touch after receiving Bexsero. The nurse thinking it was because we didn't use a large enough needle for the patient size to get it into the muscle far enough. And, those given were from the same box.  The nurse asked for awareness of other clinics having this problem.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever for almost 8 days; This case was reported by a consumer and described the occurrence of fever in a 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 fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  AAdditional details were provided as follows: The age at vaccination was not reported. The patient had fever for almost 8 days starting the day after the first Shingrix vaccine. The patient stated that was unusual. The patient wanted to know if he did not take the second dose and still he would protected and approximately how much. The patient was wondering whom to talk on your medical team to get some more information to make a more informed decision.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Outbreak of Herpes simplex virus; This case was reported by a nurse via sales rep and described the occurrence of herpes simplex in a 60-year-old female patient 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 herpes simplex. The patient was treated with acyclovir. On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Nurse (Department Manager). The patient reported an outbreak of herpes simplex after 1st dose of shingrix. She was put on acyclovir after the break out. The reporter agrees to follow up. For tolerances of 2nd dose, refer case US2019GSK111457, reported by same reporter for the same patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin E decreased, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: rash; Injection site swelling; injection site red; This case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received Shingrix. On 26th April 2019, 9 days after receiving Shingrix, the patient experienced injection site rash, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site rash, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site rash, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Medical assistant (MA). The patient experienced rash, swelling and redness starting at injection site. On 29th April 2019, the patient was seen on office and did Immunoglobulin E test but it was low so not determined not an allergic reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Outbreak of Herpes simplex virus; This case was reported by a nurse via sales rep and described the occurrence of herpes simplex in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, refer case US2019AMR107844).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex. The patient was treated with acyclovir. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Nurse (Department Manager). The patient reported an outbreak of herpes simplex after 2nd dose of shingrix. She was put on acyclovir after the break out. The reporter agrees to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Periarthritis
Clinical narrative: shoulder lockup; This case was reported by a consumer via call center representative and described the occurrence of frozen shoulder in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced frozen shoulder. The patient was treated with ambiguous medication nos (Cortisone (Nos)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the frozen shoulder was recovering/resolving.   It was unknown if the reporter considered the frozen shoulder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 65 or 66 years. The patient received the 1st dose in left arm. The patient received 2nd dose of Shingrix in January 2019 (intramuscular). After the first dose, the patient experienced her left shoulder locking up, which was the same shoulder she received the first dose of Shingrix. The patient reported that her shoulder issue did not resolve and when it was time for second dose of Shingrix, she had it administered in right arm and had no issues.  The patient reported that she had to see orthopedic surgeon in April 2019 due to her left shoulder issues, and that he prescribed physical therapy which helped some and she then required a cortisone shot recently in the shoulder and it has gotten much better but was still not back to normal. The reporter had consented to follow up. Emergency room Visit required.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Herpes zoster, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Shingles; Skin peeling; Rash/ Cutaneous eruption/ bright red patch; Chest Burning; aching; Headache; stiff neck; This case was reported by a physician via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Embrel. Concurrent medical conditions included rheumatoid arthritis and immunocompromised (Compromised immune System). Concomitant products included adalimumab (Humira), prednisone, meloxicam (Mobic) and lansoprazole (Prevacid).   In May 2019, the patient received Shingrix. In May 2019, immediately after receiving Shingrix, the patient experienced pain, headache and stiff neck. On 5th June 2019, the patient experienced burning sensation. On 6th June 2019, the patient experienced red rash. On 7th June 2019, the patient experienced shingles and skin peeling. The patient was treated with valaciclovir hydrochloride (Valtrex). In June 2019, the outcome of the pain, headache and stiff neck were recovered/resolved. On an unknown date, the outcome of the shingles and skin peeling were unknown and the outcome of the burning sensation was not recovered/not resolved and the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the shingles, pain, headache, stiff neck, burning sensation, red rash and skin peeling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine 2 weeks ago, from the date of reporting. The patient was seen by rheumatologist first and then referred to dermatologist. Immediately after vaccination the patient experienced aching, headache, and stiff neck which lasted for about 2 weeks. On 5th June 2019, the patient visited her chiropractor due to stiff neck. Later that evening, the patient felt like burning fire on her chest. On next day morning, she woke up with bright red patch from midline on her chest to left breast to mid neck. Along with circular rash below both medial breasts. The patient came to dermatologist on 7th June 2019. The dermatologist stated it was perfect presentation of dermatomal distribution of t5 and t6. The dermatologist diagnosed the condition as Shingles, and has put the patient on Valtrex 1 tablet three times daily for 2 weeks. The cutaneous eruption had improved, but the burning was present, at the time of reporting.  The patient's rash underneath the breast was peeling off like a severe sunburn. The peeling rash stopped at middle of chest to spinal area, and to the back and stopped at mid line below the nipple and umbilicus. There were no discreet vesicles present. No further details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Skin exfoliation, Sunburn
Clinical narrative: Shingles; Skin peeling; Rash/ Cutaneous eruption/ bright red patch; Chest Burning; aching; Headache; stiff neck; This case was reported by a physician via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Embrel. Concurrent medical conditions included rheumatoid arthritis and immunocompromised (Compromised immune System). Concomitant products included adalimumab (Humira), prednisone, meloxicam (Mobic) and lansoprazole (Prevacid).   In May 2019, the patient received Shingrix. In May 2019, immediately after receiving Shingrix, the patient experienced pain, headache and stiff neck. On 5th June 2019, the patient experienced burning sensation. On 6th June 2019, the patient experienced red rash. On 7th June 2019, the patient experienced shingles and skin peeling. The patient was treated with valaciclovir hydrochloride (Valtrex). In June 2019, the outcome of the pain, headache and stiff neck were recovered/resolved. On an unknown date, the outcome of the shingles and skin peeling were unknown and the outcome of the burning sensation was not recovered/not resolved and the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the shingles, pain, headache, stiff neck, burning sensation, red rash and skin peeling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine 2 weeks ago, from the date of reporting. The patient was seen by rheumatologist first and then referred to dermatologist. Immediately after vaccination the patient experienced aching, headache, and stiff neck which lasted for about 2 weeks. On 5th June 2019, the patient visited her chiropractor due to stiff neck. Later that evening, the patient felt like burning fire on her chest. On next day morning, she woke up with bright red patch from midline on her chest to left breast to mid neck. Along with circular rash below both medial breasts. The patient came to dermatologist on 7th June 2019. The dermatologist stated it was perfect presentation of dermatomal distribution of t5 and t6. The dermatologist diagnosed the condition as Shingles, and has put the patient on Valtrex 1 tablet three times daily for 2 weeks. The cutaneous eruption had improved, but the burning was present, at the time of reporting.  The patient's rash underneath the breast was peeling off like a severe sunburn. The peeling rash stopped at middle of chest to spinal area, and to the back and stopped at mid line below the nipple and umbilicus. There were no discreet vesicles present. No further details were provided.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling at injection site; redness at injection site; soreness at injeciton site/site is still tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix in left arm and reported that she experienced swelling at the injection site about the size of a grapefruit, redness and soreness.  The patient stated swelling and redness resolved but site was still tender to the touch, The patient also reported that she received a flu shot this year (product name unknown) and she experienced pain at injection site that resolved. The reporter did not consent to follow up. This case has been linked with case US2019104323 and US2019GSK105595, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: hives on back and torso; itching all over; This case was reported by a consumer via call center representative and described the occurrence of hives in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. In May 2019, 1 day after receiving Shingrix, the patient experienced hives and generalized pruritus. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hives and generalized pruritus were recovering/resolving.   It was unknown if the reporter considered the hives and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 75 or 76 years. The patient reported that he received Shingrix sometime in mid-May 2019. The patient reports the next day he experienced itching. The day after that, the patient noticed hives on his torso and back.  The patient went to the emergency room and was give steroids. The patient then followed up with his dermatologist who continued steroid therapy. The itching has subsided. The reporter had consented to follow up. Emergency room visit required. Lot number and specific date of injection and events was not remembered by the patient. The patient said that his pharmacist may have called the event into GlaxoSmithKline or VAERS. Outcome of the events were reported as Fatal in source document, which seems to be discrepant from narrative hence it was kept as recovering or resolving as reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Skin lesion
Clinical narrative: HSV-2 Outbreak; lesions; This case was reported by a other health professional via call center representative and described the occurrence of herpes simplex in a female patient 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 herpes simplex and skin lesion. On an unknown date, the outcome of the herpes simplex and skin lesion were unknown.   The reporter considered the herpes simplex and skin lesion to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Pharmacy Intern. The age at vaccination was not reported. It was reported that a patient had an outbreak of HSV-2 after receiving the 1st dose of Shingrix. The patient later received the 2nd dose of Shingrix and after the HSV outbreak persisted lab testing came back to confirm the etiology of the lesions.  The patient believes there was a relationship between Shingrix and the new medical diagnosis of HSV-2. The patient was consented to follow up. The reporter stated, the event was reported in VAERS but the reporter was fine with receiving a letter from safety.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular, Scratch, Urticaria
Clinical narrative: looks like chicken pox; itching; pain in chest; pain in chest; scratches.; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2019, the patient received Shingrix (intramuscular) .5 ml. On 15th April 2019, 1 days after receiving Shingrix, the patient experienced varicella-like rash, itchy rash, painful rash, pain and scratch. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the varicella-like rash, itchy rash, painful rash, pain and scratch were not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash, itchy rash, painful rash, pain and scratch to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in his left arm.  The next day his right arm broke out in what looked like hives. The breakout no longer looks like hives, but looks like chicken pox and it had traveled to his back and chest. It was very itchy and on his chest it was painful as well. The rest was not painful unless he scratches. The breakout was continuing to get worse. He saw his internist for a regular appointment and showed him the breakout and was referred to a dermatologist.  The dermatologist took a scraping from his back and said it was not shingles. He had now gone to an allergist, who drew several vials of blood. He had taken steroids and steroid creams, but the breakout continues to get worse. The reporter had consented to follow up. Emergency room visit required.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Product supply issue
Clinical narrative: shingles; product supply issue; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown.   The reporter considered the shingles to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's 2nd dose of Shingrix was delayed past the six month mark because of Shingrix lack of availability.  The patient then developed shingles before getting the 2nd dose of Shingrix. The reporter was in office and did not have time to provide further details about patient, product or incident.  The reporter agreed to receive a follow up letter.   The reporter did not think the shingles was related to Shingrix.