chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin disorder, Vaccination failure
Clinical narrative: Got the vaccine about 3 years ago, soon had shingles/ Suspected vaccination failure; Soon had shingles; Broke out with another skin condition; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and skin disorder. The patient was treated with steroids nos (Steroids), antibiotics nos, medication unknown (Pill (Medication Unknown)) and dermatologicals nos (Salve (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and skin disorder were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and skin disorder to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got the vaccine about 3 years prior to the reporting. Soon he had shingles. The patient had received steroids and antibiotics later, he broke out with another skin condition with one of those long names. The patient had more prescribed with steroids, antibiotics, trips by a dermatologist. He was still taking pills that cancer patients took and used in a special salve to control the outbreak. The patient had no trust on vaccine. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Death; suspected vaccination failure/ Got shingles shot. Got shingles in eyes, died in a month; Shingles in eyes, close to brain, died in a month; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure and ophthalmic herpes zoster were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-Sep-2022 Reporter's comment: This case was reported by a patient's friend via interactive digital media. Reporter stated patient got the Shingles vaccine. The patient got shingls in eyes, was too close to patient's brain, however died under a month. Additional supportive information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Death NOS
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and still get Shingles/Suspected vaccination failure; Shingles, mild case; 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: 17-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles shot. The reporter stated that after received Shingles vaccine the patient still get shingles, but very mild cases. Follow-up would not possible as no contact details were available. 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: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got both shots, still get it, Had it two times/Suspected vaccination failure; Got both shots, still get it, Had it two times; 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 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 Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the new vaccine both shots, he/she guessed what you still get them. The patient had them two times so it was not. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered powder reconstituting it with non-GSK diluent; administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   On 25th August 2022, the patient received the 1st dose of Menveo (intramuscular). On 25th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter reported that the patient received Menveo in that administered powder reconstituting it with non-GSK diluent. The patient was still trying to revaccination. All five potential patients were recalled for revaccination. No adverse reactions known. The reporter stated that the system was utilized from 6th September 2022. Diluent would be dispensed with the powder in this machine. RNS to check all vials for vaccines prior to administration. The reporter associated the events to erroneous administration and lack of effect. The reporter did not consider the event wrong solution used in drug reconstitution and inappropriate dose of vaccine administered to be related to Menveo. The reporter did consent to follow up. Additional supportive information: Menveo reconstituted with non-GSK diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022124956:Same reporter/ original report US-GSK-US2022AMR131200:Same reporter US-GSK-US2022AMR131247:Same reporter US-GSK-US2022AMR131240:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: Sicker than a dog; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date refer case- US2022AMR131402).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR131402   Additional Information: GSK Receipt Date:11-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that was one set of shots he/she got.  They made patient sicker than a dog.  The patient hope and pray they were much more effective than the phony Covid shots that had not worked for anyone. Additional supportive information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR131402:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2022, the patient received Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingles vacc   Additional Information: GSK Receipt Date: 11-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles vaccine three days ago and he/she was having hives and wanted to know what he/she could do. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Capillary fragility
Clinical narrative: Shingrix burst capillaries in  arm; This case was reported by a consumer via interactive digital media and described the occurrence of broken capillary in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced broken capillary. On an unknown date, the outcome of the broken capillary was unknown.   It was unknown if the reporter considered the broken capillary to be related to Shingrix.  Additional Information: GSK Receipt Date: 11-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, the Shingrix vaccine burst many capillaries in his/her arm.  The reporter wanted to know whom he/she should report this to. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: received in early 2021, Covid hit, clinic closed down; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in early 2021).   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 Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received a 1st dose of Shingrix vaccine. Then Covid hit and the clinic where he/she was getting the 2nd closed down. It had been about 1 and half years.  The patient wanted to know did he/she started over. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: This case was reported by the consumer via interactive digital media. The reporter's stepmother received second dose of Shingles vaccine and right after vaccination the patient got shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter reported that he/she had Shingles twice once he was 16 years old and when he/she was much older. The reporter stated that he/she did not want to receive shot because he/she knewpeople that received Shingles vaccine and right after they experienced Shingles. Additional supportive information: This case had been linked with US2022AMR132562 and US2022AMR132557 reported by same reporter for different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR132562:Same reporter US-GSK-US2022AMR132557:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: No 2nd dose due to health insurance issues; 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.   Previously administered products included Shingrix (received 1st Shingrix shot 3 years ago).   On an unknown date, the patient did not 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 Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. Patient did not got 2nd dose due to health insurance issues. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral
Clinical narrative: my lips are going numb periodically; This case was reported by a consumer via call center representative and described the occurrence of numb lips in a 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 numb lips. On an unknown date, the outcome of the numb lips was not recovered/not resolved.   It was unknown if the reporter considered the numb lips to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comment: The case was self reported by the patient. The patient received second dose of Shingrix and nowhis/her lips were going numb periodically.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix 18 months ago; 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.   Previously administered products included Shingrix (received 1st dose on an unknown date 18 months ago from 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: 15-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient asked did he/she need to start the series again. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: myalgia at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The pharmacist reported that the patient received first dose of Shingrix and experienced myalgia at the injection site and two weeks later the patient still had it. The reporter consented to follow up by email.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Muscle spasms, Pyrexia
Clinical narrative: Fatigue; Upset stomach; Fever; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fatigue, upset stomach, fever and muscle pain. On an unknown date, the outcome of the fatigue, upset stomach, fever and muscle pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, upset stomach, fever and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter stated that the patient received 1st dose of vaccine in unknown arm, four months prior to the reporting. The reporter stated that after received Shingrix vaccine the patient experienced muscle pain, fever, upset stomach and fatigue. The reporter had nothing else to report. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLU4, HEP, HEPA, TDAP
Symptoms: Product storage error
Clinical narrative: Vaccines may have been administered after excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received Havrix, Boostrix, Engerix B and FluLaval Quadrivalent. On an unknown date, unknown after receiving Havrix, Boostrix, Engerix B and FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 12-Sep-2022 Reporter's comment: The pharmacy director stated that vaccines Havrix, Boostrix, Engerix-B and Flualval were exposed to above recommended temperatures for months.  The pharmacy director stated that they were exposed to a max temperature of 48.59 F and were above 47 F for at least a month.  The vaccines might had been administered, but investigation was ongoing. No further details are available at this time.  The reporter consent to follow up. Additional Supportive Information: The vaccines were exposed to a max temperature above recommended temperature, which led to incorrect storage of drug.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose, as of the time of the call, had not yet been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 20-year-old female 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.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 2nd 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 by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-SEP-2022 Reporters comment: The patients received the 1st dose on 29th August 2022 of Twinrix intending to complete the accelerated schedule, but it had been two weeks since dose one. Second dose, as of the time of the reporting, had not yet been administered. The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive the second dose which led to incomplete course of vaccination.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Overdose, Wrong technique in product usage process
Clinical narrative: Administered 1ml of Boostrix to patient; 2 vaccines drawn up into one syrige and administered.; 2 Boostrix administered, Last tdap Mar 2021; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 37-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Previously administered products included tdap vaccine (the patient received tdap vaccine in March 2021).   On 13th September 2022, the patient received Boostrix 1 ml. On 13th September 2022, unknown after receiving Boostrix, the patient experienced overdose, wrong technique in drug usage process and drug dose administration interval too short. On an unknown date, the outcome of the overdose, wrong technique in drug usage process and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 13-SEP-2022 and 15-SEP-2022 Reporter's Comment: The reporter reported that, they had just injected 1ml of Boostrix vaccine to adult patient by error. The reporter stated that, the patient received 2 Boostrix vaccines drawn up into one syringe and administered.  The poison control was contacted and said patient would be fine.  The patient had no side effects. The reporter did not consent to follow-up.  Additional Supportive Information: The reporter stated that, the patient received 2 Boostrix vaccines drawn up into one syringe and administered and last dose of tdap was in March 2021, which led to overdose, wrong technique in drug usage process and drug dose administration interval too short.
Age: 48.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received Infanrix instead of Boostrix; Received Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 48-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Infanrix .5 mg/ml and Infanrix Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and wrong vaccine administered. On an unknown date, the outcome of the adult use of a child product and wrong vaccine administered 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-SEP-2022 Reporter's Comment: The reporter stated that, 48 year old a patient received Infanrix, instead of receiving the prescribed Boostrix. Additional Supportive Information: The patient of 48 year old received Infanrix, instead of receiving the prescribed Boostrix, which led to adult use of a child product and wrong vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second vaccine 3 weeks after first; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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: 13-SEP-2022 Reporter's Comments: The reporter was a GSK vaccine representative reporting an adverse event with limited information for Shingrix. The representative stated that a physician at one of their accounts gave a patient their second Shingrix vaccine 3 weeks after the first vaccine.  The representative had no further information regarding the patient or vaccine. The reporter did not consent to follow up. Additional supportive information: The patient received the Shingrix dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Myalgia; Fatigue; Emesis; Headache; Fever; Chills; slightly elevated blood pressure; unable to complete their daily activities due to symptoms; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingrix. On 12th September 2022, less than a day after receiving Shingrix, the patient experienced myalgia, fatigue, vomiting, headache, fever, chills, increased blood pressure and activities of daily living impaired. On an unknown date, the outcome of the myalgia, fatigue, vomiting, headache, fever, chills, increased blood pressure and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, fatigue, vomiting, headache, fever, chills, increased blood pressure and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: The caller was the patient.  The patient reported that received first dose of Shingrix, in the left arm.  The patient experiencing myalgia, fatigue, emesis, headache, fever, chills, and slightly elevated blood pressure during the night of 12th Sep 2022 and all symptoms were ongoing.   The patient reported being unable to complete their daily activities due to symptoms. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Myalgia; Fatigue; Emesis; Headache; Fever; Chills; slightly elevated blood pressure; unable to complete their daily activities due to symptoms; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingrix. On 12th September 2022, less than a day after receiving Shingrix, the patient experienced myalgia, fatigue, vomiting, headache, fever, chills, increased blood pressure and activities of daily living impaired. On an unknown date, the outcome of the myalgia, fatigue, vomiting, headache, fever, chills, increased blood pressure and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, fatigue, vomiting, headache, fever, chills, increased blood pressure and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: The caller was the patient.  The patient reported that received first dose of Shingrix, in the left arm.  The patient experiencing myalgia, fatigue, emesis, headache, fever, chills, and slightly elevated blood pressure during the night of 12th Sep 2022 and all symptoms were ongoing.   The patient reported being unable to complete their daily activities due to symptoms. The reporter did not consent to follow up.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult was administered pediatric dose; adult was administered pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number MB744, expiry date 1st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Engerix B pediatric and Engerix B 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-SEP-2022 Reporter's Comment: The reporter was senior clinical manager. The reporter stated that, an adult patient was administered the pediatric dose of Engerix-B before the day of reporting. The reporter consented to follow up via mail. Additional Supportive Information: The reporter stated that, an adult patient was administered the pediatric dose of Engerix-B before the day of reporting, which led to underdose and adult use of a child product.
Age: 1.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix to a 8 months old patient; 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 patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 13th September 2022, 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: 13-Sep-2022 Reporter's Comment: The case was reported by the nurse. Nurse stated administration of Kinrix to an 8 months old patient. Nurse did not report any additional information apart from the age of the patient and the vaccine administered. Nurse did not know patient´s initials and gender and any information regarding vaccine lot number and expiration date. Additional supportive information: As Kinrix was administered to 8 month patient which led to inappropriate age at vaccination.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Administered Bexsero after exposed to 29.8 F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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: 13-SEP-2022 Reporters comment: The medical assistant stated that Bexsero was exposed to 29.8 F and was administered to a patient. The reporter consent to follow-up via mail. Additional Supportive information: The patient received Bexsero was exposed to 29.8 F which led to incorrect storage of drug. This was one of 5 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022132076:Same reporter. US-GSK-US2022132077:Same reporter. US-GSK-US2022132079:Same reporter. US-GSK-US2022132075:Same reporter.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient got a 0.5mL pediatric dose; Adult patient got a 0.5mL pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 47-year-old male patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis.   On 8th September 2022, the patient received the 1st dose of Engerix B pediatric .5 ml. On 8th September 2022, unknown after receiving Engerix B pediatric, 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.   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comments: Nurse reported that a 47 year old male patient was administered a 0.5 mL pediatric dose of Engerix-B vaccine on 08th September 2022. This was the patient's 1st dose in the series. At the time of reporting, the patient had not been redosed. The reporter had consented to follow-up. Reporter did not want contact information stored in GlaxoSmithKline database, but agreed to follow-up by safety. Additional supportive information: The patient who had received pediatric dose of Engerix-B was 47 years old adult patient, which had led to underdose and adult use of a child product.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Use of Kinrix for a child who is age 7; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) 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: 14-Sep-2022  Reporter's comment: The reporter asked a question that was there any efficacy, safety data or post marketing information on the use of Kinrix for a child who was age 7?  The sales representative confirmed the label of Kinrix was through the age of 6 years but customer was requesting information on the question above.  The sales representative had been unable to get confirmation if there was a medical error that had already occurred in this 7-year-old patient.  It was unknown at this time if Kinrix was indeed administered to the 7 year old.  The reporter consent to follow up. Additional Supportive Information: The seven years old patient was given Kinrix, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR218071:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of the adjuvant only; Administration of the adjuvant only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female 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 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: 14-Sep-2022 Reporter's comment: The pharmacist reported that the patient was administered with the adjuvant of Shingrix without prior reconstitution.  The pharmacist did not provide any other information. The reporter consent to follow up. Additional Supportive Information: The patient was administered with the adjuvant of Shingrix without prior reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2021, did not get 2nd dose; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix was administered on 10th May 2021).   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 Information: GSK receipt date: 15-SEP-2022 Reporter's comment: The Healthcare Professional(HCP) reported that the patient did not get the 2nd dose. The physician had told to restart the series. No other information available. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 29.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 29 YO patient received Kinrix; Patient received Kinrix instead of Boostrix; 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 29-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 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 and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 16-SEP-2022 Reporter's comment: The reporter stated that the 29 years old patient received Kinrix instead of Boostrix (booster dose).  The reporter consented to follow-up. Additional Supportive Information: The 29 years old patient received Kinrix instead of Boostrix (booster dose), which led to Inappropriate age at vaccine administration and Wrong vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo given with an alternate diluent (sterile water); This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The nurse stated that while completing reconciliation of the vaccines, it was noted that the clinic had two remaining vials of Menveo liquid portions, with one remaining vial of powder.  One dose of the powder given out of the nine doses administered was given with an alternate diluent, likely sterile water. The reporter stated they could not determine which patient was given a partial dose.  No further details were available, investigation was ongoing and the reporter intended to follow up with disease control for recommendations. The reporter consented to follow-up.  Additional supportive information: The patient received powder of Menveo with alternate diluent, which led to wrong solution used in drug reconstitution.
Age: 96.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with normal saline; Shingrix reconstituted with normal saline; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 96-year-old female patient who received Herpes zoster (Shingrix) (batch number AT772, expiry date 5th October 2023) for prophylaxis.   On 15th September 2022, the patient received Shingrix. On 15th September 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's comment: HCP (Health Care Professional) reported that patient received the Shingrix reconstituted with normal saline. No reactions were reported. The reporter consented to follow-up via email. Additional Supportive Information: The patient received Shingrix reconstituted with normal saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 16 year old received adult dose; 16 year old received adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old male patient who received HAV (Havrix adult) (batch number 2ba99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2022, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 16th September 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an adult dose of Havrix, which led to overdose and adult product administered to child.