chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: PNC, PPV
Symptoms: Anger, Asthenia, Influenza like illness, Pain, Stomatitis
Clinical narrative: he "was achy like I had the flu"; I have sores in my mouth; no energy; angry; This spontaneous report was received from a 69-year-old male patient, referring to himself. The patient's historical conditions included low thyroid issue, atrial fibrillation, heart problems (unspecified), blood pressure a little high, tinnitus and incontinence (unspecified). The patient's concurrent condition included kidney issue "on edge of kidney disease stage 3". The patient was allergic to rifampicin (MYCINS), sulfacetamide sodium (+) sulfadiazine (+) sulfadimidine (+) sulfamerazine (SULFAS), penicillin and tetracyclines. The patient's concomitant medications included levothyroxine, apixaban (ELIQUIS), losartan, pravastatin or maybe something else now (unspecified), citalopram, oxybutynin, pyridoxine hydrochloride (VITAMINE) and what not" (unspecified) and influenza vaccine (FLU).     On an unknown date in November 2020 (also reported as last year), the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) or pneumococcal vaccine conj 7v (crm197) (PREVNAR) (reported as PREVNAR 23, it was unsure which products he has received) (strength, dose detail, lot# and expiration date not reported; route reported as injection) for prophylaxis due to the patient was told by the doctor that he needed to receive it if he have not had it yet. It was reported that the patient did not have any side effects.  On an unknown date in 2021 (also reported as "past few days" and "recently"), the patient received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or pneumococcal vaccine conj 7v (crm197) (PREVNAR) (it was unsure which products he has received) again along with the influenza vaccine (FLU) shot (unspecified) in the same arm.  On unknown dates in 2021 (reported as "in the last few days"), the patient was achy like he had the flu, he had sores in mouth (reported as less today than yesterday) and no energy. The patient wanted to know if the sores were going to go away. He was taking ibuprofen (ADVIL) for the reported effects noted above and "felt a bit better", 4 hours later, he took a second dose of ibuprofen (ADVIL) and "feels better" but "left with sores in his mouth". The patient became angry. On an unknown date (reported as recently), the patient had kidney labs without results provided. Therapy was reported as not discontinued. The outcome of the events was reported as not recovered. The causality assessment was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2021229149).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The reporter asked questions regarding Shingrix because she was thinking about getting it. The reporter stated her husband had Shingrix in the past and he only had a sore arm.  Limited information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: I am still getting pain at the injection site; Retricted arm movement at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 85-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had an occurrence of shingles 56 years ago).   On 28th July 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingrix and till the time of reporting, patient still getting pain and restricted arm movement at the injection site. The patient asked how long is the pain going to persist because he/she was reluctant to get the second injection. The patient stated that he/she was good in health. The patient had an occurrence of shingles in the exactly 56 years ago, possibly originated from contact with someone who had Chicken Pox at the wedding reception and did not know if that still affects the immunity. The patient asked for some advice and if he/she need to persue further medical advice. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, 3 weeks 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 age at vaccination was not reported. The doctor told the patient to get his shingles shot and 3 weeks later, had shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster
Clinical narrative: shingles; tiredness; 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.   Previously administered products included Shingles vaccine (had vaccine 16 years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles and tiredness. The patient was treated with medication unknown (Pill (Medication Unknown)). On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the shingles and tiredness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient had new vaccine which was better and was diagnosed within 72 hours of onset. The patient was taking pills for 7 days (3x/ day) and was fortunate to escaped the blisters. The patient was just getting over shingles. Still the patient was not over the tiredness. The patient was glad to had the vaccine. The patient stated vaccines worked. The follow up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: extremely sick from shingles shots; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got extremely sick from the shingles shots, both of them.but glad I got them. The follow up would not possible as no contact information was available. for tolerance of second dose refer linked case US2021AMR230977, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR230977:second dose, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Got mine 3 days ago. Horrible pain iny arms; I couldn't sleep; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 3rd November 2021, the patient received the 1st dose of Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and insomnia. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the pain in arm and insomnia were unknown.   It was unknown if the reporter considered the pain in arm and insomnia to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient got 1st dose 3 days ago of reporting date. The patient experienced horrible pain in arms and the patient could not sleep.  The patient took Motrin. The patient was advice to go back after two months for the second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral
Clinical narrative: lost 95% of the vision in one eye; This case was reported by a consumer via  interactive digital media and described the occurrence of unqualified visual loss, one eye 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 unqualified visual loss, one eye (serious criteria GSK medically significant). On an unknown date, the outcome of the unqualified visual loss, one eye was unknown.   The reporter considered the unqualified visual loss, one eye to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's best high school friend. The age at vaccination was not reported. The patient lost 95 percent of the vision in one eye because of the Shingrix vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles vaccine and still got shingles. 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, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/both doses and still got shingles; shingles/Mild case but still excruciating; Mild case but still excruciating; 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received both the doses and still got shingles. Patient stated that stress was powerful thing. It was a mild case but still excruciating. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details found.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and I got them/ suspected vaccination failure; had the shot and I got 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 Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had the shingles shot and experienced shingles so bad and they still reoccur so year. 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, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have had all the vaccines for shingles but I keep getting it.; I keep getting 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had all the Shingles vaccines for shingles but keep getting shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: got the shots, got shingles; shingles; Not feeling so good; 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 Shingles vaccine and Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling unwell. On an unknown date, the outcome of the vaccination failure, shingles and feeling unwell were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling unwell to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles vaccine a couple years ago before reporting date. The patient stated he/she got shingles a week ago before reporting date. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Headache, Herpes zoster, Illness, Vaccination failure
Clinical narrative: have had it and took the two shots/ suspected vaccination failure; have had it and took the two shots; sick that I was in bed for a week; dizzy; headache; 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, sickness, dizziness and headache. On an unknown date, the outcome of the vaccination failure, shingles, dizziness and headache were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, dizziness and headache to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she took two Shingles shot and had shingles. The 2nd Shingles shot made he/she so sick that was in bed for a week. The patient stated he/she still dizzy and headache. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: injection site swelling; minor pain; This case was reported by a consumer and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling and pain. On an unknown date, the outcome of the injection site swelling and pain were unknown.   It was unknown if the reporter considered the injection site swelling and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine at the end of this September 2021. The patient experienced injection site swelling and minor pain. The case has been linked with the case US2021AMR232228 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR232228:Same reporter
Sex: U
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Bexsero given instead of Trumenba; This case was reported by a nurse via other manufacturer and described the occurrence of interchange of vaccine products in a adolescent patient who received Men B NVS (Bexsero) 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 and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 8th November 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of TRUMENBA. On 8th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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 unknown. The reporter stated that, the patient received initial dose of Trumenba.  On 8th November 2021, the patient visited the clinic to receive second dose of Trumenba but was given Bexsero, which led to interchange of vaccine products. The reporter was contacted to find out what should be done, whether the patient be given a second dose of Bexsero or Trumenba, was the patient at risk or not. The reporter had no answers. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: had both doses last year, now have a mild case of shingles/ suspected vaccination failure; a mild case of shingles; rash; This case was reported by a consumer via (shingrix  interactive digital media and described the occurrence of suspected vaccination failure in a 66-year-old 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, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was unknown. The reporter stated that, he/she had both doses of Shingrix last year and now had a rash which seemed like a mild case of shingles. The reporter asked if that was imminent. This case was considered as suspected vaccination failure as details regarding the laboratory test confirming shingles was unknown at the time of reporting. The consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got the first shot, didn't know about 2nd, it's now 8 months later; 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 day 8 month before 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 information was provided as follows: The age at vaccination was not applicable for this report. The patient didin't knew about the 2nd shot. Till the time of reporting the patient did not receive the 2nd dose of vaccination which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; 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 Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, 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 details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232215:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; 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 Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, 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 details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232215:Same reporter US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; 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 Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, 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 details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; 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 Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, 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 details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; 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 Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, 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 details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232215:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; 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 Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, 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 details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232215:Same reporter US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; 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 Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, 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 details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232215:Same reporter, different patient US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine 3 months later got shingles/ Suspected vaccination failure; Shingles, right arm Lasted 1 month; 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, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles vaccine 3 months later got shingles in right arm lasted 1 month. 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, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case has been linked to the case US2021AMR233762 reported by the same reporter for 1st outbreak.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233762:1st outbreak
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: shingles in left arm/ 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, 6 weeks 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated 6 weeks after Shingles vaccine had shingles in left arm another month of pain. 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, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case has been linked to the case US2021AMR233752 reported by the same reporter for 2nd outbreak.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233752:2nd outbreak
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got her first / injection early last March but has not received her second dose / March 2020 Is the correct date of the vaccination; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020).   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 course of vaccination. The patient did not consented to follow- up. No further information were provided by the patient.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only liquid portion; received only liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA592A, expiry date 31st August 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The registered nurse reported that a patient between 11 and 17 year old received only liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. She could not tell the exact age of the patient but the patient might be between 11 and 17 years of age. The nurse provided limited information since information was not available regarding the date of vaccination, demographic details from patient who received liquid portion of menveo.  The consent to follow up granted.
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: Last dose was given when patient was 2 years; Received 3 doses of the D-tap series, the last was with 2 y/o; 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 7-year-old male patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTaP vaccine (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received DTaP vaccine and the 3rd dose of DTaP vaccine. On an unknown date, not applicable after receiving DTaP vaccine and unknown after receiving DTaP vaccine, the patient experienced inappropriate age at vaccine administration and incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.  Additional details were provided as follows: The age at vaccination was 2 years old for the last dose that is 3rd dose The age at vaccination was not applicable for 5th and 4th dose. The Health Care Professional reported that the patient had received, 3 doses of the D-tap series,  The reporter was just inquiring about giving Boostrix to patient but it was not administered at the time of the call.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered adjuvant instead of the reconstituted dose; Administered adjuvant instead of the reconstituted dose; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate reconstitution technique in a unk 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 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: The age at vaccination were not reported The GSK reporter called to report on behalf of HCP that a patient was administered adjuvant of SHINGRIX instead of the reconstituted dose. No other patient details were provided. The reporter Consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Incorrect dose administered, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: arm is sore at the injection site; Raised rash, below the injection site; red, below the injection site; had to use 3 vials of Shingrix to mix the dose; had to use 3 vials of Shingrix to mix the dose; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 3rd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On 5th November 2021, the patient experienced injection site pain, rash and erythema. On an unknown date, the outcome of the injection site pain, rash and erythema were not recovered/not resolved and the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the rash and erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 1st dose of Shingrix in right arm.  2 days after receiving Shingrix, the patient experienced a rash that was raised and red about 1 inch below the injection site. Her arm was sore at the injection site.  The patient wanted to also report that, she was not comfortable with the immunizer at her pharmacy as he looked confused when mixing the Shingrix vaccine.  The immunizer told the patient that, he had to use 3 vials of Shingrix to mix the dose which led to inappropriate reconstitution technique and it made her felt like she did not get the correct vaccine which led to inappropriate dose of vaccine administered. The patient did not give permission to contact healthcare professional. The reporter did not consent to follow-up.