chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2014 (conflicting information: prior to date of vaccination), the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-APR-2016, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). In May 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JAN-2013, a healthcare provider administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In September 2016, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). In January 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In August 2016, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In January 2017, the patient was treated by a healthcare provider at an urgent care for shingles. 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 the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to 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. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider at a family practice recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-DEC-2008, a healthcare provider at a family practice administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2014, the patient was treated by a healthcare provider at a family practice for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2009, a healthcare provider administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2012, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-OCT-2009, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On or about 03-JAN-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-APR-2013, a healthcare provider administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On or about 24-OCT-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Feeling hot, Gait disturbance, Impaired work ability
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a 66-year-old patient who received SHINGRIX for prophylaxis. On 10th November 2018, the patient received the 1st dose of SHINGRIX. On 11th November 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, unstable feeling and injection site itching. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty and unstable feeling were recovered/resolved and the outcome of the injection site itching was not recovered/not resolved. It was unknown if the reporter considered the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, unstable feeling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient initially felt fine the day of vaccination. However, approximately 24 hours after vaccination, patient said arm become swollen and hot, developed low grade fever, and developed joint pain. Patient felt unsteady and had trouble walking, needing to hold onto surroundings for support. Patient did not seek treatment for symptoms but did stay home from work up to 12th November 2018 because of the symptoms. On 13th November 2018, the patient was still bothered by symptoms but felt well enough to return to work the following day. As of 28th November 2018 (reporting date), symptoms were fully resolved except for a remaining itchiness at the injection site.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a 66-year-old patient who received SHINGRIX for prophylaxis. On 10th November 2018, the patient received the 1st dose of SHINGRIX. On 11th November 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, unstable feeling and injection site itching. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty and unstable feeling were recovered/resolved and the outcome of the injection site itching was not recovered/not resolved. It was unknown if the reporter considered the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, unstable feeling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient initially felt fine the day of vaccination. However, approximately 24 hours after vaccination, patient said arm become swollen and hot, developed low grade fever, and developed joint pain. Patient felt unsteady and had trouble walking, needing to hold onto surroundings for support. Patient did not seek treatment for symptoms but did stay home from work up to 12th November 2018 because of the symptoms. On 13th November 2018, the patient was still bothered by symptoms but felt well enough to return to work the following day. As of 28th November 2018 (reporting date), symptoms were fully resolved except for a remaining itchiness at the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Lacrimation increased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lower abdominal pain in a female patient who received SHINGRIX for prophylaxis. On 29th November 2018, the patient received the 2nd dose of SHINGRIX. On 29th November 2018, less than a day after receiving SHINGRIX, the patient experienced lower abdominal pain and pain in arm. On an unknown date, the outcome of the lower abdominal pain and pain in arm were unknown. It was unknown if the reporter considered the lower abdominal pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX a day before reporting at 11:30. The patient's arm was really sore, which was expected. The patient did not expect a debilitating really sharp pains in her lower right quadrant, which started at night on the day of vaccination and continued on the day of reporting. The pain was so sharp that it doubles her over and brings tears to her eyes. The patient asked if this was a normal side effect.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and swelling. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the injection site erythema, swelling and pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, swelling and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 69 or 70 years. After receiving SHINGRIX at the beginning of November, the patient experienced severe redness, swelling and soreness. Soreness lasted for several weeks, redness and swelling lasted for 5 days. The pharmacist did not agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cold sores lip in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold sores. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown. It was unknown if the reporter considered the cold sores lip to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that within 48 to 72 hours of receiving the 1st dose of SHINGRIX she started to get a cold sore on her upper lip. The patient had a history of cold sores and this one came on quickly and stayed longer than usual. Lasting 10 days. She took her prescription for the cold sore as well.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Skin lesion
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a elderly male 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 injection site pain, injection site erythema, injection site blisters and skin lesion. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site blisters and skin lesion were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site blisters and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 72 or 73 years old. The clinic did not know lot number of SHINGRIX. The patient came in the clinic complaining of pain and tenderness at injection site. There was a red blister with a lesion at injection site. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Aphasia, Asthenia, Fatigue, Lacrimation increased
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of aphasia 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 aphasia, fatigue, watering eyes and weakness. On an unknown date, the outcome of the aphasia, fatigue, watering eyes and weakness were unknown. It was unknown if the reporter considered the aphasia, fatigue, watering eyes and weakness 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. The patient received SHINGRIX and sometime post the vaccine dose the patient experienced extreme fatigue, eye watering, could not speak and weakness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Nausea, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in extremity in a 63-year-old female patient who received SHINGRIX for prophylaxis.  On 27th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in extremity, headache, nausea and impaired work ability. On an unknown date, the outcome of the pain in extremity, headache, nausea and impaired work ability were unknown. It was unknown if the reporter considered the pain in extremity, headache, nausea and impaired work ability to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in her arm and leg as well as a headache and nausea. She had to stay at home from work one day.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Incorrect route of product administration, Injection site pain, Injection site urticaria, Wrong product administered
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of joint pain in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season) for prophylaxis. On 5th December 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intradermal). On 5th December 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced joint pain, injection site wheal, injection site stinging, intramuscular formulation administered by other route and wrong product administered. On an unknown date, the outcome of the joint pain, injection site wheal, injection site stinging, intramuscular formulation administered by other route and wrong product administered were unknown. It was unknown if the reporter considered the joint pain, injection site wheal and injection site stinging to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient went to a clinic today to obtain a TB test. When the nurse practitioner (NP) performed the intradermal test it appeared to be a large amount and it stung. The patient mentioned this to the nurse. When NP went to chart the test, she looked at the box and told the patient she would have to repeat the test since she had used something else which would take two weeks. The patient had to call the clinic back to ask what NP injected since the patient had a large welt on her arm. The NP had given the patient an intradermal shot of FLULAVAL QUADRIVALENT 2018-2019 season instead of a TB skin test, which led to intramuscular formulation administered by other route and wrong product administered. The patient experienced significant joint pain on left knee and hip. Nothing that the patient would normally experience. The patient did receive the skin test on the opposite arm. The patient's concern was for any adverse effects that might be known such as problems at the site of the intradermal injection of an intramuscular substance. The patient would see her primary care physician (PCP) tomorrow. The reporter denied consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal lymphadenopathy, Erythema, Influenza like illness, Lymphadenopathy, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lymph node disorder in a female patient who received SHINGRIX for prophylaxis. On 29th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced lymph node disorder, influenza-like symptoms, pain in arm, erythema and abdominal lymphadenopathy. On an unknown date, the outcome of the lymph node disorder, influenza-like symptoms, pain in arm, erythema and abdominal lymphadenopathy were unknown. It was unknown if the reporter considered the lymph node disorder, influenza-like symptoms, pain in arm, erythema and abdominal lymphadenopathy to be related to SHINGRIX. Additional details were reported as follows: The patient received Shingles vaccine on the previous Thursday evening, to the date of reporting. The patient had many side effects, very sore left arm, redness, flu like symptoms for several days. The patient had a PET (positron emission tomogram) scan for enlarged abdominal lymph nodes. They detected a lymph node problem in patients left arm pit area. The patient asked could this be a result of the Shingles vaccine reactions. The patient stated she would not see her physician until Monday.
Sex: F
Vaccine: VARZOS
Symptoms: Positron emission tomogram abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lymph node disorder in a female patient who received SHINGRIX for prophylaxis. On 29th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced lymph node disorder, influenza-like symptoms, pain in arm, erythema and abdominal lymphadenopathy. On an unknown date, the outcome of the lymph node disorder, influenza-like symptoms, pain in arm, erythema and abdominal lymphadenopathy were unknown. It was unknown if the reporter considered the lymph node disorder, influenza-like symptoms, pain in arm, erythema and abdominal lymphadenopathy to be related to SHINGRIX. Additional details were reported as follows: The patient received Shingles vaccine on the previous Thursday evening, to the date of reporting. The patient had many side effects, very sore left arm, redness, flu like symptoms for several days. The patient had a PET (positron emission tomogram) scan for enlarged abdominal lymph nodes. They detected a lymph node problem in patients left arm pit area. The patient asked could this be a result of the Shingles vaccine reactions. The patient stated she would not see her physician until Monday.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of malaise in a 51-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (experienced after receiving 1st dose in April 2018, refer case US2018GSK129946). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced malaise, chills and vomiting. On an unknown date, the outcome of the malaise, chills and vomiting were recovered/resolved. It was unknown if the reporter considered the malaise, chills and vomiting to be related to SHINGRIX. Additional details were provided as follows: This case was reported by nurse for himself. The day after receiving 2nd dose of SHINGRIX, the patient experienced malaise, chills and vomiting. Reactions were bad enough that he left work. All symptoms were resolved by the following day. The reporter was agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced fever, pain, chills, headache and insomnia. On an unknown date, the outcome of the fever, pain, chills, headache and insomnia were unknown. It was unknown if the reporter considered the fever, pain, chills, headache and insomnia to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient asked how long does the side effects of shingle shot last. The patient experienced fever, aches, chills, headache and could not sleep. The patient refused to provide the healthcare providers details.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 59-year-old male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were received as follows: After vaccination with SHINGRIX, the patient developed shingles within two weeks following the vaccination. The patient was inquiring what the recommendation was and whether she should get the second dose.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chest pain in a male patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received SHINGRIX 50 µg. On 17th August 2018, less than a day after receiving SHINGRIX, the patient experienced chest pain. On an unknown date, the outcome of the chest pain was not recovered/not resolved. It was unknown if the reporter considered the chest pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The suspect vaccine batch number and expiry date was not reported. Within 24 hours after receiving SHINGRIX, the patient experienced chest pains. The patient was still experiencing some chest pain at the time of reporting and was under the care of physician.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of feeling unwell in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a clinic operations manager about one of the doctors in the clinic she supervised. The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The reporter did not known which dose in series, lot number or when and in which arm the vaccine was given or any concomitant immunizations. The patient did not feel well for several days. The reporter was unaware if the patient sought medical attention or other interventions or how long it lasted. The reporter was also unaware of specifics as to when this occurred but would reach out to determine if healthcare professional (HCP) would like to provide additional insight into the experience post immunization. The reporter did not consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a 73-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 42 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be in between 72 to 73 year. In 2018, 6 to 7 weeks after receiving SHINGRIX dose, the patent experienced possible Shingles rash and secondary rash on arm. The reporter agreed to follow up contact.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes simplex
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of Bell's palsy in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes simplex. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several months after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant) and herpes simplex. On an unknown date, the outcome of the Bell's palsy and herpes simplex were unknown. It was unknown if the reporter considered the Bell's palsy and herpes simplex to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter's ex took the shingles vaccine in his part of the herpes simplex virus. Few months after vaccination, the patient came down with Bell's palsy, which was a part of the herpes simplex virus. The patient did not take any shots of that nature anymore.
Sex: M
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pericarditis in a male patient who received 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 pericarditis (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis was unknown. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: This case is reported by the consumer who was inquiring about getting vaccinated her husband with SHINGRIX 2nd dose. While doing inquiry the reporter had provided an information about 2 patients who had experienced pericarditis after receiving SHINGRIX. The patient age at vaccination was not reported. On an unknown date the patient got pericarditis after the vaccination. The patient had already filed the report with centers for disease control and prevention (CDC). The reporters husband has underwent stem cell transplant and they wanted him to get shingles vaccine at 2 months. This case has been linked to the case US2018GSK224235, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pericarditis in a male patient who received 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 pericarditis (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis was unknown. It was unknown if the reporter considered the pericarditis to be related to SHINGRIX. Additional details were provided as follows: This case is reported by the consumer who was inquiring about getting vaccinated her husband with SHINGRIX 2nd dose. While doing inquiry the reporter had provided an information about 2 patients who had experienced pericarditis after receiving SHINGRIX. The patient age at vaccination was not reported. On an unknown date the patient got pericarditis after the vaccination. The patient had already filed the report with centers for disease control and prevention (CDC). The reporters husband has underwent stem cell transplant and they wanted him to get shingles vaccine at 2 months. This case has been linked to the case US2018GSK224232, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 22nd June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 59 or 60 years. The patient experienced arm soreness. The patient did not consent to follow-up. For tolerance to the 2nd dose of SHINGRIX refer case US2018221114, for the same patient.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. 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 pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The patient felt achy for a day. This case has been linked with case US2018201060 (wife's case), reported by the same reporter and for tolerance after 2nd dose refer case US2018GSK225498.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number MJ432, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 19th November 2018, less than a year after receiving FLUARIX QUADRIUVALENT 2018-2019 season, the patient experienced pain in arm, injection site erythema and injection site warmth. On an unknown date, the outcome of the pain in arm, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site erythema and injection site warmth to be related to FLUARIX QUADRIVLENT 2018-2019 season. Additional information received as follows: The healthcare professional reported that the patient who received the dose of Fluarix QIV on Monday developed arm soreness, redness, and warmness at the injection site which was ongoing, till the time of reporting.  The patient had reportedly had flu vaccines in the past without adverse reactions which had lasted for so long. No further details were provided regarding the event. The reporter did not give consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of painful 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, immediately after receiving SHINGRIX, the patient experienced painful rash and itchy rash. On an unknown date, the outcome of the painful rash and itchy rash were unknown. It was unknown if the reporter considered the painful rash and itchy rash to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The healthcare professional reported that the patient developed a rash on his leg shortly after receiving the dose of SHINGRIX. The rash was about the size of a small plate and was somewhat itchy and painful. This case was reported via webform. No additional details were available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 74-year-old female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 16th April 2018 (batch number 539A2, expiry date 30th March 2020)). On 19th September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vesicular rash and nerve pain. On an unknown date, the outcome of the vesicular rash and nerve pain were not recovered/not resolved. It was unknown if the reporter considered the vesicular rash and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported to the pharmacist, on the date of reporting that she had a shingles like rash and nerve pain on her lower back.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in June 2018 with no adverse events). In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced shingles, itchy upper limbs and blistery rash. The patient was treated with Cream (Medication Unknown). On an unknown date, the outcome of the shingles, itchy upper limbs and blistery rash were recovered/resolved. It was unknown if the reporter considered the shingles, itchy upper limbs and blistery rash to be related to SHINGRIX. Additional details were reported as follows: Approximately 1 week after receiving the 2nd dose of SHINGRIX, the patient noted rash with blisters on both arms and one knee. The patient saw a dermatologist who diagnosed shingles. The patient was prescribed an unspecified cream and symptoms improved at time of report. The reporter gave consent to follow up. The reporter gave permission to send letter asking for permission to contact doctor for further follow up.