chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year 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 provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced Shingles. No further information was known or provided. This case has been linked with US2018090555, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Erythema, Herpes zoster, Insomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year 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 provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced Shingles. No further information was known or provided. This case has been linked with US2018090555, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year 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 provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced Shingles. No further information was known or provided. This case has been linked with US2018090555, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year 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 provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced Shingles. No further information was known or provided. This case has been linked with US2018090555, reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a 80-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) and (batch number X3M27, expiry date 29th August 2020). Concomitant products included escitalopram oxalate, NORVASC, pantoprazole and BELSOMRA. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In May 2018, less than a year after receiving SHINGRIX, the patient experienced raised rash, pruritus and chickenpox. On an unknown date, the outcome of the raised rash and chickenpox were not recovered/resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the raised rash, pruritus and chickenpox to be related to SHINGRIX. Additional details were provided as follows: The second batch number was also reported for SHINGRIX as X3M27 with expiry date 29th August 2020. The pharmacist reported consumer called her today reporting she had 7 chicken pox like raised bumps without a head, that were very itchy. She had one under her arm, back shoulder, back, wrist line and on her knee. The pharmacist reported the consumer could not recall her history if she had chicken pox. The patient had not notified her physician but was concerned about her husband being exposed, because he was under going Chemotherapy.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash pruritic, Rash vesicular, Varicella
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a 80-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) and (batch number X3M27, expiry date 29th August 2020). Concomitant products included escitalopram oxalate, NORVASC, pantoprazole and BELSOMRA. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In May 2018, less than a year after receiving SHINGRIX, the patient experienced raised rash, pruritus and chickenpox. On an unknown date, the outcome of the raised rash and chickenpox were not recovered/resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the raised rash, pruritus and chickenpox to be related to SHINGRIX. Additional details were provided as follows: The second batch number was also reported for SHINGRIX as X3M27 with expiry date 29th August 2020. The pharmacist reported consumer called her today reporting she had 7 chicken pox like raised bumps without a head, that were very itchy. She had one under her arm, back shoulder, back, wrist line and on her knee. The pharmacist reported the consumer could not recall her history if she had chicken pox. The patient had not notified her physician but was concerned about her husband being exposed, because he was under going Chemotherapy.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a 80-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) and (batch number X3M27, expiry date 29th August 2020). Concomitant products included escitalopram oxalate, NORVASC, pantoprazole and BELSOMRA. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In May 2018, less than a year after receiving SHINGRIX, the patient experienced raised rash, pruritus and chickenpox. On an unknown date, the outcome of the raised rash and chickenpox were not recovered/resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the raised rash, pruritus and chickenpox to be related to SHINGRIX. Additional details were provided as follows: The second batch number was also reported for SHINGRIX as X3M27 with expiry date 29th August 2020. The pharmacist reported consumer called her today reporting she had 7 chicken pox like raised bumps without a head, that were very itchy. She had one under her arm, back shoulder, back, wrist line and on her knee. The pharmacist reported the consumer could not recall her history if she had chicken pox. The patient had not notified her physician but was concerned about her husband being exposed, because he was under going Chemotherapy.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a 80-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) and (batch number X3M27, expiry date 29th August 2020). Concomitant products included escitalopram oxalate, NORVASC, pantoprazole and BELSOMRA. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In May 2018, less than a year after receiving SHINGRIX, the patient experienced raised rash, pruritus and chickenpox. On an unknown date, the outcome of the raised rash and chickenpox were not recovered/resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the raised rash, pruritus and chickenpox to be related to SHINGRIX. Additional details were provided as follows: The second batch number was also reported for SHINGRIX as X3M27 with expiry date 29th August 2020. The pharmacist reported consumer called her today reporting she had 7 chicken pox like raised bumps without a head, that were very itchy. She had one under her arm, back shoulder, back, wrist line and on her knee. The pharmacist reported the consumer could not recall her history if she had chicken pox. The patient had not notified her physician but was concerned about her husband being exposed, because he was under going Chemotherapy.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Chest discomfort, Chills
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX. Concomitant products included HUMIRA. 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 drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced significant side effects after receiving the first dose of SHINGRIX. The HCP was unsure of what specific side effects the patient experienced but might be able to provide additional details, and would like to follow up by fax.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX. Concomitant products included HUMIRA. 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 drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced significant side effects after receiving the first dose of SHINGRIX. The HCP was unsure of what specific side effects the patient experienced but might be able to provide additional details, and would like to follow up by fax.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX. Concomitant products included HUMIRA. 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 drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced significant side effects after receiving the first dose of SHINGRIX. The HCP was unsure of what specific side effects the patient experienced but might be able to provide additional details, and would like to follow up by fax.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX. Concomitant products included HUMIRA. 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 drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced significant side effects after receiving the first dose of SHINGRIX. The HCP was unsure of what specific side effects the patient experienced but might be able to provide additional details, and would like to follow up by fax.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Computerised tomogram, Facial paralysis, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of Bell's palsy in a 72-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. The reporter considered the Bell's palsy to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician's office manager. The age at vaccination was not reported. The patient had gotten SHINGRIX shot and about 7 to 10 days afterwards was diagnosed with Bell's palsy. The exact date of SHINGRIX administration was not available. The reporter stated that the patient was hospitalized and seen by an Ear, Nose and Throat specialist (ENT) and Neurologist and that both of them considered it possible that the Bell's palsy is related to SHINGRIX administration. The pharmacy demographics were not available and that reporter was willing to provide more details about the patient to safety team if they contact her. The contact details of the physician was provided.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of Bell's palsy in a 72-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. The reporter considered the Bell's palsy to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician's office manager. The age at vaccination was not reported. The patient had gotten SHINGRIX shot and about 7 to 10 days afterwards was diagnosed with Bell's palsy. The exact date of SHINGRIX administration was not available. The reporter stated that the patient was hospitalized and seen by an Ear, Nose and Throat specialist (ENT) and Neurologist and that both of them considered it possible that the Bell's palsy is related to SHINGRIX administration. The pharmacy demographics were not available and that reporter was willing to provide more details about the patient to safety team if they contact her. The contact details of the physician was provided.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash macular, Skin warm
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of red blotches in a 81-year-old female patient who received SHINGRIX (batch number B9739 ?, expiry date 22nd November 2020). On 22nd May 2018 17:50, the patient received the 1st dose of SHINGRIX. In May 2018, several hours after receiving SHINGRIX, the patient experienced red blotches. On an unknown date, the patient experienced skin warm. The patient was treated with BENADRYL (NOS). On an unknown date, the outcome of the red blotches and skin arm were recovering/resolving. It was unknown if the reporter considered the red blotches and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The healthcare professional (HCP) reports that several hours after receipt of the SHINGRIX vaccine, the patient developed red splotches on both arms, her face, and one leg. One spot on her arm was warm to the touch. The HCP did not know which arm was warm to the touch, patient took BENADRYL as advised by the pharmacy and the event was resolving at the time of reporting.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Skin warm
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of red blotches in a 81-year-old female patient who received SHINGRIX (batch number B9739 ?, expiry date 22nd November 2020). On 22nd May 2018 17:50, the patient received the 1st dose of SHINGRIX. In May 2018, several hours after receiving SHINGRIX, the patient experienced red blotches. On an unknown date, the patient experienced skin warm. The patient was treated with BENADRYL (NOS). On an unknown date, the outcome of the red blotches and skin arm were recovering/resolving. It was unknown if the reporter considered the red blotches and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The healthcare professional (HCP) reports that several hours after receipt of the SHINGRIX vaccine, the patient developed red splotches on both arms, her face, and one leg. One spot on her arm was warm to the touch. The HCP did not know which arm was warm to the touch, patient took BENADRYL as advised by the pharmacy and the event was resolving at the time of reporting.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chills, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of optic nerve damage in a 57-year-old male patient who received SHINGRIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX. On 9th May 2018, less than a day after receiving SHINGRIX, the patient experienced chills and sweating. In May 2018, the patient experienced optic nerve damage (serious criteria GSK medically significant), eye pain, headache, fever, sensation of pressure in eye and photophobia. In May 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the optic nerve damage, eye pain, headache, chills, sweating, sensation of pressure in eye and photophobia were not recovered/not resolved. It was unknown if the reporter considered the optic nerve damage, eye pain, headache, fever, chills, sweating, sensation of pressure in eye and photophobia to be related to SHINGRIX. Additional details were provided as follows: On 9th May 2018, 6 hours after receiving SHINGRIX, the patient experienced fever which lasted for about 48 hours. The patient's body temperature was recorded as 101 degree F. The patient also developed terrible headaches and eye pain. The physician mentioned that nerve damage as a possible cause of eye pain and eye pain as rare occurrence. The first night the patient had fever up to 101, chills, sweats, and severe headache (grade 3 pains). The second day the patient started feeling pressure behind his eyes and became extremely light sensitive. The ophthalmologist looked it up on his computer and he found no information on how to get relief. The patient spoken with primary care physician over the phone but she did not know what to do about headache and eye pain. The patient also became incredibly light sensitive and the patients had been stocked indoors mostly dark rooms because of the light sensitivity and pain. The fever resolved however the rest of the symptoms was present till the date of reporting. On 14th May 2018, the physician was notified by the patient of his symptoms. She asked the patient to go to the emergency room to get a spinal tap and CT scan but did not hear back from the patient. The patient believed SHINGRIX had caused these symptoms.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Photophobia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of optic nerve damage in a 57-year-old male patient who received SHINGRIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX. On 9th May 2018, less than a day after receiving SHINGRIX, the patient experienced chills and sweating. In May 2018, the patient experienced optic nerve damage (serious criteria GSK medically significant), eye pain, headache, fever, sensation of pressure in eye and photophobia. In May 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the optic nerve damage, eye pain, headache, chills, sweating, sensation of pressure in eye and photophobia were not recovered/not resolved. It was unknown if the reporter considered the optic nerve damage, eye pain, headache, fever, chills, sweating, sensation of pressure in eye and photophobia to be related to SHINGRIX. Additional details were provided as follows: On 9th May 2018, 6 hours after receiving SHINGRIX, the patient experienced fever which lasted for about 48 hours. The patient's body temperature was recorded as 101 degree F. The patient also developed terrible headaches and eye pain. The physician mentioned that nerve damage as a possible cause of eye pain and eye pain as rare occurrence. The first night the patient had fever up to 101, chills, sweats, and severe headache (grade 3 pains). The second day the patient started feeling pressure behind his eyes and became extremely light sensitive. The ophthalmologist looked it up on his computer and he found no information on how to get relief. The patient spoken with primary care physician over the phone but she did not know what to do about headache and eye pain. The patient also became incredibly light sensitive and the patients had been stocked indoors mostly dark rooms because of the light sensitivity and pain. The fever resolved however the rest of the symptoms was present till the date of reporting. On 14th May 2018, the physician was notified by the patient of his symptoms. She asked the patient to go to the emergency room to get a spinal tap and CT scan but did not hear back from the patient. The patient believed SHINGRIX had caused these symptoms.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Eye pain, Headache, Hyperhidrosis, Ocular discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of optic nerve damage in a 57-year-old male patient who received SHINGRIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX. On 9th May 2018, less than a day after receiving SHINGRIX, the patient experienced chills and sweating. In May 2018, the patient experienced optic nerve damage (serious criteria GSK medically significant), eye pain, headache, fever, sensation of pressure in eye and photophobia. In May 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the optic nerve damage, eye pain, headache, chills, sweating, sensation of pressure in eye and photophobia were not recovered/not resolved. It was unknown if the reporter considered the optic nerve damage, eye pain, headache, fever, chills, sweating, sensation of pressure in eye and photophobia to be related to SHINGRIX. Additional details were provided as follows: On 9th May 2018, 6 hours after receiving SHINGRIX, the patient experienced fever which lasted for about 48 hours. The patient's body temperature was recorded as 101 degree F. The patient also developed terrible headaches and eye pain. The physician mentioned that nerve damage as a possible cause of eye pain and eye pain as rare occurrence. The first night the patient had fever up to 101, chills, sweats, and severe headache (grade 3 pains). The second day the patient started feeling pressure behind his eyes and became extremely light sensitive. The ophthalmologist looked it up on his computer and he found no information on how to get relief. The patient spoken with primary care physician over the phone but she did not know what to do about headache and eye pain. The patient also became incredibly light sensitive and the patients had been stocked indoors mostly dark rooms because of the light sensitivity and pain. The fever resolved however the rest of the symptoms was present till the date of reporting. On 14th May 2018, the physician was notified by the patient of his symptoms. She asked the patient to go to the emergency room to get a spinal tap and CT scan but did not hear back from the patient. The patient believed SHINGRIX had caused these symptoms.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Optic nerve injury, Photophobia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of optic nerve damage in a 57-year-old male patient who received SHINGRIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX. On 9th May 2018, less than a day after receiving SHINGRIX, the patient experienced chills and sweating. In May 2018, the patient experienced optic nerve damage (serious criteria GSK medically significant), eye pain, headache, fever, sensation of pressure in eye and photophobia. In May 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the optic nerve damage, eye pain, headache, chills, sweating, sensation of pressure in eye and photophobia were not recovered/not resolved. It was unknown if the reporter considered the optic nerve damage, eye pain, headache, fever, chills, sweating, sensation of pressure in eye and photophobia to be related to SHINGRIX. Additional details were provided as follows: On 9th May 2018, 6 hours after receiving SHINGRIX, the patient experienced fever which lasted for about 48 hours. The patient's body temperature was recorded as 101 degree F. The patient also developed terrible headaches and eye pain. The physician mentioned that nerve damage as a possible cause of eye pain and eye pain as rare occurrence. The first night the patient had fever up to 101, chills, sweats, and severe headache (grade 3 pains). The second day the patient started feeling pressure behind his eyes and became extremely light sensitive. The ophthalmologist looked it up on his computer and he found no information on how to get relief. The patient spoken with primary care physician over the phone but she did not know what to do about headache and eye pain. The patient also became incredibly light sensitive and the patients had been stocked indoors mostly dark rooms because of the light sensitivity and pain. The fever resolved however the rest of the symptoms was present till the date of reporting. On 14th May 2018, the physician was notified by the patient of his symptoms. She asked the patient to go to the emergency room to get a spinal tap and CT scan but did not hear back from the patient. The patient believed SHINGRIX had caused these symptoms.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Erythema, Fatigue, Headache
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX. On 10th May 2018, the patient received the 1st dose of SHINGRIX. On 10th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and heaviness in limbs. On an unknown date, the outcome of the pain in arm and heaviness in limbs were recovered/resolved. It was unknown if the reporter considered the pain in arm and heaviness in limbs to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who herself was the patient. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced arm pain and heaviness in the same arm which lasted for about 2 days. The outbound vaccines center heard an adverse drug reaction and the representative called to report it. This was their process. No other details were known at time of report.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX. On 10th May 2018, the patient received the 1st dose of SHINGRIX. On 10th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and heaviness in limbs. On an unknown date, the outcome of the pain in arm and heaviness in limbs were recovered/resolved. It was unknown if the reporter considered the pain in arm and heaviness in limbs to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who herself was the patient. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced arm pain and heaviness in the same arm which lasted for about 2 days. The outbound vaccines center heard an adverse drug reaction and the representative called to report it. This was their process. No other details were known at time of report.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX. On 10th May 2018, the patient received the 1st dose of SHINGRIX. On 10th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and heaviness in limbs. On an unknown date, the outcome of the pain in arm and heaviness in limbs were recovered/resolved. It was unknown if the reporter considered the pain in arm and heaviness in limbs to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who herself was the patient. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced arm pain and heaviness in the same arm which lasted for about 2 days. The outbound vaccines center heard an adverse drug reaction and the representative called to report it. This was their process. No other details were known at time of report.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acidosis, Acute kidney injury, Anion gap, Atrial fibrillation, Blood creatine phosphokinase increased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. Concurrent medical conditions included membranous nephropathy (primary). Concomitant products included rituximab. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever (serious criteria death and hospitalization) and influenza-like symptoms (serious criteria death and hospitalization). On 30th May 2018, the outcome of the fever and influenza-like symptoms were fatal. The patient died on 30th May 2018. The reported cause of death was fever and influenza-like symptoms. The reporter considered the fever and influenza-like symptoms to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by an acute care nurse practitioner (ACNP). The age at vaccination was not reported. The nurse practitioner reported that he had limited information available regarding the patient and event. The nurse practitioner reported that the patient was recently diagnosed with primary membranous nephropathy and had received rituximab therapy prior to the SHINGRIX administration. The nurse practitioner did not have information on date or facility where SHINGRIX was administered. The nurse practitioner reported that shortly after receiving the SHINGRIX, the patient experienced fever and flu like symptoms that became worse. The patient declined and was presented to a local hospital and was then transferred to his facility where the patient expired on 30th May 2018. The nurse practitioner reported that his facility already completed a VAERS report and that autopsy for the patient would be completed on 1st June 2018. The nurse practitioner requested that GSK safety contact him directly if any specific samples or data requested as part of this autopsy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatinine increased, Blood lactic acid, Blood potassium normal, Blood sodium decreased, Carbon dioxide decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. Concurrent medical conditions included membranous nephropathy (primary). Concomitant products included rituximab. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever (serious criteria death and hospitalization) and influenza-like symptoms (serious criteria death and hospitalization). On 30th May 2018, the outcome of the fever and influenza-like symptoms were fatal. The patient died on 30th May 2018. The reported cause of death was fever and influenza-like symptoms. The reporter considered the fever and influenza-like symptoms to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by an acute care nurse practitioner (ACNP). The age at vaccination was not reported. The nurse practitioner reported that he had limited information available regarding the patient and event. The nurse practitioner reported that the patient was recently diagnosed with primary membranous nephropathy and had received rituximab therapy prior to the SHINGRIX administration. The nurse practitioner did not have information on date or facility where SHINGRIX was administered. The nurse practitioner reported that shortly after receiving the SHINGRIX, the patient experienced fever and flu like symptoms that became worse. The patient declined and was presented to a local hospital and was then transferred to his facility where the patient expired on 30th May 2018. The nurse practitioner reported that his facility already completed a VAERS report and that autopsy for the patient would be completed on 1st June 2018. The nurse practitioner requested that GSK safety contact him directly if any specific samples or data requested as part of this autopsy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Hypotension, Immediate post-injection reaction, Malaise, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. Concurrent medical conditions included membranous nephropathy (primary). Concomitant products included rituximab. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever (serious criteria death and hospitalization) and influenza-like symptoms (serious criteria death and hospitalization). On 30th May 2018, the outcome of the fever and influenza-like symptoms were fatal. The patient died on 30th May 2018. The reported cause of death was fever and influenza-like symptoms. The reporter considered the fever and influenza-like symptoms to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by an acute care nurse practitioner (ACNP). The age at vaccination was not reported. The nurse practitioner reported that he had limited information available regarding the patient and event. The nurse practitioner reported that the patient was recently diagnosed with primary membranous nephropathy and had received rituximab therapy prior to the SHINGRIX administration. The nurse practitioner did not have information on date or facility where SHINGRIX was administered. The nurse practitioner reported that shortly after receiving the SHINGRIX, the patient experienced fever and flu like symptoms that became worse. The patient declined and was presented to a local hospital and was then transferred to his facility where the patient expired on 30th May 2018. The nurse practitioner reported that his facility already completed a VAERS report and that autopsy for the patient would be completed on 1st June 2018. The nurse practitioner requested that GSK safety contact him directly if any specific samples or data requested as part of this autopsy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Procalcitonin increased, Pyrexia, Respiratory failure, Seizure, Septic shock
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. Concurrent medical conditions included membranous nephropathy (primary). Concomitant products included rituximab. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever (serious criteria death and hospitalization) and influenza-like symptoms (serious criteria death and hospitalization). On 30th May 2018, the outcome of the fever and influenza-like symptoms were fatal. The patient died on 30th May 2018. The reported cause of death was fever and influenza-like symptoms. The reporter considered the fever and influenza-like symptoms to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by an acute care nurse practitioner (ACNP). The age at vaccination was not reported. The nurse practitioner reported that he had limited information available regarding the patient and event. The nurse practitioner reported that the patient was recently diagnosed with primary membranous nephropathy and had received rituximab therapy prior to the SHINGRIX administration. The nurse practitioner did not have information on date or facility where SHINGRIX was administered. The nurse practitioner reported that shortly after receiving the SHINGRIX, the patient experienced fever and flu like symptoms that became worse. The patient declined and was presented to a local hospital and was then transferred to his facility where the patient expired on 30th May 2018. The nurse practitioner reported that his facility already completed a VAERS report and that autopsy for the patient would be completed on 1st June 2018. The nurse practitioner requested that GSK safety contact him directly if any specific samples or data requested as part of this autopsy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Troponin increased, Viral test, White blood cell count increased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. Concurrent medical conditions included membranous nephropathy (primary). Concomitant products included rituximab. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever (serious criteria death and hospitalization) and influenza-like symptoms (serious criteria death and hospitalization). On 30th May 2018, the outcome of the fever and influenza-like symptoms were fatal. The patient died on 30th May 2018. The reported cause of death was fever and influenza-like symptoms. The reporter considered the fever and influenza-like symptoms to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by an acute care nurse practitioner (ACNP). The age at vaccination was not reported. The nurse practitioner reported that he had limited information available regarding the patient and event. The nurse practitioner reported that the patient was recently diagnosed with primary membranous nephropathy and had received rituximab therapy prior to the SHINGRIX administration. The nurse practitioner did not have information on date or facility where SHINGRIX was administered. The nurse practitioner reported that shortly after receiving the SHINGRIX, the patient experienced fever and flu like symptoms that became worse. The patient declined and was presented to a local hospital and was then transferred to his facility where the patient expired on 30th May 2018. The nurse practitioner reported that his facility already completed a VAERS report and that autopsy for the patient would be completed on 1st June 2018. The nurse practitioner requested that GSK safety contact him directly if any specific samples or data requested as part of this autopsy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Death, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. Concurrent medical conditions included membranous nephropathy (primary). Concomitant products included rituximab. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever (serious criteria death and hospitalization) and influenza-like symptoms (serious criteria death and hospitalization). On 30th May 2018, the outcome of the fever and influenza-like symptoms were fatal. The patient died on 30th May 2018. The reported cause of death was fever and influenza-like symptoms. The reporter considered the fever and influenza-like symptoms to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by an acute care nurse practitioner (ACNP). The age at vaccination was not reported. The nurse practitioner reported that he had limited information available regarding the patient and event. The nurse practitioner reported that the patient was recently diagnosed with primary membranous nephropathy and had received rituximab therapy prior to the SHINGRIX administration. The nurse practitioner did not have information on date or facility where SHINGRIX was administered. The nurse practitioner reported that shortly after receiving the SHINGRIX, the patient experienced fever and flu like symptoms that became worse. The patient declined and was presented to a local hospital and was then transferred to his facility where the patient expired on 30th May 2018. The nurse practitioner reported that his facility already completed a VAERS report and that autopsy for the patient would be completed on 1st June 2018. The nurse practitioner requested that GSK safety contact him directly if any specific samples or data requested as part of this autopsy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Malaise, Pain, Rash
Clinical narrative: She got her 1st dose of SHINGRIX on 3.16.2018. A few days following the shot, patient felt ill. She noticed a rash developed on late Saturday 3/17. On Sunday 3/18, she took the photos of the rash on the arm. She had soreness and warmth on the injection site. She notified her doctor regarding the rash on Monday 3/19. She informed her doctor that she got the SHINGRIX vaccine and developed achiness and a rash on the arm. She was advised to apply heat to the injection site and contact her doctor if no improvements. Her symptoms improved so she did not contact her doctor again. It took approximately 1 month for the rash to resolve. As for the achiness on the arm, it lasted about 6 weeks. I examined her left arm today, which is Thursday 5.31.2018. The rash is gone. She mentioned that she has some residual tenderness in the left arm if pressure is applied to the injection site. I recommended that she consults with her doctor regarding the 2nd dose of SHINGRIX since she had adverse reactions to the 1st dose. She confirmed that she will follow up with her doctor.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Erythema, Headache, Nausea
Clinical narrative: Starting 1 day after the vaccination, and lasting for approximately 3 days, patient experienced:  diarrhea, nausea, headache, dizziness. Arm was red and slightly swollen/red for 4 days. No increased temperature noted during that time.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Starting 1 day after the vaccination, and lasting for approximately 3 days, patient experienced:  diarrhea, nausea, headache, dizziness. Arm was red and slightly swollen/red for 4 days. No increased temperature noted during that time.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Chills, fever nausea redness and pain at injection site.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Colonoscopy, Endoscopy, Feeling abnormal, Flushing
Clinical narrative: Patient came in at 9am 5/30/2018 to report arm tenderness and swelling due to PPSV23 vaccination from yesterday. She showed me her arm, which presented a significant inflammatory reaction (redness/flushed, tenderness, swollen, painful/sensitive to touch, very warm) that involved the upper left arm, shoulder, and the top of the forearm. She stated it was so painful she couldn't sleep all night. She also stated she had a bad headache and just didn't feel good so she would go to her doctor to follow up. Considering it may have been an allergic reaction, I recommended patient take BENADRYL to reduce the inflammatory/allergy response. I also recommended for her to drink plenty of fluids, ice the area on/off for 10 minute intervals to reduce acute swelling and pain. I recommended TYLENOL for the headache. I asked if she has any GI or stomach problems and she said she just had an endoscopy and colonoscopy to diagnose some stomach pains. I recommended she talk to her doctor first before taking any anti-inflammatories (ie, ibuprofen) for that matter. The patient thanked me for taking the time and attention to address her concerns before leaving the store. I called her primary care physician's office and spoke with nurse @930am shortly after the patient left. I informed them of patient's symptoms and gave them advanced notice that patient would be coming in to be seen for treatment without an appointment scheduled. We will follow up with the patient.