chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events.; patient received VAQTA pediatric dose instead of adult dose; patient received VAQTA pediatric dose instead of adult dose; This spontaneous report was received from a nurse referring to a patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 12-NOV-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # S021092 and expiration date 18-MAY-2020; dose and route were not provided) pediatric dose instead of adult dose for prophylaxis (incorrect dose administered and product administered to patient of inappropriate age). No additional adverse events.
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 47 years old patient received a dose of garadsil 9; This spontaneous report was received from a registered nurse referring to a 47-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 06-DEC-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1621934 expiry date 29-JAN-2022, 1 dose for prophylaxis (route was not reported) (product administered to patient of inappropriate age). The product quality complaint was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional symptoms reported; patient received second dose of VARIVAX series that was improperly stored; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On 18-NOV-2019, the patient was vaccinated with second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S008692, expiry date : 21-MAR-2021) for prophylaxis. The patient's concomitant therapies included sterile diluent which was properly stored.   It was reported that the vaccine experienced a temperature excursion of 6.5 degrees Fahrenheit for 20 minutes (product storage error). There was previous temperature excursion of 8.1 degrees Fahrenheit for 25 minutes. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient has reported no symptoms.; patient received unspecified dose in VAQTA series that was improperly stored; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.  On 06-NOV-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # S009562, expiration date reported as 26-JUL-2019, but upon internal validation established as 05-MAY-2019; dose and route were not provided) for prophylaxis (product storage error). The vaccine underwent temperature 48 Fahrenheit for a duration of 30 minutes. There was previous temperature excursion at 50.4 Fahrenheit and 47.3 Fahrenheit both for a duration of 30 minutes. The call was because of data logger. Patient has reported no symptoms.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient has reported no symptoms; Received unspecified dose in VAQTA series that was improperly stored; Expired vaccine used; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, drug reactions/allergies and concomitant medications were not reported. On 29-OCT-2019, the patient was vaccinated with unspecified dose in hepatitis a vaccine, inactivated (VAQTA) series, lot # S009562 and expiration date was reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019 (expired product administered) (strength, dose, route and anatomical location not reported) for prophylaxis that was improperly stored (product storage error). The storage temperature was reported as 48 Fahrenheit (F) for the time frame of 30 minutes. Previous temperature excursion included 50.4 F and 47.3 F for 30 minutes. Digital data logger involved. The patient had reported no symptoms (no adverse event). No product quality complaint (PQC) present.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms; improperly stored vaccine administered; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) of lot # S009562, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019 for prophylaxis (strength, dose, route of administration and anatomical location was unknown) (product storage error). No symptoms reported (no adverse event). The outcome of product storage error was unknown. It was reported that the vaccine was exposed to a temperature of 48 Fahrenheit (F) for a time frame of 30 minutes. There was previous temperature excursion reported as 50.4 F for 30 minutes and 47.3F for 30 minutes. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Antibody test abnormal
Clinical narrative: Minimum side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient was a platelets donor at local hospital. The patient developed minimum side effects from the shot. The patient waited 60 days after second dose to make platelets donation. The patient received a call stating that could not be a donor for platelets any more because antibodies had changed. The patient had not been ill.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Rash, Rash erythematous
Clinical narrative: now I have a red rash on my hand; rash; I got the 2nd shingles shot Friday and had chills Friday night and also ached like the flu; I got the 2nd shingles shot Friday and had chills Friday night and also ached like the flu; This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 2nd dose of Shingrix. On 15th November 2019, less than a day after receiving Shingrix, the patient experienced chills and flu-like aching. On 19th November 2019, the patient experienced red rash and rash. On an unknown date, the outcome of the chills and flu-like aching were recovered/resolved and the outcome of the red rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the chills, flu-like aching, red rash and rash to be related to Shingrix.  Additional details were reported as follows: The patient received  2nd Shingrix shot Friday and had chills Friday night and also ached like the flu,  The patient reported now (day of reporting) 4 days after receiving vaccination he had red rash on hand. All the event was recovered, except the worst was the shivering Friday night,slept in a coat long pajamas and socks. No further information was available.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Impaired work ability, Pain in extremity, Sensitive skin
Clinical narrative: my resting heart rate has also elevated; Serious pain in my arm; high sensitivity in hands; Vision a bit off; Fatigued; Unable to do anything; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced heart rate increased, pain in arm, sensitive skin, blurred vision, fatigue and inability to work. On an unknown date, the outcome of the heart rate increased, pain in arm, sensitive skin, blurred vision, fatigue and inability to work were unknown.   It was unknown if the reporter considered the heart rate increased, pain in arm, sensitive skin, blurred vision, fatigue and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix on sunday 17th November 2019 and till the time of reporting still had side effects. After vaccination, the patient had serious pain in arm and high sensitivity in hands. The patient washed the hands with cold water and felt the coldness more pronounced. The patient's vision was bit off and was very fatigue. The patient asked, was this typical 4 days later. The patient stated that, was in great shape and work out daily including running. After vaccination, the patient had been completely unable to do anything. The patient asked that, the heart rate was elevated, was that common due to pain or injection or both.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: my resting heart rate has also elevated; Serious pain in my arm; high sensitivity in hands; Vision a bit off; Fatigued; Unable to do anything; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced heart rate increased, pain in arm, sensitive skin, blurred vision, fatigue and inability to work. On an unknown date, the outcome of the heart rate increased, pain in arm, sensitive skin, blurred vision, fatigue and inability to work were unknown.   It was unknown if the reporter considered the heart rate increased, pain in arm, sensitive skin, blurred vision, fatigue and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix on sunday 17th November 2019 and till the time of reporting still had side effects. After vaccination, the patient had serious pain in arm and high sensitivity in hands. The patient washed the hands with cold water and felt the coldness more pronounced. The patient's vision was bit off and was very fatigue. The patient asked, was this typical 4 days later. The patient stated that, was in great shape and work out daily including running. After vaccination, the patient had been completely unable to do anything. The patient asked that, the heart rate was elevated, was that common due to pain or injection or both.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Myalgia, Pruritus
Clinical narrative: Injection site pain; Itchy; Muscle pain; Fever; Shivering; redness; This case was reported by a consumer  via sales rep and described the occurrence of injection site erythema in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (1st dose received on 15th August 2019, refer case US2019AMR211832).   On 15th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, pruritus, muscle pain, fever and shivering. On an unknown date, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema and pruritus were not recovered/not resolved and the outcome of the injection site pain, muscle pain, fever and shivering were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, pruritus, muscle pain, fever and shivering to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced reaction was severe with muscle pain, fever, shivering. The red area was 4 inches by 6 inches. On 16th November 2019, the patient had to go to urgent care. The patient was concerned about reaction as the patient was healthy and drug free at 74, never reacting like this for any previous medication or shot. On 23rd November 2019, arm was still red in the area and itchy. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: Injection site pain; Itchy; Muscle pain; Fever; Shivering; redness; This case was reported by a consumer  via sales rep and described the occurrence of injection site erythema in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (1st dose received on 15th August 2019, refer case US2019AMR211832).   On 15th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, pruritus, muscle pain, fever and shivering. On an unknown date, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema and pruritus were not recovered/not resolved and the outcome of the injection site pain, muscle pain, fever and shivering were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, pruritus, muscle pain, fever and shivering to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced reaction was severe with muscle pain, fever, shivering. The red area was 4 inches by 6 inches. On 16th November 2019, the patient had to go to urgent care. The patient was concerned about reaction as the patient was healthy and drug free at 74, never reacting like this for any previous medication or shot. On 23rd November 2019, arm was still red in the area and itchy. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Rash pruritic
Clinical narrative: burning sensation; itchy rash; This case was reported by a consumer via call center representative and described the occurrence of burning sensation 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, unknown after receiving Shingrix, the patient experienced burning sensation and itchy rash. On an unknown date, the outcome of the burning sensation and itchy rash were recovered/resolved.   It was unknown if the reporter considered the burning sensation and itchy rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received Shingrix and developed a burning itchy rash that has lasted 5 days. The patient was inquiring that should they received 2nd dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Lymphoedema, Malaise, Myalgia
Clinical narrative: Pain; Shivering; Fever; Malaise; Muscle pain; Upset stomach; Moderate to severe axillary lymphedema on the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain, chills, fever, malaise, myalgia, upset stomach and lymphedema. On an unknown date, the outcome of the pain, chills, fever, malaise, myalgia, upset stomach and lymphedema were unknown.   It was unknown if the reporter considered the pain, chills, fever, malaise, myalgia, upset stomach and lymphedema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced pain, shivering, fever, malaise, muscle pain and upset stomach for the last 3 days. The patient also experienced moderate to severe axillary lymphedema on the injection site. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pain; Shivering; Fever; Malaise; Muscle pain; Upset stomach; Moderate to severe axillary lymphedema on the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain, chills, fever, malaise, myalgia, upset stomach and lymphedema. On an unknown date, the outcome of the pain, chills, fever, malaise, myalgia, upset stomach and lymphedema were unknown.   It was unknown if the reporter considered the pain, chills, fever, malaise, myalgia, upset stomach and lymphedema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced pain, shivering, fever, malaise, muscle pain and upset stomach for the last 3 days. The patient also experienced moderate to severe axillary lymphedema on the injection site. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: temperature of 102-103; This case was reported by a physician via sales rep and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date the patient received the first dose of Shingrix (for tolerance please refer to case US2018158673).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced fever. Rechallenge with Shingrix was positive. 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.  Additional information was received as follows: The age at vaccination was not reported. The patient experienced temperature of 102 to 103 degree F, which resolved on its own.      Lab Comments: On an unknown date, the lab test was performed.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: lots of pain in arm; could not lift my arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 4 weeks ago and experienced lots of pain in arm and could not lift arm. The reporter consented to follow up.
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 11th October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, less than a month after receiving Influenza vaccine Quadrivalent 2019-2020 season, 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 Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter was patient herself. One month before the reporting date, the patient received flu vaccine (unknown manufacturer). The patient experienced pain at the injection site. The patient planned to follow up with her physician on an unknown date. The patient consented to follow up. This case has been linked to US2019203732, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Cheilitis, Lip blister, Rash vesicular
Clinical narrative: tiny blister rash; Rash lips; Blistery rash; This case was reported by a consumer via call center representative and described the occurrence of lip blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced lip blister, rash lips and blistery rash. The patient was treated with cortisone (non-proprietary) (Cortisone Cream), ascorbic acid,betacarotene,lysine hydrochloride,zinc amino acid chelate (Cold Sore (Ascorbic Acid + Betacarotene + Lysine + Zinc Amino Acid Chelate)) and neosporin (nos) (Neosporin). On an unknown date, the outcome of the lip blister, rash lips and blistery rash were not recovered/not resolved.   It was unknown if the reporter considered the lip blister, rash lips and blistery rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced tiny blister rash that comes and goes under bottom lip, after receiving 1st dose of Shingrix. It was been over a month since patient had this shot. The reporter wanted to know how could get rid of it as it was very ugly and what should be put on it.
Age: 30.0
Sex: U
Vaccine: HEPAB
Symptoms: Xanthelasma
Clinical narrative: xanthelasma; This case was reported by a consumer via call center representative and described the occurrence of xanthelasma in a 30-year-old patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, unknown after receiving Twinrix, the patient experienced xanthelasma. On an unknown date, the outcome of the xanthelasma was unknown.   It was unknown if the reporter considered the xanthelasma to be related to Twinrix.  Additional case details were reported as follows: The patient received Twinrix and had xanthelassma.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Feel terrible; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional case details were reported as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingix and felt terrible.  The reporter asked what could be done to feel better. The reporter did not had additional information.
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Pain, Swelling
Clinical narrative: pain; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a 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, unknown after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were unknown.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had local reactions of pain and swelling.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: had a reaction to vaccine; This case was reported by a consumer and described the occurrence of adverse reaction in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine the patient had a reaction. The follow up consent was granted.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Loss of consciousness, Oropharyngeal discomfort
Clinical narrative: starting to pass out; shortness of breath; gurgling sounds in her throat; This case was reported by a pharmacist via sales rep and described the occurrence of passed out 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, less than an hour after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), shortness of breath and throat discomfort. The patient was treated with epinephrine. On an unknown date, the outcome of the passed out and throat discomfort were unknown and the outcome of the shortness of breath was recovered/resolved.   It was unknown if the reporter considered the passed out, shortness of breath and throat discomfort to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was reported. In 2018, about a year, the patient received 1st dose of Shingrix and within a few minutes after receiving her vaccine, she developed shortness of breath and gurgling sounds in her throat. The pharmacist who administer vaccine to the patient was holding her up as she was starting to pass out, and called for help from another pharmacist nearby. The patient was administered epinephrine and she came back around quickly.  The reporter still called the emergency Medical Technician (EMTs) to come check her out and transport her.  The reporter eported this already to the CDC, and they are pretty sure they told GSK also.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: nauseous; Dizzy; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received Shingrix. On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were unknown.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The age at vaccination was not reported. The reporter stated that the patient had nausea and dizziness after vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Neuropathy peripheral
Clinical narrative: Neuropathy; GBS; This case was reported by a other health professional via sales rep and described the occurrence of neuropathy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy and guillain barre syndrome were unknown.   It was unknown if the reporter considered the neuropathy and guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The reporter had third hand information about the case from  the clinic. The reporter did not wish to be contacted. It was reported that, the case had been reported to VAERS and the reporter was unaware of the outcome. This case is 1 of the 3 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Encephalitis viral
Clinical narrative: Viral encephalitis; This case was reported by a other health professional via sales rep and described the occurrence of viral encephalitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced viral encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the viral encephalitis was unknown.   It was unknown if the reporter considered the viral encephalitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The reporter had third hand information about the case from  the clinic and did not wish to be contacted. This case is 1 of the 3 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome, Respiratory failure
Clinical narrative: Death; guillain barre syndrome; respiratory failure; This case was reported by a lawyer and described the occurrence of death in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and respiratory failure (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the guillain barre syndrome and respiratory failure were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death, guillain barre syndrome and respiratory failure to be related to Shingrix.  Additional details were provided as follow: The initial information received via legal attorney indicating a client whose relative experienced Guillain Barre syndrome and resulting respiratory failure and death an unspecified amount of time after receiving Shingrix.; Reported Cause(s) of Death: unknown cause of death
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Left arm pain.  Seen on 11/13/2018 ; PT 2x per week for 4 weeks recommended
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Lymphadenopathy, Neck pain
Clinical narrative: Feeling really bad with flu-like symptoms; Felt like glands were swollen; Tenderness in throat; Tenderness in neck; Very painful when the vaccine was going into arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced influenza-like symptoms, swollen glands, throat discomfort and neck pain. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, swollen glands, throat discomfort and neck pain were recovering/resolving.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, swollen glands, throat discomfort and neck pain to be related to Shingrix.  Additional details were received as follows: The patient stated that after vaccination She described that it was very painful when the vaccine was going into her arm. The patient said she experienced 72 hours of feeling really bad with flu-like symptoms.   The patient felt like her glands were swollen and had tenderness in her throat and neck. These symptoms started to taper after three days, however, she did not feel back to normal until approximately 10 days later. This case has been linked to US2019AMR204588, reported by the same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal discomfort, Tenderness
Clinical narrative: Feeling really bad with flu-like symptoms; Felt like glands were swollen; Tenderness in throat; Tenderness in neck; Very painful when the vaccine was going into arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced influenza-like symptoms, swollen glands, throat discomfort and neck pain. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, swollen glands, throat discomfort and neck pain were recovering/resolving.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, swollen glands, throat discomfort and neck pain to be related to Shingrix.  Additional details were received as follows: The patient stated that after vaccination She described that it was very painful when the vaccine was going into her arm. The patient said she experienced 72 hours of feeling really bad with flu-like symptoms.   The patient felt like her glands were swollen and had tenderness in her throat and neck. These symptoms started to taper after three days, however, she did not feel back to normal until approximately 10 days later. This case has been linked to US2019AMR204588, reported by the same reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Influenza like illness, Injected limb mobility decreased, Malaise
Clinical narrative: flu like symptoms; Left arm was extremely sore; Could barely lift arm; Malaise / Sick; chills; feel worse; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Measles vaccine (received vaccine on an unknown date with no reactions) and Flu vaccine (received on an unknown date).   On 12th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th October 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, injected limb mobility decreased, malaise, chills and feeling abnormal. On 15th October 2019, the outcome of the influenza-like symptoms was resolved with sequelae and the outcome of the pain in arm, injected limb mobility decreased, malaise and chills were recovered/resolved. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, injected limb mobility decreased, malaise, chills and feeling abnormal to be related to Shingrix.  Additional details were received as follows: The patient reported that she received the first dose of Shingrix  and within a couple of hours her left arm was extremely sore and she could barely lift her arm. The patient started to feel worse in the night and experienced malaise and chills. The patient also indicated that she always gets the flu shot and has had the measles vaccine previously with no reactions. The patient consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: flu like symptoms; Left arm was extremely sore; Could barely lift arm; Malaise / Sick; chills; feel worse; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Measles vaccine (received vaccine on an unknown date with no reactions) and Flu vaccine (received on an unknown date).   On 12th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th October 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, injected limb mobility decreased, malaise, chills and feeling abnormal. On 15th October 2019, the outcome of the influenza-like symptoms was resolved with sequelae and the outcome of the pain in arm, injected limb mobility decreased, malaise and chills were recovered/resolved. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, injected limb mobility decreased, malaise, chills and feeling abnormal to be related to Shingrix.  Additional details were received as follows: The patient reported that she received the first dose of Shingrix  and within a couple of hours her left arm was extremely sore and she could barely lift her arm. The patient started to feel worse in the night and experienced malaise and chills. The patient also indicated that she always gets the flu shot and has had the measles vaccine previously with no reactions. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site was painful; Injection site was swollen; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received on an unknown date).   On 5th September 2019, the patient received the 1st dose of Shingrix. On 5th September 2019, the dose was an unknown dose. On 5th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination experienced  injection site pain and injection site swelling. On 12th November 2019 the patient received the 2nd dose and it sprayed all over her arm.  On an unknown date this year, the Health care professional received an unknown flu vaccine and it sprayed all over her arm. The patient consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Insomnia, Malaise
Clinical narrative: tired; headache; muscle pain; fever; sweating; couldn't sleep; Felt sick; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 17th November 2019, the patient received the 2nd dose of Shingrix. On 17th November 2019, the dose was an unknown dose. In November 2019, less than a week after receiving Shingrix, the patient experienced tiredness, headache, muscle pain, fever, sweating, sleeplessness and feeling unwell. On an unknown date, the outcome of the tiredness, headache, muscle pain, fever, sweating, sleeplessness and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the tiredness, headache, muscle pain, fever, sweating, sleeplessness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: After vaccination with dose of Shingrix, the patient felt very tired, had bad headache, muscle pain, fever and sweting and trouble sleeping. The patient felt sick for 3 days. On 19th November 2019, the patient started feeling better. The reporter did not consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: tired; headache; muscle pain; fever; sweating; couldn't sleep; Felt sick; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 17th November 2019, the patient received the 2nd dose of Shingrix. On 17th November 2019, the dose was an unknown dose. In November 2019, less than a week after receiving Shingrix, the patient experienced tiredness, headache, muscle pain, fever, sweating, sleeplessness and feeling unwell. On an unknown date, the outcome of the tiredness, headache, muscle pain, fever, sweating, sleeplessness and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the tiredness, headache, muscle pain, fever, sweating, sleeplessness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: After vaccination with dose of Shingrix, the patient felt very tired, had bad headache, muscle pain, fever and sweting and trouble sleeping. The patient felt sick for 3 days. On 19th November 2019, the patient started feeling better. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: redness at injection site; blister at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax.   On 19th November 2019, the patient received the 1st dose of Shingrix. On 20th November 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site blisters. Shingrix was continued with no change. On an unknown date, the outcome of the injection site erythema and injection site blisters were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient noticed redness at the injection site and started applying a cold compress to the site.  The patient stated that, she later noticed a blister at the injection site as well. The reporter did not consented to follow up. The patient declined to provide address, date of birth, or healthcare professional information.
Sex: U
Vaccine: MENB
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This case was reported by a consumer via sales rep and described the occurrence of fever 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 fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Bexsero.  Additional information was received as follows: The age at vaccination was not reported. The patient experienced fever and chills with no loss of consciousnesses after received Bexsero. Information about health care provider was not provided as the reporter did not have the information.Information about patient was not provided as the reporter did not have the information.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema, Peripheral swelling
Clinical narrative: redness at injection site; pimples with small red dots from knees to ankles; swelling on legs; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Concurrent medical conditions included penicillin allergy. Concomitant products included METHOTREXATE (RASUVO) and ADALIMUMAB (HUMIRA).   On 12th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th November 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, pimples and swelling of legs. On an unknown date, the outcome of the injection site erythema, pimples and swelling of legs were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, pimples and swelling of legs to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient received dose of Shingrix in the phaymacy. The patient received Rasuvo and Humira as a concomitant medication. The reporter provided only partial information at the pharmacy. The reporter consented to follow up with the patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity
Clinical narrative: Leg and back body pain; body aches in her legs and back area; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 11 hrs after receiving Shingrix, the patient experienced leg pain and back pain. On an unknown date, the outcome of the leg pain and back pain were unknown.   It was unknown if the reporter considered the leg pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 20th November 2019, at 2 pm, the patient received dose of Shingrix and at about 1am at night later experienced body aches in her legs and back area. No further details were provided. The reporter did not consent to follow up.