chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia, Neuritis, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Calcium and Cranberry. On 14th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema, muscle pain, tingling, chills, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury. On an unknown date, the outcome of the pain in arm, tingling, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury were not recovered/not resolved and the outcome of the injection site erythema, muscle pain and chills were recovered/resolved. The reporter considered the pain in arm, injection site erythema, muscle pain, tingling, chills and shoulder pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site tenderness, injected limb mobility decreased and nerve injury to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included centrum and probiotic. The patient received SHINGRIX on left arm. After vaccination, the patient experienced some chills that went away quickly, some muscle pain that started to come on but also went away quickly, and redness at the injection site that has also resolved. The patient's shoulder began to hurt badly enough that she could not lift her arm. The pain had persisted and also experienced tingling down her arm to her fingers. The patient visited an orthopedist for about these symptoms and was told that the tingling indicates nerve involvement and maybe the nerve in her arm was grazed during the injection. The patient was going to see her regular orthopedist on Wednesday on 6th June 2018. The patient's arm was continuing to get worse because she had to use it. By the end of the day it hurts more than when she woke up and she noted that it still hurts to touch the area of her arm where she received the injection. The patient was not sure if she would get the 2nd dose or not but it would be probably be at 6 months instead of 2 months. This is 1 of 3 cases, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site reaction, Nerve injury, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Calcium and Cranberry. On 14th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema, muscle pain, tingling, chills, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury. On an unknown date, the outcome of the pain in arm, tingling, shoulder pain, injection site tenderness, injected limb mobility decreased and nerve injury were not recovered/not resolved and the outcome of the injection site erythema, muscle pain and chills were recovered/resolved. The reporter considered the pain in arm, injection site erythema, muscle pain, tingling, chills and shoulder pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site tenderness, injected limb mobility decreased and nerve injury to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included centrum and probiotic. The patient received SHINGRIX on left arm. After vaccination, the patient experienced some chills that went away quickly, some muscle pain that started to come on but also went away quickly, and redness at the injection site that has also resolved. The patient's shoulder began to hurt badly enough that she could not lift her arm. The pain had persisted and also experienced tingling down her arm to her fingers. The patient visited an orthopedist for about these symptoms and was told that the tingling indicates nerve involvement and maybe the nerve in her arm was grazed during the injection. The patient was going to see her regular orthopedist on Wednesday on 6th June 2018. The patient's arm was continuing to get worse because she had to use it. By the end of the day it hurts more than when she woke up and she noted that it still hurts to touch the area of her arm where she received the injection. The patient was not sure if she would get the 2nd dose or not but it would be probably be at 6 months instead of 2 months. This is 1 of 3 cases, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Pain of skin, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included fluid in middle ear. Concomitant products included Levothyroxine, omeprazole, hydrochlorothiazide, meloxicam, MYRBETRIQ and PREMARIN. On 2nd June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 2nd June 2018, 2 hrs after receiving SHINGRIX, the patient experienced fever, hypersensation skin, joint pain, lethargic and influenza. On an unknown date, the outcome of the fever, hypersensation skin, joint pain, lethargic and influenza were recovered/resolved. The reporter considered the fever, hypersensation skin, joint pain, lethargic and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 4:00 pm, the patient received SHINGRIX vaccine on right arm. The patient experienced fever (the patient's body temperature was recorded as 100.5) and then the following day her fever was 100 and had not resolved. After speaking to the patient, she reported that her fever finally broke last evening from the date of reporting. The patient also reported that within two hours she felt like she had a mild case of the flu with joint aches and skin sensitivity and she was lethargic.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Hyperaesthesia, Influenza, Lethargy, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included fluid in middle ear. Concomitant products included Levothyroxine, omeprazole, hydrochlorothiazide, meloxicam, MYRBETRIQ and PREMARIN. On 2nd June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 2nd June 2018, 2 hrs after receiving SHINGRIX, the patient experienced fever, hypersensation skin, joint pain, lethargic and influenza. On an unknown date, the outcome of the fever, hypersensation skin, joint pain, lethargic and influenza were recovered/resolved. The reporter considered the fever, hypersensation skin, joint pain, lethargic and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 4:00 pm, the patient received SHINGRIX vaccine on right arm. The patient experienced fever (the patient's body temperature was recorded as 100.5) and then the following day her fever was 100 and had not resolved. After speaking to the patient, she reported that her fever finally broke last evening from the date of reporting. The patient also reported that within two hours she felt like she had a mild case of the flu with joint aches and skin sensitivity and she was lethargic.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 58-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Concomitant products included Acetaminophen and ALEVE. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, 1 hr after receiving SHINGRIX, the patient experienced weakness, general body pain and dizziness. On 2nd June 2018, the patient experienced arthralgia, muscle pain, nausea, headache and inability to work. On 3rd June 2018, the patient experienced tiredness. In June 2018, the patient experienced erythema of extremities and skin warm. The patient was treated with BENADRYL. On an unknown date, the outcome of the weakness, arthralgia, muscle pain, tiredness, dizziness and headache were not recovered/not resolved and the outcome of the general body pain and erythema of extremities were recovering/resolving and the outcome of the nausea, skin warm and inability to work were unknown. The reporter considered the weakness, general body pain, arthralgia, muscle pain, tiredness, nausea, erythema of extremities, skin warm, dizziness and headache to be related to SHINGRIX. It was unknown if the reporter considered the inability to work to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for herself. The patient wears a continuous positive airway pressure (CPAP). The patient had been taking Acetaminophen every four hours and then switched to ALEVE. The pharmacist reported that, around 2:00 PM she received the SHINGRIX vaccine and an hour later she felt weak and dizzy and had a slight body ache. On 1st June 2018 (Saturday), 1 day after vaccination, the patient had severe body aches and she could not work with joint ache and muscle pain which included the lower back, knee and ankle that was so bad with a dizzy headache and she felt nauseous on the same day and she went to bed. The patient went home early and took BENADRYL. Later on the same day at night, she took 100 mg of BENADRYL with two doses of 275 mg tablets of ALEVE at 4:30 and then 10:00 PM. On 2nd June 2018 (Sunday), the patient did not go to work and she felt weak and achy all day. In June 2018, (less than a week after vaccination) in the last couple of days the experienced redness and hot to the touch on her arm which gotten brighter but the brightest was on a day before the reporting and on the date of reporting, it was not as raised in appearance. The patient was feeling tired till the time of reporting and she did not want to do anything. It was taking a real effort to do anything and she did not go out for her anniversary because she did not feel well. She reported that her body ache was better at the time of reporting. This information had already been reported to VAERS. The patient reported to Medical Information that she felt like a wasp bit her and the stinger was still in there at the reporting time.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 58-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Concomitant products included Acetaminophen and ALEVE. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, 1 hr after receiving SHINGRIX, the patient experienced weakness, general body pain and dizziness. On 2nd June 2018, the patient experienced arthralgia, muscle pain, nausea, headache and inability to work. On 3rd June 2018, the patient experienced tiredness. In June 2018, the patient experienced erythema of extremities and skin warm. The patient was treated with BENADRYL. On an unknown date, the outcome of the weakness, arthralgia, muscle pain, tiredness, dizziness and headache were not recovered/not resolved and the outcome of the general body pain and erythema of extremities were recovering/resolving and the outcome of the nausea, skin warm and inability to work were unknown. The reporter considered the weakness, general body pain, arthralgia, muscle pain, tiredness, nausea, erythema of extremities, skin warm, dizziness and headache to be related to SHINGRIX. It was unknown if the reporter considered the inability to work to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for herself. The patient wears a continuous positive airway pressure (CPAP). The patient had been taking Acetaminophen every four hours and then switched to ALEVE. The pharmacist reported that, around 2:00 PM she received the SHINGRIX vaccine and an hour later she felt weak and dizzy and had a slight body ache. On 1st June 2018 (Saturday), 1 day after vaccination, the patient had severe body aches and she could not work with joint ache and muscle pain which included the lower back, knee and ankle that was so bad with a dizzy headache and she felt nauseous on the same day and she went to bed. The patient went home early and took BENADRYL. Later on the same day at night, she took 100 mg of BENADRYL with two doses of 275 mg tablets of ALEVE at 4:30 and then 10:00 PM. On 2nd June 2018 (Sunday), the patient did not go to work and she felt weak and achy all day. In June 2018, (less than a week after vaccination) in the last couple of days the experienced redness and hot to the touch on her arm which gotten brighter but the brightest was on a day before the reporting and on the date of reporting, it was not as raised in appearance. The patient was feeling tired till the time of reporting and she did not want to do anything. It was taking a real effort to do anything and she did not go out for her anniversary because she did not feel well. She reported that her body ache was better at the time of reporting. This information had already been reported to VAERS. The patient reported to Medical Information that she felt like a wasp bit her and the stinger was still in there at the reporting time.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Continuous positive airway pressure, Dizziness, Erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 58-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Concomitant products included Acetaminophen and ALEVE. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, 1 hr after receiving SHINGRIX, the patient experienced weakness, general body pain and dizziness. On 2nd June 2018, the patient experienced arthralgia, muscle pain, nausea, headache and inability to work. On 3rd June 2018, the patient experienced tiredness. In June 2018, the patient experienced erythema of extremities and skin warm. The patient was treated with BENADRYL. On an unknown date, the outcome of the weakness, arthralgia, muscle pain, tiredness, dizziness and headache were not recovered/not resolved and the outcome of the general body pain and erythema of extremities were recovering/resolving and the outcome of the nausea, skin warm and inability to work were unknown. The reporter considered the weakness, general body pain, arthralgia, muscle pain, tiredness, nausea, erythema of extremities, skin warm, dizziness and headache to be related to SHINGRIX. It was unknown if the reporter considered the inability to work to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for herself. The patient wears a continuous positive airway pressure (CPAP). The patient had been taking Acetaminophen every four hours and then switched to ALEVE. The pharmacist reported that, around 2:00 PM she received the SHINGRIX vaccine and an hour later she felt weak and dizzy and had a slight body ache. On 1st June 2018 (Saturday), 1 day after vaccination, the patient had severe body aches and she could not work with joint ache and muscle pain which included the lower back, knee and ankle that was so bad with a dizzy headache and she felt nauseous on the same day and she went to bed. The patient went home early and took BENADRYL. Later on the same day at night, she took 100 mg of BENADRYL with two doses of 275 mg tablets of ALEVE at 4:30 and then 10:00 PM. On 2nd June 2018 (Sunday), the patient did not go to work and she felt weak and achy all day. In June 2018, (less than a week after vaccination) in the last couple of days the experienced redness and hot to the touch on her arm which gotten brighter but the brightest was on a day before the reporting and on the date of reporting, it was not as raised in appearance. The patient was feeling tired till the time of reporting and she did not want to do anything. It was taking a real effort to do anything and she did not go out for her anniversary because she did not feel well. She reported that her body ache was better at the time of reporting. This information had already been reported to VAERS. The patient reported to Medical Information that she felt like a wasp bit her and the stinger was still in there at the reporting time.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Impaired work ability, Myalgia, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 58-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Concomitant products included Acetaminophen and ALEVE. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, 1 hr after receiving SHINGRIX, the patient experienced weakness, general body pain and dizziness. On 2nd June 2018, the patient experienced arthralgia, muscle pain, nausea, headache and inability to work. On 3rd June 2018, the patient experienced tiredness. In June 2018, the patient experienced erythema of extremities and skin warm. The patient was treated with BENADRYL. On an unknown date, the outcome of the weakness, arthralgia, muscle pain, tiredness, dizziness and headache were not recovered/not resolved and the outcome of the general body pain and erythema of extremities were recovering/resolving and the outcome of the nausea, skin warm and inability to work were unknown. The reporter considered the weakness, general body pain, arthralgia, muscle pain, tiredness, nausea, erythema of extremities, skin warm, dizziness and headache to be related to SHINGRIX. It was unknown if the reporter considered the inability to work to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for herself. The patient wears a continuous positive airway pressure (CPAP). The patient had been taking Acetaminophen every four hours and then switched to ALEVE. The pharmacist reported that, around 2:00 PM she received the SHINGRIX vaccine and an hour later she felt weak and dizzy and had a slight body ache. On 1st June 2018 (Saturday), 1 day after vaccination, the patient had severe body aches and she could not work with joint ache and muscle pain which included the lower back, knee and ankle that was so bad with a dizzy headache and she felt nauseous on the same day and she went to bed. The patient went home early and took BENADRYL. Later on the same day at night, she took 100 mg of BENADRYL with two doses of 275 mg tablets of ALEVE at 4:30 and then 10:00 PM. On 2nd June 2018 (Sunday), the patient did not go to work and she felt weak and achy all day. In June 2018, (less than a week after vaccination) in the last couple of days the experienced redness and hot to the touch on her arm which gotten brighter but the brightest was on a day before the reporting and on the date of reporting, it was not as raised in appearance. The patient was feeling tired till the time of reporting and she did not want to do anything. It was taking a real effort to do anything and she did not go out for her anniversary because she did not feel well. She reported that her body ache was better at the time of reporting. This information had already been reported to VAERS. The patient reported to Medical Information that she felt like a wasp bit her and the stinger was still in there at the reporting time.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 58-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Concomitant products included Acetaminophen and ALEVE. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, 1 hr after receiving SHINGRIX, the patient experienced weakness, general body pain and dizziness. On 2nd June 2018, the patient experienced arthralgia, muscle pain, nausea, headache and inability to work. On 3rd June 2018, the patient experienced tiredness. In June 2018, the patient experienced erythema of extremities and skin warm. The patient was treated with BENADRYL. On an unknown date, the outcome of the weakness, arthralgia, muscle pain, tiredness, dizziness and headache were not recovered/not resolved and the outcome of the general body pain and erythema of extremities were recovering/resolving and the outcome of the nausea, skin warm and inability to work were unknown. The reporter considered the weakness, general body pain, arthralgia, muscle pain, tiredness, nausea, erythema of extremities, skin warm, dizziness and headache to be related to SHINGRIX. It was unknown if the reporter considered the inability to work to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for herself. The patient wears a continuous positive airway pressure (CPAP). The patient had been taking Acetaminophen every four hours and then switched to ALEVE. The pharmacist reported that, around 2:00 PM she received the SHINGRIX vaccine and an hour later she felt weak and dizzy and had a slight body ache. On 1st June 2018 (Saturday), 1 day after vaccination, the patient had severe body aches and she could not work with joint ache and muscle pain which included the lower back, knee and ankle that was so bad with a dizzy headache and she felt nauseous on the same day and she went to bed. The patient went home early and took BENADRYL. Later on the same day at night, she took 100 mg of BENADRYL with two doses of 275 mg tablets of ALEVE at 4:30 and then 10:00 PM. On 2nd June 2018 (Sunday), the patient did not go to work and she felt weak and achy all day. In June 2018, (less than a week after vaccination) in the last couple of days the experienced redness and hot to the touch on her arm which gotten brighter but the brightest was on a day before the reporting and on the date of reporting, it was not as raised in appearance. The patient was feeling tired till the time of reporting and she did not want to do anything. It was taking a real effort to do anything and she did not go out for her anniversary because she did not feel well. She reported that her body ache was better at the time of reporting. This information had already been reported to VAERS. The patient reported to Medical Information that she felt like a wasp bit her and the stinger was still in there at the reporting time.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eye irritation, Herpes ophthalmic, Herpes virus infection, Vision blurred
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of unqualified visual loss, one eye in a elderly female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced unqualified visual loss, one eye (serious criteria GSK medically significant). On an unknown date, the outcome of the unqualified visual loss, one eye was not recovered/not resolved. It was unknown if the reporter considered the unqualified visual loss, one eye to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced the loss of vision in one eye 3 weeks after receiving SHINGRIX. Till the time of reporting, the patient was experiencing complete vision loss in the same eye. The patient had already contacted GlaxoSmithKline and reported the event, however no duplicate case was found. She also contacted the pharmacy to let them know that GSK would be contacting them about this adverse event. This case has been linked to the case US2018GSK101804 and US2018GSK105481, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blindness unilateral
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of unqualified visual loss, one eye in a elderly female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced unqualified visual loss, one eye (serious criteria GSK medically significant). On an unknown date, the outcome of the unqualified visual loss, one eye was not recovered/not resolved. It was unknown if the reporter considered the unqualified visual loss, one eye to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced the loss of vision in one eye 3 weeks after receiving SHINGRIX. Till the time of reporting, the patient was experiencing complete vision loss in the same eye. The patient had already contacted GlaxoSmithKline and reported the event, however no duplicate case was found. She also contacted the pharmacy to let them know that GSK would be contacting them about this adverse event. This case has been linked to the case US2018GSK101804 and US2018GSK105481, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of unqualified visual loss, one eye in a elderly female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced unqualified visual loss, one eye (serious criteria GSK medically significant). On an unknown date, the outcome of the unqualified visual loss, one eye was not recovered/not resolved. It was unknown if the reporter considered the unqualified visual loss, one eye to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced the loss of vision in one eye 3 weeks after receiving SHINGRIX. Till the time of reporting, the patient was experiencing complete vision loss in the same eye. The patient had already contacted GlaxoSmithKline and reported the event, however no duplicate case was found. She also contacted the pharmacy to let them know that GSK would be contacting them about this adverse event. This case has been linked to the case US2018GSK101804 and US2018GSK105481, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eye irritation, Herpes ophthalmic, Herpes virus infection, Vision blurred
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced flu-like symptoms for 5 days. The pharmacist did not have specifics for the patient as she was very busy. This case has been linked to the case US2018GSK101803 and US2018GSK105481, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blindness unilateral
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced flu-like symptoms for 5 days. The pharmacist did not have specifics for the patient as she was very busy. This case has been linked to the case US2018GSK101803 and US2018GSK105481, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced flu-like symptoms for 5 days. The pharmacist did not have specifics for the patient as she was very busy. This case has been linked to the case US2018GSK101803 and US2018GSK105481, reported by the same reporter.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: Big lump at injection site that is very painful and feels bruised. Lump appeared a month after injection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient is a 58-year-old retired female who recently received shingles vaccine and complains of lower extremity myalgias that developed the following day and lasted 24 hours -although myalgias are a known side effect with SHINGRIX and the package insert noted up to 57% of patient who receive this vaccine can report myalgias, I suspect that her previous days' activity (300 squats and 150 crunches) at least partially contributed to her symptoms, especially given myalgias were limited to her lower extremities with no complaint of a large local reaction or upper extremity myalgias -nonetheless, we will file a VAERS report for the AEFI -I do not feel these self-limited myalgias are a contraindication to the second dose of SHINGRIX -I would recommend avoid exercise the day before and for a couple days after SHINGRIX #2 -patient may also pre-medicate with TYLENOL or ibuprofen the day of and the day after vaccination to help mitigate any symptoms-Recommend delaying SHINGRIX #2 until after the first of the year due to the known shortage and patient's relatively young age (some data to support good efficacy with a single dose in this younger population) -Patient voiced understanding and agrees with plan, All questions were answered. -Patient to follow-up as needed or if she develops any adverse event following dose #2.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Severe pain, skin was red, some swelling and hot to the touch. Right arm diffusely TTP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms. Tired, body aches, fever, chills.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash over entire body, fever - start 6/8/18 until present.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Redness and swelling of legs below the knee with non-blanching rash, apply mild moisturizer, symptoms were gone within 72 hours.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: At 9:30PM, 6 hours post immunization, Patient started feeling very strong itch on the sole of her right foot, next hive appeared there, shortly thereafter, within another couple minutes 3 more prominent hives appeared on her left ankle (one) and left thigh (2). Her cheeks week bright pink. At 9:45PM she was given 10mg table of ZYRTEC. Doctor on call was consulted, decision to manage the outbreak at home was reached. By 10:25PM itch started to subside. Patient was monitored over night every 2 hours. Currently she is on ZYRTEC, her hives are not as big, but very visible.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 20 years old female patient. On unknown dates, patient was administered 3 doses of GARDASIL or GARDASIL 9 (doses and route unknown, unspecified lots and expiration dates and could not confirm whether GARDASIL or GARDASIL 9) by an unspecified Gynecologist. On 30-JAN-2014, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot# and expiration date unknown), and on 14-MAY-2018, the patient was vaccinated with the second dose of GARDASIL 9 (dose and route unknown, lot # N013698, expiration date: 19-DEC-2019) respectively for prophylaxis (inappropriate schedule of drug administration). On 14-MAY-2018, after the vaccination, the patient was dizzy and had to lay down for 30 seconds and then the dizziness went away. The causality assessments were not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On 17-JAN-2017, the licensed practical nurse reported that the GARDASIL 9 was improperly stored (product storage error). On 23-MAY-2018, the patient  inadvertently was vaccinated with an expired dose of GARDASIL 9, (expired vaccine used) intramuscular, lot # M021407 (expiration date 30-APR-2018) for prophylaxis (strength, dose and frequency were not reported).Temperature excursion was 35°F and time frame was approximately 18 hours. No adverse effects reported. No further information provided. Lot number [M021407] is an invalid lot number for [HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)].
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a male patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 01-DEC-2017, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (strength, dose and frequency were unknown) lot # N014949, expiration date 11-NOV-2018 for an unknown indication, which had a temperature excursion of 15°F to 46°F for 93 hours. The reporter stated that the product had no previous temperature excursion and that it was detected by a data logger. In addition, it was stated that the vaccine was administered with an properly stored MERCK STERILE DILUENT.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 14 year old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 23-MAY-2018, the patient was inadvertently vaccinated with PROQUAD lot number: N025927, expiration date: 18-MAR-2019, for prophylaxis (strength, route and dosage schedule were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (strength, dose, route and frequency were unknown) lot # N029673, expiration date 21-APR-2019, for prophylaxis, which had a temperature excursion of 6°F to 14°F for 20 minutes. The reporter stated that the vaccine had no previous temperature excursion and It was detected by a data logger. It was reported that the vaccine was reconstituted with a properly stored MERCK STERILE DILUENT.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The reporting medical assistant informed that on 30-MAY-2018, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 Injection, lot # M018810, expiration date 28-MAY-2018 (strength, dose number, dose and route not reported). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The reporting medical assistant informed that on 30-MAY-2018, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 Injection, lot # M018810, expiration date 28-MAY-2018, for prophylaxis (strength, dose, dose number, route and anatomical location were not reported). No adverse effects reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, who refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-JUN-2018, the patient was inadvertently vaccinated with one expired dose of RECOMBIVAX HB lot # M010671 and expiration date on 02-JUN-2018, for prophylaxis (route of administration and dose were not reported). The reporter stated that no adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  During November 2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-JUN-2016, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, ZOSTAVAX suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-JUL-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), at a healthcare facility/office (by an unspecified healthcare professional), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-SEP-2016, the patient was treated at the healthcare facility/office (by an unspecified healthcare professional), for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 01-JUN-2017, the patient sought subsequent treatment at a medical center/hospital, for a continued and worsening vesicular outbreak, which were diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (Date of vaccination, lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated at a clinic (by an unspecified healthcare professional) for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient (h)as suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-AUG-2011, the patient was treated (by an unspecified healthcare professional) at a medical center, for a persistent and severe vesicular rash which was diagnosed as herpes zoster.  The patient was prescribed acyclovir for management of his painful symptoms. On or about 28-NOV-2011, the patient sought subsequent treatment from the medical center, for a persistent vesicular rash, which was diagnosed as post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient was prescribed hydrocodone for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient (age and gender unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 24-SEPTEMBER-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), at a healthcare facility/office (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated (by an unspecified healthcare professional) at a medical center, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-OCT-2009, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster.  On or about 28-OCT-2013, the patient was treated at the same medical center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.