chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that it was possible that the patient was given Hiberix that may have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have specific patient information or dates administered at the time of report. The reporter stated the specific lot was administered over a range of a couple of months. The reporter consented to follow up. This case has been linked to other 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.  Additional details were reported as follows: Age at vaccination was not applicable. The patient received a dose of Hiberix where it was reconstituted with sterile water instead of saline water, which led to inappropriate reconstitution technique and incorrect dose administered. It is one of the 9 cases, reported by the same reporter. Consent to follow up was granted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first one in July, Need a second; This case was reported by a consumer 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  (received 1st dose in July 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 details were provided as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter wanted to know the maximum amount of time between 2 doses. The reporter stated that, he/she needed a second dose and didn't wanted to wait too long. The reporter also stated that, his/her doctor was aware about the 2nd dose and had booked the same.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Still get em; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she had the Shingles shot twice and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had taken the shingles vaccine, Just started/suspected vaccination failure; Just started, get over it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In February 2022, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had taken the Shingles vaccine a few years back and shingles just started this weekend, but he/she thought that he/she was getting symptoms and could not explain.  The patient was on steroids and medicines. The patient stated that now a 2 times vaccine was recommended after he/she got over it. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had 2 vaccine shots/currently have shingles!/Suspected vaccination failure; Currently have shingles!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In 2019, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 shots of Shingrix in 2019 and currently had shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had a shot for it and still got it/ suspected vaccination failure; Still got it; Very very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, had shingles twice and was very painful. The patient had shot for it and still got shingles second time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Both doses hurt like hell, the shot hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR025388  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got both Shingles shots and he/she mentioned that it hurted like heck, but rather had the shot hurt then to had shingles. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR025388:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain, Vaccine positive rechallenge
Clinical narrative: Both doses hurt like hell, the shot hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st shot on an unknown date and the patient had hurt like heck, the shot hurt, refer case US2022AMR025380).   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 pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR025380  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got both Shingles shots and he/she mentioned that it hurted like heck, but rather had the shot hurt then to had shingles. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR025380:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient mentioned he got the 1st dose of Shingrix and had a sore arm. Consent to follow up was denied.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose yesterday, had a dose Oct2019; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (might had received 1st dose in October 2019).   On 9th February 2022, the patient received the 2nd dose of Shingrix. On 9th February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient might had received one dose in October of 2019.  The store had it logged that, the patient received the dose, but he/she did not remember. The patient received a dose on 9th February 2022, later than the recommended schedule which led to lengthening of vaccination schedule. The patient asked, if he/she should go ahead and had another dose in 2 to 6 months for the series.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got first shot and 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 the 1st dose of Shingles vaccine. On an unknown date, unknown 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 details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient never had chicken pox, all of his/her 5 kids did and he/she worked in a daycare that had a chicken pox out break.  The patient  got the first shot and got shingles for the third time, once after the first shot since he/she got the second shot he/she haven't had them again.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots and still got it/suspected vaccination failure; still got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got the Shingle shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Scar, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; still have scars; It was painful; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, scar and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, scar and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she never had chicken pox and had two shingles shot and got shingles, further stated, it was painful and took several weeks to go away. The patient took pills and cream, still had scars. The patient hoped he/she did not get it again. The patient asked if the shot helped. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Had them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. Age at vaccination was not reported. The patient received several shots of shingles long time ago and experienced Shingles. The consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting
Sex: U
Vaccine: VARZOS
Symptoms: Product prescribing error
Clinical narrative: doctor said nothing about second dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug prescribing error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient lost side effects and went to GlaxoSmithKline's site to look them up and found that the site said it was 2 doses. The patient's doctor's office said nothing about a second dose, which led to drug prescribing error.  The patient asked, if 2 doses still recommended.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with cyanocobalamin (Vitamin B12). On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, the vaccine did not help, still got shingles 2 to 3 times after took vaccine. The patient got shingles most recently last week  from the date of reporting. The reporter stated that the best way was keep the medicine at home. The patient advised when you have that feeling, just take the medicine right away. And take B12, it could reduce the pain This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Hot arm; Arm still red; Arm still swollen; This case was reported by a consumer via interactive digital media and described the occurrence of extremities hot feeling of in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2022, the patient received Shingrix. In February 2022, less than a week after receiving Shingrix, the patient experienced extremities hot feeling of, erythema of extremities and swelling arm. On an unknown date, the outcome of the extremities hot feeling of, erythema of extremities and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the extremities hot feeling of, erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient had the vaccine for shingles on Wednesday and his/her arm was still hot, red and swollen. The patient asked that how long this should last. The follow-up could not be possible as no contact details were available
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose JUL-2020, second SEP-2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number PG35Z, expiry date 11th March 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th July 2020).   On 24th September 2021, the patient received the 2nd dose of Shingrix. On 24th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient was now presenting to the reporter saying he was told to come back for another dose. At the time of reporting, a third dose had not been administered.  The reporter did not have the lot number and expiration date of dose one. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose
Clinical narrative: administered 2 doses at the same time; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 21-year-old female patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.  Additional details were provided as follows: The age at vaccination was unknown. The reporter stated that, the patient was inadvertently administered 2 doses of adult Engerix-b at the same time, couple of months ago from the day of reporting, around fall, which led to accidental overdose. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up via phone. No other detail was available. Note: As per the convention only one suspect was coded for same Brand of vaccine.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given Hiberix reconstituted with sterile water; given Hiberix reconstituted with 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 Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Continues to have shingles breakouts; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 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 details were provided as follows: The age at vaccination was not reported. The reporter stated they had a patient who had both Shingrix vaccines and continued to have shingles break outs. The reporter further stated he/she did understand it was not 100 percent effective but at some time and wanted to know if there was a recommended 3rd Shingrix dosage. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nausea; Tiredness; Headache; This case was reported by a consumer via call center representative and described the occurrence of nausea in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced nausea, tiredness and headache. On an unknown date, the outcome of the nausea, tiredness and headache were recovered/resolved.   It was unknown if the reporter considered the nausea, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient enquired if she need to had the 2nd dose of Shingrix as she experienced side effects with the first dose.  The patient did not remember when she received the first dose but she experienced nausea, tiredness and headache the day following administration of the vaccine. Consent obtained to contact health care professional and consumer for follow-up The reporter consented to follow up.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th February 2022, the patient received the 1st dose of Engerix B (intramuscular) 1 ml and Engerix B Pre-Filled Syringe Device. On 8th February 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter called to report that the patient received an expired dose of Engerix-B in his left deltoid which led to expired vaccine used.   The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: Accidental eye exposure with the solution for injection of the vaccine; Accidental eye exposure with the solution for injection of the vaccine; This case was reported by a other health professional via call center representative and described the occurrence of accidental occupational exposure to product 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 accidental occupational exposure to product and exposure via eye contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via eye contact were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional reported that the employee had accidental eye exposure with the solution for injection of the Shingrix vaccine, which led to accidental occupational exposure to product and exposure via eye contact. The reporter informed that the event happened a week before the date of the call but the HCP (health care professional) could not be specific about the date. The reporter had no information regarding the lot number or expiration date of the vaccine, no personal information regarding the employee at the moment of the call. No further events or details about the event were clarified.  The reporter consented to follow-up.
Age: 14.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Given Pediarix instead of TDAP-IPV-HEP-B; inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number IN259, expiry date 5th October 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the 14 years old patient received dose of Pediarix instead of the combo TDAP-IPV-HEP-B, which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) 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.   On 9th February 2022, the patient received the 1st dose of Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow-up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019, not received other 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 49-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 18th June 2019, intramuscularly).   On an unknown date, the patient received 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 details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. After receiving 1st dose of Twinrix, the patient did not realize that there was a 2nd and 3rd dose in the series.  Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete vaccination schedule. Reporter could not provide lot number, expiration date, or route of administration. The patient gave consent to contact healthcare professional but could not provide healthcare professional demographics. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. An expired dose of Kinrix was administered to the patient, which led to expired vaccine used. The reporter did not have the patient's demographics to provide. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose FEB2021, 2nd hasnt been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th February 2021, batch number ey93j, expiry date 30th April 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient wanted to get 2nd dose of Shingrix but till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose a year ago; This case was reported by a other health professional 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 (received 1st dose, an year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. No information from the reporter was given during the chat. No information given about the patient receiving the second dose of the vaccine till the time of reporting. The reporter did not consent to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Received a vaccine expire 10 days before the vaccination; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXAA1EZ, expiry date 31st January 2022) 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 10th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Bexsero, which was expired 10 days before the vaccination, which led to expired vaccine used. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Lymphoedema, Malaise, Pyrexia, Swelling
Clinical narrative: tightness in throat; lymphedema; neck swelling; malaise; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2022, the patient received the 2nd dose of Shingrix. On 10th January 2022, less than a day after receiving Shingrix, the patient experienced malaise, fever, weakness, throat tightness, lymphedema and neck swelling. On an unknown date, the outcome of the malaise, fever and weakness were recovered/resolved and the outcome of the throat tightness, lymphedema and neck swelling were not recovered/not resolved.   It was unknown if the reporter considered the malaise, fever, weakness, throat tightness, lymphedema and neck swelling to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and experienced fever, malaise, weakness for 3 to 4 days, tightness in throat, lymphedema, and neck swelling. Consent to follow up was granted.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: tightness in throat; lymphedema; neck swelling; malaise; fever; weakness; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2022, the patient received the 2nd dose of Shingrix. On 10th January 2022, less than a day after receiving Shingrix, the patient experienced malaise, fever, weakness, throat tightness, lymphedema and neck swelling. On an unknown date, the outcome of the malaise, fever and weakness were recovered/resolved and the outcome of the throat tightness, lymphedema and neck swelling were not recovered/not resolved.   It was unknown if the reporter considered the malaise, fever, weakness, throat tightness, lymphedema and neck swelling to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and experienced fever, malaise, weakness for 3 to 4 days, tightness in throat, lymphedema, and neck swelling. Consent to follow up was granted.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose still not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old child was given kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-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 9th February 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 9th February 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 details were provided as follows: The reporter stated that a 4 months patient was administered the kinrix vaccine in left thigh, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pyrexia, Tachycardia
Clinical narrative: Tachycardia; Fever; Insomnia or trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2022, the patient received the 1st dose of Shingrix. On 8th February 2022, less than a day after receiving Shingrix, the patient experienced insomnia. On 9th February 2022, the patient experienced tachycardia and fever. The patient was treated with paracetamol (Tylenol (Acetaminophen)). On an unknown date, the outcome of the insomnia, tachycardia and fever were recovered/resolved.   It was unknown if the reporter considered the insomnia, tachycardia and fever to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and experienced insomnia or trouble sleeping that evening. Next day during dentist appointment, he was found to have tachycardia and fever. All the symptoms were resolved. The patient took Tylenol 500mg as a treatment for fever as suggested by his healthcare professional. Consent to follow up was granted.