chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st shot received on an unknown date).   On 6th April 2021, the patient received the 2nd dose of Shingrix. On 6th April 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the day of reporting, the patient got 2nd shot of Shingles and experienced sore arm. The patient asked, if he/she could take Advil or Tylenol for a sore arm.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pruritus, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shingles shot and I broke out on my head; inching / inching bad; my whole head hurts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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), shingles, pruritus and headache. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and headache were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and headache to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporting for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. After receiving Shingles vaccine, the patient broke out on his/her head. It was driving the patient crazy. The patient's head was hurt and itching bad. 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 were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I got the shingles shot and I have had shingles 4 times since; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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 reporting for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had shingles 4 times. 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 were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain in the area where the shot was given; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several hours after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporting for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The patient stated that, the Shingles vaccine itself did not hurt but after few hours, there was terrible pain in the area where the shot was given for about 3 days. The patient also stated that, it is best to get the Shingles vaccine rather than the shingles because it would be very painful, and you would be very uncomfortable.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: suffered miserably ever since; This case was reported by a consumer and described the occurrence of feeling miserable in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2019, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was not recovered/not resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. Age at the vaccination was not reported, however age group was captured as an adult as per vaccine indication. Patient got the shingle shot and had suffered miserably ever since Been to over 10 doctors and had found no relief, had totally taken his/her life away.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingle; 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.   Co-suspect products included COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID 19 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. After receiving Shingle shot and Covid 19 shot, the patient had shingle. It was unknown if the reporter considered the shingles to be related to COVID 19 VACCINE. 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 were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; Got the shot and had shingles; it's a pain like no other constant 24 hrs a day; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got the shingles shot and had shingles. The patient reported that it was a pain like no other constant 24 hrs a day no ease and no rest at all worst than having a baby. This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Pruritus, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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), shingles, post herpetic neuralgia and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia and pruritus were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and pruritus to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got vaccinated with shingles vaccine and got the shingles probably 3 to 4 years ago and still had the nerve pain and itch at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Theyre also painful/ Pain during injection; This case was reported by a consumer via interactive digital media  and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date 3 years ago, refer case US2021AMR077282).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at the vaccination was not reported, however age group was captured as an adult as per vaccine indication. The patient stated he/she had vaccine 3 years ago and they were painful but having the disease was more horrible so better to have the vaccine; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077282:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: I had 2 shots 3 yrs ago...theyre also painful; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult 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, immediately after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at the vaccination was not reported, however age group was captured as an adult as per vaccine indication. The patient stated he/she had vaccine 3 years ago and they were painful but having the disease was more horrible so better to have the vaccine. The reporter consent to follow up. This case has been linked with US2021AMR077251 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077251:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Scar, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Suspected vaccination failure; shingles; Scar; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).   Co-suspect products included Herpes zoster (Shingle's vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles 4 years ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine and Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and scar. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure, shingles and scar were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Shingle's vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient took the shot and would not wish them on his or her worse friend, they were terrible and did leave scars just like chicken pox do. This case was considered as suspected vaccination failure as details regarding time to onset for target disease (shingles) and laboratory confirmation were unknown at the time of reporting. The reporter stated that 2 of his or her sisters did not take them but 1 and he or she, did a slept in the same bed till mamma had to make him or her a bed in a chair away from the other kids. The patient had them so bad than the shingles 4 years ago. This case had been linked with the case- US2021AMR077311 and US2021AMR077319, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077319: same reporter
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have shingles / had the shingle shots about 2 years ago/ 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 adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and covid-19 vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and covid-19 vaccine at an unknown dose and frequency. On an unknown date, more than a year 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: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had last Covid vaccine about 5 weeks before the date of reporting, and had shingles in the week of reporting.  The patient did not know if there was any connection or not. The patient had the shingle shots about 2 years before the date of reporting, and they were only 51% effective. This case was considered as suspected vaccination failure as laboratory confirmation for target disease was unknown at the time of reporting.; Reporter's Comments: .
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had shingles, shot and shingles the third time/ suspected vaccination failure; I had shingles, shot and shingles the third time.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).   On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's 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 Shingle's vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had shingles shot and had shingles the third time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had 2 shingles shots and still got the shingles/suspected vaccination failure; I had 2 shingles shots and still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 1st dose of Shingles vaccine and the 2nd 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: The reporter was patient itself. The age group was not reported but was captured as adult as per vaccine indication. The patient received 2 doses of Shingles vaccine and experienced shingles  and had no pain. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles / No good; have had three shingles vaccine / No good; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).    Co-suspect products included Herpes zoster (Shingle's vaccine) and Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingle's vaccine, Shingle's vaccine and Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved, and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine, Shingle's vaccine and Shingle's vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided but was captured as adult as per vaccine indication. The patient received 3 doses of Shingles vaccine and experienced shingles a year ago and stated they would not go away. The patient received 3rd dose of Shingle's vaccine, which led to extra dose of administered. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My husband was Vaccinated and still had singles; This case was reported by a consumer 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 details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine and experienced shingles. The reporter mentioned that the patient did not had a serious reaction. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: MEN
Symptoms: Death
Clinical narrative: died; This case was reported by a consumer via interactive media and described the occurrence of unknown cause of death in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B 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 reporter considered the unknown cause of death to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by the sibling of the patient. The age at vaccination was not reported. The reporter stated that the patient died from the vaccine.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer 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 reported for himself or herself. The age at vaccination was not reported. The patient had shingles vaccine several years ago and had shingles 3 different times. The reporter stated vaccine does not completely prevent shingles, it just makes them not as bad the patien thought. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. This case was linked with case US2021AMR077445, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077445:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have had shingles / friend / had the shits and he has had them 6 different times; have had shingles / friend / had the shits and he has had them 6 different times; This case was reported by a consumer via (SHINGRIX) interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's 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 Shingle's vaccine.  Additional details were provided as follows: The reporter reported for his friend. The age at vaccination was not reported. The reporter stated that, his friend had shingle's shot and had shingles for 6 different times. The reporter stated that the vaccine did not completely prevent them. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingle's, time to onset for event and laboratory confirmation for shingle's were not provided. This case was linked with case US2021AMR077439, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077439: Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, then he got the shingles/suspected vaccination failure; got the shingles; This case was reported by a consumer 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 details were provided as follows: The age at vaccination was not reported.  The reporter was patient's wife. The patient got Shingles after Shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Epidural analgesia, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had them two years ago / thing is I had the vaccine / suspected vaccination failure; I had them two years ago & it was horrible; pain was unbearably; This case was reported by a consumer 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), shingles and pain. The patient was treated with medication unknown (Epidural Injection (Ingredients Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient had the vaccine and he/she was told it was not any good.  The patient experienced shingles two years before the date of reporting and it was horrible. The patient's pain was unbearable and he/she thanks to one of his/her doctor who gave him/her a epidural shot and patient was thankful that doctor cared enough to help him/her. This case was considered as suspected vaccination failure, as information about Shingles vaccine dose number, laboratory test confirmation for shingles infection and time to event onset was unknown.
Age: 10.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: KINRIX was administrated to a 10-year-old boy; This case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 10-year-old male patient who received DTPa-IPV (Kinrix) (batch number B75MY, expiry date 15th June 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 10 years old patient was administered with Kinrix, which led to inappropriate age of vaccine administration. No additional adverse event was reported. No Product quality complaint was reported.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: product dispensing error; product administration error; Expired dose of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3SN5B, expiry date 4th December 2020) for prophylaxis.   Concurrent medical conditions included asthma.   On 7th December 2020, the patient received Boostrix. On 7th December 2020, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the patient experienced product dispensing error and product administration error. On an unknown date, the outcome of the expired vaccine used, product dispensing error and product administration error were unknown.  Follow up information received from a nurse on 2nd April 2021: The patient's demographic details were updated. The patient had current condition of asthma and had NKA (No known Allergies). The patient received Boostrix that expired 3 days prior to the administration of vaccine. As per reporter, error occurred in dispensing and administration, which led to product dispensing error and product administration error. The reporter was unsure why error occurred. There were no adverse effects from this event. As per medical director's recommendations, the patient's parent was advised to consult physician if any injury due to unknown efficacy of the expiration date. The VAERS details updated.
Age: 16.0
Sex: F
Vaccine: HEPA, HEPAB
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: 3 doses of Hepatitis B in the past / 1 dose of Twinrix; received 1 dose of Twinrix when she was when she was 16 or 17 years old / administered pediatric Havrix yesterday; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received HAV (Havrix pediatric) (batch number Y4FL4, expiry date unknown) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 3 doses of Hepatitis B in the past on an unknown date) and Twinrix (received 1 dose of Twinrix when the patient was 16 or 17 years old).   On 31st March 2021, the patient received Havrix pediatric. On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Havrix pediatric and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination 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 age at vaccination was not reported. The patient received Havrix Paediatric, which led to wrong product administered. Till the time of reporting, patient did not received further doses of twinrix, which led to incomplete course of vaccination. The reporter stated that, the patient had received 3 doses of Hepatitis B vaccine in the past. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of patient.  The age at vaccination was not reported. The patient received Shingrix and had sore arm for several days. The reporter did not consent to follow up. No demographics collected for the patient, who was the husband of the reporter.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: missed the third dose of Twinrix at appropriate time and is 2 months late; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date) and Twinrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made 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. Till the time of reporting ,the patient did not receive the 3rd dose ,which led to incomplete course of vaccination.  The  reporter consented to follow up via call.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on 12Mar2019 / second dose had not been given at time of report; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th March 2019).   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 age at vaccination was not applicable for this report. Till the time of reporting, the patient not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked for recommendation regarding the administration of a late 2nd dose of Shingrix. The reporter refused any patient or other AE information and wanted only the dosing recommendations. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: after the second dose of Shingrix had tachycardia; This case was reported by a other health professional via sales rep and described the occurrence of tachycardia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tachycardia. On an unknown date, the outcome of the tachycardia was unknown.   It was unknown if the reporter considered the tachycardia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter consented to follow up. Patient's identifiers, lot number, expiration date and vaccination date were not provided.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Havrix on 17Jan2018 / has not received the second dose yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 4-year-old female patient who received HAV (Havrix) for an unknown indication.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received on 17th January 2018, batch number 77D5K, expiry date 26th March 2020).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination. The reporter consented to follow up. Reported VARES details pertains to 1st Havrix administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got her first dose of Shingrix on 19Jun2019 / has not received the 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 19th June 2019).   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: Age at vaccination was not applicable for this report. A patient who got her 1st dose of Shingrix on 19th June 2019 and had not received the 2nd dose yet which led to incomplete course of vaccination. The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Product dose omission issue, Social problem
Clinical narrative: first dose of Shingrix roughly a year ago / COVID hit they missed their second dose; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received Shingrix roughly a year ago).   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 reported as follows: The age at vaccination was not applicable to this report. The age group was not reported but captured as an adult as per vaccine indication. Patient did not received 2nd dose of Shingrix due to Covid hit. HCP declined to provide date of birth and did not have any additional vaccine information as she was not at work. The reporter consented to follow up. The case is linked with US2021075985, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075985:same reporter
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of Infanrix instead of Boostrix for 11 year old; Administration of Infanrix instead of Boostrix for 11 year old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th March 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced adult use of a child product. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 provided as follows: The reporter reported administration of Infanrix instead of Boostrix for 11 year old, which led to inappropriate age at vaccine administration. Consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First Shingrix vaccine 12/2019. He has not yet had his second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly in December 2019).   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 case was reported by the patient himself. The age at vaccination was not applicable for this report. Lot number and expiry date was unknown. The patient received first shot of Shingrix and till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up with the health care professional..
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Syringe issue
Clinical narrative: 'The needle leaked / not sure how much of the vaccine was administered; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number MB7RR, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date).   On 3rd April 2021, the patient received the 2nd dose of Shingrix. On 3rd April 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional details was reported as follows: The age at vaccination was not reported. Pharmacist reported that while administering a Shingrix vaccine to a patient the needle leaked about 4 drops, so the reporter was not sure how much of the vaccine was administered, which led to accidental underdose. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate, Heart rate increased, Nausea
Clinical narrative: EXCESSIVE URINATION; VOMITING; INCREASED HEART RATE; CHILLS; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 134 pounds, and height was 176.78 centimeters. The patient's concurrent conditions included supraventricular tachycardia, high cholesterol, thinning bones, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no no allergies/no history of drug abuse/no past history of similar event/no adverse event after any previous vaccinations/ no history of allergy to vaccine, drug or food/ no history of hospitalization in last 30 days, with cause/no family history of any disease (relevant to vaccination) or allergy. the patient was not pregnant at the time of event. the patient was not currently breastfeeding.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered to the left deltoid, on 07-MAR-2021 16:30 for prophylactic vaccination. The batch number was not provided and has been requested. Concomitant medications included fish oil for heart health, pravastatin for high cholesterol, metoprolol succinate for supraventricular tachycardia, and calcium carbonate/colecalciferol for thinning bones. On 07-MAR-2021, the subject experienced excessive urination. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced increased heart rate. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive urination, vomiting, increased heart rate, nausea, and fatigue on 08-MAR-2021, and chills on 07-MAR-2021. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as the case is non serious