chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyskinesia, Eye swelling, Fall, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX. The patient's past medical history included diabetes. Concurrent medical conditions included blood pressure high and heart disorder. On 2nd May 2018 11:00, the patient received the 1st dose of SHINGIRX. In May 2018, 14 hrs after receiving SHINGRIX, the patient experienced fever, tremor limb, low blood pressure, tongue thick, fatigue, chills, eye swelling, fall, feeling cold and jerkiness. The patient was treated with methylprednisolone. On 5th May 2018, the outcome of the fever was recovered/resolved. On 6th May 2018, the outcome of the tremor limb, tongue thick, chills, eye swelling and jerkiness were recovered/resolved. In May 2018, the outcome of the low blood pressure was recovered/resolved. On an unknown date, the outcome of the fatigue was recovering/resolving and the outcome of the fall and feeling cold were unknown. The reporter considered the fever, tremor limb, low blood pressure, tongue thick, fatigue chills, eye swelling and feeling cold to be related to SHINGRIX. It was unknown if the reporter considered the fall and jerkiness to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received SHINGRIX on left arm without discussing it with his doctor. He received some information from the pharmacist, but he did not think it was enough of warning of possible side effects. The patient stated that when he woke up the tremors in his arms and legs were so bad that he thought he might be having a seizure. The patient said the chills made him feel like he was freezing and could not get warm. About an hour and a half after he got up at 1:00 am, he tried to go to the bathroom and fell. The patient was so cold he said that he had a sheet, an electric blanket and a comforter on top of him in the bed to try to get warm. The patient could get an appointment to see his doctor on Thursday, 3rd May 2018. The doctor was not familiar with the vaccine and did not know what to do. When they took his blood pressure at the office it was 101 by 63 and was told that was very low. The patient was told that if his pressure had gotten any lower, it could be a potential stroke. The doctor did give the patient a prescription for Methylprednisolone, a steroid to help with the side effects. The most side effects were resolved by Saturday afternoon. The jerking and shaking did not stop until Sunday. The patient said that on the reporting date he still felt fatigued. He wanted the company to have the feedback and awareness. He did mention that the pharmacist had reported this case to the FDA a week before the reporting date.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling cold, Hypotension, Pyrexia, Tongue disorder, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX. The patient's past medical history included diabetes. Concurrent medical conditions included blood pressure high and heart disorder. On 2nd May 2018 11:00, the patient received the 1st dose of SHINGIRX. In May 2018, 14 hrs after receiving SHINGRIX, the patient experienced fever, tremor limb, low blood pressure, tongue thick, fatigue, chills, eye swelling, fall, feeling cold and jerkiness. The patient was treated with methylprednisolone. On 5th May 2018, the outcome of the fever was recovered/resolved. On 6th May 2018, the outcome of the tremor limb, tongue thick, chills, eye swelling and jerkiness were recovered/resolved. In May 2018, the outcome of the low blood pressure was recovered/resolved. On an unknown date, the outcome of the fatigue was recovering/resolving and the outcome of the fall and feeling cold were unknown. The reporter considered the fever, tremor limb, low blood pressure, tongue thick, fatigue chills, eye swelling and feeling cold to be related to SHINGRIX. It was unknown if the reporter considered the fall and jerkiness to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received SHINGRIX on left arm without discussing it with his doctor. He received some information from the pharmacist, but he did not think it was enough of warning of possible side effects. The patient stated that when he woke up the tremors in his arms and legs were so bad that he thought he might be having a seizure. The patient said the chills made him feel like he was freezing and could not get warm. About an hour and a half after he got up at 1:00 am, he tried to go to the bathroom and fell. The patient was so cold he said that he had a sheet, an electric blanket and a comforter on top of him in the bed to try to get warm. The patient could get an appointment to see his doctor on Thursday, 3rd May 2018. The doctor was not familiar with the vaccine and did not know what to do. When they took his blood pressure at the office it was 101 by 63 and was told that was very low. The patient was told that if his pressure had gotten any lower, it could be a potential stroke. The doctor did give the patient a prescription for Methylprednisolone, a steroid to help with the side effects. The most side effects were resolved by Saturday afternoon. The jerking and shaking did not stop until Sunday. The patient said that on the reporting date he still felt fatigued. He wanted the company to have the feedback and awareness. He did mention that the pharmacist had reported this case to the FDA a week before the reporting date.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Loss of consciousness, Malaise, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 71-year-old female patient who received SHINGRIX. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, 8 hrs after receiving SHINGRIX, the patient experienced nausea. On 6th May 2018, the patient experienced passed out (serious criteria GSK medically significant) and faint. In May 2018, the patient experienced weight loss, diarrhea, feeling bad and dehydration. The patient was treated with Intravenous Fluids and ZOFRAN. The action taken with SHINGRIX was unknown. On 6th May 2018, the outcome of the passed out and faint were recovered/resolved. On an unknown date, the outcome of the nausea, diarrhea and feeling bad were recovered/resolved and the outcome of the weight loss was recovering/resolving and the outcome of the dehydration was unknown. The reporter considered the passed out, nausea, weight loss and diarrhea to be related to SHINGRIX. It was unknown if the reporter considered the faint, feeling bad and dehydration to be related to SHINGRIX. Additional details were provided as follows: Approximately 8 hours after vaccination, the patient experienced horrible nausea and felt like she had been poisoned and felt like she was dying. The patient stated that she never vomited, however, the nausea continued on the next day and got worse. The patient stated that the next day after vaccination, she felt faint and passed out for approximately 2 minutes. The patient stated that her daughter took her to the emergency room and they wanted to admit her but she did not want to stay, so she was not admitted. The patient's all lab work and tests came back normal. The patient stated that she had lost 5 lbs weight since all of this had happened. The patient stated that she went to visit her doctor on Monday because she was feeling pretty bad. In May 2018, the outcome of the nausea, diarrhea and feeling bad were resolved. The patient stated that she was currently eating the BRAT diet and was finally able to eat again and feels pretty good at the time of reporting. The patient stated that she was healthy individual and felt fine before she received the vaccine. The patient stated that she did not think she would get the second vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Dehydration, Diarrhoea, Enzyme level test, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 71-year-old female patient who received SHINGRIX. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, 8 hrs after receiving SHINGRIX, the patient experienced nausea. On 6th May 2018, the patient experienced passed out (serious criteria GSK medically significant) and faint. In May 2018, the patient experienced weight loss, diarrhea, feeling bad and dehydration. The patient was treated with Intravenous Fluids and ZOFRAN. The action taken with SHINGRIX was unknown. On 6th May 2018, the outcome of the passed out and faint were recovered/resolved. On an unknown date, the outcome of the nausea, diarrhea and feeling bad were recovered/resolved and the outcome of the weight loss was recovering/resolving and the outcome of the dehydration was unknown. The reporter considered the passed out, nausea, weight loss and diarrhea to be related to SHINGRIX. It was unknown if the reporter considered the faint, feeling bad and dehydration to be related to SHINGRIX. Additional details were provided as follows: Approximately 8 hours after vaccination, the patient experienced horrible nausea and felt like she had been poisoned and felt like she was dying. The patient stated that she never vomited, however, the nausea continued on the next day and got worse. The patient stated that the next day after vaccination, she felt faint and passed out for approximately 2 minutes. The patient stated that her daughter took her to the emergency room and they wanted to admit her but she did not want to stay, so she was not admitted. The patient's all lab work and tests came back normal. The patient stated that she had lost 5 lbs weight since all of this had happened. The patient stated that she went to visit her doctor on Monday because she was feeling pretty bad. In May 2018, the outcome of the nausea, diarrhea and feeling bad were resolved. The patient stated that she was currently eating the BRAT diet and was finally able to eat again and feels pretty good at the time of reporting. The patient stated that she was healthy individual and felt fine before she received the vaccine. The patient stated that she did not think she would get the second vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Nausea, Syncope, Weight decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 71-year-old female patient who received SHINGRIX. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, 8 hrs after receiving SHINGRIX, the patient experienced nausea. On 6th May 2018, the patient experienced passed out (serious criteria GSK medically significant) and faint. In May 2018, the patient experienced weight loss, diarrhea, feeling bad and dehydration. The patient was treated with Intravenous Fluids and ZOFRAN. The action taken with SHINGRIX was unknown. On 6th May 2018, the outcome of the passed out and faint were recovered/resolved. On an unknown date, the outcome of the nausea, diarrhea and feeling bad were recovered/resolved and the outcome of the weight loss was recovering/resolving and the outcome of the dehydration was unknown. The reporter considered the passed out, nausea, weight loss and diarrhea to be related to SHINGRIX. It was unknown if the reporter considered the faint, feeling bad and dehydration to be related to SHINGRIX. Additional details were provided as follows: Approximately 8 hours after vaccination, the patient experienced horrible nausea and felt like she had been poisoned and felt like she was dying. The patient stated that she never vomited, however, the nausea continued on the next day and got worse. The patient stated that the next day after vaccination, she felt faint and passed out for approximately 2 minutes. The patient stated that her daughter took her to the emergency room and they wanted to admit her but she did not want to stay, so she was not admitted. The patient's all lab work and tests came back normal. The patient stated that she had lost 5 lbs weight since all of this had happened. The patient stated that she went to visit her doctor on Monday because she was feeling pretty bad. In May 2018, the outcome of the nausea, diarrhea and feeling bad were resolved. The patient stated that she was currently eating the BRAT diet and was finally able to eat again and feels pretty good at the time of reporting. The patient stated that she was healthy individual and felt fine before she received the vaccine. The patient stated that she did not think she would get the second vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 72-year-old female patient who received SHINGRIX. The patient's past medical history included pulmonary embolism (2 years before reporting date). Concurrent medical conditions included urinary tract infection (just finished the nitrofurantoin on). Concomitant products included COUMADIN, simvastatin, vitamin D, Vitamin B12, nitrofurantoin and warfarin. On 1st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 2nd May 2018, the patient experienced unwell, weakness, headache, appetite absent and pain. On 4th May 2018, the patient experienced fever and felt faint. In May 2018, the patient experienced shortness of breath. The patient was treated with TYLENOL. On 5th May 2018, the outcome of the fever was recovered/resolved. In May 2018, the outcome of the weakness, pain in arm and appetite absent were recovered/resolved. On an unknown date, the outcome of the unwell, shortness of breath, pain and felt faint were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the unwell, shortness of breath, pain and felt faint to be related to SHINGRIX. The reporter considered the weakness, fever, headache, pain in arm and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. Less than a day, after receiving SHINGRIX, the patient reported a sore arm. The next day, the patient felt weak and achy, had no appetite and stayed in bed all day. The patient experienced getting very ill. The patient felt better on Thursday afternoon and was able to go out. The patient still did not have appetite and did not eat much Friday or Saturday. At Friday afternoon, 3 days after receiving SHINGRIX, the patient felt weak and felt like she was going to faint. The patient took an afternoon nap and woke up at 6:00 pm and was burning up with a 102 fever which lasted through the next day. Less than month, after receiving SHINGRIX, the patient had shortness of breath. The patient started to feel better on Sunday. The patient took TYLENOL throughout the week to help her symptoms. The patient left a voice message in the after hours message line. The patient provided details of her doctor and asked that if any new information come about this vaccine, that she was contacted. The patient had the right to know all information and was hesitated to get the 2nd dose.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 72-year-old female patient who received SHINGRIX. The patient's past medical history included pulmonary embolism (2 years before reporting date). Concurrent medical conditions included urinary tract infection (just finished the nitrofurantoin on). Concomitant products included COUMADIN, simvastatin, vitamin D, Vitamin B12, nitrofurantoin and warfarin. On 1st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 2nd May 2018, the patient experienced unwell, weakness, headache, appetite absent and pain. On 4th May 2018, the patient experienced fever and felt faint. In May 2018, the patient experienced shortness of breath. The patient was treated with TYLENOL. On 5th May 2018, the outcome of the fever was recovered/resolved. In May 2018, the outcome of the weakness, pain in arm and appetite absent were recovered/resolved. On an unknown date, the outcome of the unwell, shortness of breath, pain and felt faint were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the unwell, shortness of breath, pain and felt faint to be related to SHINGRIX. The reporter considered the weakness, fever, headache, pain in arm and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. Less than a day, after receiving SHINGRIX, the patient reported a sore arm. The next day, the patient felt weak and achy, had no appetite and stayed in bed all day. The patient experienced getting very ill. The patient felt better on Thursday afternoon and was able to go out. The patient still did not have appetite and did not eat much Friday or Saturday. At Friday afternoon, 3 days after receiving SHINGRIX, the patient felt weak and felt like she was going to faint. The patient took an afternoon nap and woke up at 6:00 pm and was burning up with a 102 fever which lasted through the next day. Less than month, after receiving SHINGRIX, the patient had shortness of breath. The patient started to feel better on Sunday. The patient took TYLENOL throughout the week to help her symptoms. The patient left a voice message in the after hours message line. The patient provided details of her doctor and asked that if any new information come about this vaccine, that she was contacted. The patient had the right to know all information and was hesitated to get the 2nd dose.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 72-year-old female patient who received SHINGRIX. The patient's past medical history included pulmonary embolism (2 years before reporting date). Concurrent medical conditions included urinary tract infection (just finished the nitrofurantoin on). Concomitant products included COUMADIN, simvastatin, vitamin D, Vitamin B12, nitrofurantoin and warfarin. On 1st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 2nd May 2018, the patient experienced unwell, weakness, headache, appetite absent and pain. On 4th May 2018, the patient experienced fever and felt faint. In May 2018, the patient experienced shortness of breath. The patient was treated with TYLENOL. On 5th May 2018, the outcome of the fever was recovered/resolved. In May 2018, the outcome of the weakness, pain in arm and appetite absent were recovered/resolved. On an unknown date, the outcome of the unwell, shortness of breath, pain and felt faint were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the unwell, shortness of breath, pain and felt faint to be related to SHINGRIX. The reporter considered the weakness, fever, headache, pain in arm and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. Less than a day, after receiving SHINGRIX, the patient reported a sore arm. The next day, the patient felt weak and achy, had no appetite and stayed in bed all day. The patient experienced getting very ill. The patient felt better on Thursday afternoon and was able to go out. The patient still did not have appetite and did not eat much Friday or Saturday. At Friday afternoon, 3 days after receiving SHINGRIX, the patient felt weak and felt like she was going to faint. The patient took an afternoon nap and woke up at 6:00 pm and was burning up with a 102 fever which lasted through the next day. Less than month, after receiving SHINGRIX, the patient had shortness of breath. The patient started to feel better on Sunday. The patient took TYLENOL throughout the week to help her symptoms. The patient left a voice message in the after hours message line. The patient provided details of her doctor and asked that if any new information come about this vaccine, that she was contacted. The patient had the right to know all information and was hesitated to get the 2nd dose.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced injection site itching. On 23rd April 2018, the patient experienced headache. On 24th April 2018, the patient experienced injection site erythema, injection site swelling, injection site pain and injection site discoloration. On an unknown date, the patient experienced injection site hypersensitivity. The patient was treated with CLARITIN, (NOS) BENADRYL and ALEVE. On an unknown date, the outcome of the injection site erythema, injection site swelling, headache, injection site pain, injection site discoloration and injection site itching were unchanged and the outcome of the injection site hypersensitivity was unknown. The reporter considered the injection site erythema, injection site swelling, headache, injection site pain, injection site pain, injection site discoloration, injection site hypersensitivity to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received SHINGRIX on left arm. The patient stated that, on the day vaccination, around 9 PM at night the patient experienced headache and took 2 ALEVE's to help with the headache. Next day after vaccination, she started to see redness, burning, swelling and pain at the injection site. The patient specifically stated the itching at the injection site started approximately about a week later. She had an area on her arm which kept getting red and bigger and was about 4 inch by 4 inch oval size. This area on her skin had peculiar discoloration on the arm and it fades away from time to time. In 2018, less than a month after vaccination, the skin around the area had become sensitive at the reporting time and felt funny as per the reporter. She took 2 BENADRYL and CLARITIN to help with her situation. The patient gave permission to contact their healthcare provider and provided contact details for the same. Healthcare provider's medical assistant details was provided since she would be able to provide more information as per the patient. The patient was really concerned about the side effects that she had experienced.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site discolouration, Injection site erythema, Injection site hypersensitivity, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced injection site itching. On 23rd April 2018, the patient experienced headache. On 24th April 2018, the patient experienced injection site erythema, injection site swelling, injection site pain and injection site discoloration. On an unknown date, the patient experienced injection site hypersensitivity. The patient was treated with CLARITIN, (NOS) BENADRYL and ALEVE. On an unknown date, the outcome of the injection site erythema, injection site swelling, headache, injection site pain, injection site discoloration and injection site itching were unchanged and the outcome of the injection site hypersensitivity was unknown. The reporter considered the injection site erythema, injection site swelling, headache, injection site pain, injection site pain, injection site discoloration, injection site hypersensitivity to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received SHINGRIX on left arm. The patient stated that, on the day vaccination, around 9 PM at night the patient experienced headache and took 2 ALEVE's to help with the headache. Next day after vaccination, she started to see redness, burning, swelling and pain at the injection site. The patient specifically stated the itching at the injection site started approximately about a week later. She had an area on her arm which kept getting red and bigger and was about 4 inch by 4 inch oval size. This area on her skin had peculiar discoloration on the arm and it fades away from time to time. In 2018, less than a month after vaccination, the skin around the area had become sensitive at the reporting time and felt funny as per the reporter. She took 2 BENADRYL and CLARITIN to help with her situation. The patient gave permission to contact their healthcare provider and provided contact details for the same. Healthcare provider's medical assistant details was provided since she would be able to provide more information as per the patient. The patient was really concerned about the side effects that she had experienced.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced injection site itching. On 23rd April 2018, the patient experienced headache. On 24th April 2018, the patient experienced injection site erythema, injection site swelling, injection site pain and injection site discoloration. On an unknown date, the patient experienced injection site hypersensitivity. The patient was treated with CLARITIN, (NOS) BENADRYL and ALEVE. On an unknown date, the outcome of the injection site erythema, injection site swelling, headache, injection site pain, injection site discoloration and injection site itching were unchanged and the outcome of the injection site hypersensitivity was unknown. The reporter considered the injection site erythema, injection site swelling, headache, injection site pain, injection site pain, injection site discoloration, injection site hypersensitivity to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received SHINGRIX on left arm. The patient stated that, on the day vaccination, around 9 PM at night the patient experienced headache and took 2 ALEVE's to help with the headache. Next day after vaccination, she started to see redness, burning, swelling and pain at the injection site. The patient specifically stated the itching at the injection site started approximately about a week later. She had an area on her arm which kept getting red and bigger and was about 4 inch by 4 inch oval size. This area on her skin had peculiar discoloration on the arm and it fades away from time to time. In 2018, less than a month after vaccination, the skin around the area had become sensitive at the reporting time and felt funny as per the reporter. She took 2 BENADRYL and CLARITIN to help with her situation. The patient gave permission to contact their healthcare provider and provided contact details for the same. Healthcare provider's medical assistant details was provided since she would be able to provide more information as per the patient. The patient was really concerned about the side effects that she had experienced.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX. Previously administered products included Pneumonia vaccine with an associated reaction of injection site erythema and Pneumonia vaccine with an associated reaction of extensive swelling of vaccinated limb (received an year ago from the date of reporting). On 6th May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 6th May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route and off label use. In May 2018, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route and off label use were unknown. The reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine subcutaneously intentionally instead of intramuscular route in the left arm (at a pharmacy), because the pharmacist stated it was supposed to be administered subcutaneously, which led to inappropriate route of vaccination. As SHINGRIX vaccine subcutaneously intentionally, which led to off label use. About 1 to 2 hours after receiving SHINGRIX, the patient experienced a bright red and swollen injection site reaction (4 X 2 inches) extended from the injection site. The patient stated, these reactions were more severe. The reaction had not improved as per the healthcare professional. The patient does not have the lot number or expiry dates of the vaccine. The patient also did not provide address details as she worked in the operating room at multiple facilities.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Incorrect route of drug administration, Injection site erythema, Injection site swelling, Off label use
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX. Previously administered products included Pneumonia vaccine with an associated reaction of injection site erythema and Pneumonia vaccine with an associated reaction of extensive swelling of vaccinated limb (received an year ago from the date of reporting). On 6th May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 6th May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route and off label use. In May 2018, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route and off label use were unknown. The reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine subcutaneously intentionally instead of intramuscular route in the left arm (at a pharmacy), because the pharmacist stated it was supposed to be administered subcutaneously, which led to inappropriate route of vaccination. As SHINGRIX vaccine subcutaneously intentionally, which led to off label use. About 1 to 2 hours after receiving SHINGRIX, the patient experienced a bright red and swollen injection site reaction (4 X 2 inches) extended from the injection site. The patient stated, these reactions were more severe. The reaction had not improved as per the healthcare professional. The patient does not have the lot number or expiry dates of the vaccine. The patient also did not provide address details as she worked in the operating room at multiple facilities.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site pain, Malaise, Pyrexia
Clinical narrative: Fever up to 104, lasting 4 hours. Chills. Malaise. Severe pain at the injection site lasting several weeks.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 53 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot number R002930, expiration date 31-JAN-2019 (dose and route were not reported) for prophylaxis. No adverse effects were reported. The temperature involved was 49.4 degrees Fahrenheit for 12 hours. Previous temperature excursion was not reported, and a data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was inadvertently vaccinated with an adult dose of VAQTA intramuscularly for prophylaxis (frequency, lot number and expiration date were not provided); Moreover, the reporter could not provide the lot number of the administered VAQTA and provided the lot number that was currently using (Lot # R000180 with expiration date 21-MAR-2019). No adverse effects were reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 09-MAR-2018 (reported as "2 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 intramuscular route, in her left upper arm region (dose, frequency, anatomical location, lot # and expiration date were unknown) for human papillomavirus (HPV) prevention. On an unspecified date in May 2018, (reported as "a few days") after receiving injection, the patient reported what felt like "a small pebble under her skin at the injection site". Pharmacist reported that on 08-MAY-2018 patient returned to the Pharmacy and she palpated the small pebble under the skin at injection site. At the time of the report, the outcome of injection site mass was unknown. The pharmacist did not mention the causality assessment between the events of injection site mass and GARDASIL 9. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA004067.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 09-MAR-2018 (reported as "2 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 intramuscular route, in her left upper arm region (dose, frequency, anatomical location, lot # and expiration date were unknown) for human papillomavirus (HPV) prevention. On an unspecified date in May 2018, (reported as "a few days") after receiving injection, the patient reported what felt like "a small pebble under her skin at the injection site". Pharmacist reported that on 08-MAY-2018 patient returned to the Pharmacy and she palpated the small pebble under the skin at injection site. At the time of the report, the outcome of injection site mass was unknown. The pharmacist did not mention the causality assessment between the events of injection site mass and GARDASIL 9. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA004067.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-JAN-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route 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 01-JUN-2015, the patient was treated by a physician for a vesicular rash, which was diagnosed as shingles and Bell's Palsy, a condition involving neurological interference and paralysis of facial muscles secondary to zoster infections. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Upon internal review, Bell's Palsy was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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 12-APR-2013, the patient was inoculated with ZOSTAVAX at a pharmacy 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 20-JUN-2016, the patient was treated by a physician at a medical center for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed prednisone, gabapentin, acetaminophen and oxycodone (PERCOCET), and valacyclovir (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-OCT-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 with complications. During 2016, the patient was treated at a family health center for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 04-JAN-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician 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 14-AUG-2015, the patient was treated at a nursing center for a vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed acyclovir and a topical ointment to manage his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 21-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 05-JUN-2017, the patient was treated at a dermatology clinic for a blistering vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed valacyclovir and acetaminophen-hydrocodone to manage his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-JAN-2016, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-JUN-2016, the patient was treated by a physician (site not specified), for a blistering vesicular outbreak, 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 condition of herpes zoster. On or about 01-JUN-2016, the patient was treated by a physician at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician 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 condition of herpes zoster. During June 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.