chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 732044), concerns a 79-year-old, elderly female patient. The patient's medical history, current illness, lab data were unknown. The patient was allergic to seafood, chocolate and experienced nausea with egg. On 18-Dec-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number 179601, expiry date: not reported) and PREVNAR 13 (dose: 1 dose, route of administration: intramuscular, anatomical location: right arm, batch number, expiry date: not reported). On 19-Dec-2017, the next day of vaccination, the patient experienced a lot of pain and stiffness in hands and legs. The events lasted for about 3 days (recovered). The reporter assessed the case as non-serious.
Age: 23.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Influenza, Pyrexia
Clinical narrative: Subject is enrolled on a clinical trial that is evaluating the nonavalent HPV vaccine in cancer survivors and received HPV Vaccine Dose 1 -3 on 8/15/17, 10/16/17 and 2/14/18, respectively. On 3/8/18 patient was diagnosed with a secondary malignancy, cancer therapy-related acute myeloid leukemia (AML). Patient passed away on 7/1/18 secondary to refractory AML. The event has been deemed by the responsible site physician and by the overall responsible physician for the study as unrelated to HPV vaccine and definitely related to prior cancer therapy (chemotherapy, radiation, HCT) that the patient received for treatment of his primary cancer.
Age: 23.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Acute myeloid leukaemia, Death, Second primary malignancy
Clinical narrative: Subject is enrolled on a clinical trial that is evaluating the nonavalent HPV vaccine in cancer survivors and received HPV Vaccine Dose 1 -3 on 8/15/17, 10/16/17 and 2/14/18, respectively. On 3/8/18 patient was diagnosed with a secondary malignancy, cancer therapy-related acute myeloid leukemia (AML). Patient passed away on 7/1/18 secondary to refractory AML. The event has been deemed by the responsible site physician and by the overall responsible physician for the study as unrelated to HPV vaccine and definitely related to prior cancer therapy (chemotherapy, radiation, HCT) that the patient received for treatment of his primary cancer.
Age: 72.0
Sex: F
Vaccine: CHOL, CHOL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case report was received from a nurse (PVX2018-1085) on 12-Apr-2018. The report describes an elderly female consumer who "took VAXCHORA at the age of 72 years". The consumer was receiving VAXCHORA for cholera vaccine. It was reported that on 05-Apr-2018, a 72-year-old female consumer took VAXCHORA. She did not experience any adverse effects after that. The action taken with VAXCHORA with respect to the event "took VAXCHORA at the age of 72 years" was not applicable. The clinical outcome of the event "took VAXCHORA at the age of 72 years" was unknown. Company's comment: The causality of the event "took VAXCHORA at the age of 72 years" was considered as not applicable. Sender's Comments: Company's comment: The causality of the event "took VAXCHORA at the age of 72 years" was considered as not applicable.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Oedema peripheral, Pain, Pyrexia, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever were recovered/resolved. The reporter considered the injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient then experienced swelling or Lymphadenopathy of the left axilla. It was unable to verify if adverse event was previously reported. The health care professional was unsure.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever were recovered/resolved. The reporter considered the injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient then experienced swelling or Lymphadenopathy of the left axilla. It was unable to verify if adverse event was previously reported. The health care professional was unsure.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever were recovered/resolved. The reporter considered the injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient then experienced swelling or Lymphadenopathy of the left axilla. It was unable to verify if adverse event was previously reported. The health care professional was unsure.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever were recovered/resolved. The reporter considered the injection site erythema, general body pain, local swelling, lymphadenopathy axillary, rash, injection site warmth and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient then experienced swelling or Lymphadenopathy of the left axilla. It was unable to verify if adverse event was previously reported. The health care professional was unsure.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient was healthy and in good shape. The patient had the SHINGRIX vaccine 8 days ago. Since that time the patient had had fevers, arm pain, headaches, general flu type symptoms and full-blown head colds. The patient had missed several days of work, cancelled a hiking trip, and basically felt lousy since the SHINGRIX vaccine was administered with no end in sight. The patient was not sure about that 2nd shot and wanted to know what in the world was in this stuff. This case has been linked with case US2018GSK112845, reported by same reporter for patient's wife.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache, Impaired work ability, Influenza like illness, Nasopharyngitis
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient was healthy and in good shape. The patient had the SHINGRIX vaccine 8 days ago. Since that time the patient had had fevers, arm pain, headaches, general flu type symptoms and full-blown head colds. The patient had missed several days of work, cancelled a hiking trip, and basically felt lousy since the SHINGRIX vaccine was administered with no end in sight. The patient was not sure about that 2nd shot and wanted to know what in the world was in this stuff. This case has been linked with case US2018GSK112845, reported by same reporter for patient's wife.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, pain in arm, headache, head cold, inability to work and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient was healthy and in good shape. The patient had the SHINGRIX vaccine 8 days ago. Since that time the patient had had fevers, arm pain, headaches, general flu type symptoms and full-blown head colds. The patient had missed several days of work, cancelled a hiking trip, and basically felt lousy since the SHINGRIX vaccine was administered with no end in sight. The patient was not sure about that 2nd shot and wanted to know what in the world was in this stuff. This case has been linked with case US2018GSK112845, reported by same reporter for patient's wife.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from office manger refers to a 16 year old male patient. The patient's concurrent conditions included excessive sweating. The patient's medical history, drug reactions and allergies were not reported. The patient's concomitant medication included cefprozil (CEFZIL). On an unspecified date, the patient was vaccinated with first dose of GARDASIL 9 (0.5 ml, frequency not reported) (lot# and expiration date not reported), on 02-JAN-2018, the patient was vaccinated with second dose of GARDASIL 9 (0.5 ml, frequency not reported) (lot# and expiration date not reported) and on 18-JUN-2018, the patient was vaccinated third dose of GARDASIL 9 (0.5 ml, frequency not reported) (lot# N026814 and expiration date: 15-JUL-2020) for HPV prevention. On 18-JUN-2018, several hours after receiving the GARDASIL 9, the patient started to have a stiff neck (musculoskeletal stiffness) and a headache. It was reported that, the patient went to urgent care either on 18-JUN-2018 or 19-JUN-2018 with complaints of stiff neck and headache. The patient was recovered from the events. The reporter did not provide causal relationship for the events with suspect therapy GARDASIL 9. No product quality complaint was involved.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX. On 23rd June 2018, 10 hrs after receiving SHINGRIX, the patient experienced injection site pain, feeling cold, tremor of hands, difficulty sleeping and fever. On an unknown date, the outcome of the injection site pain, feeling cold, tremor of hands and difficulty sleeping were recovered/resolved and the outcome of the fever was recovering/resolving. The reporter considered the injection site pain, feeling cold, tremor of hands, difficulty sleeping and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: At approximately noon, the patient received SHINGRIX in left arm. About 10 hours later, the patient experienced soreness at the injection site, feeling cold, shaking hands, and difficulty sleeping that night. Less than a day after receiving SHINGRIX, the patient experienced fever went up to 101 degrees F. The injection site pain, feeling cold, tremor of hands and difficulty sleeping lasted about 2 days. This case has been linked with US2018114196 (patient's husband), reported by same reporter. The patient had denied permission to contact their physician. The patient was in a hurry. The patient demanded to talk to an health care professional for advice and/or one of the clinical study researchers.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling cold, Injection site pain, Insomnia, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received the 1st dose of SHINGRIX. On 23rd June 2018, 10 hrs after receiving SHINGRIX, the patient experienced injection site pain, feeling cold, tremor of hands, difficulty sleeping and fever. On an unknown date, the outcome of the injection site pain, feeling cold, tremor of hands and difficulty sleeping were recovered/resolved and the outcome of the fever was recovering/resolving. The reporter considered the injection site pain, feeling cold, tremor of hands, difficulty sleeping and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: At approximately noon, the patient received SHINGRIX in left arm. About 10 hours later, the patient experienced soreness at the injection site, feeling cold, shaking hands, and difficulty sleeping that night. Less than a day after receiving SHINGRIX, the patient experienced fever went up to 101 degrees F. The injection site pain, feeling cold, tremor of hands and difficulty sleeping lasted about 2 days. This case has been linked with US2018114196 (patient's husband), reported by same reporter. The patient had denied permission to contact their physician. The patient was in a hurry. The patient demanded to talk to an health care professional for advice and/or one of the clinical study researchers.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Shingrix for prophylaxis. On 23rd June 2018, the patient received the 1st dose of Shingrix. On 23rd June 2018, 10 hrs after receiving Shingrix, the patient experienced injection site pain, feeling cold, fever, nausea and less than a day after receiving Shingrix, the patient experienced chills, shoulder pain and myalgia. On an unknown date, the outcome of the injection site pain, feeling cold, fever, nausea, chills, shoulder pain and myalgia were recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. The reporter considered the feeling cold, fever, nausea, chills, shoulder pain and myalgia to be almost certainly related to Shingrix. Additional details were provided as follows: The wife was the reporter for both herself and her husband. At approximately noon, the patient received Shingrix in left arm. About 10 hours later, the patient experienced soreness at the injection site, feeling cold, fever, and nausea. Events began to improve about 3 days after injection. This case has been linked with US2018114195 (patient's wife), reported by same reporter. The reporter had denied permission to contact their physician. The reporter was in a hurry. The reporter demanded to talk to an health care professional for advice and/or one of the clinical study researchers.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Shingrix for prophylaxis. On 23rd June 2018, the patient received the 1st dose of Shingrix. On 23rd June 2018, 10 hrs after receiving Shingrix, the patient experienced injection site pain, feeling cold, fever, nausea and less than a day after receiving Shingrix, the patient experienced chills, shoulder pain and myalgia. On an unknown date, the outcome of the injection site pain, feeling cold, fever, nausea, chills, shoulder pain and myalgia were recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. The reporter considered the feeling cold, fever, nausea, chills, shoulder pain and myalgia to be almost certainly related to Shingrix. Additional details were provided as follows: The wife was the reporter for both herself and her husband. At approximately noon, the patient received Shingrix in left arm. About 10 hours later, the patient experienced soreness at the injection site, feeling cold, fever, and nausea. Events began to improve about 3 days after injection. This case has been linked with US2018114195 (patient's wife), reported by same reporter. The reporter had denied permission to contact their physician. The reporter was in a hurry. The reporter demanded to talk to an health care professional for advice and/or one of the clinical study researchers.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Shingrix for prophylaxis. On 23rd June 2018, the patient received the 1st dose of Shingrix. On 23rd June 2018, 10 hrs after receiving Shingrix, the patient experienced injection site pain, feeling cold, fever, nausea and less than a day after receiving Shingrix, the patient experienced chills, shoulder pain and myalgia. On an unknown date, the outcome of the injection site pain, feeling cold, fever, nausea, chills, shoulder pain and myalgia were recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. The reporter considered the feeling cold, fever, nausea, chills, shoulder pain and myalgia to be almost certainly related to Shingrix. Additional details were provided as follows: The wife was the reporter for both herself and her husband. At approximately noon, the patient received Shingrix in left arm. About 10 hours later, the patient experienced soreness at the injection site, feeling cold, fever, and nausea. Events began to improve about 3 days after injection. This case has been linked with US2018114195 (patient's wife), reported by same reporter. The reporter had denied permission to contact their physician. The reporter was in a hurry. The reporter demanded to talk to an health care professional for advice and/or one of the clinical study researchers.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Hypersensitivity, Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Shingrix for prophylaxis. On 23rd June 2018, the patient received the 1st dose of Shingrix. On 23rd June 2018, 10 hrs after receiving Shingrix, the patient experienced injection site pain, feeling cold, fever, nausea and less than a day after receiving Shingrix, the patient experienced chills, shoulder pain and myalgia. On an unknown date, the outcome of the injection site pain, feeling cold, fever, nausea, chills, shoulder pain and myalgia were recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. The reporter considered the feeling cold, fever, nausea, chills, shoulder pain and myalgia to be almost certainly related to Shingrix. Additional details were provided as follows: The wife was the reporter for both herself and her husband. At approximately noon, the patient received Shingrix in left arm. About 10 hours later, the patient experienced soreness at the injection site, feeling cold, fever, and nausea. Events began to improve about 3 days after injection. This case has been linked with US2018114195 (patient's wife), reported by same reporter. The reporter had denied permission to contact their physician. The reporter was in a hurry. The reporter demanded to talk to an health care professional for advice and/or one of the clinical study researchers.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Shingrix for prophylaxis. On 23rd June 2018, the patient received the 1st dose of Shingrix. On 23rd June 2018, 10 hrs after receiving Shingrix, the patient experienced injection site pain, feeling cold, fever, nausea and less than a day after receiving Shingrix, the patient experienced chills, shoulder pain and myalgia. On an unknown date, the outcome of the injection site pain, feeling cold, fever, nausea, chills, shoulder pain and myalgia were recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. The reporter considered the feeling cold, fever, nausea, chills, shoulder pain and myalgia to be almost certainly related to Shingrix. Additional details were provided as follows: The wife was the reporter for both herself and her husband. At approximately noon, the patient received Shingrix in left arm. About 10 hours later, the patient experienced soreness at the injection site, feeling cold, fever, and nausea. Events began to improve about 3 days after injection. This case has been linked with US2018114195 (patient's wife), reported by same reporter. The reporter had denied permission to contact their physician. The reporter was in a hurry. The reporter demanded to talk to an health care professional for advice and/or one of the clinical study researchers.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Confusional state, Fatigue, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of faint in a 73-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Zostavax. Concomitant products included acyclovir, Levothyroxine, Liothyronine, Tylenol, Premarin Vaginal Cream and raloxifene. On 22nd June 2018 17:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, less than a week after receiving Shingrix, the patient experienced cough, cold, somnolence and pain in arm. In June 2018, the patient experienced tiredness, nausea, confusion and unsteadiness. On 22nd June 2018, the patient experienced faint and feeling abnormal. On an unknown date, the outcome of the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold and pain in arm were recovered/resolved and the outcome of the somnolence was unknown. The reporter considered the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold, somnolence and pain in arm to be related to Shingrix. Additional details were provided as follows: At around 4 to 5 PM, the patient received Shingrix in left arm. That night, the patient woke up in the middle of the night and several hours after vaccination felt a little faint, but went back to sleep. 18 hours after vaccination, the patient got up the next morning, 23rd June 2018, and felt a little off, but not very bad. The patient went to a meeting at 11 AM and started feeling very faint, tired, nauseous, confused and unsteady on her feet. The patient's coworkers were very concerned and one followed her as she drove home. The patient got home and sat down on the couch around 2 PM and fell asleep. She woke up around 7:30 PM and got something to eat, then went back to sleep until 9:30 AM on 24th June 2018. At that time the symptoms had all resolved. Sometime during this experience, she coughed once while in the shower, like she was getting a cold. She found the whole experience awful. The patient was unable to stay awake even if she wanted to. If she had been driving when this happened, she could had killed someone. If her house had caught fire she would not have been able to get out. The patient felt like she was drugged (feeling abnormal). She was not expecting this sort of reaction. The patient's arm was sore after the injection, but that had resolved by today, 25th July 2018. The patient was not concerned about the sore arm.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of faint in a 73-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Zostavax. Concomitant products included acyclovir, Levothyroxine, Liothyronine, Tylenol, Premarin Vaginal Cream and raloxifene. On 22nd June 2018 17:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, less than a week after receiving Shingrix, the patient experienced cough, cold, somnolence and pain in arm. In June 2018, the patient experienced tiredness, nausea, confusion and unsteadiness. On 22nd June 2018, the patient experienced faint and feeling abnormal. On an unknown date, the outcome of the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold and pain in arm were recovered/resolved and the outcome of the somnolence was unknown. The reporter considered the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold, somnolence and pain in arm to be related to Shingrix. Additional details were provided as follows: At around 4 to 5 PM, the patient received Shingrix in left arm. That night, the patient woke up in the middle of the night and several hours after vaccination felt a little faint, but went back to sleep. 18 hours after vaccination, the patient got up the next morning, 23rd June 2018, and felt a little off, but not very bad. The patient went to a meeting at 11 AM and started feeling very faint, tired, nauseous, confused and unsteady on her feet. The patient's coworkers were very concerned and one followed her as she drove home. The patient got home and sat down on the couch around 2 PM and fell asleep. She woke up around 7:30 PM and got something to eat, then went back to sleep until 9:30 AM on 24th June 2018. At that time the symptoms had all resolved. Sometime during this experience, she coughed once while in the shower, like she was getting a cold. She found the whole experience awful. The patient was unable to stay awake even if she wanted to. If she had been driving when this happened, she could had killed someone. If her house had caught fire she would not have been able to get out. The patient felt like she was drugged (feeling abnormal). She was not expecting this sort of reaction. The patient's arm was sore after the injection, but that had resolved by today, 25th July 2018. The patient was not concerned about the sore arm.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Confusional state, Cough, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of faint in a 73-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Zostavax. Concomitant products included acyclovir, Levothyroxine, Liothyronine, Tylenol, Premarin Vaginal Cream and raloxifene. On 22nd June 2018 17:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, less than a week after receiving Shingrix, the patient experienced cough, cold, somnolence and pain in arm. In June 2018, the patient experienced tiredness, nausea, confusion and unsteadiness. On 22nd June 2018, the patient experienced faint and feeling abnormal. On an unknown date, the outcome of the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold and pain in arm were recovered/resolved and the outcome of the somnolence was unknown. The reporter considered the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold, somnolence and pain in arm to be related to Shingrix. Additional details were provided as follows: At around 4 to 5 PM, the patient received Shingrix in left arm. That night, the patient woke up in the middle of the night and several hours after vaccination felt a little faint, but went back to sleep. 18 hours after vaccination, the patient got up the next morning, 23rd June 2018, and felt a little off, but not very bad. The patient went to a meeting at 11 AM and started feeling very faint, tired, nauseous, confused and unsteady on her feet. The patient's coworkers were very concerned and one followed her as she drove home. The patient got home and sat down on the couch around 2 PM and fell asleep. She woke up around 7:30 PM and got something to eat, then went back to sleep until 9:30 AM on 24th June 2018. At that time the symptoms had all resolved. Sometime during this experience, she coughed once while in the shower, like she was getting a cold. She found the whole experience awful. The patient was unable to stay awake even if she wanted to. If she had been driving when this happened, she could had killed someone. If her house had caught fire she would not have been able to get out. The patient felt like she was drugged (feeling abnormal). She was not expecting this sort of reaction. The patient's arm was sore after the injection, but that had resolved by today, 25th July 2018. The patient was not concerned about the sore arm.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Middle insomnia, Nasopharyngitis, Nausea, Pain in extremity, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of faint in a 73-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Zostavax. Concomitant products included acyclovir, Levothyroxine, Liothyronine, Tylenol, Premarin Vaginal Cream and raloxifene. On 22nd June 2018 17:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, less than a week after receiving Shingrix, the patient experienced cough, cold, somnolence and pain in arm. In June 2018, the patient experienced tiredness, nausea, confusion and unsteadiness. On 22nd June 2018, the patient experienced faint and feeling abnormal. On an unknown date, the outcome of the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold and pain in arm were recovered/resolved and the outcome of the somnolence was unknown. The reporter considered the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold, somnolence and pain in arm to be related to Shingrix. Additional details were provided as follows: At around 4 to 5 PM, the patient received Shingrix in left arm. That night, the patient woke up in the middle of the night and several hours after vaccination felt a little faint, but went back to sleep. 18 hours after vaccination, the patient got up the next morning, 23rd June 2018, and felt a little off, but not very bad. The patient went to a meeting at 11 AM and started feeling very faint, tired, nauseous, confused and unsteady on her feet. The patient's coworkers were very concerned and one followed her as she drove home. The patient got home and sat down on the couch around 2 PM and fell asleep. She woke up around 7:30 PM and got something to eat, then went back to sleep until 9:30 AM on 24th June 2018. At that time the symptoms had all resolved. Sometime during this experience, she coughed once while in the shower, like she was getting a cold. She found the whole experience awful. The patient was unable to stay awake even if she wanted to. If she had been driving when this happened, she could had killed someone. If her house had caught fire she would not have been able to get out. The patient felt like she was drugged (feeling abnormal). She was not expecting this sort of reaction. The patient's arm was sore after the injection, but that had resolved by today, 25th July 2018. The patient was not concerned about the sore arm.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of faint in a 73-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Zostavax. Concomitant products included acyclovir, Levothyroxine, Liothyronine, Tylenol, Premarin Vaginal Cream and raloxifene. On 22nd June 2018 17:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, less than a week after receiving Shingrix, the patient experienced cough, cold, somnolence and pain in arm. In June 2018, the patient experienced tiredness, nausea, confusion and unsteadiness. On 22nd June 2018, the patient experienced faint and feeling abnormal. On an unknown date, the outcome of the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold and pain in arm were recovered/resolved and the outcome of the somnolence was unknown. The reporter considered the faint, feeling abnormal, tiredness, nausea, confusion, unsteadiness, cough, cold, somnolence and pain in arm to be related to Shingrix. Additional details were provided as follows: At around 4 to 5 PM, the patient received Shingrix in left arm. That night, the patient woke up in the middle of the night and several hours after vaccination felt a little faint, but went back to sleep. 18 hours after vaccination, the patient got up the next morning, 23rd June 2018, and felt a little off, but not very bad. The patient went to a meeting at 11 AM and started feeling very faint, tired, nauseous, confused and unsteady on her feet. The patient's coworkers were very concerned and one followed her as she drove home. The patient got home and sat down on the couch around 2 PM and fell asleep. She woke up around 7:30 PM and got something to eat, then went back to sleep until 9:30 AM on 24th June 2018. At that time the symptoms had all resolved. Sometime during this experience, she coughed once while in the shower, like she was getting a cold. She found the whole experience awful. The patient was unable to stay awake even if she wanted to. If she had been driving when this happened, she could had killed someone. If her house had caught fire she would not have been able to get out. The patient felt like she was drugged (feeling abnormal). She was not expecting this sort of reaction. The patient's arm was sore after the injection, but that had resolved by today, 25th July 2018. The patient was not concerned about the sore arm.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Neuralgia, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. The patient's past medical history included shingles (occurred in November 2016). On 8th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On 9th June 2018, the patient experienced swelling arm and nerve pain. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site erythema, injection site pain, swelling arm and nerve pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, swelling arm and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. After receiving SHINGRIX, the patient developed injection site redness and soreness at day one of receiving the vaccine. One day after receiving SHINGRIX, the patient developed increased arm swelling and nerve pain. The healthcare professional reported that the patient stated nerve pain was similar to pain experienced during active case of shingles in 2016. The patient initially treated pain with ADVIL, which was not helpful. The patient eventually went to their chiropractor and received laser treatment which helped with the pain. The patient condition was currently stable with no further complaints of pain and symptoms have since completely resolved. No further information was reported.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Laser therapy, Neuralgia, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. The patient's past medical history included shingles (occurred in November 2016). On 8th June 2018, the patient received the 1st dose of SHINGRIX. On 8th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On 9th June 2018, the patient experienced swelling arm and nerve pain. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site erythema, injection site pain, swelling arm and nerve pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, swelling arm and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. After receiving SHINGRIX, the patient developed injection site redness and soreness at day one of receiving the vaccine. One day after receiving SHINGRIX, the patient developed increased arm swelling and nerve pain. The healthcare professional reported that the patient stated nerve pain was similar to pain experienced during active case of shingles in 2016. The patient initially treated pain with ADVIL, which was not helpful. The patient eventually went to their chiropractor and received laser treatment which helped with the pain. The patient condition was currently stable with no further complaints of pain and symptoms have since completely resolved. No further information was reported.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site irritation, Injection site warmth, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 67-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020) for prophylaxis. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site warmth, chills, nausea and injection site erythema. On an unknown date, the outcome of the injection site warmth, chills, nausea and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site warmth, chills, nausea and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patients received the SHINGRIX vaccine and experienced redness at the injection site, warmth at the injection site, chills and nausea. The pharmacist had some pictures of the site of injection if the company wanted them.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 67-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020) for prophylaxis. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site warmth, chills, nausea and injection site erythema. On an unknown date, the outcome of the injection site warmth, chills, nausea and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site warmth, chills, nausea and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patients received the SHINGRIX vaccine and experienced redness at the injection site, warmth at the injection site, chills and nausea. The pharmacist had some pictures of the site of injection if the company wanted them.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of papulovesicular rash in a female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. The patient's past medical history included shingles. On 22nd June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 3 days after receiving SHINGRIX, the patient experienced papulovesicular rash, injection site erythema and injection site swelling. On an unknown date, the outcome of the papulovesicular rash, injection site erythema and injection site swelling were unchanged. It was unknown if the reporter considered the papulovesicular rash, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient developed redness and swelling at injection site which eventually lead to small pimples or fluid-filled bumps or blisters around the injection site. The patient had history of shingles and stated it looked similar to shingles per the healthcare professional report. No further information was reported regarding the event.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Rash papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of papulovesicular rash in a female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. The patient's past medical history included shingles. On 22nd June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 3 days after receiving SHINGRIX, the patient experienced papulovesicular rash, injection site erythema and injection site swelling. On an unknown date, the outcome of the papulovesicular rash, injection site erythema and injection site swelling were unchanged. It was unknown if the reporter considered the papulovesicular rash, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient developed redness and swelling at injection site which eventually lead to small pimples or fluid-filled bumps or blisters around the injection site. The patient had history of shingles and stated it looked similar to shingles per the healthcare professional report. No further information was reported regarding the event.