chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; an expired VARlVAX was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-MAR-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S006022, expiration date: 27-FEB-2021, 0.5 milliliter (formulation, strength, frequency, route of administration were not reported) for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Corneal erosion, Herpes zoster, Macular fibrosis, Ophthalmic herpes simplex
Clinical narrative: herpes simplex keratitis of left eye/cornea; epiretinal membrane of the left eye; corneal erosion of the left eye; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 21-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster, herpes simplex keratitis of left eye/cornea (ophthalmic herpes simplex), corneal erosion of the left eye, and epiretinal membrane of the left eye (macular fibrosis). The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events ophthalmic herpes simplex, and macular fibrosis were determine to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues; multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues; multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues; Information had been received on 08-MAR-2021 from a lawyer regarding a case in litigation. This case is regarding a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified date, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information was not provided) for routine health maintenance and the prevention of shingles. On unspecified date after vaccination, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, and vision issues. As a result of these symptoms the patient was seen and treated by medical providers and was still under their care. As a result of the receipt of Zoster Vaccine Live (ZOSTAVAX) the patient sustained severe and permanent personal injuries, also reported as serious, progressive, permanent, and incurable injuries. At the time of the report, the patient had not recovered from the events, and the reporter considered the adverse events to be related to suspect therapy. According to the reporter, the events of herpes zoster, post herpetic neuralgia and vision impairment were considered disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder, Post herpetic neuralgia
Clinical narrative: shingles, and Postherpetic neuralgia and other zoster-related conditions; shingles, and Postherpetic neuralgia and other zoster-related conditions; shingles, and Postherpetic neuralgia and other zoster-related conditions; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 17-JUL-2010, the patient was vaccinated at the pharmacy with zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported).        On an unknown date, subsequent to zoster vaccine live(ZOSTAVAX) inoculation, the patient was treated by healthcare providers, at the medical office for shingles, and Postherpetic neuralgia and other zoster-related conditions. Consequently the patient suffered and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The outcome of herpes zoster, ill-defined disorder and post herpetic neuralgia was considered as not recovered.   The lawyer considered herpes zoster, ill-defined disorder and post herpetic neuralgia to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: multiple outbreaks of a painful itchy rash and herpes zoster; multiple outbreaks of a painful itchy rash and herpes zoster; multiple outbreaks of a painful itchy rash and herpes zoster; The information was received from a lawyer refers to a patient of unknown age and gender. The patient's concurrent conditons, historical conditions and concomitant therapy were not reported. On or about 26-SEP-2017, patientf was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered multiple outbreaks of a painful itchy rash and herpes zoster. As a result of these symptoms, patient  was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using the product. Patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition.As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, 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. As a direct and proximate result of company's conduct, patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The events were considered to be related to zoster vaccine live (ZOSTAVAX).      On 26-SEP-2017 the patient was vaccinated with zoster vaccine live (ZOSTAVAX), unknown for routine health maintenance and prophylaxis.       On an unknown date the patient experienced rash pruritic (disability), herpes zoster (disability) and rash (disability).    The outcome of herpes zoster, rash and rash pruritic is unknown.   The reporter considered rash pruritic, herpes zoster and rash to be related to Zoster Vaccine Live(ZOSTAVAX).     {Additional information has been requested. / Additional information is not expected.}
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; Information had been received on 09-MAR-2021 from a lawyer regarding a case in litigation. This case is regarding a currently 72-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 11-SEP-2012, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information was not provided) for the prevention of shingles at the physician's office. On unspecified date after vaccination, the patient suffered rheumatoid arthritis. At the time of the report, the patient's outcome was unknown, and the reporter considered the adverse event to be related to suspect therapy.  Upon internal review, the event of rheumatoid arthritis was considered medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles and other zoster-related conditions.; shingles and other zoster-related conditions.; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. Information regarding the pt's concurrent conditions, medical history and concomitant medications was not provided.     On or about 12-AUG-2012, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.         On an unknown date, subsequently to  zoster vaccine live(ZOSTAVAX) administration, the pt experienced shingles and other zoster-related conditions treated by the family doctor. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continued suffering  ongoing injuries, including but not limited to: mental, physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continued to suffer such losses, and damages in the future.  By the time of this report, the pt had not recovered from shingles. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Illness, Product dose omission issue
Clinical narrative: second GARDASIL 9 dose which she has not yet received; missed dose GARDASIL 9 vaccine; due to illness; This spontaneous report was received from a pharmacist referring to a 27-year-old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.    On 17-OCT-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml, for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were not reported).         On 17-DEC-2020, the patient experienced illness. On an unreported date, she missed a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).   On 10-MAR-2021, she was vaccinated with SARS-CoV-2 vaccine (unspecified) (reported as "COVID 19 vaccine"). At the time of reporting, the outcome of the event was unknown.   The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: no additional adverse event reported; the patient received her first dose 21AUG2018 and her second dose 27DEC2018 and has not received her third dose yet; This spontaneous report was received from a pharmacist and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 21-aug-2018, the patient was vaccinated with fist and on 27-DEC-2018, with the second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration dates were not reported) for prophylaxis. The patient did not receive her third dose yet. No additional adverse event was reported.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: dizzy; throwing up; fever; headache; nausea; This case was reported by a consumer via other manufacturer and described the occurrence of dizziness in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TOZINAMERAN (PFIZER-BIONTECH COVID-19 VACCINE) for prophylaxis.   The patient's past medical history included splenectomy. Previously administered products included Shingles vaccine (1st dose received in right arm).   On 8th January 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE. In January 2021, less than a week after receiving Shingles vaccine, the patient experienced dizziness, vomiting, fever, headache and nausea. On an unknown date, the outcome of the dizziness, vomiting, fever, headache and nausea were unknown.   It was unknown if the reporter considered the dizziness, vomiting, fever, headache and nausea to be related to Shingles vaccine.  Additional information was provided as follows: The case was reported by patient herself. The age at vaccination was not reported, however she was in her 60s. Last Friday from the day of reporting, the patient got her mass shingles vaccine shot in her left arm.  The patient experienced reactions that were dizzy, throwing up, headache, fever and nausea. The patient wanted to know how long till she get the 2nd dose of the COVID vaccine, Could she get the COVID vaccine elsewhere if did not get it at work a day after reporting and were both doses of the COVID vaccine from the same company. The patient would like to know what Pfizers recommendation was. Should she get the COVID vaccine shot a day after reporting based on her reaction to another vaccine. The patient's family doctors nurse said to go ahead and get the vaccine. The reporter did not consent to follow up. It was unknown if the reporter considered the dizziness, vomiting, fever, headache and nausea to be related to Pfizer-Biontech COVID-19 Vaccine.
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: little arm ache; still had antibodies in my system; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included covid-19 (isolated himself in his loft from 17th March 2020 till 01st April 2020).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On 23rd November 2020, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced covid-19. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and covid-19 were unknown.   It was unknown if the reporter considered the pain in arm and covid-19 to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine every year and experienced arm ache. Seven months after his initial Covid infection, on 23rd November 2020, the patient still had antibodies in his system. The patient did not have respiratory issues. For the tolerance of Shingrix dose, refer linked case US2021AMR011219.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR011219:same patient, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Scar
Clinical narrative: scar; This case was reported by a nurse via interactive digital media and described the occurrence of scar in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2007).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced scar. On an unknown date, the outcome of the scar was unknown.   It was unknown if the reporter considered the scar to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had the two shots in 2019.  Had a scar on neck from them.  The patient I can't wear a backless because of my scar.  It was reported they do affect your life sometimes, by the way the patient was a retired nurse.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Cough, Headache
Clinical narrative: Intense symptoms bad headache; Intense symptoms / Chills and shaking and couldn't hold a cup to drink; Intense symptoms / Muscles / ached and were painful; Intense symptoms / Joints ached and were painful; Intense symptoms / Bilateral lower back pain; Intense symptoms / Cough; couldn't hold a cup to drink; This case was reported by a nurse via other manufacturer and described the occurrence of headache in a 74-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, less than a day after receiving Shingrix, the patient experienced headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder. On an unknown date, the outcome of the headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder were unknown.   It was unknown if the reporter considered the headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had intense symptoms bad headache, chills and shaking and could not hold a cup to drink, muscles and joints ached and were painful bilateral lower back pain and a cough. The events resolved but still had a dry cough and developed and odor, burning plastic and taste started to diminish.  Odor continued and no taste and pharyngitis.  No fever reported. For tolerances of 2nd dose, refer case US2021AMR028715, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028715:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Hypogeusia, Loss of personal independence in daily activities, Myalgia, Parosmia, Pharyngitis
Clinical narrative: Intense symptoms bad headache; Intense symptoms / Chills and shaking and couldn't hold a cup to drink; Intense symptoms / Muscles / ached and were painful; Intense symptoms / Joints ached and were painful; Intense symptoms / Bilateral lower back pain; Intense symptoms / Cough; couldn't hold a cup to drink; This case was reported by a nurse via other manufacturer and described the occurrence of headache in a 74-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, less than a day after receiving Shingrix, the patient experienced headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder. On an unknown date, the outcome of the headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder were unknown.   It was unknown if the reporter considered the headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had intense symptoms bad headache, chills and shaking and could not hold a cup to drink, muscles and joints ached and were painful bilateral lower back pain and a cough. The events resolved but still had a dry cough and developed and odor, burning plastic and taste started to diminish.  Odor continued and no taste and pharyngitis.  No fever reported. For tolerances of 2nd dose, refer case US2021AMR028715, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028715:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Intense symptoms bad headache; Intense symptoms / Chills and shaking and couldn't hold a cup to drink; Intense symptoms / Muscles / ached and were painful; Intense symptoms / Joints ached and were painful; Intense symptoms / Bilateral lower back pain; Intense symptoms / Cough; couldn't hold a cup to drink; This case was reported by a nurse via other manufacturer and described the occurrence of headache in a 74-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, less than a day after receiving Shingrix, the patient experienced headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder. On an unknown date, the outcome of the headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder were unknown.   It was unknown if the reporter considered the headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had intense symptoms bad headache, chills and shaking and could not hold a cup to drink, muscles and joints ached and were painful bilateral lower back pain and a cough. The events resolved but still had a dry cough and developed and odor, burning plastic and taste started to diminish.  Odor continued and no taste and pharyngitis.  No fever reported. For tolerances of 2nd dose, refer case US2021AMR028715, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028715:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm turned really red; Arm turned really / swelled up; This case was reported by a nurse via other manufacturer and described the occurrence of erythema of extremities in a 74-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 erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were reported as follows: The patient was a retired residential nurse. The patient had no medical history (including any illness) and no family medical history relevant to adverse events. The patient stated that she got her 1st dose of Shingrix and her arm turned really red and swelled up, so her physician told her not to take the 2nd dose. In 2019, the patient had a spinal fusion and had been doing great. The reporter consented to follow-up but did not consent to follow-up with prescribing healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: my arm was swollen; big rash on my arm; This case was reported by a consumer via other manufacturer and described the occurrence of swelling arm 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 swelling arm and rash. On an unknown date, the outcome of the swelling arm and rash were unknown.   It was unknown if the reporter considered the swelling arm and rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. 3 years ago, or so, the patient received 1st dose of Shingrix and experienced a big rash on my arm and was swollen. The physician said it was not a normal response and after that doctor told her to do not take the 2nd shot. The patient stated that she did not like that physician very much, so she called somebody, a nurse practitioner who gives vaccines for when you travel and the nurse advised her to take an ibuprofen and Benadryl before vaccinations.  The reporter's and healthcare professional s consent to follow-up was reported as not applicable.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Looks like flu; I felt like crap; Headache; Fever; Muscle / aches; Joint aches; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 10th February 2021, the patient received the 2nd dose of Shingrix. On 10th February 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, feels awful, headache, fever, muscle pain and joint pain. On an unknown date, the outcome of the influenza-like symptoms, feels awful, headache, fever, muscle pain and joint pain were unknown.   The reporter considered the influenza-like symptoms, feels awful, headache, fever, muscle pain and joint pain to be possibly related to Shingrix. Additional details were provided as follows: The patient was reporting for himself. The age at vaccination was not reported. On 10th February 2020, the patient received Shingrix in afternoon and in night he experienced flu like reaction. Overnight, the patient felt like crap with headache, fever, muscle and joint pain.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Fever; Chills; Aching left leg; Left leg tender; Left leg / red / Leg is still /pink; Left leg / swollen / Still swollen / foot; Still swollen ankle; Leg is peeling; Leg is / still warm to touch; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced fever, chills, leg pain, tenderness, redness of legs, swelling of legs, ankle swelling, skin peeling and skin warm. On an unknown date, the outcome of the fever, chills, leg pain, tenderness, redness of legs, swelling of legs, ankle swelling, skin peeling and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, leg pain, tenderness, redness of legs, swelling of legs, ankle swelling, skin peeling and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. Two weeks after second shot the patient experienced fever, chills, aching left leg tender, red and swollen. After four weeks the patient had still swollen ankle and foot leg was peeling and still warm to touch and pink.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Skin exfoliation, Skin warm, Tenderness
Clinical narrative: Fever; Chills; Aching left leg; Left leg tender; Left leg / red / Leg is still /pink; Left leg / swollen / Still swollen / foot; Still swollen ankle; Leg is peeling; Leg is / still warm to touch; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced fever, chills, leg pain, tenderness, redness of legs, swelling of legs, ankle swelling, skin peeling and skin warm. On an unknown date, the outcome of the fever, chills, leg pain, tenderness, redness of legs, swelling of legs, ankle swelling, skin peeling and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, leg pain, tenderness, redness of legs, swelling of legs, ankle swelling, skin peeling and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. Two weeks after second shot the patient experienced fever, chills, aching left leg tender, red and swollen. After four weeks the patient had still swollen ankle and foot leg was peeling and still warm to touch and pink.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: head aches since taking shot a month or so ago; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.  Additional information was provided as follows: The case was reported by patient. The age at vaccination was not reported, however could be 65 or 66 years old. The patient experienced head aches since taking shot a month or so before reporting. The patient was asking when would head aches go away. The patient did not know the name of vaccine, only knew it was for shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Bad reaction after the first dose / Fever; Bad reaction after the first dose / Flu like reactions; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2019, the patient received Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingles vaccine.  Additional details were reported as follows: The patient reporter for herself. The age at vaccination was not reported. The patient experienced fever and flu like reactions after having 1st dose of Shingles. The patient had 2nd dose of vaccination in February 2020 The patient consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: "super sore arm."; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine (received the previous shingles vaccine prior to the 1st dose of the Shingrix).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years 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 patient received Shingrix about 2 years ago and not having any side effects from it except sore arm. The reporter consented to follow up. Not all information was available and was unable to provide the lot number, expiration for the vaccine.  The patient did give permission to follow up with their HCP and was unable to provide HCP's email and fax. For tolerances of 2nd dose, refer case US2021048462, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021048462:same patient, same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: some patients feel "a little peeked"; This case was reported by a consumer and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not reported. The reporter's physician stated that, the some patients felt a little peeked the next day after vaccination. The patient believed in vaccinations, but if asked by friends and acquaintances, will provide an honest and unflattering appraisal of his or her experience and understand it was his or her immune response working, but would suggest research to discover a way to mitigate side effects. Otherwise, there would be reluctance from the public to acquire this vaccine as it was reputation spreads. This case was linked with US2021AMR028707, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028707:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccinated Shingrix / (1/25/2020, 11/22/2019) / I recently got Shingles; Vaccinated Shingrix / (1/25/2020, 11/22/2019) / I recently got Shingles; This case was reported by a consumer and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 22nd November 2019, the patient received the 1st dose of Shingrix. On 25th January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient was vaccinated Shingrix and recently got Shingles.  The patient asked besides the 90 percent affective, could you explain why the patient experienced Shingles. This case was considered as suspected vaccination failure since details regarding laboratory confirmation was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Injection site pain, Pain, Pyrexia
Clinical narrative: Chills; Fever; Bodyaches; injection site pain; Is there anything I can take to ease the discmfort; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever, general body pain, injection site pain and discomfort. On an unknown date, the outcome of the chills, fever, general body pain, injection site pain and discomfort were unknown.   It was unknown if the reporter considered the chills, fever, general body pain, injection site pain and discomfort to be related to Shingrix.  Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient was not comfortable to provide personal information. The patient took 2nd Shot of shingrix and experienced chills, fever,  body aches, injection site pain and asked for treatment of this discomfort.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Had 3 emergency room visits and one hospitalization; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a adult 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 hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient asked was it wise for the patient to get a COVID shot if the patient had 3 emergency room visits and one hospitalization after receiving the first shot of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: I had a tingling sensation in both arms; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a adult 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 tingling of extremity. On an unknown date, the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the tingling of extremity 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 it was selected as adult as per the vaccine indication. The patient received the shingrix vaccine and experienced tingling in both the arms. The patient asked, if this could be concern to not get 2nd dose. No further information reported. The patient consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic shock
Clinical narrative: Had anaphylactic shock; This case was reported by a consumer via other manufacturer and described the occurrence of anaphylactic shock in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced anaphylactic shock (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic shock was unknown.   It was unknown if the reporter considered the anaphylactic shock to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The reporter reported for herself. The age at vaccination was not reported. The patient had anaphylactic shock with the flu shot.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Influenza like illness, Injury corneal, Ophthalmic herpes zoster
Clinical narrative: flu like symptoms; fever; body aches.; Corneal damage; 1 year later / developed / shingles outbreak in October of 2020; October outbreak was severe / able to clear / without further vision loss / ophthalmological shingles; 1 year later / developed / shingles outbreak in October of 2020; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2020, 1 year after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and injury corneal. On an unknown date, the patient experienced influenza-like symptoms, fever and general body pain. On an unknown date, the outcome of the vaccination failure, shingles and injury corneal were unknown and the outcome of the ophthalmic herpes zoster, influenza-like symptoms, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, influenza-like symptoms, fever, general body pain and injury corneal to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and injury corneal to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was shingles sufferer and thus had to wait for a vaccine until they were completely convinced and was shingle free for 3 months before receiving 1st dose. The 1st dose of Shingrix injection was fine. Less than year after receiving 2nd dose of Shingrix, the patient experienced flu like symptoms, i.e., fever, body aches and stated no problem, patient would take 1 day of misery for protection from shingles. Moving ahead, 1 year later the developed another shingles outbreak in October 2020, then again in December 2020. The October outbreak was severe, the ophthalmologist was certain that the patient would lose the rest of vision. The patient was fortunate, that was able to clear both outbreaks without further vision loss. The patient asked that was Shingrix evaluated for effectiveness against ophthalmological shingles. The patient had severe corneal damage now in left eye and was born legally blind in right eye. The patient was hoping that Shingrix would protect the patient from further outbreaks. The patient understands the blood supply was limited to the eye and asked was this why Shingrix offered no protection from outbreaks.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061099:Duplicate case-
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Vaccination failure
Clinical narrative: flu like symptoms; fever; body aches.; Corneal damage; 1 year later / developed / shingles outbreak in October of 2020; October outbreak was severe / able to clear / without further vision loss / ophthalmological shingles; 1 year later / developed / shingles outbreak in October of 2020; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2020, 1 year after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and injury corneal. On an unknown date, the patient experienced influenza-like symptoms, fever and general body pain. On an unknown date, the outcome of the vaccination failure, shingles and injury corneal were unknown and the outcome of the ophthalmic herpes zoster, influenza-like symptoms, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, influenza-like symptoms, fever, general body pain and injury corneal to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and injury corneal to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was shingles sufferer and thus had to wait for a vaccine until they were completely convinced and was shingle free for 3 months before receiving 1st dose. The 1st dose of Shingrix injection was fine. Less than year after receiving 2nd dose of Shingrix, the patient experienced flu like symptoms, i.e., fever, body aches and stated no problem, patient would take 1 day of misery for protection from shingles. Moving ahead, 1 year later the developed another shingles outbreak in October 2020, then again in December 2020. The October outbreak was severe, the ophthalmologist was certain that the patient would lose the rest of vision. The patient was fortunate, that was able to clear both outbreaks without further vision loss. The patient asked that was Shingrix evaluated for effectiveness against ophthalmological shingles. The patient had severe corneal damage now in left eye and was born legally blind in right eye. The patient was hoping that Shingrix would protect the patient from further outbreaks. The patient understands the blood supply was limited to the eye and asked was this why Shingrix offered no protection from outbreaks.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061099:Duplicate case-