chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Bone pain, Herpes zoster, Influenza like illness
Clinical narrative: bone aches; difficulty to move; flu like symptoms; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 30-SEP-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the vaccine, the pt suffered blisters and pain in lower back, left leg to bottom of foot, body and bone aches, difficulty to move and flu like symptoms, and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of vaccination, she 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 the vaccine, the pt also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).   All the events were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: bone aches; difficulty to move; flu like symptoms; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 30-SEP-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the vaccine, the pt suffered blisters and pain in lower back, left leg to bottom of foot, body and bone aches, difficulty to move and flu like symptoms, and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of vaccination, she 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 the vaccine, the pt also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).   All the events were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Facial pain, Herpes zoster, Rash, Skin lesion
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 27-JUL-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot# and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered facial painful rash, swollen cheeks, blisters and small lesions that expanded to large lesions, pain and swelling of face and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), her symptoms resulted in physical limitations not presented prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was determined to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 27-JUL-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot# and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered facial painful rash, swollen cheeks, blisters and small lesions that expanded to large lesions, pain and swelling of face and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), her symptoms resulted in physical limitations not presented prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was determined to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster viral infection of face and ear nerves; shingles; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 27-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered chronic herpes zoster outbreaks and diagnosed with herpes zoster viral infection of face and ear nerves, shingles, and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered all events to be disability.  Upon internal review, the event of herpes zoster oticus was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litgation on 30-MAR-2021. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 30-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, route of administration and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after receiving zoster vaccine live (ZOSTAVAX), the patient experienced herpes zoster. As a result of these symptoms, she was seen and treated by her medical providers and was still under their care. As a result and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, patient's symptoms had resulted in sustained severe, permanent and incurable personal injuries not present prior to vaccination, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of herpes zoster was considered as not recovered. The reporters considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered herpes zoster as a disabling event.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Cough, Dyspnoea, Pain
Clinical narrative: chronic obstructive pulmonary disease exacerbation; viral infection with superimposed pneumonia; viral infection with superimposed pneumonia; This spontaneous report was received from a lawyer and a male patient of unknown age regarding a case in litgation on 30-MAR-2021. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 25-APR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, route of administration and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after receiving zoster vaccine live (ZOSTAVAX), the patient experienced increased shortness of breath, body aches and cough, which was diagnosed as viral infection with superimposed pneumonia and chronic obstructive pulmonary disease exacerbation, which required hospitalization on unspecified dates. As a result and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, patient's symptoms had resulted in sustained severe, permanent and incurable personal injuries not present prior to vaccination, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome ofviral infection with superimposed pneumonia and chronic obstructive pulmonary disease exacerbation was considered as not recovered. The reporters considered all the events to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered viral infection with superimposed pneumonia and chronic obstructive pulmonarydisease exacerbation as a disabling events. Upon internal review, the event of pneumonia was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia, Viral infection
Clinical narrative: chronic obstructive pulmonary disease exacerbation; viral infection with superimposed pneumonia; viral infection with superimposed pneumonia; This spontaneous report was received from a lawyer and a male patient of unknown age regarding a case in litgation on 30-MAR-2021. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 25-APR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, route of administration and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after receiving zoster vaccine live (ZOSTAVAX), the patient experienced increased shortness of breath, body aches and cough, which was diagnosed as viral infection with superimposed pneumonia and chronic obstructive pulmonary disease exacerbation, which required hospitalization on unspecified dates. As a result and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, patient's symptoms had resulted in sustained severe, permanent and incurable personal injuries not present prior to vaccination, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome ofviral infection with superimposed pneumonia and chronic obstructive pulmonary disease exacerbation was considered as not recovered. The reporters considered all the events to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered viral infection with superimposed pneumonia and chronic obstructive pulmonarydisease exacerbation as a disabling events. Upon internal review, the event of pneumonia was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness neurosensory
Clinical narrative: sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 03-MAY-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from and was diagnosed with sensorineural hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of sensorineural hearing loss was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event of sensorineural hearing loss to be disability.  Upon internal review, the event of sensorineural hearing loss was determined to be medically significant.
Age: 3.0
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no further AE; Patient was administed PREVNAR 13 followed by PNEUMOVAX 23 before the recommended 8 week administration spacing interval.; This spontaneous report was received from a nurse and refers to a 3-year-old patient of unknown gender. The patient's concurrent conditions included human immunodeficiency virus (HIV) infection. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 11-MAR-2021, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (exact dose, injection site, route of administration, lot # and expiration date were not reported). On 29-MAR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vial, 0.5 milliliter, lot # S028602, expiration date 28-JUN-2021 (injection site and route of administration were not reported) for prophylaxis.  The reporter stated it was sooner than the recommended spacing of 8 weeks between the 2 vaccines for immunocompromised patients. There was not further adverse events.
Sex: F
Vaccine: FLUN4
Symptoms: Illness
Clinical narrative: Getting sick from flu shot; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2016-2017 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (dose received on an unknown date, for tolerance refer case US2021AMR072617). Concurrent medical conditions included asthma, renal insufficiency, intestinal obstruction, shellfish allergy, sulfonamide allergy and allergy to antibiotic (Allergic to bactrim). Concomitant products included simvastatin.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2016-2017 season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2016-2017 season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent 2016-2017 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Influenza vaccine Quadrivalent 2016-2017 and experienced sickness. The patient could not get infulenza vaccine because it contains egg content. The patient also took versed which made her quit breathing. The patient was allergic to Bactrim and almost died at the hospital, went to acute renal failure and partial bowel blockage.  The patient now had renal insufficiency that scared her right kidney. The patient had been taking ACE inhibitors and simvastatin which worked well and gave her lungs more protection. The patient could not have any contrast dyes that caused anaphylactic shock and could not take Doxycycline. The patient was asking if the vaccine contains iodine. The patient did not want to be contacted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR072618:Friend's case US-GLAXOSMITHKLINE-US2021AMR072617:Shingrix case
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Mild reactions / Shingles break out; Reaction might be from the binders; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of illness (received Flu shot in 2016, for tolerance refer case- US2021AMR072602). Concurrent medical conditions included asthma, renal insufficiency (scared her right kidney), shellfish allergy and allergy to antibiotic (was allergic to sulfa antibiotics like Bactrim). Concomitant products included simvastatin.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and reaction to excipient. The patient was treated with benadryl (nos) (Benadryl) and steroids nos (Steroids). On an unknown date, the outcome of the shingles and reaction to excipient were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine and had mild reactions to it and shingles broke out. The reporter mentioned that, the reactions might be from the binders. The follow up dose was pretreated because of shingles break out. The patient had been taking Benadryl and steroids as a treatment medication. The patient also took versed which made her quit breathing. The patient was allergic to Bactrim and almost died at the hospital, went to acute renal failure and partial bowel blockage. The patient now had renal insufficiency that scared her right kidney. The patient had been taking ACE inhibitors and simvastatin which worked well and gave her lungs more protection. The patient could not have any contrast dyes that caused anaphylactic shock and could not take Doxycycline. The patient was asking if the vaccine contains iodine. The patient did not want to be contacted. The case had been linked with the case- US2021AMR072618 and US2021AMR072602, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR072618:Reporter's case (Shingles vaccine) US-GLAXOSMITHKLINE-US2021AMR072602:Shingrix case
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain
Clinical narrative: it was like kind of hard to breathe sometimes; Sore body; This case was reported by a consumer via patient support programs and described the occurrence of general body pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain and difficulty breathing. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the difficulty breathing was unknown.   It was unknown if the reporter considered the general body pain and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: Patient received Shingrix dose on an unknown date. Age was not reported. Shingrix shot caused him to be sore for 2 weeks.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073236:Pharma case
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Aches; Tiredness; This case was reported by a consumer and described the occurrence of fever 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 fever, pain and tiredness. On an unknown date, the outcome of the fever, pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the fever, pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received 2nd dose of Shingrix vaccine and experienced fever, aches and tiredness. The patient wanted to know how long these events might last. No further information was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; I got shingles from the shot too; horrible pain; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. After receiving Shingles vaccine, the patient experienced shingles. The patient also had horrible pain for 6 weeks. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073599:same reporter
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: not reconstituted with the supplied diluent / possibly reconstituted with sterile water; patient received a dose of Hiberix that was not reconstituted with the supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 4925E, expiry date 24th October 2021) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was a medical assistant. The age at vaccination was not reported. The reporter stated that the patient received a dose of Hiberix that was not reconstituted with the supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter stated that the incorrect dose was possibly reconstituted with sterile water. The reporter consented to follow up. No further information reported. This is 1 of 4 cases reported by the same reporter. Note: All the linked cases were conservatively kept valid as the reporter was unsure which patient had received the incorrectly reconstituted dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073598:same reporter US-GLAXOSMITHKLINE-US2021073386:same reporter US-GLAXOSMITHKLINE-US2021AMR073597:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles from the shot too/suspected vaccination failure; I got shingles from the shot too; This case was reported by a consumer via and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting. This case had been linked with case US2021AMR073595, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073595:same reporter, different patient
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: Chills; Vomiting; Diarrhea; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, vomiting and diarrhea. On an unknown date, the outcome of the chills, vomiting and diarrhea were unknown.   It was unknown if the reporter considered the chills, vomiting and diarrhea to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination not reported. The reporter stated, she experienced chills, vomiting and diarrhea, after unspecified shingles vaccine. The reporter did not want to fill adverse event report form. The case had been linked with US2021AMR072113 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR072113:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; My friend got the vaccine and still got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's friend. 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 received the vaccine and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: go through it it was awful; This case was reported by a consumer and described the occurrence of feels awful in a 93-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient's son/daughter. The age at vaccination was not reported. The patient received vaccine and felt awful. No other information was reported. This case has been linked with case US2021AMR073663, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073663:same reporter
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: sore arm; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm, erythema and swelling. On an unknown date, the outcome of the pain in arm, erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: Office manager reported the case for her daughter. The age at vaccination was not reported. The patient had had sore arm, redness, and swelling for approximately one week following a dose of Bexsero. The reporter did not consent to follow up. For tolerance of 2nd dose of Bexsero refer link case US2021AMR073690.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073690:same patient
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Vaccine positive rechallenge
Clinical narrative: sore arm; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pain in extremity (1st dose received on an unknown date, patient experienced redness and swelling, refer link case US2021AMR073688).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm, erythema and swelling. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the pain in arm, erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: Office manager reported the case for her daughter. The age at vaccination was not reported. The patient had had sore arm, redness, and swelling for approximately one week following a dose of Bexsero. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073688:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: angioedema of the face; allergic reaction to the Shingrix vaccine; hives over entire body; pruritus; This case was reported by a other health professional via other manufacturer and described the occurrence of angioedema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included seafood allergy, iodine allergy and nickel sensitivity.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), allergic reaction, hives and pruritus. On an unknown date, the outcome of the angioedema, allergic reaction, hives and pruritus were unknown.   It was unknown if the reporter considered the angioedema, allergic reaction, hives and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient had allergies to all seafood, Iodine, Nickel and Acacia. Approximately 24 to 36 hours after receiving Shingrix vaccine, the patient developed angioedema of the face, hives over entire body and pruritus. The reporter if the pfizer covid vaccine could be recommended for the patient. The reporter did not consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: received his first dose / on 12/29/2020. He reported left arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2020, the patient received the 1st dose of Shingrix. On 29th December 2020, 4 hrs after receiving Shingrix, the patient experienced pain in arm. On 9th January 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The patient received 1st dose of Shingrix in the left arm at pharmacy. The reporter consented to follow up. This case was 1 of 2 linked cases, reported by same reporter. Lot numbers and expiration dates for vaccine was not known.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073779:same reporter (reporter´s case)
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness in her left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received the 1st dose of Shingrix in the left arm on 29th December 2020, refer case US2021073779). Concurrent medical conditions included vitamin d deficiency. Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 3rd March 2021, the patient received the 2nd dose of Shingrix. On 3rd March 2021, 4 hrs after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The lot numbers and expiration dates of all vaccines were not known. The patient received Shingrix in left arm and 4 hours later experienced soreness in her left arm. The reporter consented to follow up and gives permission to contact Facility.  The reporter refused offer to email Shingrix PI but did take MI telephone number to give to HCP.  The patient received another dose of Covid vaccines on 18th March 2021.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073782:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021AMR074237:Same reporter US-GLAXOSMITHKLINE-US2021073779:same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Reaction to previous exposure to any vaccine, Vaccine positive rechallenge
Clinical narrative: soreness in her left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received the 1st dose of Shingrix in the left arm on 29th December 2020, refer case US2021073779). Concurrent medical conditions included vitamin d deficiency. Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 3rd March 2021, the patient received the 2nd dose of Shingrix. On 3rd March 2021, 4 hrs after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The lot numbers and expiration dates of all vaccines were not known. The patient received Shingrix in left arm and 4 hours later experienced soreness in her left arm. The reporter consented to follow up and gives permission to contact Facility.  The reporter refused offer to email Shingrix PI but did take MI telephone number to give to HCP.  The patient received another dose of Covid vaccines on 18th March 2021.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073782:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021AMR074237:Same reporter US-GLAXOSMITHKLINE-US2021073779:same reporter
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: received his second dose / on 03/03/2021/ reported right arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 29th December 2020, refer case US2021AMR074237). Concomitant products included COVID-19 VACCINE.   On 3rd March 2021, the patient received the 2nd dose of Shingrix. On 3rd March 2021, 4 hrs after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On 7th March 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. On 17th February 2021, the patient received 1st dose of Covid vaccine in unknown arms. The patient stated that he received 2nd dose of Shingrix in right arm at pharmacy and experienced pain in arm after 4 hours and was resolved on 7th March 2021. The reporter consented to follow up and given permission to contact his healthcare professional.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073779:same reporter (reporter´s case) US-GLAXOSMITHKLINE-US2021AMR074237:Same reporter
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Reaction to previous exposure to any vaccine, Vaccine positive rechallenge
Clinical narrative: received his second dose / on 03/03/2021/ reported right arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 29th December 2020, refer case US2021AMR074237). Concomitant products included COVID-19 VACCINE.   On 3rd March 2021, the patient received the 2nd dose of Shingrix. On 3rd March 2021, 4 hrs after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On 7th March 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. On 17th February 2021, the patient received 1st dose of Covid vaccine in unknown arms. The patient stated that he received 2nd dose of Shingrix in right arm at pharmacy and experienced pain in arm after 4 hours and was resolved on 7th March 2021. The reporter consented to follow up and given permission to contact his healthcare professional.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073779:same reporter (reporter´s case) US-GLAXOSMITHKLINE-US2021AMR074237:Same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: All over body rash; This case was reported by a physician via sales rep and described the occurrence of generalized rash in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had all over body rash. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Couldn't lift her arm for several days; Couldn't lift her arm for several days / still hurts 2 weeks later; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a 18-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   In March 2021, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, less than 2 weeks after receiving Meningococcal B vaccine, the patient experienced mobility decreased and pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the mobility decreased and pain in arm to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent. The patient got the second shot 2 weeks before the date of reporting and she could not lift her arm for several days and it still hurt 2 weeks later. It was reported that it had never happened to the patient with other vaccines, and she had an extremely high pain tolerance. The reporter commented that it was scary reading all the posts with adverse reactions to this vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Have a rash that itches behind both knees and behind my elbows; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. On 29th March or 30th March 2021, the patient noticed a rash that itched behind both knees and behind elbows.  The patient asked if this was normal.