chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus, Pyrexia, Rash
Clinical narrative: experienced shingles/Suspected vaccination failure; Shingles; rash on side of the body, face, along nerve path; Blisters; Scabs; Pain; Itching; Tingling; Numbness; Fever; Headache; Not feeling well; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, blister, scab, pain, pruritus, tingling, numbness, fever, headache and feeling unwell. On an unknown date, the outcome of the vaccination failure, pain, pruritus, tingling, numbness, fever, headache and feeling unwell were unknown and the outcome of the shingles, rash, blister and scab were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, blister, scab, pain, pruritus, tingling, numbness, fever, headache and feeling unwell to be related to Shingrix.  Additional details were reported as follows: This case was reported by patients wife. The age at vaccination was not reported. The patient experienced all symptoms listed except gastrointestinal issues. The listed symptoms were as follows: Shingles typically produces a painful rash that blisters and scabs over in 7 to 10 days and clears up within 2 to 4 weeks. The reporter stated that 1 to 5 days before the rash appears, people might experience pain, itching, tingling, or numbness in the area where the rash would develop. Other symptoms at this time could include fever, headache, and a sense of not feeling well. The rash usually erupts in a single stripe on either the left or right side of the body, or sometimes the face, along a nerve path. The reporter stated that it could develop on the arm, thigh, head and even the ear or eye. It was most common on the chest and abdomen. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up would not possible as contact information not available.
Sex: M
Vaccine: VARZOS
Symptoms: Scab, Vaccination failure
Clinical narrative: experienced shingles/Suspected vaccination failure; Shingles; rash on side of the body, face, along nerve path; Blisters; Scabs; Pain; Itching; Tingling; Numbness; Fever; Headache; Not feeling well; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, blister, scab, pain, pruritus, tingling, numbness, fever, headache and feeling unwell. On an unknown date, the outcome of the vaccination failure, pain, pruritus, tingling, numbness, fever, headache and feeling unwell were unknown and the outcome of the shingles, rash, blister and scab were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, blister, scab, pain, pruritus, tingling, numbness, fever, headache and feeling unwell to be related to Shingrix.  Additional details were reported as follows: This case was reported by patients wife. The age at vaccination was not reported. The patient experienced all symptoms listed except gastrointestinal issues. The listed symptoms were as follows: Shingles typically produces a painful rash that blisters and scabs over in 7 to 10 days and clears up within 2 to 4 weeks. The reporter stated that 1 to 5 days before the rash appears, people might experience pain, itching, tingling, or numbness in the area where the rash would develop. Other symptoms at this time could include fever, headache, and a sense of not feeling well. The rash usually erupts in a single stripe on either the left or right side of the body, or sometimes the face, along a nerve path. The reporter stated that it could develop on the arm, thigh, head and even the ear or eye. It was most common on the chest and abdomen. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up would not possible as contact information not available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inflammation, Pain, Vaccination failure
Clinical narrative: shingles, both doses of Shingrix/Suspected Vaccination failure; I had an outbreak/second outbreak; not as inflamed; just as painful; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (suffered from shingles outbreaks for years, isolated to a single spot about the size of a quarter just above my right eye), pain and inflammation. Previously administered products included Shingles vaccine (had the original shingles vaccine when it first came out).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, inflammation and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, inflammation and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, inflammation and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had suffered from shingles outbreaks for years and outbreaks was mild by most standards. They are isolated to a single spot about the size of a quarter just above right eye. The concern of course was the proximity to eyes so patient watch it closely. The patient had the original shingles vaccine when it first came out and then both doses of Shingrix.  The second vaccination was approximately in December 2020 and was everything was fine until about 6 weeks before the date of reporting, when patient had an outbreak. The patient experienced, less than 6 weeks later, second outbreak.  The outbreaks was not as inflamed as they were prior to the vaccine, but they remain just as painful. The patient wanted to report the lack of effectiveness for records. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed 2nd shot; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose which led to incomplete course of vaccination. It's 2 years since the 1st one. The patient enquired if he/she could receive one or two more shots. Follow-up would not be possible as no contact details provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body ache is terrible/feels he just got hit by bus; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th October 2021, the patient received Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient ex. The age at vaccination was not reported. Patient got his Shingrix shot last Thursday and felt just got hit by bus and had body ache was terrible.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles twice; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient.  The age at vaccination was not reported. The patient had shingles twice after being vaccinated for shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided
Sex: U
Vaccine: TDAP
Symptoms: Feeling hot, Hypersensitivity, Peripheral swelling
Clinical narrative: Doc said I was allergic and not to take it again; Arm swelled up; Arm was hot; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced allergic reaction, swelling arm and extremities hot feeling of. On an unknown date, the outcome of the allergic reaction, swelling arm and extremities hot feeling of were unknown.   It was unknown if the reporter considered the allergic reaction, swelling arm and extremities hot feeling of to be related to Tdap Vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Tdap Vaccine and his/her arm swelled up and was hot. The physician said patient was allergic to something in it. The patient stated that he/she can't take it. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Got the shot, Get it/ Suspected vaccination failure; Get it under the skin; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and still got shingles again but it stayed under the skin this time and it does last a long while. The patient was just getting over shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Bad case of shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's sister in law. The age at vaccination was not reported. The reporter stated that the patient got shingles shot and had a bad case of shingles after it. The reporter was afraid to get shingles shot.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/ Can still get shingles even if you get the shot; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got shingles even though he/she got the shot. The patient stated that the shot was supposed to help with symptoms and the patient thought it did not work. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: got the shingles after second shingles vaccine/Suspected vaccination failure; shingles/ It spread on the inside of right arm; it blistered; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 7 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient got the shingles 7 months after the he/she got the 2nd shingles vaccine. The patient had no pain at all, no itching. The patient stated that it just blistered and spread on the inside of right arm. The patient stated that dermatologist said it was shingles and prescribed medication. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles were not provided. The follow up would not possible as contact information was not available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Round 1 was 3 years after the shingles vaccine/shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient experienced 1st round of shingles 3 years after the Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. For the tolerance of the 2nd round of shingles, refer linked case US2021AMR211140, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR211140:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles; burns; hurts; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had as a child).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported this case. The age at vaccination was not reported. The patient received Shingles vaccine, few years before the date of reporting. Three years before the date of reporting, the patient got shingles. The patient stated that, it still burns and hurt at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Deafness unilateral, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Including my L eye; lost all hearing in L ear; shingles on the L side of my face/2nd time of shingles after the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (1st round of shingles was 3 years after the shingles vaccine, refer case US2021AMR211136).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), deafness unilateral (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, deafness unilateral and shingles were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, deafness unilateral and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. At the time of reporting, the patient just finished 2nd time round of shingles. The patient stated that It was a miserable disease. The patient said, this time they were on the left side of the patient face, including left eye and lost all hearing in left ear. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR211136:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching on both fore arms; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2021, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The patient received a dose of Shingrix vaccine and about a week later patient experienced itching on fore arms, No rash occured it just itches. The patient asked if they had heard of other reports of this and could this be a side effect of the vaccine. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching on my fore arms; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shingles vaccine and started itching on his/her fore arms.  The patient asked could this be a side effect from the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: sore throat; shiver/ chills; muscle ache; headache; tired; temperature of 100.5; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced sore throat, shivers, muscle pain, headache, tiredness and fever. On an unknown date, the outcome of the sore throat, shivers, muscle pain, headache, tiredness and fever were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, shivers, muscle pain, headache, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported. The patient received Shingric vaccine and experienced temperature of 100.5 degree Fahrenhiet and chills/shiver, muscle ache, headache, tired and throat hurts. The reporter wanted to know could the shingles vaccine cause sore throat. The reporter was wondering if she should go to the doctor because her symptoms had not yet resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: sore throat; shiver/ chills; muscle ache; headache; tired; temperature of 100.5; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced sore throat, shivers, muscle pain, headache, tiredness and fever. On an unknown date, the outcome of the sore throat, shivers, muscle pain, headache, tiredness and fever were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, shivers, muscle pain, headache, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported. The patient received Shingric vaccine and experienced temperature of 100.5 degree Fahrenhiet and chills/shiver, muscle ache, headache, tired and throat hurts. The reporter wanted to know could the shingles vaccine cause sore throat. The reporter was wondering if she should go to the doctor because her symptoms had not yet resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; agony with nerve pain; can't even stand a shirt; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after starting lidocaine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain and activities of daily living impaired. The patient was treated with lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, nerve pain and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The patient was in agony with nerve pain that had lasted for 5 months. The patient was now on Lidocaine cream. The reporter asked if there was any pill medication. The patient got the vaccine and got a really bad case of shingles. The patient could not even stand a shirt and had to make a tent in bed so the covers won't touch him. Three trips to the doctor and no relief. The reporter and the patient were both about nuts with this. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: shingles in her eye; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's neighbor. The age at vaccination was not reported. The patient received shingles shot and right after got shingles in right eye.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and no reaction just sore first 2 days. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR211412:same report, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: Two about 4 weeks apart; sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date refer case US2021AMR211397).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain and drug dose administration interval too short. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and no reaction just sore first 2 days and dose was received earlier than the recommended interval 4 weeks apart, which led to shortening of vaccine schedule. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR211397:same report, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: didn't receive second shot because of pandemic; This case was reported by a consumer via  interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient did not get the second shot because of the pandemic, which led to social problem. The reporter enquired if he/ she could just sign up to get the second shot now or if the patient had to start over.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Loss of personal independence in daily activities
Clinical narrative: few hives; nausea; sick; don't feel well; Severe muscle aches; back spasms; severe fatigue; headache; no energy; itchy; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 24th September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced muscle pain, spasms, fatigue, headache, loss of energy and pruritus. On 24th September 2021, the patient experienced sickness and unwell. On 28th September 2021, the patient experienced hives and nausea. On an unknown date, the outcome of the sickness, unwell, muscle pain, spasms, fatigue, headache, hives, nausea, loss of energy and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the sickness, unwell, muscle pain, spasms, fatigue, headache, hives, nausea, loss of energy and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself The patient received 2nd dose of Shingrix shot on Friday in the right arm and was sick and still did not feel well. The patient enquired how long would it last. The patient had side effects few hours after shot but still didn't felt well 4 days later. The patient was aware about the side effects and they were still lingering. The had triggered severe muscle aches to the point that he/she had back spasms, severe fatigue, headache, back spasms, a few hives on the day of reporting and nausea.  The patient had no health problems and did not take medication. The patient reported that he/she had contacted doctor and she said it was his/her body building up immunity and patient felt awful. The patient had no energy and was active and owned a horse but did not able to ride because he/she did not feel well. The patient was itchy.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Muscle spasms, Myalgia, Nausea, Pruritus
Clinical narrative: few hives; nausea; sick; don't feel well; Severe muscle aches; back spasms; severe fatigue; headache; no energy; itchy; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 24th September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced muscle pain, spasms, fatigue, headache, loss of energy and pruritus. On 24th September 2021, the patient experienced sickness and unwell. On 28th September 2021, the patient experienced hives and nausea. On an unknown date, the outcome of the sickness, unwell, muscle pain, spasms, fatigue, headache, hives, nausea, loss of energy and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the sickness, unwell, muscle pain, spasms, fatigue, headache, hives, nausea, loss of energy and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself The patient received 2nd dose of Shingrix shot on Friday in the right arm and was sick and still did not feel well. The patient enquired how long would it last. The patient had side effects few hours after shot but still didn't felt well 4 days later. The patient was aware about the side effects and they were still lingering. The had triggered severe muscle aches to the point that he/she had back spasms, severe fatigue, headache, back spasms, a few hives on the day of reporting and nausea.  The patient had no health problems and did not take medication. The patient reported that he/she had contacted doctor and she said it was his/her body building up immunity and patient felt awful. The patient had no energy and was active and owned a horse but did not able to ride because he/she did not feel well. The patient was itchy.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: few hives; nausea; sick; don't feel well; Severe muscle aches; back spasms; severe fatigue; headache; no energy; itchy; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 24th September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced muscle pain, spasms, fatigue, headache, loss of energy and pruritus. On 24th September 2021, the patient experienced sickness and unwell. On 28th September 2021, the patient experienced hives and nausea. On an unknown date, the outcome of the sickness, unwell, muscle pain, spasms, fatigue, headache, hives, nausea, loss of energy and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the sickness, unwell, muscle pain, spasms, fatigue, headache, hives, nausea, loss of energy and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself The patient received 2nd dose of Shingrix shot on Friday in the right arm and was sick and still did not feel well. The patient enquired how long would it last. The patient had side effects few hours after shot but still didn't felt well 4 days later. The patient was aware about the side effects and they were still lingering. The had triggered severe muscle aches to the point that he/she had back spasms, severe fatigue, headache, back spasms, a few hives on the day of reporting and nausea.  The patient had no health problems and did not take medication. The patient reported that he/she had contacted doctor and she said it was his/her body building up immunity and patient felt awful. The patient had no energy and was active and owned a horse but did not able to ride because he/she did not feel well. The patient was itchy.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the Shot and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot and one year late got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: have gotten the shot twice and I still get small patches on my butt\ suspected vaccination failure; still get small patches on my butt; small patches on my butt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and patchy rash. On an unknown date, the outcome of the vaccination failure, shingles and patchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and patchy rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot twice and still got small patches on butt. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have had shingles and the shots\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots about five years ago and had shingles. The patient asked he/she could had Shingles shots again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both shots, but got shingles\ suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got both Shingles shot but got shingles anyway. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter