chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Irritability
Clinical narrative: was sick for three days; pissed off had to pay to get sick; 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.   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 and feeling irritated. On an unknown date, the outcome of the sickness and feeling irritated were recovered/resolved.   It was unknown if the reporter considered the sickness and feeling irritated to be related to Shingles vaccine.     Additional Information: GSK Receipt Date:11-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient was sick for three days when the patient got the first shingle shot. The patient hope he or she would not that sick when get the second one. The patient also pissed off that had to pay to get sick. Additional Supportive Information: Follow up would not be possible since no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: running 100.1 fever; 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 12th May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced fever. 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 Shingles vaccine.     Additional Information: GSK Receipt Date:13-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingrix on the day before the date of reporting. The patient experienced the fever and it was running 100.1 degree Fahrenheit. The patient asked if it could run the fever.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles even though vaccinated with 2 doses/suspected Vaccination failure; shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's comment: The patient came down with bad case of shingles even though vaccinated with the 2 doses of Shingrix received 2 years prior to the reporting date. The reporter agreed to follow up.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Peeling of the skin of both hands; This case was reported by a physician via sales rep and described the occurrence of skin peeling in a male 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 skin peeling. On an unknown date, the outcome of the skin peeling was unknown.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR078931   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient received dose of Shingrix vaccine and experienced peeling of the skin in both hands. The reporter consented to follow-up. Additional supportive information: For the tolerance of 2nd dose of Shingrix, refer linked case US2022AMR078931.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR078931:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the 2nd 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th May 2019).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 16-MAY-2022 Reporter's comment: This case was reported by the patient. The patient received only 1st Shingrix and never received the 2nd dose. The patient asked if he or she should get 2nd dose or start the vaccination series over again with the 1st and then 2 to 6 month later to get the 2nd dose. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 7 moths too late for 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 15-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient asked if 7 months was too late for 2nd dose of Shingrix Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've had 2 vax last June/September, now having mild 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 2nd dose of Shingrix. In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had 2 Shingrix vaccine in last June/September, now having mild shingles. The reporter wanted to know that if he/she was contagious to children or other post vaccines. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I got a 1st shot on June 2018 but never got the 2nd shot.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 84-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2018).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 16-MAY-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient never got second dose of Shingrix. The patient asked should he/she get the second shot now, should he/she start the series over, or just leave well enough alone. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I've had the Shingles shots and still get/Suspected vaccination failure; Still get 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 Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after second vaccine/suspected vaccination failure; shingles after second vaccine; 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.   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 was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles which lasted for 7 weeks. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot, then got shingles/Suspected vaccination failure; then got 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 Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles so bad. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I've have them twice/Suspected vaccination failure; I've have them twice; Miserable pain; Miserable pain; 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), shingles, pain and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles, pain and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles twice, which was most miserable painful anyone could have, and they sucked him/her both the times. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Stress, Vaccination failure
Clinical narrative: 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and stress. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-MAY-2022. Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles, two weeks ago from the date of reporting. The patient also had stress. The patient was going to take garlic every day and all day. This fresh he'll was unbelievable. The patient stated that, Acyclovir had not done it yet. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: caused Lymph nodes in neck and ear to swell up; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   The reporter considered the enlargement of lymph nodes to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-May-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The Shingles vaccine caused lymph nodes in patient's neck and behind the ear to swell up. The patient stated that he/she did not think he/she would get the second shot. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: low-grade fever; 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.   The patient's past medical history included allergic reaction (some allergy reaction on hands that would come and go and would travel further every time it happened).   In May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-May-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient kept having some allergy reaction on his/her hands that would come and go and would travel further every time it happens, so the patient scared himself/ herself into starting the shingles shot. The patient thought it might have been the shingles trying to start, but though it was some allergy reaction. The patient had one shot last week from reporting date and would have the other one in two months. The patient stated that he/she needed the shot anyway, but he/she did not like the low-grade fever that came with it, his/ her body did not like shots. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccine gave me 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient stated that, Shingles vaccine gave him/her shingles. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot and got shingles/Suspected vaccination failure; Got shingles again the following year; 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, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. Following year after receiving Shingles vaccine, the patient got shingles again. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shots did not work I still get them/Suspected vaccination failure; Shots did not work I still get them; 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 Information: GSK Receipt Date: 14-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient paid 90.00 for Shingles shot but it did not work. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles, 3 months after getting the shot/Suspected vaccination failure; I got 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, 3 months 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 Information: GSK Receipt Date: 14-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the liquid component of the vaccine; Patient received only the liquid component of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA688A, expiry date 30th April 2023) for prophylaxis.   On 15th April 2022, the patient received Menveo. On 15th April 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: The patient received only the liquid component of the Menveo vaccine. The consent to follow up was given. Additional Supportive Information: The patient received only the liquid component of the Menveo, which led to inappropriate preparation of medication and incorrect dose administered.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Hypoaesthesia, Nausea, Pain in extremity
Clinical narrative: fever; chills; nausea; backache; arm soreness; numbness on left side of face; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of 0.5 ml of Shingrix in left arm intramuscularly in February 2022).   On 10th May 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 10th May 2022, 12 hrs after receiving Shingrix, the patient experienced fever, chills, nausea, back pain, pain in arm and numbness facial. On an unknown date, the outcome of the fever, chills, nausea and back pain were recovered/resolved and the outcome of the pain in arm and numbness facial were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, nausea, back pain, pain in arm and numbness facial to be related to Shingrix.     Additional Information: GSK receipt date: 11-May-2022 Reporter's comment: The patient self reported this case. The patient received a dose of Shignrix in left arm and about 12 hours after the vaccination, the patient developed fever, chills, nausea, backache, arm soreness, and numbness on the left side of her face. The patient still had at soreness and numbness in her face. The patient did not want to provide any more demographics and had to go before could inquire about lot/expiry date of the vaccine or whether she would like follow up with her health care professional.  No health care professional for the follow-up. Did not consent to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; chills; nausea; backache; arm soreness; numbness on left side of face; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of 0.5 ml of Shingrix in left arm intramuscularly in February 2022).   On 10th May 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 10th May 2022, 12 hrs after receiving Shingrix, the patient experienced fever, chills, nausea, back pain, pain in arm and numbness facial. On an unknown date, the outcome of the fever, chills, nausea and back pain were recovered/resolved and the outcome of the pain in arm and numbness facial were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, nausea, back pain, pain in arm and numbness facial to be related to Shingrix.     Additional Information: GSK receipt date: 11-May-2022 Reporter's comment: The patient self reported this case. The patient received a dose of Shignrix in left arm and about 12 hours after the vaccination, the patient developed fever, chills, nausea, backache, arm soreness, and numbness on the left side of her face. The patient still had at soreness and numbness in her face. The patient did not want to provide any more demographics and had to go before could inquire about lot/expiry date of the vaccine or whether she would like follow up with her health care professional.  No health care professional for the follow-up. Did not consent to follow-up.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Patients were administered with vaccines after they experienced an above temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unknown number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number 31A745, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving 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 Information: GSK Receipt Date: 11-May-2022 Reporter's comments: The health care provided reported that some patients were administered with Boostrix vaccines after they experienced an above temperature excursion of 12 degree Celsius for 6 months since 8th December  2021. When asked about patient or vaccine details, the healthcare professional stated she did not have any data available. Only batch number was provided. The consent to follow up was given. Additional Supportive Information: The patients received Boostrix that was exposed to temperature excursion of 12 degree Celsius, which led to incorrect storage of drug.
Sex: U
Vaccine: HEP, HEPA, MENB, VARZOS
Symptoms: Product storage error
Clinical narrative: stored at a minimum of -0.6C and a highest of 53F over a month; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Shingrix, Havrix, Bexsero, Bexsero Pre-Filled Syringe Device and Engerix B. On an unknown date, unknown after receiving Shingrix, Havrix, Bexsero, Bexsero Pre-Filled Syringe Device and Engerix B, 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 Information: GSK Receipt Date: 13-MAY-2022 Reporter's comment: The vaccine coordinator reported that the vaccines involved were Shingrix, Bexsero, Havrix, Engerix B stored at a minimum temperature of minus 0.6 Degree Celsius and a highest of 53 Fahrenheit over a month.  The reporter reported that some of the vaccines were administered, and reporter was not aware of how many patient or which vaccines were used.  The reporter stated that the HCP (health care professional) would call with all the information needed. Agent accidentally forgot to ask for consent to FU (follow up). Additional Supportive Information: The reporter reported that the vaccines involved were Shingrix, Bexsero, Havrix, Engerix B stored at a minimum temperature of minus 0.6 Degree Celsius and a highest of 53 Fahrenheit over a month, which led to incorrect storage of drug.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR078653:same reporter
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: adult patient received one dose of pediatric Havrix (720 EL.U./0.5mL); adult patient received one dose of pediatric Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult female patient who received HAV (Havrix 720 Junior) (batch number 95EJ7, expiry date 2nd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th May 2022, the patient received Havrix 720 Junior .5 ml and Havrix Pre-Filled Syringe Device. On 13th May 2022, unknown after receiving Havrix 720 Junior and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose 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 Information: GSK Receipt Date:13-May-2022 Reporter's comments: An adult patient received one dose of pediatric Havrix. The consent to follow-up was given. Additional Supportive Information: An adult patient received one dose of pediatric Havrix, which led to underdose and adult use of a child product.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix 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 Information: GSK Receipt Date: 13-MAY-2022 Additional supportive information: The patient received Infanrix at inappropriate age which led to inappropriate age at vaccine administration. The reporter consented to follow up. Note: The age of the patient was not provided but as per reported verbatim case was kept as valid with Inappropriate age event.
Age: 89.0
Sex: M
Vaccine: MNQ
Symptoms: Therapeutic response unexpected
Clinical narrative: After getting the vaccine, the phlegm problem he'd had for years went away; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 89-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   The patient's past medical history included phlegm (had a chronic condition for many years).   On 17th April 2022, the patient received the 1st dose of Menveo (intramuscular) .5 ml. In April 2022, several days after receiving Menveo, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Menveo.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient self-reported the case. The patient had a chronic condition for many years where phlegm comes into his mouth several times a day.   The patient received Menveo in left arm. He reported that, a few days after getting the Menveo vaccine, the phlegm problem he had for years went away. The reporter did not consent to follow-up.
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: reported a kinrix maladministration, as an 18 months old male patient/Kinrix out of indication; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) 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 Information: GSK Receipt Date: 16-MAY-2022 Reporter's comment: A nurse reported a Kinrix maladministration, as an 18 months old patient received a dose by mistake. The reporter consented to follow up. Additional supportive information: The patient of 18 months old received a dose of Kinrix by mistake, which led to inappropriate age at vaccine administration.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: Incorrect dose administered
Clinical narrative: Patient mistakenly received two DTaP vaccines; This case was reported by a consumer via call center representative and described the occurrence of accidental overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2kl4k, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number ak443, expiry date 16th September 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th May 2022, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On 16th May 2022, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose 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 Information: GSK Receipt Date: 16-MAY-2022 Reporter's comment: The reporter was the patient's mother. The patient mistakenly received two DTaP vaccines (Kinrix and Infanrix) on the reporting day.  The reporter had nothing else to report. The reporter consented to follow up. Additional supportive information: The patient mistakenly received two DTaP vaccines which led to accidental overdose.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 8 years old male patient was administrated with Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa (Infanrix) (batch number 8k443, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 4th May 2022, unknown after receiving Infanrix and Infanrix 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 Information: GSK receipt date: 16-MAY-2022 Reporter's comment: Nurse reported that 8 years old male patient was administrated with Infanrix.  No adverse event was reported. The vaccine administration facility was the same as primary reporter. No expiration date provided Consented to follow up.  Additional Supportive Information: The 8-year-old patient received Infanrix, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: After second dose, developed shingles/Suspected vaccination failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK receipt date: 17-May-2022 Reporter's comment: The pharmacist reported that the patient was administrated with the two doses of Shingrix in 2019.  After the second dose, the patient developed shingles. No other adverse event was reported. No lot number and expiration date were provided. It was not known when had shingles, how long it lasted and when it stopped having shingles. The reporter consented to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: pain at the injections site; Fatigue; Chills; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 16th May 2022, the patient received the 2nd dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, fatigue, chills and muscle pain. On an unknown date, the outcome of the injection site pain, fatigue, chills and muscle pain were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, chills and muscle pain to be related to Shingrix.     Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment:  The patient reported case for himself. The patient reported that he received his second dose of Shingrix and experienced pain at the injections site, fatigue, chills, and muscle aches. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose less than 4 weeks apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 3rd February 2022, the patient received the 2nd dose of Shingrix. On 3rd February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date:17-May-2022 Reporter's comments: The patient received 2nd dose of Shingrix less than 4 weeks apart. The recommendation of schedule for Shingrix was to take the 2nd dose 2 to 6 months apart The pharmacist did not have more information about patient and vaccine at the moment of the conversation. The consent to follow up was given. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than recommended time frame, which led to shortening of interval between vaccine doses.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the 1st dose 4 years ago and didn't get the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 years before the date of reporting).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 17-May-2022 Reporter's comments: The pharmacist called in to inquire if the patient need to start series all over. The patient did not get the second dose. The pharmacist was unable to provide vaccine details. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.