chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; get them yearly in the same spot on my back on the side I got the shot on; This case was reported by a consumer via 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 the patient himself or herself. The age at vaccination was not reported. The patient got Shingles vaccine and got shingles yearly in the same spot on his/her back and on the side of shot. The patient took vaccine as doctor had insisted. 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. For 1st occurrence of shingles after receiving Shingles vaccine refer linked case US2021AMR170517, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170517:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got a severe case of shingles; Very painful; This case was reported by a consumer via 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that, no more vaccine, he/she got a severe case of shingles 3 months later .  No kind of pain medication took by patient, but very painful.  The patient stated that, hope he/she did not get it again.  The doctor tried to talk to patient into getting the new vaccine, he/she said hell no. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Illness
Clinical narrative: became "really sick."; This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, 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 Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported. The reporter stated that, the patient received the Shingrix vaccine and the flu (unknown manufacturer) vaccine and became really sick. No patient identifiers were provided. The reporter did not consent to follow up.  The reporter declined to provide health care professional information. This is US2021170654 linked  case, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170654:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: felt achy; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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, less than a month after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received the second dose of Shingrix couple of weeks ago and since then felt achy.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed a very mild shingles infection; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got both the shots and had very mild shingles. The patient enquired that he/she can't get it again and was there any need to repeat the shot. 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: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; they are the worst; pain; just want to feel back to normal; This case was reported by a consumer via 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, pain and feeling abnormal. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the dose of Shingles vaccine and patient experienced shingles. The reporter stated that the patient had been dealing with the pain for almost three months till reporting date and patient got vaccine for them. The reporter stated that he/she just wanted to feel back to normal, they were worst. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: people /got the shot and/ got /shingles\ Suspected Vaccination failure; got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks 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 age at vaccination was not applicable for this report. The patients got Shingles shot and several weeks later got the 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: M
Vaccine: VARZOS
Symptoms: Blood bilirubin increased
Clinical narrative: Second dose / (8-12-2021) / total bilirubin was 2.2 today (8-13-2021); This case was reported by a consumer via call center representative and described the occurrence of bilirubin total increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blood bilirubin increased (1st dose received in June 2021 and total bilirubin was 1.7 in June, refer case US2021171387).   On 12th August 2021, the patient received the 2nd dose of Shingrix. On 13th August 2021, 1 days after receiving Shingrix, the patient experienced bilirubin total increased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bilirubin total increased was unknown.   It was unknown if the reporter considered the bilirubin total increased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself. The age at vaccination was not reported. On 13th August 2021, the patient's total bilirubin was 2.2. The limited demographics and details obtained, due to reporter disconnecting call abruptly after being told that they would not receive a copy of the adverse event report and definitive confirmation of whether Shingrix caused the increased total bilirubin. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021171387:Same reporter.
Sex: U
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Two patients / completed / series / younger than / preferred age; Series was repeated / received / four doses; Two patients / completed / series / younger than / preferred age; Series was repeated / received / four doses; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 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, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 2nd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 3rd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 4th dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, extra dose administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, extra dose administered, inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The physician stated that, the patients who completed the series at a different practice were younger than the centers for disease control and prevention preferred age range of 16-18, which led to inappropriate age at vaccine administered. And the series was repeated to ensure maximum protection during peak risk ages, which led to extra dose administered. The patients received a total of four doses. The reporter consented to follow up. The physician did not have additional patient details at the time of reporting, but she does provide permission for safety to follow up via email if additional details were needed. This is 2 of the 2 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021171388:Same reporter. Pt 1 of 2.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Got shingles in October 2020; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2020, less than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix in 2019. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter agreed to follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site injury, Injection site pain
Clinical narrative: A lot of pain / where / injection was administered; Nickel-sized depression / where / injection was administered; This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In April 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain and injection site injury. On an unknown date, the outcome of the injection site pain and injection site injury were unknown.   It was unknown if the reporter considered the injection site pain and injection site injury to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. In February 2021, the patient received 1st dose of Shingrix. There was no issues reported with first dose. The patient experienced a lot of pain and small nickel-sized depression developed in the deltoid where the injection was administered. The reporter asked if there had been any reports of this with the vaccine and if so,the deltoids of those patients returned to normal.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rash
Clinical narrative: my whole left back torso broke out.; Not 2 nd booster for Me; This case was reported by a consumer and described the occurrence of skin breakout in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 3 little scars). Previously administered products included Steroid.   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 not applicable after receiving Shingles vaccine, the patient experienced skin breakout and incomplete course of vaccination. On an unknown date, the outcome of the skin breakout and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the skin breakout 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 applicable for this report for 2nd dose. The patient received Shingles vaccine and whole left back, torso broke out. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd Shingle shot; This case was reported by a consumer via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, the patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Gastrointestinal disorder
Clinical narrative: gastro issues; light headed; This case was reported by a consumer and described the occurrence of gastrointestinal disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th August 2021, the patient received Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced gastrointestinal disorder and light headedness. On an unknown date, the outcome of the gastrointestinal disorder and light headedness were not recovered/not resolved.   It was unknown if the reporter considered the gastrointestinal disorder and light headedness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingrix vaccine and experienced gastro issues and light headed. The patient wanted to know how long would this last. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: TDAP
Symptoms: Illness
Clinical narrative: got very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Tdap Vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received TDAP several years ago and would never again. The patient got very sick for several days. The follow up would not be possible as no contact details were available. This case is linked to the case US2021AMR172350, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172350:Same reporter
Sex: M
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: My son / seizures after a DPT shot; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   The reporter considered the seizure to be related to DTPa vaccine.  Additional details were provided as follows: The patient was the reporter's son. The age at vaccination was not reported. The patient started having seizures after a DPT shot. The doctor said it was the pertussis part that did it. The reporter further mentioned that after that incident, the patient and the rest of the reporter's kids received only DT shots without the pertussis.
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Activities of daily living impaired; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the activities of daily living impaired to be related to Tdap Vaccine.  Additional details were reported as follows: The reporter reported for lady patient. The age at vaccination was not reported. A patient took the vaccine and had to be out of work a week and see her doctor.  They were given by the local health department. The follow up would not be possible as no contact details were available. This case is linked to the case US2021AMR172337, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172337:Same reporter
Sex: M
Vaccine: MEN
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Terrible reaction / swollen arm; Arm / red; Hot to touch; Arm / very sore; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of swelling arm in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced swelling arm, erythema, feeling hot and pain in arm. On an unknown date, the outcome of the swelling arm, erythema, feeling hot and pain in arm were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema, feeling hot and pain in arm to be related to Meningococcal B vaccine.  Additional details were reported as follows: This case was reported by the patient parent for his son. The age at vaccination was not reported. The patient received MenB vaccine and had terrible reaction to it swollen arm, red, hot to touch and very sore for over a week.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Have them now. Second time; This case was reported by a consumer via 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 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 patient had reported for him/herself. The age at vaccination was not reported. The patient stated that the patient had Shingles at the time of reporting. It was second time and was vaccinated. 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 were not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Severe case of Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient was the reporter's sister. The age at vaccination was not reported. After receiving both the doses of Shingles vaccine, the patient was suffering from severe case of shingles at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; she got it again; very painful; This case was reported by a consumer via media  and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows The patient was the reporter's stepmother. The age at vaccination was not reported. The patient got the vaccine after getting the shingles low and behold, she got it again. The reporter stated it was very painful. 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 were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Quarantine, Vaccination failure
Clinical narrative: Suspected vaccination failure; All / got Shingles; Quarantine from the rest of us; 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 quarantine. On an unknown date, the outcome of the vaccination failure, shingles and quarantine were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and quarantine to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not applicable. The reporter stated that, all who took Shingles shot got shingles and was quarantine from the rest of them. When it was aksed to the patient if he/she would like the shot, the patient said no. 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 were 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 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, 90 days 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 reported this case for him/herself. The age at vaccination was not reported. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles in the mouth; This case was reported by a consumer via 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 was the reporter's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles in the mouth. 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 were not provided. This case has been linked with case US2021AMR077206, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077206:Same reporter
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 case was reported by the patient himself/herself. The age at vaccination was not reported. The patient got the shingles shot and still got shingles. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot/ still got shingles/suspected vaccination failure; got 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, less than a year 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 reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had the shot last fall but still just had shingles.  The patient had shingles and said that they were not fun, also it was not a guarantee. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Illness, Pyrexia
Clinical narrative: Sick; Fever; Chills; Arm was hot; Arm was /red; This case was reported by a consumer 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, chills, extremities hot feeling of and erythema of extremities. On an unknown date, the outcome of the sickness, fever, chills, extremities hot feeling of and erythema of extremities were unknown.   It was unknown if the reporter considered the sickness, fever, chills, extremities hot feeling of and erythema of extremities to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that patient received shingles vaccines and felt sick too,fever,chills, arm was hot and red. This case is linked to the case US2021AMR158035,reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR158035:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shot doesn't / work/ Suspected Vaccination failure; shot doesn't / work; 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 was a living proof of the Shingles shot as did not always work. 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 follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got a shingles shot / ended up getting the shingles!/Suspected Vaccination failure; Shingles! / twice; 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 are as follows: The case was reported by patient's sister. The age at vaccination was not reported. The patient got a Shingles shot and she ended up getting the shingles. Not once, but twice. The reporter reported that the patient's doctor had recommended one. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure/had the two dose vaccine / still had occurrences/ won't stop them; still had occurrences/ won't stop 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (have had repeated episodes of shingles).   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 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 and Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The case was reported by patient himself/herself. The patient have had repeated episodes of shingles and had received two doses of Shingles vaccine and still had occurrences. It would not stop them, might lessen the effects in some people but definitely would not eliminate the chance. This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with case US2021AMR172857 by same reporter. Follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172857:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got 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.   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: The age at vaccination was not reported. It was reported that the patient got two shots, and still experienced shingles. The case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not given.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed a shingles; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days 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 reported as follows: The reporter reported this case for her aunt. The age at vaccination was not reported. The reporter reported that the patient paid for shingles shot and developed shingles after few days later. The reporter reported that the patient never got a refund. The reporter reported that chances are if you don't get the shot, you probably won't get them. This case is linked to the case US2021AMR172883, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172883:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose given 10 days early; This case was reported by a other health professional via interactive digital media and described the occurrence of drug dose administration interval too short in a 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.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   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 reported as follows: The age at vaccination was not reported. The reporter stated that had they had a client who walked in for the 2nd dose of Bexsero vaccine. After receiving a vaccine it was informed first dose was administered 20 days ago (so the second dose was given 10 days early),which led to drug dose administration interval too short. The reporter wanted to know was there anything that they should be aware of.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shot /ended up getting 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 Shingles shot and still ended up 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 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: 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, less than 9 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: The age at vaccination was not reported. The patient received the shingles the shot this year and experienced shingles for two weeks. This case was considered as suspected vaccination failure since the details regarding completion of primary schedule and laboratory confirmation was not known.
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Post herpetic neuralgia
Clinical narrative: shingles; painful; neuropathy pain; This case was reported by a consumer 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, unknown after receiving Shingles vaccine, the patient experienced shingles, pain and post herpetic neuralgia. On an unknown date, the outcome of the shingles and pain were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and post herpetic neuralgia 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 took the first vaccine but got shingles. They were painful but probably could have been worse if the patient had not been vaccinated.  The patient reported that the bad part was that they sometimes return in other places and the patient had painful neuropathy.  The patient reported that, he/she received both dose of latest Shingles vaccine, but the neuropathy pain stayed with him/her. The patient was not sure if it would ever go away.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR173031:Same reporter