chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass, Pain, Pain in extremity, Swelling, Tenderness
Clinical narrative: little lump where I received my shot; arm is very sore; pain; swelling; This case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site lump, pain in arm, pain and swelling. On an unknown date, the outcome of the injection site lump, pain in arm, pain and swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site lump, pain in arm, pain and swelling to be related to Shingrix.  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 reported that, he/she received Shingrix vaccine yesterday from the date of reporting and his/her arm was very sore and a little lump where the patient received the shot. The patient asked could he/she apply a heating pad or ice pack to reduce pain and swelling.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness around the shot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a 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 injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The reporter asked about how long does the redness around the shot last.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left leg pain; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient took the Shingrix vaccine and had left leg pain not too bad. The follow-up would not possible as contact information was not available. For tolerance of 2nd dose refer case US2021AMR198918, reported by same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198918:Same patient,second dose
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: sicker; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received first dose on an unknown date and experienced sickness, refer case US2021AMR198943).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness 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 shingles shot and got sicker than hell. The patient also stated that it was still better than getting shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198943:same patient 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and got the shingles /suspected vaccination failure; shingles; This case was reported by a consumer via (Facebook) 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 reporter was the patient's husband. The age at vaccination was not reported. The reporter stated that, his wife got the shot and still got 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: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot, still 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.   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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the shot, still got 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: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age vaccination was not reported. The patient got shot and he/she felt like the arm was killing him/her. The patient said he/she rather get the vaccine than shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: Took the shot and three months later I got shingles/ suspected vaccination failure; got shingles on right side of my face and it effected my eye; got shingles on right side of my face; painful; This case was reported by a consumer via media and described the occurrence of 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), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, took the shot and three months later got shingles on right side of face and it effected eye, very painful. 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: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got the shot,going thru 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.   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 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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, gone through 11th round with shingles. The reporter got the preventative shot and it did not stop from getting shingles again and again. 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: had been vaccinated, still got the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 age at vaccination was not reported. The reporter stated that, his or her friend had been vaccinated and still got the shingles really bad. 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: Pain, Pain in extremity
Clinical narrative: body achy; arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice mild cases).   On 15th September 2021, the patient received the 1st dose of Shingles vaccine. On 15th September 2021, less than a day after receiving Shingles vaccine, the patient experienced general body pain. In September 2021, the patient experienced pain in arm. On an unknown date, the outcome of the general body pain was unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the general body pain and pain in arm 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 4 days ago and his/her arm was still killing, body achy the first night. The patient cannot wait for the second shot. The follow up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: its been 18 months since receiving first dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 18 months ago).   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 were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter asked what to do regarding second dose of Shingrix. It had been 18 months since receiving first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked did he need to start over with 2 doses or was one additional dose still effective.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: fever; joint pain throughout body; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and joint pain. On an unknown date, the outcome of the fever and joint pain were recovered/resolved.   It was unknown if the reporter considered the fever and joint 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 had a horrible reaction to it that lasted almost a year. Starting with fevers to joint pains throughout his/her body. The patient researched and did find some cases that were worse than patient. The patient gather he/she was rather lucky. The patient brother had shingles and lasted for a few months until he healed.  The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR199708 and US2021AMR199709 reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199708:Same reporter US-GLAXOSMITHKLINE-US2021AMR199709:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia eye, Ophthalmic herpes zoster, Paraesthesia, Vaccination failure
Clinical narrative: Had the shot, got shingles/ suspected vaccination failure; shingles in eyes; shingles; numbness above eye; tingling in head; This case was reported by a consumer via 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, eye numbness and tingling. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown and the outcome of the eye numbness and tingling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, eye numbness and tingling to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the shot 4 years ago and got shingles on left side of face, in eye and head this spring. The patient still had numbness above eye and tingling in head. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine 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 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, 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 case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient got the vaccine and still got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles AFTER vaccinated / 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 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 case details were reported as follows: The reporter was patient's son or daughter. The age at vaccination was not reported. The patient did not get shingles until after she had been vaccinated. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The repoter asked did need to restart series over.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and I 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, 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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the shot then got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had two shots he now has the 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 male 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 case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had two shots and he now had the shingles. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have the shingles got all my 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got all the shots a few months ago and had the shingles. The reporter requested everyone needs to get the shots. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Oral herpes, Vaccination failure
Clinical narrative: had shot, trigger herpes outbreak / suspected vaccination failure; herpes outbreak / cold sores; sick; 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), oral herpes and sickness. On an unknown date, the outcome of the vaccination failure, oral herpes and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, oral herpes and sickness to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient had shot and felt sick a few days. The reporter enquired did this normal and did the shot trigger herpes outbreak such as cold sores. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: passed away; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 11th September 2021, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 11th September 2021. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's husband. The reporter stated that they lost time when they got the Shingles shots.  The patient suffered and contribute to her life. The patient passed away. The reporter advised to get the Shingles shot especially for seniors like him. The follow-up would not possible as no contact details were available. Note: The term suffering was unspecified hence not coded as an event. Also, as per convention it cannot be coded with Ill-defined disorder or unspecified adverse event.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the shots and I 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.   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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient took the shots and still got shingles. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot in 2018 can I get the second shot; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital 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 (1st dose received in November 2018).   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 were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, if could get 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: because of COVID, have not received 2nd shot; 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 (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, because of the shingrix not being available and then COVID, the patient had not been able to receive the second dose of Shingrix, which led to social problem.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: Pain at injection site; Arm soreness; Nausea; Sore throat; injection given too deeply into the muscle; first dose on 2/11/2021 and 2nd dose on 08/19/2021; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 11th February 2021, refer case US2021AMR176934).   On 19th August 2021, the patient received the 2nd dose of Shingrix. On 19th August 2021, unknown after receiving Shingrix, the patient experienced wrong injection technique and drug dose administration interval too long. On an unknown date, the patient experienced injection site pain, pain in arm, nausea and sore throat. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in arm, nausea and sore throat were not recovered/not resolved and the outcome of the wrong injection technique and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, nausea and sore throat to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, the patient experienced pain at the injection site, arm soreness, nausea, and sore throat after receiving second dose of Shingrix. The arm soreness began immediately after injection, nausea and sore throat began approximately 16 hours after administration. The reporter stated that, pain at time of injection, due to belief injection was given too deeply into the muscle, which led to wrong injection technique. The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up. This case was linked with case US2021AMR176934, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176934:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge, Wrong technique in product usage process
Clinical narrative: Pain at injection site; Arm soreness; Nausea; Sore throat; injection given too deeply into the muscle; first dose on 2/11/2021 and 2nd dose on 08/19/2021; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 11th February 2021, refer case US2021AMR176934).   On 19th August 2021, the patient received the 2nd dose of Shingrix. On 19th August 2021, unknown after receiving Shingrix, the patient experienced wrong injection technique and drug dose administration interval too long. On an unknown date, the patient experienced injection site pain, pain in arm, nausea and sore throat. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in arm, nausea and sore throat were not recovered/not resolved and the outcome of the wrong injection technique and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, nausea and sore throat to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, the patient experienced pain at the injection site, arm soreness, nausea, and sore throat after receiving second dose of Shingrix. The arm soreness began immediately after injection, nausea and sore throat began approximately 16 hours after administration. The reporter stated that, pain at time of injection, due to belief injection was given too deeply into the muscle, which led to wrong injection technique. The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up. This case was linked with case US2021AMR176934, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176934:same reporter
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 39-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 39D2G, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received FluLaval Quadrivalent (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2021, 1 days after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives. The patient was treated with doxylamine, famotidine (Pepcid), cetirizine hydrochloride (Zyrtec), benadryl (nos) (Benadryl Spray), benadryl (nos) (Benadryl Cream) and benadryl (nos) (Benadryl Oral). On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows:  The patient self-reported this case. A day after vaccination in the morning, the patient had hives all over her body. The hives were treated with Benadryl by mouth, Benadryl spray, Benadryl cream, Zyrtec, Pepcid and doxylamine.   The patient's hives were not recovered till the time of reporting. The patient consented to follow up with the physician. The reporter consented to follow-up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 1 years old received adult dose; 1 years old received adult dose; This case was reported by a nurse and described the occurrence of overdose in a 1-year-old female patient who received HAV (Havrix) (batch number j95h7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   On 13th September 2021, the patient received Havrix and hepatitis A vaccine pre-filled syringe device. On 13th September 2021, unknown after receiving Havrix and hepatitis A vaccine pre-filled syringe device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were 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 patient received an adult dose of Havrix, which led to adult product administered to child and overdose. No adverse event was reported  The reporter consented to follow up.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; expired dose administered; Inappropriate age at vaccine administration; This case was reported by a nurse and described the occurrence of underdose in a 44-year-old male patient who received HAV (Havrix 720) (batch number 3hr79, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2021, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 17th September 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose, expired vaccine used and adult use of a child product. On an unknown date, the outcome of the underdose, expired vaccine used and adult use of a child product were 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 reported as follows: Nurse reported an expired pediatric dose of Havrix was administered to an adult patient earlier today, which led to expired vaccine used, adult use of a child product and underdose. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The wrong vaccine was selected; 3-year-old received Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number T031201, expiry date 14th June 2022) for prophylaxis.   On 17th September 2021, the patient received Boostrix (intramuscular) .5 ml. On 17th September 2021, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter was a representative of a pediatric medical facility. The 3 year old patient received Boostrix vaccine instead of Hepatitis A vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up with health care profession.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired dose administration; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HT429, expiry date 8th August 2021) for prophylaxis.   On 17th September 2021, the patient received Boostrix. On 17th September 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: On 17th September 2021, patient was given an Boostrix vaccine, which was expired on 8th August  2021. The reporter consented to follow up
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number LE79N, 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 17th September 2021, the patient received Fluarix Quadrivalent 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. On 17th September 2021, unknown after receiving Fluarix Quadrivalent 2019-2020 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 reported as follows: On 17th September 2021, patient received Fluarix vaccine, which was expired on 30th June 2021. The reporter consented to follow up. This case has been linked with US2019124829, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019124829:same reporter
Age: 64.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Product storage error
Clinical narrative: exposure to freezing temperatures; This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a 64-year-old male patient who received HBV (Engerix B) (batch number LR537, expiry date 3rd January 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number KN5VR, expiry date 16th April 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received Engerix B, Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered the vaccines that were in the temperature excursion, which led to incorrect storage of drug. This patient was administered Boostrix and Engerix on the same day. The Medical Information agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2021, the patient received the 2nd dose of Shingrix. On 14th September 2021, 1 days after receiving Shingrix, the patient experienced fever. The patient was treated with ibuprofen, pseudoephedrine hydrochloride (Advil Cold + Sinus) and ibuprofen. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received her dose of Shingrix on Monday and next day, she developed a fever.  The patient took Advil Cold and Sinus on Tuesday which lowered her fever.  No fever reducing medication was taken on Wednesday.  On 16th September 2021, Thursday, the fever returned.  On the day of reporting, patient was taking ibuprofen. Reporter provided limited information and did not want to answer any further questions related to adverse event.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Shivering; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)) for prophylaxis.  On 17th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug and the 2nd dose of FLUZONE (FLU SHOT) (intramuscular) 50 µg. On 17th September 2021, 9 hrs after receiving Shingrix, the patient experienced fever and shivering. On 18th September 2021, the outcome of the fever and shivering were recovered/resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received dose of Shingrix vaccine and Fluzone vaccine on the same day in left deltoid and after approximately 9 hours patient experienced shivering and fever.  The symptoms were resolved the next day. The patient was unsure whether the symptoms were due to Shingrix or Fluzone. The patient did not have expiry date for Shingrix vaccine. However, she provided NDC number (NDC: 58160-0823-11). The patient did not have expiry date or NDC number for Fluzone. The reporter did not a consent to follow-up with health care professional, as she did not have health care professional. Therefore, health care professional contact information was not collected. She did not provide her personal email address. It was unknown if the reporter considered the fever and shivering to be related to fluzone.