chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Central nervous system lesion, Headache, Herpes zoster, Migraine, Noninfective encephalitis
Clinical narrative: SLE; inflammatory infectious changes in her brain and 20 to 25 lesions on her brain; migraine headache syndrome; vasculitis; shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On 11-FEB-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) at a physician office for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately April 2016 (reported as "within two to three months of receiving zoster vaccine live(ZOSTAVAX)"), pt suffered severe and debilitating shingles, rashes and severe headaches and was subsequently diagnosed with migraine headache syndrome, vasculitis and systemic lupus erythematosus(SLE) due to inflammatory infectious changes in her brain and 20 to 25 lesions on her brain. All of these injuries were caused by zoster vaccine live(ZOSTAVAX). These symptoms and injuries remain today. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live(ZOSTAVAX), pt sustained severe and debilitating personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, 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), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, systemic lupus erythematosus due to inflammatory infectious changes in her brain and 20 to 25 lesions on her brain were determined to be medically significant. The events shingles, migraine headache syndrome, vasculitis and SLE due to inflammatory infectious changes in her brain and 20 to 25 lesions on her brain were considered as disability.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Systemic lupus erythematosus, Vasculitis
Clinical narrative: SLE; inflammatory infectious changes in her brain and 20 to 25 lesions on her brain; migraine headache syndrome; vasculitis; shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On 11-FEB-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) at a physician office for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately April 2016 (reported as "within two to three months of receiving zoster vaccine live(ZOSTAVAX)"), pt suffered severe and debilitating shingles, rashes and severe headaches and was subsequently diagnosed with migraine headache syndrome, vasculitis and systemic lupus erythematosus(SLE) due to inflammatory infectious changes in her brain and 20 to 25 lesions on her brain. All of these injuries were caused by zoster vaccine live(ZOSTAVAX). These symptoms and injuries remain today. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live(ZOSTAVAX), pt sustained severe and debilitating personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, 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), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, systemic lupus erythematosus due to inflammatory infectious changes in her brain and 20 to 25 lesions on her brain were determined to be medically significant. The events shingles, migraine headache syndrome, vasculitis and SLE due to inflammatory infectious changes in her brain and 20 to 25 lesions on her brain were considered as disability.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Nerve injury, Pain, Skin lesion
Clinical narrative: nerve damage; permanent tremors; neurological injuries; painful shingles, lesions and blisters; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On 21-OCT-2014, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live(ZOSTAVAX), pt suffered debilitating injuries including painful shingles, lesions and blisters, nerve damage, permanent tremors and neurological injuries. These injuries were caused by zoster vaccine live(ZOSTAVAX). As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical injuries and limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, 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), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The events painful shingles, lesions and blisters, nerve damage, permanent tremors and neurological injuries were considered as disability.
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: nerve damage; permanent tremors; neurological injuries; painful shingles, lesions and blisters; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On 21-OCT-2014, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live(ZOSTAVAX), pt suffered debilitating injuries including painful shingles, lesions and blisters, nerve damage, permanent tremors and neurological injuries. These injuries were caused by zoster vaccine live(ZOSTAVAX). As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical injuries and limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX). As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, 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), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The events painful shingles, lesions and blisters, nerve damage, permanent tremors and neurological injuries were considered as disability.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This case was reported by a physician via call center representative and described the occurrence of adverse reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The health care professional reported that many patients had Adverse reaction associated with Shingrix. The doctor would not provide any additional information.  The reporter did not consent to follow-up. This case linked with US2019209063, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue
Clinical narrative: tiredness; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness and upset stomach. On an unknown date, the outcome of the tiredness and upset stomach were recovered/resolved.   It was unknown if the reporter considered the tiredness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After consultation with the representative the patient understood that the tiredness and upset stomach were normal. At the time of this report, the patient did not need any information and stated if the patient would experience any further problem, then the patient will contact with his/her Primary Care Physician (PCP). The patient inquired, what should be the average length of time for the side effects to last. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Injection site erythema
Clinical narrative: Seems all listed i have now (Soreness at the injection site); Seems all listed i have now (Redness at the injection site); Seems all listed i have now (Itching at the injection site); Seems all listed i have now (Swelling at the injection site); Fever; Seems all listed i have now (myalgia); Seems all listed i have now (fatigue); Seems all listed i have now (headache); Seems all listed i have now (shivering); Seems all listed i have now (gastrointestinal symptoms); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site itching, injection site swelling, fever, myalgia, fatigue, headache, shivering and gastrointestinal symptom nos. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site itching, injection site swelling, fever, myalgia, fatigue, headache, shivering and gastrointestinal symptom nos were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site itching, injection site swelling, fever, myalgia, fatigue, headache, shivering and gastrointestinal symptom nos to be related to Shingrix.  Additional case details were reported as follows: The age group was not reported, but was selected adult as per vaccine indication. The patient had vaccine on day before reporting. The patient asked whether he or she could take any over the counter medications for the fever. The patient reported it had been 24 hrs. hours at the time of reporting. The patient seems to have all listed events of the agency. The permission to follow up was denied.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Seems all listed i have now (Soreness at the injection site); Seems all listed i have now (Redness at the injection site); Seems all listed i have now (Itching at the injection site); Seems all listed i have now (Swelling at the injection site); Fever; Seems all listed i have now (myalgia); Seems all listed i have now (fatigue); Seems all listed i have now (headache); Seems all listed i have now (shivering); Seems all listed i have now (gastrointestinal symptoms); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site itching, injection site swelling, fever, myalgia, fatigue, headache, shivering and gastrointestinal symptom nos. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site itching, injection site swelling, fever, myalgia, fatigue, headache, shivering and gastrointestinal symptom nos were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site itching, injection site swelling, fever, myalgia, fatigue, headache, shivering and gastrointestinal symptom nos to be related to Shingrix.  Additional case details were reported as follows: The age group was not reported, but was selected adult as per vaccine indication. The patient had vaccine on day before reporting. The patient asked whether he or she could take any over the counter medications for the fever. The patient reported it had been 24 hrs. hours at the time of reporting. The patient seems to have all listed events of the agency. The permission to follow up was denied.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling cold, Feeling hot, Peripheral swelling
Clinical narrative: Feverish; Chills; Shaking; her arm was hot, swollen and red; her arm was hot, swollen and red; her arm was hot, swollen and red; Feeling cold; This case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 1st October 2021) for prophylaxis.   The patient's past medical history included shingles (many years ago before first shingles vaccine several years ago). Previously administered products included Shingles vaccine (received 1st Shingles vaccine several years ago).   On 29th July 2019, the patient received the 1st dose of Shingrix .5 ml. On 29th July 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, tremor, swelling arm, extremities hot feeling of, erythema of extremities and feeling cold. On 1st August 2019, the outcome of the fever, chills, tremor, swelling arm, extremities hot feeling of, erythema of extremities and feeling cold were resolved with sequelae.   It was unknown if the reporter considered the fever, chills, tremor, swelling arm, extremities hot feeling of, erythema of extremities and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient received vaccination on left arm. Post vaccination the patient's arm was hot, swollen and red. The patient also reported feeling feverish and cold, chills and shaking. The symptoms lasted approximately 2 to 3 days. Batch number was updated from AJ9N5 to KJ9N5 as per sales data sheet.  The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2019219253.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Feverish; Chills; Shaking; her arm was hot, swollen and red; her arm was hot, swollen and red; her arm was hot, swollen and red; Feeling cold; This case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 1st October 2021) for prophylaxis.   The patient's past medical history included shingles (many years ago before first shingles vaccine several years ago). Previously administered products included Shingles vaccine (received 1st Shingles vaccine several years ago).   On 29th July 2019, the patient received the 1st dose of Shingrix .5 ml. On 29th July 2019, less than a day after receiving Shingrix, the patient experienced fever, chills, tremor, swelling arm, extremities hot feeling of, erythema of extremities and feeling cold. On 1st August 2019, the outcome of the fever, chills, tremor, swelling arm, extremities hot feeling of, erythema of extremities and feeling cold were resolved with sequelae.   It was unknown if the reporter considered the fever, chills, tremor, swelling arm, extremities hot feeling of, erythema of extremities and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient received vaccination on left arm. Post vaccination the patient's arm was hot, swollen and red. The patient also reported feeling feverish and cold, chills and shaking. The symptoms lasted approximately 2 to 3 days. Batch number was updated from AJ9N5 to KJ9N5 as per sales data sheet.  The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2019219253.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   Previously administered products included Shingrix (1st dose was received on 23rd November 2018).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. The action taken with Shingrix was unknown. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to receive 2nd dose at the time of reporting. The batch number and expiration dates were not provided as the first dose of the vaccine was administered in another facility.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site inflammation
Clinical narrative: redness at the injection site; inflammation at injection site on her left arm; received the 1st dose of Shingrix subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 29RD5, expiry date 16th April 2022) and (batch number 3EC24, expiry date 10th May 2022) for prophylaxis.   On 26th November 2019, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, the dose was an unknown dose. On 26th November 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site erythema and injection site inflammation. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site erythema, injection site inflammation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema and injection site inflammation to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The patient experienced redness and inflammation at the injection site on her left arm. The reporter consented to follow up. The batch number was updated from  3EG24 to 3EC24 as per sales data sheet.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Herpes zoster, Influenza like illness
Clinical narrative: pain; herpes zoster; her arm hurt where the shot was administered; Chills; pain; red dot/rashes; flu-like symptoms; upset stomach; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of herpes zoster in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   The patient's past medical history included shingles (has a history of previous shingles). Previously administered products included Valacyclovir.   On 17th August 2019, the patient received the 1st dose of Shingrix .5 ml. In October 2019, less than 2 months after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced red rash. On an unknown date, the patient experienced herpes zoster, injection site pain, pain in arm, influenza-like symptoms, abdominal discomfort, fatigue, chills and pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the herpes zoster, injection site pain and pain were unknown and the outcome of the red rash, pain in arm, influenza-like symptoms, abdominal discomfort, fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the herpes zoster, injection site pain, red rash, pain in arm, influenza-like symptoms, abdominal discomfort, fatigue, chills and pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in her left arm deltoid and had red dot rashes which was herpes zoster along the back of her right hip and the middle of her lower back more towards the right side.The patient was instructed to take valacyclovir when these spots reappear. The patient did experience left arm pain and flulike symptoms which resolved in a few days.  The patient had red dots rash along the back of her right hip which extends to the middle of her lower back. The patient took valacyclovir and the red dots resolved immediately. The reporter consented to follow up. The patient advised that she had flu like symptoms like the chills, upset stomach and feeling tired. The symptoms lasted for three days. The patient also advised that her arm hurt where the shot was administered.  No further information was provided.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Rash erythematous
Clinical narrative: pain; herpes zoster; her arm hurt where the shot was administered; Chills; pain; red dot/rashes; flu-like symptoms; upset stomach; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of herpes zoster in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   The patient's past medical history included shingles (has a history of previous shingles). Previously administered products included Valacyclovir.   On 17th August 2019, the patient received the 1st dose of Shingrix .5 ml. In October 2019, less than 2 months after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced red rash. On an unknown date, the patient experienced herpes zoster, injection site pain, pain in arm, influenza-like symptoms, abdominal discomfort, fatigue, chills and pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the herpes zoster, injection site pain and pain were unknown and the outcome of the red rash, pain in arm, influenza-like symptoms, abdominal discomfort, fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the herpes zoster, injection site pain, red rash, pain in arm, influenza-like symptoms, abdominal discomfort, fatigue, chills and pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in her left arm deltoid and had red dot rashes which was herpes zoster along the back of her right hip and the middle of her lower back more towards the right side.The patient was instructed to take valacyclovir when these spots reappear. The patient did experience left arm pain and flulike symptoms which resolved in a few days.  The patient had red dots rash along the back of her right hip which extends to the middle of her lower back. The patient took valacyclovir and the red dots resolved immediately. The reporter consented to follow up. The patient advised that she had flu like symptoms like the chills, upset stomach and feeling tired. The symptoms lasted for three days. The patient also advised that her arm hurt where the shot was administered.  No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Incomplete course of vaccination, Malaise, Nausea
Clinical narrative: Incomplete course of vaccination; nausea; swollen arm; hot arm; feverish; red arm; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In September 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the patient experienced nausea, swelling arm, extremities hot feeling of, fever, erythema of extremities and feeling unwell. On an unknown date, the outcome of the nausea, swelling arm, extremities hot feeling of, fever, erythema of extremities and feeling unwell were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the nausea, swelling arm, extremities hot feeling of, fever, erythema of extremities and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix either in September or October 2018. The patient experienced a bad reaction to the vaccine. She experienced swollen arm, red arm, hot arm. She said that it was the same arm where she received Shingrix.  The patient was also feverish, had nausea, and did not feel well.  The patient's symptoms lasted for about 2.5 weeks.  Till the time of reporting, the patient had not received the 2nd dose Shingrix, which led to incomplete course of vaccination. The patient planned on having the 2nd dose soon. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Incomplete course of vaccination; nausea; swollen arm; hot arm; feverish; red arm; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In September 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the patient experienced nausea, swelling arm, extremities hot feeling of, fever, erythema of extremities and feeling unwell. On an unknown date, the outcome of the nausea, swelling arm, extremities hot feeling of, fever, erythema of extremities and feeling unwell were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the nausea, swelling arm, extremities hot feeling of, fever, erythema of extremities and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix either in September or October 2018. The patient experienced a bad reaction to the vaccine. She experienced swollen arm, red arm, hot arm. She said that it was the same arm where she received Shingrix.  The patient was also feverish, had nausea, and did not feel well.  The patient's symptoms lasted for about 2.5 weeks.  Till the time of reporting, the patient had not received the 2nd dose Shingrix, which led to incomplete course of vaccination. The patient planned on having the 2nd dose soon. The reporter did not consent to follow-up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: little reaction around his arm; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received Shingrix. On 9th December 2019, 1 days after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovering/resolving.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were received as follows: This case was reported by the reporter for her husband. The reporter stated that the patient had a little reaction on his arm after his Shingrix injection. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Nausea, Pain, Swelling
Clinical narrative: Influenza type symptoms; Localized swelling; Redness at the injection site; Body aches; Nausea; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, swelling, injection site erythema, general body pain and nausea. On an unknown date, the outcome of the influenza-like symptoms, swelling, injection site erythema, general body pain and nausea were unknown.   It was unknown if the reporter considered the influenza-like symptoms, swelling, injection site erythema, general body pain and nausea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced localized swelling and redness at the injection site with severe all over body aches and influenza type symptoms, including nausea. The reporter consented to follow up.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Macular degeneration, Photopsia
Clinical narrative: macular degeneration; headache; opened her eyes saw a flashing light, moving back and forth in the room; Initial and additional information received on 09-Dec-2019 regarding an unsolicited valid serious case from a consumer.  This case involves a 71 years old female patient who developed macular degeneration (macular degeneration), opened her eyes saw a flashing light, moving back and forth in the room (photopsia) and headache (headache), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Blindness unilateral.    On 30-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via unknown route in right arm.  On 01-Dec-2019, the patient developed a non-serious opened her eyes saw a flashing light, moving back and forth in the room (photopsia), one days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient experienced a serious macular degeneration (macular degeneration), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious headache (headache), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was macular degeneration, headache and photopsia.  The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache.  The outcome was not reported for macular degeneration.  The patient was not recovered from photopsia and was recovering from headache.  Information on the batch number was requested.; Sender's Comments: This case involves a 71 years old female patient who presented with macular degeneration, photopsia and headache after vaccination with FLUZONE HIGH DOSE. The time to onset is unknown. She has significant medical history of unilateral blindness. Moreover, patient's medical condition and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms lasting about 24 hours for some patients after either first or second dose; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report.. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter stated that flu like symptoms lasting about 24 hours for some patients after either 1st or 2nd dose of Shingrix. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: severe reaction; This case was reported by a pharmacist via sales rep and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient experienced severe reaction to first dose of Shingrix. The reporter unaware of characterization of severe reaction, but would forward safety report to patient's provider upon receipt for more detailed completion of report. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: muscle aches; flu like symptoms; arm pain /arm pain at the injection site/ Pain in arm worsening; redness /area turned bright red in a rectangle shape; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix. On 26th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 27th October 2019, the patient experienced injection site erythema, muscle pain and influenza-like symptoms. On 29th October 2019, the outcome of the muscle pain was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, muscle pain and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in right arm. The patient reported arm pain at the injection site the day of the vaccine. The following day the area turned bright red in a rectangle shape and she experienced muscle aches that she described as flu like symptoms. The redness lasted 3 to 4 days before fading and the muscle aches took a couple of days to resolve. The arm pain persisted and become worse. The patient refused to provide date of birth. The reporter consented to follow up. The outcome of the event pain in arm was reported as not recovered/resolved however in source document, it was mentioned as recovering/resolving.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: shingles; rash genr; blster on his left cheek bone and by the corner of his left eye and in his left ear canal; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included feeling bad, headache, fever, pain and hives.   On 23rd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles, rash and blister. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, rash and blister were unknown.   The reporter considered the shingles, rash and blister to be unrelated to Shingrix.  Additional details were received as follows: The patient reported that he started to feel bad a couple of days before getting his first dose of shingrix.  The patient had headache and felt feverish and also had some pain in the top of his head at the crown and some markings that looked like hives on his left cheek. The patient after vaccination experienced  rash progressed and he developed blisters on his left cheek bone and by the corner of his left eye and in his left ear canal. The rash was also at the top, bottom and behind his left ear.  The patient was confident that the vaccine did not cause the shingles.   The patient stated that he waited too long to get treatment and it just progressed after receiving the shot. The patient did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dysphonia, Hypersomnia, Lethargy
Clinical narrative: profound lethargy; violent chills; trembling voice; loss of strength; Shaking; Loss of function where he slept for 2 days; Slept for 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of lethargy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received Shingrix. In August 2018, less than a day after receiving Shingrix, the patient experienced lethargy, chills, voice disturbance, strength loss of, tremor and sleep excessive. On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the lethargy, chills, voice disturbance, strength loss of, tremor and sleep excessive were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the lethargy, chills, voice disturbance, strength loss of, tremor, sleep excessive and activities of daily living impaired to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient had an episode in late August 2018 within 24 hrs after he received the vaccine Shingrix, 1/2 hour of violent chills, shaking, trembling voice, loss of strength, then profound lethargy and loss of function where he slept for 2 days. Approximately after 2 to 3 days, the symptoms resolved. He had subsequent episodes approximately 1 month apart since receiving the vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Tremor
Clinical narrative: profound lethargy; violent chills; trembling voice; loss of strength; Shaking; Loss of function where he slept for 2 days; Slept for 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of lethargy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received Shingrix. In August 2018, less than a day after receiving Shingrix, the patient experienced lethargy, chills, voice disturbance, strength loss of, tremor and sleep excessive. On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the lethargy, chills, voice disturbance, strength loss of, tremor and sleep excessive were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the lethargy, chills, voice disturbance, strength loss of, tremor, sleep excessive and activities of daily living impaired to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient had an episode in late August 2018 within 24 hrs after he received the vaccine Shingrix, 1/2 hour of violent chills, shaking, trembling voice, loss of strength, then profound lethargy and loss of function where he slept for 2 days. Approximately after 2 to 3 days, the symptoms resolved. He had subsequent episodes approximately 1 month apart since receiving the vaccine. The reporter consented to follow up.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Blood glucose normal, Dyskinesia, Fall, Headache, Seizure
Clinical narrative: He had an episode at school in which he fell from his chair and was seen to have a "seizure" for a few seconds.  Jerking movements reported to look like a seizure. Mom was called to school and when she arrived patient seemed sleepy but reports that he has since returned to his neurologic baseline.  No prior history of seizures. No family history of seizures.  Reported a front headache but says no headache currently.  No fever.  Seems like himself to parents. No recent complaints of headaches.  No vomiting. No meds given.  Unremarkable morning before school.  Parents report he had a normal day yesterday although he did take a nap which is a little out of character but they had been at a party the night before. Seen at ER. c/o headache at ER. Parents report that patient had an esotropia before but feel that it is currently "a little more prominent than they remember."
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Somnolence
Clinical narrative: He had an episode at school in which he fell from his chair and was seen to have a "seizure" for a few seconds.  Jerking movements reported to look like a seizure. Mom was called to school and when she arrived patient seemed sleepy but reports that he has since returned to his neurologic baseline.  No prior history of seizures. No family history of seizures.  Reported a front headache but says no headache currently.  No fever.  Seems like himself to parents. No recent complaints of headaches.  No vomiting. No meds given.  Unremarkable morning before school.  Parents report he had a normal day yesterday although he did take a nap which is a little out of character but they had been at a party the night before. Seen at ER. c/o headache at ER. Parents report that patient had an esotropia before but feel that it is currently "a little more prominent than they remember."
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient states gradual red spreading  down arm.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Flu shot on Oct. 9th. Pain since the day after he got a shot. No pain the day of the shot. + flu shot in the past. No reaction ever. Woke the next am with pain. That was 6 weeks ago..Pain was at his AC joint. Has not been active since that day, just walking. Typically plays basketball but not that night. Iced the first week. Pain persists.  Seen by PA on 11/8/2019 - tx with heat, regular ibuprofen and ROM exercises.  Follow up appt on 11/22/2019 sx persist, but are resolving
Age: 39.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Staff administered incorrect vaccine to patient. Patient wanted an MMR vaccine, but was initially given the flu vaccine. Patient has already had a dose of the flu vaccine on 11/08/2019 at a different facility, and did not request/want a second dose. Patient did not have any adverse effects reported, but was upset at the error.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient presents to clinic with right deltoid soreness and shoulder pain at injection site after receiving the flu shot.  She received the flu shot on November 20th.  Symptoms have persisted since.  She denies other injury or trauma.  Patient reports pain when she lays on her right side to sleep.  Also pain when working out in the gym or raising her arm.  She has had the flu shot in the past without issues.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Injection site swelling, Pain
Clinical narrative: I woke up at 5am the day after getting the shot and it felt like I had the flu. I had body aches all over and a bad headache. The injection site was painful and swollen to about 3" long, 2" wide and 1/4" high. I checked my temperature twice and it was 96.4F. The symptoms lasted for roughly 48 hours. I took two Extra Strength Tylenol every 6 hours and that did help alleviate the symptoms.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: She has a 3" in diameter welt on the back of her left upper arm where the vaccine was injected.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Heart rate increased
Clinical narrative: Patient received the vaccine on 12/11/19 at approximately 4:15pm.  He was in the pharmacy today and reported that following the vaccine he developed an increased heart rate which lasted for approximately 8 hours.