chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itchy, redness hives started on back, progressed to abdomen. Up neck and down arms and legs by 10/20/18.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Dysphonia, Feeling jittery, Feeling of body temperature change
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 77-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. The patient's past medical history included penicillin allergy. Concurrent medical conditions included chronic obstructive pulmonary disease. On 24th September 2018, the patient received FLUARIX QUADRIVALENT. On 25th September 2018, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced influenza, blood pressure high, diarrhea, headache, fever, swelling arm, hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness. On an unknown date, the outcome of the influenza, headache and fever were unchanged and the outcome of the blood pressure high was unknown and the outcome of the diarrhea and swelling arm were recovering/resolving and the outcome of the hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness were not recovered/not resolved. It was unknown if the reporter considered the influenza, blood pressure high, diarrhea, headache, fever, swelling arm, hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient's historical conditions included asbestos in lung. The patient did not remember the word all the time, in her lungs, it was like somebody would get it. On Monday in afternoon the patient received FLUARIX QUADRIVALENT. On Tuesday morning, when the patient woke up, she was sick, very sick, she had the chills, she was hot, she was cold, and had a headache. The patient experienced flu like symptoms consisting of fever (body temperature: 102 degree F), chills, headache, diarrhea, and high blood pressure. The patient thought that the flu shot was supposed to not give her the flu, but it gave her the flu (she guessed) and she suffered from the flu symptoms which include a hoarse voice, fever, chills, hot and cold feeling, headache, jittery and shaky feeling. The patient did not go to her physician, and her arm was very swollen. And still on Tuesday she was not feeling well. The patient stated that she was not going to ever get a flu shot again, because even on the reporting date, she was not feeling well. The patient requested compensation from Legal for the side effects she experienced and would submit her request to Legal in writing. This case was one of the 2 cases, reported by the same reporter.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypertension, Influenza, Malaise, Nervousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 77-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. The patient's past medical history included penicillin allergy. Concurrent medical conditions included chronic obstructive pulmonary disease. On 24th September 2018, the patient received FLUARIX QUADRIVALENT. On 25th September 2018, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced influenza, blood pressure high, diarrhea, headache, fever, swelling arm, hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness. On an unknown date, the outcome of the influenza, headache and fever were unchanged and the outcome of the blood pressure high was unknown and the outcome of the diarrhea and swelling arm were recovering/resolving and the outcome of the hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness were not recovered/not resolved. It was unknown if the reporter considered the influenza, blood pressure high, diarrhea, headache, fever, swelling arm, hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient's historical conditions included asbestos in lung. The patient did not remember the word all the time, in her lungs, it was like somebody would get it. On Monday in afternoon the patient received FLUARIX QUADRIVALENT. On Tuesday morning, when the patient woke up, she was sick, very sick, she had the chills, she was hot, she was cold, and had a headache. The patient experienced flu like symptoms consisting of fever (body temperature: 102 degree F), chills, headache, diarrhea, and high blood pressure. The patient thought that the flu shot was supposed to not give her the flu, but it gave her the flu (she guessed) and she suffered from the flu symptoms which include a hoarse voice, fever, chills, hot and cold feeling, headache, jittery and shaky feeling. The patient did not go to her physician, and her arm was very swollen. And still on Tuesday she was not feeling well. The patient stated that she was not going to ever get a flu shot again, because even on the reporting date, she was not feeling well. The patient requested compensation from Legal for the side effects she experienced and would submit her request to Legal in writing. This case was one of the 2 cases, reported by the same reporter.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 77-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. The patient's past medical history included penicillin allergy. Concurrent medical conditions included chronic obstructive pulmonary disease. On 24th September 2018, the patient received FLUARIX QUADRIVALENT. On 25th September 2018, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced influenza, blood pressure high, diarrhea, headache, fever, swelling arm, hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness. On an unknown date, the outcome of the influenza, headache and fever were unchanged and the outcome of the blood pressure high was unknown and the outcome of the diarrhea and swelling arm were recovering/resolving and the outcome of the hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness were not recovered/not resolved. It was unknown if the reporter considered the influenza, blood pressure high, diarrhea, headache, fever, swelling arm, hoarse voice, chills, feeling hot and cold, feeling jittery, shaky feelings and sickness to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient's historical conditions included asbestos in lung. The patient did not remember the word all the time, in her lungs, it was like somebody would get it. On Monday in afternoon the patient received FLUARIX QUADRIVALENT. On Tuesday morning, when the patient woke up, she was sick, very sick, she had the chills, she was hot, she was cold, and had a headache. The patient experienced flu like symptoms consisting of fever (body temperature: 102 degree F), chills, headache, diarrhea, and high blood pressure. The patient thought that the flu shot was supposed to not give her the flu, but it gave her the flu (she guessed) and she suffered from the flu symptoms which include a hoarse voice, fever, chills, hot and cold feeling, headache, jittery and shaky feeling. The patient did not go to her physician, and her arm was very swollen. And still on Tuesday she was not feeling well. The patient stated that she was not going to ever get a flu shot again, because even on the reporting date, she was not feeling well. The patient requested compensation from Legal for the side effects she experienced and would submit her request to Legal in writing. This case was one of the 2 cases, reported by the same reporter.
Sex: F
Vaccine: FLUX, HEP, HEPA
Symptoms: Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose, Hepatitis A vaccine at an unknown dose and Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine and Hepatitis A vaccine and an unknown time after receiving Hepatitis B vaccine, the patient experienced sickness and headache. On an unknown date, the outcome of the sickness and headache were unknown. It was unknown if the reporter considered the sickness and headache to be related to Flu vaccine, Hepatitis A vaccine and Hepatitis B vaccine. Additional information received as follows: The age at vaccination was not reported. The reporter said that she had a small frame and did not weight much. However, she always end up having the same dosing of vaccine as everyone else and had a miserable time with them. The patient reacted terribly to the vaccine. She felt sick and got a headache. That has happened with her flu vaccines, hepatitis vaccines. The patient did not want to provide any details on herself or the vaccines. This has been linked to the case US20181792010, reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 5th October 2018, the patient received FLUARIX QUADRIVALENT (intramuscular). On 5th October 2018, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On 9th October 2018, the patient experienced neck pain and shoulder pain. On an unknown date, the outcome of the injection site pain, neck pain and shoulder pain were unknown. It was unknown if the reporter considered the injection site pain, neck pain and shoulder pain to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient received Quadrivalent flu vaccine. She thought it was FLUARIX QUADRIVALENT, but was not certain. On 9th October 2018, 4 days after vaccination, the patient started having pain radiating up from the injection site, up her neck and into her shoulder towards the back side. The patient had not done anything to account for this new pain and thought it was due to her flu vaccine. She had tried heating patches and a TENS unit, but neither had helped the pain.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown. It was unknown if the reporter considered the fever and vomiting to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with a dose of SHINGRIX and experienced fever up to 101 degree F. At the time of reporting, the patient was due for her second dose and so the healthcare professional inquired whether the second dose of SHINGRIX should be administered or not to the patient, as the patient experienced the adverse events after the first dose. Lab Comments: Relevant tests: Lab test done on an unknown date.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved. It was unknown if the reporter considered the pain in arm and tiredness to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The nurse casually mentioned that she had spoken to some patients who were vaccinated with SHINGRIX and they experienced soreness and fatigue that lasted for a day or so. The nurse did not have any other details. This was casually brought up while discussing another adverse events that were already reported.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Injection site rash, Rash
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On 12th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site pain, rash, feeling bad and injection site rash. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, rash, feeling bad and injection site rash were unknown. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, rash, feeling bad and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient was in her 50s. The field representative reported that another field representative with GSK was the patient. The age at vaccination was not reported. After the injection, the patient felt lousy with flu-like symptoms. She also had a rash and pain. The reporter thought there was rash and pain at the injection site, but there might be rash on other parts of the body as well.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 22nd June 2018, the patient received the 1st dose of SHINGRIX 50 ug. On 7th October 2018, 107 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. The reporter considered the shingles to be unrelated to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. After vaccination with the first dose of SHINGRIX, a week ago before the date of reporting, the patient experienced Shingles. Till the date of reporting the patient was not vaccinated with the 2nd dose of SHINGRIX. The patient had not associated experiencing shingles as a lack of efficacy of the vaccine, however the patient also stated that she filled this adverse event to be safe since she experienced shingles.
Sex: U
Vaccine: FLU4
Symptoms: Adverse event, Off label use, Wrong technique in product usage process
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse event in an unspecified number of patients who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event, wrong injection technique and off label use. On an unknown date, the outcome of the adverse event, wrong injection technique and off label use were unknown. It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that, they had a few patients that did not tolerate flu vaccines well. For the flu vaccine they gave these patients half doses a week a part, which led to wrong injection technique and off label use. The HCP did not provide which flu vaccines the patients had been given.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult female patient who received SHINGRIX for prophylaxis. On 19th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tiredness, weakness, injection site pain and headache. On an unknown date, the outcome of the tiredness, weakness, injection site pain and headache were recovered/resolved. It was unknown if the reporter considered the tiredness, weakness, injection site pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm and she experienced pain at injection site, headache, weakness and tiredness which lasted for total of 1 day. The patient had denied permission to contact their physician. The patient was referred to her physician. No further details were provided. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK192996.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, feeling bad and general body pain. On an unknown date, the outcome of the influenza-like symptoms, feeling bad and general body pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, feeling bad and general body pain to be related to SHINGRIX. Additional details were received as follows: The patient started experiencing flu like symptoms (felt lousy and body aches), the next day that lasted a couple of days. The patient did not inform her doctor of her symptoms, and stated, what was he gonna do. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Muscular weakness, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 21st April 2018, the patient received the 1st dose of SHINGRIX. On 21st April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injected limb mobility decreased, injection site pain and weakness of arms. On 22nd April 2018, the patient experienced fever. On an unknown date, the outcome of the injection site swelling, fever, injected limb mobility decreased, injection site pain and weakness of arms were recovered/resolved. It was unknown if the reporter considered the injection site swelling, fever, injected limb mobility decreased, injection site pain and weakness of arms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the nurse for herself. The age at vaccination was not reported. The patient experienced swelling and pain at the injection site. In addition, her whole arm where she received the injection was weak because she could not move it. The next day after receiving SHINGRIX, the patient experienced fever and had to miss two days of work. The patient denied permission to contact their physician.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 61-year-old male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient's wife. The patient received SHINGRIX vaccine on left arm. The reporter stated the day after receiving SHINGRIX vaccine, the patient experienced severe body aches. This case is linked with case US2018188574, reported by same reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 11th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On 12th October 2018, the patient experienced general body pain, tiredness, headache and sleep excessive. On 14th October 2018, the patient experienced injection site rash. In October 2018, the patient experienced chills and fever. In October 2018, the outcome of the general body pain, tiredness and headache were recovered/resolved. On an unknown date, the outcome of the chills and fever were recovered/resolved and the outcome of the injection site rash was not recovered/not resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the sleep excessive and injected limb mobility decreased were unknown. It was unknown if the reporter considered the chills, general body pain, injection site rash, tiredness, pain in arm, fever, headache, sleep excessive and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX on Thursday before the reporting date. On the same day of vaccination, the patient experienced that the patient could not raise the arm where she received the injection because the whole arm was painful. On 11th October 2018, about 8 hours later the patient started with the chills and the low grade fever. The next day after vaccination, the patient experienced severe body aches all over, headache, tiredness and she ended up the fever with a 100 degree F. The patient slept all day. The patient felt better about her arm but it was not gone at the time of reporting. On Sunday, 3 days after vaccination, the patient noticed the rash, it was about 3 inches across her arm and 2 inches down at the injection site. The patient had denied permission to contact their physician.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 11th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On 12th October 2018, the patient experienced general body pain, tiredness, headache and sleep excessive. On 14th October 2018, the patient experienced injection site rash. In October 2018, the patient experienced chills and fever. In October 2018, the outcome of the general body pain, tiredness and headache were recovered/resolved. On an unknown date, the outcome of the chills and fever were recovered/resolved and the outcome of the injection site rash was not recovered/not resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the sleep excessive and injected limb mobility decreased were unknown. It was unknown if the reporter considered the chills, general body pain, injection site rash, tiredness, pain in arm, fever, headache, sleep excessive and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX on Thursday before the reporting date. On the same day of vaccination, the patient experienced that the patient could not raise the arm where she received the injection because the whole arm was painful. On 11th October 2018, about 8 hours later the patient started with the chills and the low grade fever. The next day after vaccination, the patient experienced severe body aches all over, headache, tiredness and she ended up the fever with a 100 degree F. The patient slept all day. The patient felt better about her arm but it was not gone at the time of reporting. On Sunday, 3 days after vaccination, the patient noticed the rash, it was about 3 inches across her arm and 2 inches down at the injection site. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site joint pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site joint pain in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced injection site joint pain. On an unknown date, the outcome of the injection site joint pain was not recovered/not resolved. It was unknown if the reporter considered the injection site joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient was vaccinated 2-3 months before the reporting date. Approximately 1 month after vaccination, the patient experienced unresolved pain at the injection site/shoulder. The healthcare professional was unable to provide dates for vaccination but was okay with a follow up and will research. She was not the healthcare professional that gave injection.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 54-year-old male patient who received SHINGRIX for prophylaxis. On 23rd September 2018, the patient received the 1st dose of SHINGRIX. On 3rd October 2018, 10 days after receiving SHINGRIX, the patient experienced fatigue, chills, appetite lost and fever. On an unknown date, the outcome of the fatigue, chills, appetite lost and fever were recovering/resolving. It was unknown if the reporter considered the fatigue, chills, appetite lost and fever to be related to SHINGRIX. Additional details were reported as follows: The patient felt fine until 3rd October 2018. The symptoms began to improve around 13th October 2018. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Myalgia, Nausea, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a adult female patient who received SHINGRIX (batch number 7A55L, expiry date 16th April 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, pain, muscle pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the nausea, pain, muscle pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the nausea, pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported however it could be 54 or 55 years old. The patient probably received SHINGRIX subcutaneously, which led to incorrect route of vaccination. The patient had body aches and muscle aches. This is 1 of the 2 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Myalgia, Nausea, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a adult male patient who received SHINGRIX (batch number 7A55L, expiry date 16th April 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, pain, muscle pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the nausea, pain, muscle pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the nausea, pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported however it could be 63 or 64 years. The patient probably received SHINGRIX subcutaneously, which led to incorrect route of vaccination. The patient had body aches and muscle aches. This is 1 of the 2 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized urticaria in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was unknown. It was unknown if the reporter considered the generalized urticaria to be related to SHINGRIX. Additional details were reported as follows: This case was received via website. The age at vaccination was not reported. The HCP (Healthcare Professional) reported that the patient's whole body broke out in hives after the dose of SHINGRIX. The HCP was in a corporate location and specific details were not accessible to her at the time of report. A VAERS report might have been filed by the administering site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. On 13th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to anyone. The patient was given SHINGRIX in right arm. The next day after vaccination with SHINGRIX, the patient noticed a 3 inch by 3 inch raised area at the injection site. This area was swollen, red and hot to the touch.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 67-year-old female patient who received SHINGRIX (batch number D294J, expiry date unknown) for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX. On 16th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage was unknown. It was unknown if the reporter considered the injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient developed more than expected bleeding at injection site, about 2 ml, after initial dose of SHINGRIX. No further details were provided. The reported batch number for SHINGRIX D2945 did not exist and was updated from D2945 to D294J as per sales database.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Nausea, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, nausea, general body pain and sickness. On an unknown date, the outcome of the headache, nausea, general body pain and sickness were unknown. It was unknown if the reporter considered the headache, nausea, general body pain and sickness to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The age at vaccination was not reported. Post vaccination the patient had a headache, body aches, was nauseated and she said down sick for 3 to 4 days. Chat was abandoned when additional information was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received about 5 years ago). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain, nausea, influenza-like symptoms, shivering and activities of daily living impaired. On an unknown date, the outcome of the pain, nausea, influenza-like symptoms, shivering and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the pain, nausea, influenza-like symptoms, shivering and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About 3 months ago from the date of reporting (exact date unknown), the patient received 1st dose of SHINGRIX along with her husband. After receiving SHINGRIX, the patient experienced severe flu like symptoms, achiness, shivering and nausea the same night of vaccination. The patient could not do anything and had to stay in bed the night of vaccination and the following day. It lasted about 18 hours and was in home in bed for 18 hours. On 23rd September 2018, the patient was schedule to receive 2nd dose of SHINGRIX. This case has been linked with the case US2018190196 (patient's husband), reported by same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Influenza like illness, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in 2018, about 3 months ago from the date of reporting). On 17th October 2018, the patient received the 2nd dose of SHINGRIX. On 17th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain, cold sweat, influenza-like symptoms, shivering and nausea. On an unknown date, the outcome of the pain, cold sweat, influenza-like symptoms, shivering and nausea were not recovered/not resolved. It was unknown if the reporter considered the pain, cold sweat, influenza-like symptoms, shivering and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. After receiving 1st dose of SHINGRIX, the patient did not experience any symptoms. On 17th October 2018, the patient received the 2nd dose. On the same night, before the day of reporting, the patient experienced flu like symptoms, achiness, shivering, sweating when cold and nausea. This case has been linked with the case US2018190194 (patient's wife), reported by same reporter.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dehydration, Diarrhoea, Dizziness, Lethargy
Clinical narrative: This case was reported by a nurse and described the occurrence of dehydration in a 38-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. Previously administered products included flu vaccine (was received more than 10 years ago). Additional patient notes included none; healthy. On 2nd October 2018 18:00, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 2nd October 2018 19:00, 1 hr after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dizziness and nausea. On 2nd October 2018 22:00, the patient experienced watery diarrhea. On 3rd October 2018, the patient experienced dehydration, vomiting, chills, tremor, lethargy and dry heaves. The patient was treated with ondansetron (Zofran Iv) and sodium chloride (0.9 % Sodium Chloride). On 3rd October 2018, the outcome of the vomiting and chills were recovered/resolved. On 5th October 2018, the outcome of the watery diarrhea was recovered/resolved. On an unknown date, the outcome of the dehydration, dizziness, nausea, lethargy and dry heaves were unknown and the outcome of the tremor was recovered/resolved. The reporter considered the dehydration, dizziness, nausea, watery diarrhea, vomiting, chills, tremor, lethargy and dry heaves to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received the FLUARIX QUADRIVALENT 2018-2019 season on left arm. Four hours after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced 14 episodes of watery diarrhea. On 3rd October 2018 morning, 1 day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient felt so lethargic and dehydrated from loss of fluid that she went to the urgent care. On 3rd October 2018, 1 day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient began vomiting (which was mostly dry heaving) and had severe chills and shaking and watery diarrhea continued. The patient never had a temperature or fever the entire time. The diarrhea continued until 5th October 2018. An intravenous was started and administered IV Zofran, 0.9 percentage sodium chloride 1000 ml plus another 500 ml. The patient was generally healthy and had no immediate or long term medical conditions. No other members of the household had been recently ill. The patient had not eaten anything unusual or traveled outside the country. The patient initially questioned whether this was a GI virus or a reaction to the vaccine. Since her reaction neither her husband or son has become sick. The patient and her family were in close quarters and she  prepare most of the family's food, drinks, etc. Given the time from administration to the onset of the reaction she do believe the above events were related to the vaccine.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Retching, Tremor, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of dehydration in a 38-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. Previously administered products included flu vaccine (was received more than 10 years ago). Additional patient notes included none; healthy. On 2nd October 2018 18:00, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 2nd October 2018 19:00, 1 hr after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dizziness and nausea. On 2nd October 2018 22:00, the patient experienced watery diarrhea. On 3rd October 2018, the patient experienced dehydration, vomiting, chills, tremor, lethargy and dry heaves. The patient was treated with ondansetron (Zofran Iv) and sodium chloride (0.9 % Sodium Chloride). On 3rd October 2018, the outcome of the vomiting and chills were recovered/resolved. On 5th October 2018, the outcome of the watery diarrhea was recovered/resolved. On an unknown date, the outcome of the dehydration, dizziness, nausea, lethargy and dry heaves were unknown and the outcome of the tremor was recovered/resolved. The reporter considered the dehydration, dizziness, nausea, watery diarrhea, vomiting, chills, tremor, lethargy and dry heaves to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received the FLUARIX QUADRIVALENT 2018-2019 season on left arm. Four hours after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced 14 episodes of watery diarrhea. On 3rd October 2018 morning, 1 day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient felt so lethargic and dehydrated from loss of fluid that she went to the urgent care. On 3rd October 2018, 1 day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient began vomiting (which was mostly dry heaving) and had severe chills and shaking and watery diarrhea continued. The patient never had a temperature or fever the entire time. The diarrhea continued until 5th October 2018. An intravenous was started and administered IV Zofran, 0.9 percentage sodium chloride 1000 ml plus another 500 ml. The patient was generally healthy and had no immediate or long term medical conditions. No other members of the household had been recently ill. The patient had not eaten anything unusual or traveled outside the country. The patient initially questioned whether this was a GI virus or a reaction to the vaccine. Since her reaction neither her husband or son has become sick. The patient and her family were in close quarters and she  prepare most of the family's food, drinks, etc. Given the time from administration to the onset of the reaction she do believe the above events were related to the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Scab
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vesicular rash in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 15th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vesicular rash and crust. The patient was treated with amoxicillin trihydrate (Amoxycillin). On an unknown date, the outcome of the vesicular rash and crust were unknown. It was unknown if the reporter considered the vesicular rash and crust to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX at the pharmacy. The patient developed a reaction crusted and fluid filled rash. The patient was seen in the office on 19th June 2018 and 25th June 2018. It was also stated in her (patient's) chart that the reaction could have been due to poison ivy. The reporter was unsure.  The patients was prescribed Amoxycillin. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of generalized maculopapular rash in a adult female patient who received SHINGRIX for an unknown indication. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 6 days after receiving SHINGRIX, the patient experienced generalized maculopapular rash. On an unknown date, the outcome of the generalized maculopapular rash was recovered/resolved. The reporter considered the generalized maculopapular rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but the patient was in her early 50's. The physician reported this case for a colleague. The patient experienced a generalized maculopapular rash. The rash appeared about 6 to 7 days after the dose of SHINGRIX and resolved in the next week. The patient did not require hospitalization and did not miss work due to the rash. The GlaxoSmithKline representative called to update the adverse event submitted in the initial report. The physician would like to be contacted about the adverse event that was submitted in the initial report.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Nonspecific reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nonspecific reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced nonspecific reaction, erythema, fatigue and chills. On an unknown date, the outcome of the nonspecific reaction, erythema, fatigue and chills were unknown. It was unknown if the reporter considered the nonspecific reaction, erythema, fatigue and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was reporting they had a severe reaction to SHINGRIX 1st dose. The patient had erythema in an oval shape down her arm, about 2 inches wide by 3 inches long. She also had fatigue, and the 2nd day she had chills, but no fever. The patient would not give address or any detailed information about severe reaction. The patient reported that their pharmacy had already reported this adverse event, however no duplicate case could be found.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number 9349T, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 7th July 2018 (please refer the case US2018GSK194710). On 19th September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, influenza-like symptoms, fatigue and weakness. In September 2018, the outcome of the pain in arm, swelling arm, influenza-like symptoms, fatigue and weakness were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm, influenza-like symptoms, fatigue and weakness to be related to SHINGRIX. Additional details were reported as follows: The patient experienced the same arm pain bad as she had after 1st dose, same symptoms as before but this time the pain radiated throughout the shoulder blade. She also had flulike symptoms feelings of fatigue, weakness but the symptoms subsided by the second day post administration. She did not seek any medical attention. The nurse did not agree to be followed up.