chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; patient got their first dose of GARDASIL 9 at age 18 (dose given 18Dec2020) and then did not get their second dose until 8 months later (dose given 31Aug2021); This spontaneous report was received from a pharmacist, concerning a 19-year-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 18-DEC-2020 reported as "when the patient was 18 years old", he was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot number and expiration date were not reported), as prophylaxis. On 31-AUG-2021 reported as "8 months later", he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot number and expiration date were not reported), as prophylaxis (inappropriate schedule of product administration). On 10-JAN-2022 reported as "today", the patient was at the pharmacy to receive the third dose. No further adverse events were reported.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: This spontaneous report was received from a 33-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-JAN-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot # and expiration date not reported) intramuscularly (IM) in the right buttock for prophylaxis (Product administered at inappropriate site). No additional adverse event (AE) was reported.
Age: 36.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE reported; Patient received first dose of VARIVAX at the age of 36-year-old on 09-SEP-2021. Patient received a second dose on 05-OCT-2021; This spontaneous report has been received from a nurse, regarding a 36-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were not provided.  On 09-SEP-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), and on 05-OCT-2021 with the second dose (inappropriate schedule of product administration), both as prophylaxis (exact doses, route of administration and anatomical locations of vaccination, lot numbers and expirations dates were not reported). No additional information was provided, and no adverse events (AEs) were reported (no adverse event).
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Pneunococcal vaccine was given in 2015 and 2016; This spontaneous report has been received from a lawyer (reporter), via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (case#: 1807USA003721), concerning a 65-year-old male patient.   The patient smoked cigarettes since 1968 to 1984, 1-2 packs per day. He was diagnosed with chickenpox in 1955 at the age of 6 (units were not reported). He never received chickenpox vaccine. The patient's concurrent conditions included anxiety/, depression (since 2010) , emphysema (mild), gastroesophageal reflux disease (GERD)/ reflux, high cholesterol, and hypertension (high blood pressure). The patient's surgical history included orthopedic surgery and tonsillectomy.   Historical vaccines include: unspecified influenza vaccine on 06-DEC-2007,04-NOV-2011,21-DEC-2012, in 2013 and in 2014; unspecified diphtheria vaccine on 08-AUG-2003 and in 2013 with no adverse events reported.  The patient received the following vaccinations: unspecified influenza vaccine in 2014 with no adverse events reported. .   In 2015 and in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (Inappropriate schedule of product administration). No adverse event reported.  The patient received the following vaccinations: unspecified influenza vaccine in 2015, 2016, and 2018 with no adverse events reported.   This is one of the several reports received from the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: silght rash on chest; sore at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced injection site pain and rash. On an unknown date, the outcome of the injection site pain and rash were Not Recovered/Not Resolved.   It was unknown if the reporter considered the injection site pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the first Shingrix dose about 46 hours prior to the reporting date.  No side effects except for a sore arm at the injection site, but on the reporting day, 46 hours later patient had a slight rash on chest.  The patient had temperature of 98.2 degree Fahrenheit. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: get the shingles shot / it gave it to them/ suspected vaccination failure; the shingles shot / it gave it to them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 for reporter's mother. The age at vaccination was not reported. The reporter said that he/she almost forgot, one of his/her best friends called and said they were going to go and the reporter's mother went to get the shingles shots and asked to the reporter if reporter was going to get one and reporter said no well guess what it gave shingles to them. 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. The case was linked with case US2021AMR159199, reported by same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shots fot it / still got it once/ suspected vaccination failure; had shots fot it / still got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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: This case was reported for reporter's husband. The age at vaccination was not reported. The reporter stated he had Shingles shots and still got the shingle once.  The reporter stated, the physician told him it was not good thing he had shot. He would have had a very sever case of shingles without the Shingles shot. The reporter wonders if the damebis true for COVID? 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
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the vaccine and still get shingles/ suspected vaccination failure; shingles; less 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. 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 he/she got Shingles vaccine and still get shingles with less 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.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the two vaccines and broke out\ Suspected vaccination failure; Broke out worse than ever, terrible; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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. The patient was treated with melatonin. 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 for reporter's husband. The age at vaccination was not reported. The reporter stated he got the two vaccines for shingles and has broken out worse than ever. The reporter stated that been said everyone was different, but he just had an absolutely terrible breakout last week of reporting date. The reporter went to the health food store and they told 5 mg melatonin and it has almost all healed up, worth a try and the patient was sleeping like a rock. 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
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles twice I did, no third shot allowed\ Suspected vaccination failure; Get shingles twice I did; 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and got the shingles twice, third shot not allowed. 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
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Made me sick for 24 hours; 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 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever and general body pain. On an unknown date, the outcome of the sickness, fever and general body pain were unknown.   It was unknown if the reporter considered the sickness, fever and general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient's Insurance had been covered. The patient stated that second dose made him/her sick for 24 hours. The patient experience fever and body aches. The reporter was sure better, that getting shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Got pain like pin prick. Is that how shingles strts?; This case was reported by a consumer via interactive digital media and described the occurrence of prick pain feeling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2022, the patient received Shingles vaccine. In January 2022, less than a week after receiving Shingles vaccine, the patient experienced prick pain feeling. In January 2022, the outcome of the prick pain feeling was recovered/resolved.   It was unknown if the reporter considered the prick pain feeling to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter asked could get Shingles from shot and said, it was a 4 days before in January 2022. The patient reported he/she had pain like pin prick on the side of his/her stomach earlier which was lasted for about a minute.  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Induration, Pain, Peripheral swelling
Clinical narrative: suspected vaccination failure; shingles, keep getting them; painful; arm swelled up; arm redness; arm hard; 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, 5 weeks after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, swelling arm, erythema of extremities, induration and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved and the outcome of the swelling arm, erythema of extremities and induration were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, swelling arm, erythema of extremities, induration and pain to be related to Shingles vaccine. 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 had reported for him/herself. The age at vaccination was not reported. Unknown after receiving Shingles vaccine, the patient's whole arm swelled up, red, and hard for 3 weeks. At week 5, the patient got first case of shingles and he/she kept getting them, so excruciatingly painful.  The patient wished he/she had not got the shot. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; shingles, keep getting them; painful; arm swelled up; arm redness; arm hard; 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, 5 weeks after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, swelling arm, erythema of extremities, induration and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved and the outcome of the swelling arm, erythema of extremities and induration were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, swelling arm, erythema of extremities, induration and pain to be related to Shingles vaccine. 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 had reported for him/herself. The age at vaccination was not reported. Unknown after receiving Shingles vaccine, the patient's whole arm swelled up, red, and hard for 3 weeks. At week 5, the patient got first case of shingles and he/she kept getting them, so excruciatingly painful.  The patient wished he/she had not got the shot. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyway. The patient stated that, Shingles vaccine was not absolutely preventable and stated, hope you did not get it. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; got covid; 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 December 2021, more than 2 years after receiving Shingles vaccine, the patient experienced covid-19. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine 5 years ago from the date of reporting. More than 2 years after receiving Shingles vaccine, a few days before the holidays, the patient got covid and then the shingles came out. The patient stated that, it was time to get another shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient experienced fever and chills about 4 hours in the wee hours of the night. It was worth it though. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; WORST PAIN; 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 and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain 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 received dose of Shingles vaccine and experienced shingles. The patient stated that it was by far the worst pain he/she had ever endured and was going on 4 weeks now. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose over 2 years ago / Missed second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose was taken 2 years ago).   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 patient self-reported this case. The age at vaccination was not applicable for this report.. The patient got first dose of Shingrix over 2 years ago and missed second dose, which led to incomplete course of vaccination. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product supply issue, Social problem
Clinical narrative: vaccine shortage; COVID got in the way / haven't gotten a second dose; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue and social problem. On an unknown date, the outcome of the product supply issue and social problem were unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had one dose of Shingrix over 2 years ago and then vaccine shortage and COVID got in the way, which led to product supply issue and social problem. The patient did not had a second dose. The patient asked if she just needed to get a second dose or she should start again, do two new doses.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Now has shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's child. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had shingles at the time of reporting. The reporter stated that, the vaccine was not recent either. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Singles, had vaccine\ suspected vaccination failure; shingles; nerve pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a elderly 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 post herpetic neuralgia. The patient was treated with tramadol. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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. At the time of reporting patient age 79 was rough. The patient had vaccine 4 and half years ago of reporting. They said it only last 4 to 5 years.  The patient stated got shingles 2 times. Nerve pain was unbearable, had to take tramadole pain killer for 1 night and day just to get some sleep. The reporter stated would be talking to physician about getting another vaccine. This disease was a curse. 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
Symptoms: Arthralgia
Clinical narrative: shoulder killing me; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of arthralgia (1st dose received on an unknown date, refer case US2021AMR264980).   On 10th January 2022, the patient received the 2nd dose of Shingles vaccine. In January 2022, less than a day after receiving Shingles vaccine, the patient experienced shoulder pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2021AMR264980  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced his shoulder was killing him/her. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR264980:Same patient/reporter
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: First shot 5/18/21, due to COVID no 2nd; This case was reported by a other health professional via interactive digital media and described the occurrence of social problem in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (1st dose received on 18th May 2021).   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 social problem. On an unknown date, the outcome of the social problem was unknown.   It was unknown if the reporter considered the social problem to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter gave the 1st shot of series and due to Covid and patient phone problems, the patient was now asking for the 2nd shot. The reporter asked GlaxoSmithKline what should he/she do. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First shot 5/18/21, 6 months window is past; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th May 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that the patient received first dose of Shingrix and had been AWOL (absent without leave) but now all of a sudden he wanted second shot of the series, the 6 months window was well past them. The reporter asked that what GlaxoSmithKline advice was. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: came down with shingles within 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week 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: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingles shots and came down with shingles within 2 days. The follow-up would not possible as no contact details were available. This case was linked with US2022AMR006103, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR006103:same reporter
Sex: U
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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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. 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: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingles shots at separate times and came down with shingles within 2 days.  The follow-up would not possible as no contact details were available. This case was linked with US2022AMR006100, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR006100:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter reported that the patient got shingles shortly after the vaccination. The reporter stated that the symptoms and pain went away within 2 months. The follow-up would not possible as no contact details were available. The case was linked with case US2022AMR006312, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Suicidal ideation
Clinical narrative: recently started having suicidal thoghts; has been in great pain for over a year; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suicidal ideation 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 suicidal ideation (serious criteria GSK medically significant), pain and shingles. On an unknown date, the outcome of the suicidal ideation and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the suicidal ideation, pain and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter reported that the patient got shingles shortly after the vaccination. The reporter also reported that the patient had been in great pain for over a year and had recently started having suicidal thoughts. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR006235, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles three times had shots\ Suspected vaccination failure; Shingles three times, each is worse; 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots and had shingles three times each time was worse. 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: FLU4
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2018-2019 season) (batch number 59TS2, expiry date 31st May 2019) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2018-2019 season. On an unknown date, unknown after receiving FluLaval Quadrivalent 2018-2019 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient was inadvertently administered Flulaval QIV after the vaccine had been exposed to freezing temperatures, which led to incorrect storage of vaccine.   Follow up information was received from other health care professional on 11th January 2022: The patients demographics were updated. The patient received a dose of FluLaval Quadrivalent 2018-2019 season intramuscularly with dose of 0.5 ounce which was exposed to freezing temperature. The VAERs details were updated. Patient's age was provided as 5 Years however was not able capture due to Argus behavioral issue.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 35-year-old female patient who received HBV (Engerix B adult) (batch number F73DG, expiry date 3rd July 2023) for prophylaxis. Previously administered products included Engerix B (1st, 2nd and 3rd dose received on an unknown date). On 6th January 2022, the patient received the 4th dose of Engerix B adult. On 6th January 2022, unknown after receiving Engerix B adult, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that his colleague received an Engerix-B 4th adult dose by error, which led to extra dose administered. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric patient received an adult dose; Pediatric patient received an adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-day-old female patient who received HBV (Engerix B adult) (batch number 9AX5P, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st December 2021, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 31st December 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional did not have the lot number or expiration date at the time of report. A nurse reported that a pediatric patient was given an adult dose of Engerix which led to overdose and adult product administered to child.  No symptoms were reported. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Iitching at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. About one or two days later vaccination the patient developed 4 inch diameter area of redness and itching at the injection site.  The redness and itching lasted 3 weeks.  The patient had nothing else to report. The reporter did not consent to follow up. The patient declined to provide email address or contact as their physician was not involved.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (shingrix) (batch number CZ455, expiry date 16th September 2022) for prophylaxis. Co-suspect products included Herpes zoster (shingrix) (batch number 295S7, expiry date 9th October 2022) for prophylaxis. Previously administered products included shingrix (1st dose received on 1st July 2020). On 22nd August 2021, the patient received the 2nd dose of shingrix. On 10th January 2022, the patient received Shingrix. On 22nd August 2021, unknown after receiving shingrix and not applicable after receiving shingrix, the patient experienced drug dose administration interval too long. On 10th January 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The first dose was administrated on 1st July 2020. The patient received a late second dose of shingrix on 22nd August 2021, which led to lengthening of vaccination schedule. On the 10th January 2022,at the time of reporting a dose of Shingirx was inadvertently administrated to a same patient, which led to extra dose administered. The reporter informed that no further events were reported and agreed to be contacted for follow-up. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2022004286:Same patient and reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a adult female patient who received Herpes zoster (shingrix) for prophylaxis. The patient's past medical history included shingles (patient had a history of multiple shingles episodes). On 14th July 2021, the patient received the 1st dose of shingrix. On an unknown date, less than 6 months after receiving shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was unknown. It was unknown if the reporter considered the nerve pain to be related to shingrix. Additional details were reported as follows: The case was reported by pharmacist. The age at vaccination was not reported. The patient received her first shingrix dose and the patient presented to the pharmacy on the day of reporting for second shingrix dose, however the patient was complaining of nerve pain. The patient had not seen her health care professional but was suspecting that might be developing a case of shingles due to type of pain she was experiencing again. No diagnoses by health care professional, just suspected by patient to be shingles. Upon transfer to second line specialist, the reporter added that the patient had a history of multiple shingles episodes so the patient's physician had a prescription on file for Valtrex that the patient could fill as needed. The patient felt the nerve pain on her back, so she had not been able to verify whether a rash was present because the pain was in an area she could not see. No further details provided at the time of the call. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: received Shingrix second dose less than 0.5ml; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate dose of vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix second dose less than 0.5ml, which led to inappropriate dose of vaccine administered. The reporter did not know any information about the patient and the vaccine involved. The reporter did not consent to follow-up.