chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-OCT-2009, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in March 2013 at the hospital. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death - aggravation of preexisting conditions and activation - of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in 2015. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-JAN-2011, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a physician for shingles on or about 16-APR-2012. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-MAY-2012, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a physician for shingles on or about 27-DEC-2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death - aggravation of preexisting conditions and activation - of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 16-SEP-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 23-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 20-DEC-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about11-SEP-2012, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided).On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles on or about 31-JAN- 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a 65 year old female patient reporting on herself. The patients concurrent condition included fibromyalgia that she described as pain up and down her hamstrings. The patient's concomitant therapies included ARMOUR THYROID TABLETS, aripiprazole, sertraline hydrochloride, trazodone hydrochloride, omeprazole and valacyclovir hydrochloride. The patient had no drug reactions or allergies. On 13-MAR-2018, the patient was vaccinated with PREVENAR 13. On 23-MAY-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis (dose, lot number and expiration date were not reported). Later that day, the patient developed severe pain in the vaccinated arm and shoulder (Pain in extremity)(unspecified side). Patient reported the pain was so severe that it limited her ability to move and use her arm. On an unknown date, the patient called her physician, who prescribed SALONPAS, TIGER BALM, but patient reported none of these treatments helped the arm and shoulder pain at all. Patient reported that the arm and shoulder pain had decreased in severity but was still constantly present. Patient reported that, on an unknown date, she developed "the exact same kind of pain all over" her right leg, since "about a month or two ago", in 2018, described as "getting worse when she bends her knee or lifts her leg," and that the pain was so severe, that it was limiting her ability to move and use her leg. Patient reported that this leg pain was different than pre-existing leg pain related to fibromyalgia. No lab diagnostics or studies were performed. The outcome of pain in extremity was reported as not resolved. The causal relationship between the aforementioned event and vaccination with PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Wrong technique in product usage process
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a elderly female patient who received Flu Seasonal QIV Dresden for prophylaxis. Previously administered products included Influenza vaccine (brands unknown received for many years). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced swelling arm, erythema of extremities and wrong injection technique. On an unknown date, the outcome of the swelling arm, erythema of extremities and wrong injection technique were unknown. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by an office manager. The healthcare professional (HCP) reported that the patient had received her annual influenza vaccine (brands unknown) for many years. The age at vaccination was not reported. Each time, the patient experienced a very red swollen arm. The HCP also reported that according to the patient, in the past another provider had administered the vaccine in 2 divided doses of one-half volume, which led to wrong injection technique. The HCP did not have any further information concerning the previous reactions.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and injection site pain. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the erythema of extremities and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the upper arm. The patient received SHINGRIX vaccine by a pharmacist and she had a concern that she did not get the vaccine properly because the pharmacist pinched her upper arm really hard. Her arm hurt during administration of the vaccine and the area where the pharmacist grabbed her arm was pink for over one week and it hurt. The patient has denied permission to contact their physician. The patient refused to answer any additional questions and requested to be anonymous.
Age: 75.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Blister, Headache, Rash, Skin exfoliation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine 2017-2018 season for prophylaxis and PNEUMOCOCCAL VACCINE for prophylaxis. Concurrent medical conditions included heart disorder (Patient did not mention what condition). On 22nd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular), Influenza vaccine 2017-2018 season and PNEUMOCOCCAL VACCINE. In October 2018, less than a week after receiving SHINGRIX, Influenza vaccine 2017-2018 season and PNEUMOCOCCAL VACCINE, the patient experienced headache, scalp blister, scalp peeling and skin eruption. The patient was treated with HIBICLENS and Cortisone Cream. On an unknown date, the outcome of the headache, scalp blister, scalp peeling and skin eruption were unknown. It was unknown if the reporter considered the headache, scalp blister, scalp peeling and skin eruption to be related to SHINGRIX and Influenza vaccine 2017-2018 season. Additional details were received as follows: On 22nd October 2018, the patient received flu shot and pneumonia vaccine in left arm. After an hour later, the patient went to pharmacy and received SHINGRIX vaccine in right arm. The patient experienced headache and her scalp broke out. She also experienced scalp oozing and peeling of the skin on her scalp like a burn. The oozing was on different spots on the head and the biggest one was on the hair line. She called her pharmacy on Tuesday morning and she was advised to use HIBICLENS skin cleanser and apply cortisone cream. She visited her endocrinologist on Wednesday for her current situation. The patient gave permission to contact her physician. The patient would follow up with her physician. No further details were provided.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. The patient's past medical history included chickenpox (as a child, severe case). Previously administered products included Flu vaccine with an associated reaction of influenza (also experienced low grade fever, refer case US2018GSK212776). On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 1st August 2018, less than a day after receiving SHINGRIX and not applicable after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced headache, shivering, pain in arm, erythema of extremities and stomach pain. On 2nd August 2018, the patient experienced fever, nausea and tiredness. In October 2018, the patient experienced cold. On an unknown date, the outcome of the headache, shivering, fever, pain in arm, erythema of extremities, nausea, cold, stomach pain and tiredness were recovered/resolved. It was unknown if the reporter considered the headache, shivering, fever, pain in arm, erythema of extremities, nausea, stomach pain and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the cold to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX at 12:30, later that day the patient had a headache and stomachache. She took her temperature and it was 97 degree F. Later that evening the patient started shivering so much that she could not sleep. The next day the patient had a bad headache, felt tired and nauseous. She had a temperature of 101.1 degree F. The patient's arm was sore and red for a day and a half.  At the beginning of October 2018 after receiving flu vaccine, the patient experienced cold. The patient had denied permission to contact their physician.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Insomnia, Nasopharyngitis, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. The patient's past medical history included chickenpox (as a child, severe case). Previously administered products included Flu vaccine with an associated reaction of influenza (also experienced low grade fever, refer case US2018GSK212776). On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 1st August 2018, less than a day after receiving SHINGRIX and not applicable after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced headache, shivering, pain in arm, erythema of extremities and stomach pain. On 2nd August 2018, the patient experienced fever, nausea and tiredness. In October 2018, the patient experienced cold. On an unknown date, the outcome of the headache, shivering, fever, pain in arm, erythema of extremities, nausea, cold, stomach pain and tiredness were recovered/resolved. It was unknown if the reporter considered the headache, shivering, fever, pain in arm, erythema of extremities, nausea, stomach pain and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the cold to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX at 12:30, later that day the patient had a headache and stomachache. She took her temperature and it was 97 degree F. Later that evening the patient started shivering so much that she could not sleep. The next day the patient had a bad headache, felt tired and nauseous. She had a temperature of 101.1 degree F. The patient's arm was sore and red for a day and a half.  At the beginning of October 2018 after receiving flu vaccine, the patient experienced cold. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown. The reporter considered the injection site erythema and injection site itching to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. A few days before reporting date, the reporting pharmacist gave the patient a dose of SHINGRIX and the patient experienced a large, red and itchy spot around the injection site. The reporter planned to contact the patient to inquire if the patient still had the adverse events. The reporter requested to speak with an Medical Science Liaison (MSL), which was met. The reporter agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a female patient who received 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 reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient had mild reaction when received a dose of SHINGRIX. For tolerance to 2nd dose, refer case US2018GSK211209.
Sex: U
Vaccine: VARZOS
Symptoms: Rash generalised, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of urticarial rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced urticarial rash. On an unknown date, the outcome of the urticarial rash was unknown. It was unknown if the reporter considered the urticarial rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient experienced rash from head to toe. The pharmacist also reported that, it was hives not just a rash. The pharmacist wanted to know, should the patient get the second shot of SHINGRIX.
Sex: F
Vaccine: MEN
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, less than a year after receiving Meningococcal B vaccine, 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 Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The young patient received Meningococcal B vaccine for college at the reporting time, she could not go. After receiving Meningococcal B vaccine, the patient was too sick to get out of bed, a ruined life.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was supposed to get second shot of SHINGRIX on the day of reporting but the patient had side effects with the first one. The patient asked should she get the second one.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a child male patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 305 days after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. It was unknown if the reporter considered the vaccination failure and pertussis to be related to dTpa vaccine. Additional details were provided as follows: The reporting physician stated that, her son received Tdap vaccine at 10 years of age. Ten months after receiving Tdap vaccine, the patient experienced pertussis. There was an outbreak at the patient's school and 1 out of 3 of the children were impacted. This case was considered as suspected vaccination failure since the completion status of primary immunization schedule and laboratory confirmation for the disease were unknown. The reporter did not agree to be followed up.
Sex: M
Vaccine: VARZOS
Symptoms: Myocardial infarction, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart attack in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included type II diabetes mellitus. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced heart attack (serious criteria GSK medically significant) and product supply issue. On an unknown date, the outcome of the heart attack and product supply issue were unknown. It was unknown if the reporter considered the heart attack to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient's concurrent medical conditions included other complications. The patient went to get the follow up dose only to learn that, there was no supply of SHINGRIX locally. In 2018, the patient had a heart attack. The patient mentioned that, GlaxoSmithKline website states that, there were pharmacies which had the shots, which was false. The patient wanted to get the 2nd dose soon as the patient had scheduled his surgery on 27th November 2018, and the patient had surgery and thought he would be covered prior the surgery. This case has been linked to the case US2018GSK209887, reported by the same reporter.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Death
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of arrhythmia in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced arrhythmia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the arrhythmia was fatal. The reported cause of death was arrhythmia. It was unknown if the reporter considered the arrhythmia to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. On an unknown date, the patient experienced pulmonary arrhythmia and passed away. No additional information was provided. Reported Cause(s) of Death: arrhythmia.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeding disorder, Insomnia, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received on an unknown date, for tolerance refer case US2018GSK202808). On 4th November 2018, the patient received the 2nd dose of SHINGRIX. On 4th November 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm and insomnia. On 5th November 2018, the patient experienced unable to eat. In November 2018, the patient experienced chills, fever, joint pain and general body pain. On an unknown date, the outcome of the pain in arm, chills, fever, joint pain, general body pain, unable to eat and insomnia were unknown. It was unknown if the reporter considered the pain in arm, chills, fever, joint pain, general body pain, unable to eat and insomnia to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The day before the reporting date, the patient received a dose of SHINGRIX and immediately, the patient presented with arm soreness, but she brushed it off. Less than a day after receiving SHINGRIX, in night the patient woke up in the middle with chills, fever (she was amazed that how could someone have both at the same time) and her joints and body were very sore and she could not sleep, it was that bad. The patient crawled out of bed on the reporting date, and she took a shower, thinking it would feel better after that but she was wrong. The patient was not able to eat and her entire body was aching. The patient asked a question regarding how long would this events last and would it leave side effects. The patient guessed, she should not have rushed into SHINGRIX vaccination. When the patient told lady at the pharmacy about her first experience, she was amazed and stated that it might have something else and told the patient would not get sick like that from SHINGRIX. She suggested that people should be forewarned of this problem.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received on an unknown date, for tolerance refer case US2018GSK202808). On 4th November 2018, the patient received the 2nd dose of SHINGRIX. On 4th November 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm and insomnia. On 5th November 2018, the patient experienced unable to eat. In November 2018, the patient experienced chills, fever, joint pain and general body pain. On an unknown date, the outcome of the pain in arm, chills, fever, joint pain, general body pain, unable to eat and insomnia were unknown. It was unknown if the reporter considered the pain in arm, chills, fever, joint pain, general body pain, unable to eat and insomnia to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The day before the reporting date, the patient received a dose of SHINGRIX and immediately, the patient presented with arm soreness, but she brushed it off. Less than a day after receiving SHINGRIX, in night the patient woke up in the middle with chills, fever (she was amazed that how could someone have both at the same time) and her joints and body were very sore and she could not sleep, it was that bad. The patient crawled out of bed on the reporting date, and she took a shower, thinking it would feel better after that but she was wrong. The patient was not able to eat and her entire body was aching. The patient asked a question regarding how long would this events last and would it leave side effects. The patient guessed, she should not have rushed into SHINGRIX vaccination. When the patient told lady at the pharmacy about her first experience, she was amazed and stated that it might have something else and told the patient would not get sick like that from SHINGRIX. She suggested that people should be forewarned of this problem.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Rash, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On 26th October 2018, the patient received Flu vaccine (intramuscular). On 26th October 2018, less than a day after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the patient experienced swelling and rash. On an unknown date, the outcome of the pain in arm was resolved with sequelae and the outcome of the swelling and rash were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling and rash to be related to Flu vaccine. Additional details were provided as follows: The patient reported that she received flu shot in the morning at her physician's office and experienced sore left arm for five days. The soreness started within 12 hours of vaccination. Less than a week after receiving Flu vaccine, the patient also experienced a little swelling and a bump which resolved after three days. The patient refused to provide any name or demographic information and wished to remain anonymous.
Age: 38.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 38-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received (refer case US2018200133)). Concurrent medical conditions included spina bifida. On 19th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, injection site swelling, injection site erythema and inappropriate age at vaccine administration. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, injection site swelling and injection site erythema were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were received as follows: The patient at 38 years of age received a dose of SHINGRIX, which led to inappropriate age at vaccination. The patient experienced flu-like symptoms, including a fever of 103 degrees Fahrenheit, and chills. These symptoms lasted for approximately 2.5 to 3 days. He also developed mild redness and swelling at the injection site that resolved after 1.5 weeks. The patient did not give consent to follow up. The reporter was unable to obtain additional information. This case was linked with the case US2018200133, reported by the same reporter for the same patient.
Age: 38.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 38-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received (refer case US2018200133)). Concurrent medical conditions included spina bifida. On 19th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, injection site swelling, injection site erythema and inappropriate age at vaccine administration. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, injection site swelling and injection site erythema were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were received as follows: The patient at 38 years of age received a dose of SHINGRIX, which led to inappropriate age at vaccination. The patient experienced flu-like symptoms, including a fever of 103 degrees Fahrenheit, and chills. These symptoms lasted for approximately 2.5 to 3 days. He also developed mild redness and swelling at the injection site that resolved after 1.5 weeks. The patient did not give consent to follow up. The reporter was unable to obtain additional information. This case was linked with the case US2018200133, reported by the same reporter for the same patient.
Age: 38.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 38-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received (refer case US2018200133)). Concurrent medical conditions included spina bifida. On 19th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, injection site swelling, injection site erythema and inappropriate age at vaccine administration. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, injection site swelling and injection site erythema were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were received as follows: The patient at 38 years of age received a dose of SHINGRIX, which led to inappropriate age at vaccination. The patient experienced flu-like symptoms, including a fever of 103 degrees Fahrenheit, and chills. These symptoms lasted for approximately 2.5 to 3 days. He also developed mild redness and swelling at the injection site that resolved after 1.5 weeks. The patient did not give consent to follow up. The reporter was unable to obtain additional information. This case was linked with the case US2018200133, reported by the same reporter for the same patient.
Age: 38.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age at Vaccine Administration; Headache; Swollen; Red; This case was reported by a consumer via call center representative and described the occurrence of headache in a 38-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included spina bifida.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced headache, injection site swelling, injection site erythema and inappropriate age at vaccine administration. On an unknown date, the outcome of the headache, injection site swelling and injection site erythema were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the headache, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were received as follows: The patient at 38 years of age received a dose of Shingrix, which led to inappropriate age at vaccination. The patient received a dose of Shingrix on a Friday. The patient developed horrendous headache that lasted for 1.5 days. He also presented with a softball size swelling and redness at the injection site that lasted for two weeks.  The reporter was unable to obtain additional information.  For intolerance received 2nd dose of Shingrix, please refer case US2018GSK210629.
Age: 38.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Inappropriate Age at Vaccine Administration; Headache; Swollen; Red; This case was reported by a consumer via call center representative and described the occurrence of headache in a 38-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included spina bifida.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced headache, injection site swelling, injection site erythema and inappropriate age at vaccine administration. On an unknown date, the outcome of the headache, injection site swelling and injection site erythema were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the headache, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were received as follows: The patient at 38 years of age received a dose of Shingrix, which led to inappropriate age at vaccination. The patient received a dose of Shingrix on a Friday. The patient developed horrendous headache that lasted for 1.5 days. He also presented with a softball size swelling and redness at the injection site that lasted for two weeks.  The reporter was unable to obtain additional information.  For intolerance received 2nd dose of Shingrix, please refer case US2018GSK210629.
Age: 38.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age at Vaccine Administration; Headache; Swollen; Red; This case was reported by a consumer via call center representative and described the occurrence of headache in a 38-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included spina bifida.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced headache, injection site swelling, injection site erythema and inappropriate age at vaccine administration. On an unknown date, the outcome of the headache, injection site swelling and injection site erythema were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the headache, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were received as follows: The patient at 38 years of age received a dose of Shingrix, which led to inappropriate age at vaccination. The patient received a dose of Shingrix on a Friday. The patient developed horrendous headache that lasted for 1.5 days. He also presented with a softball size swelling and redness at the injection site that lasted for two weeks.  The reporter was unable to obtain additional information.  For intolerance received 2nd dose of Shingrix, please refer case US2018GSK210629.