chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: itching on the arm; red patch below injection site; red patch below injection site and warm to touch; sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th January 2022, the patient received the 1st dose of Shingles vaccine. In January 2022, several hours after receiving Shingles vaccine, the patient experienced pruritus, skin red, skin warm and pain in arm. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the skin red, skin warm and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, skin red, skin warm and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had his/her shot yesterday (before the time of reporting).  Hours later, the patient started itching on the arm and also he/she now had a red patch on his/her skin below the injection site and warm to the touch. Itching went away at the time of reporting but the red patch was still there and sore arm.
Sex: M
Vaccine: MENB, MENB
Symptoms: Incomplete course of vaccination, Interchange of vaccine products
Clinical narrative: Should've received Bexsero, gave Trumenba; Incomplete course of vaccination; This case was reported by a other health professional via other manufacturer and described the occurrence of interchange of vaccine products in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   Previously administered products included Bexsero (1st dose received in January 2021).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 27th January 2022, the patient received TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products and incomplete course of vaccination. On an unknown date, the outcome of the interchange of vaccine products and incomplete course of vaccination 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 reported as follows: The age at vaccination was not applicable. The patient should receive his 2nd dose 1 month after 2nd dose, however he never came back. Till the timeof reporting, the patient did not receive 2nd dose of bexsero which led to incomplete course of vaccination. The day before reporting, the patient was administered Trumenba which led to interchange of vaccine products. The caller need information if patient 2nd dose of Trumenba or no further doses required as patient received 2 different product. The sufficient data not available regarding interchangibility. The 2 Men B vaccines were not iterchangable, the same vaccine must be used for all doses in series. The minimal interval between 2 doses of Men B was 4 weeks.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: getting over shingles and I had two shots/suspected vaccination failure; getting over shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was just getting over shingles and he/she had two shots.  The patient got the shot, then pharmacy told that the patient could still get shingles and the patient did but not as bad as it would had been because of the shots. It was still painful. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient was complaining about the pain when he/she received the first shot.  The patient said he/she still needed to get the second one in 6 months. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: should I still get my 2nd 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 (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had Shingrix 1st dose quite a while ago and till the time of reporting, the patient never received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: sore arm; red spot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and erythema. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient just got his/her second shingles shot. The patient only had a sore arm and a red spot as a reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: got my first shot, and it hurt; arm is killing me, very sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and pain in arm. On an unknown date, the outcome of the pain and pain in arm were unknown.   It was unknown if the reporter considered the pain and pain in arm 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 it hurt like hell his/her arm was killing him/her, very sore. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fear, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles around right eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shot, had shingles around patient's right eye and had the double shot at dollar 179 each of the two shots.  The patient stated that, it was scary stuff. 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 for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Suspected vaccination failure; but a light case; Shingles, flare ups; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (received first dose of Shingrix and experienced Shingles) and pain (received first dose of Shingrix and experienced Shingles pain).   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 suspected vaccination failure (serious criteria GSK medically significant), shingles, shingles and pain. On an unknown date, the outcome of the suspected vaccination failure, shingles, shingles and pain were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles and pain 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 stated nobody knows true pain until they have had a bad case of shingles. The patient was confined to apartment for 5 weeks by choice due to everyday pain. One year ago, this past September and for 1 year after, would have flare-ups. The patient never knowing when or where but the patient still consider him/herself one of the lucky ones as after that painful year, the patient had not had any more pain connected to shingles. The patient's doctor had told the patient some continue the rest of their lives. This was so sad to think it would be never ending and the patient pray for the many it happens too, so suggested people to receive 2 shots required, about 2 months between. The patient had 1st shot and then the patient kept putting off getting the 2nd shot, and the patient suffered. When the patient was able after, the other shot was the first place the patient went but sadly, the patient had it more than once, even with the required shots but a light case. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: both Shingrix in March2019; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In March 2019, the patient received the 2nd dose of Shingrix. In March 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix in March 2019. The patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter asked if needed booster dose.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; nerve pain/sensitivity; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and nerve pain. On an unknown date, the outcome of the suspected vaccination failure, shingles and nerve pain were unknown.   It was unknown if the reporter considered the suspected vaccination failure, shingles and nerve pain to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received two doses of Shingrix and experienced shingles and nerve pain/sensitivity. Consent to follow up was denied. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; This case was reported by a pharmacist via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   The reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed Bell's Palsy 3 to 4 days following receipt of first dose of Shingrix. The reporter thought this was related to Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Monocyte count increased
Clinical narrative: affect blood tests / high monocyte absolute reading; This case was reported by a consumer via interactive digital media and described the occurrence of monocyte count increased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced monocyte count increased. On an unknown date, the outcome of the monocyte count increased was unknown.   It was unknown if the reporter considered the monocyte count increased 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 dose of Shingrix vaccine and experienced affect blood tests and result in high monocyte absolute reading. The patient asked could Shingrix affect blood tests and result in high monocyte absolute reading. The follow-up would not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: minor aches; LOW FEVER; This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were unknown.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced minor aches and low fever. No further information reported. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swollen in my injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling 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 injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this report. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and only had swollen in his/her injection site. The follow-up could not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: refused to get 2nd shot, past a year; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year prior to the reporting date).   On an unknown date, the patients 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 reported as follows: The age at vaccination was not applicable for this report. The reporter had several patients who had chosen not to get their 2nd Shingrix shot in the appropriate time frame. Now it had even been past a year and till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked did we restart series, or just give just the 2nd dose if it had been over the year mark. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Abnormal behaviour, Personality disorder
Clinical narrative: personality and behaviour changes; behaviour changes; This case was reported by a consumer via call center representative and described the occurrence of personality disorder in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced personality disorder and behavior abnormal. On an unknown date, the outcome of the personality disorder and behavior abnormal were unknown.   It was unknown if the reporter considered the personality disorder and behavior abnormal to be related to Engerix B.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient asked if the patient discloses their mental health problems and the doctor did not warn of personality and behavior changes risks before giving the vaccine, it should be a material risk the doctor should warn of regarding Engerix B. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Pain
Clinical narrative: Abdominal cramping and pain; This case was reported by a consumer via interactive digital media and described the occurrence of abdominal cramp in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal pain (1st dose received on an unknown date, refer case US2022AMR019699).   On 1st February 2022, the patient received the 2nd dose of Shingrix. In February 2022, less than a day after receiving Shingrix, the patient experienced abdominal cramp. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the abdominal cramp was unknown.   It was unknown if the reporter considered the abdominal cramp to be related to Shingrix.  Linked case(s) involving the same patient: US2022AMR019699  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received his/her second dose of Shingrix a day before reporting. The side effects this time seem to be more severe than the first vaccine.  The abdominal cramping and pain was the most notable side effect. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR019699:same report, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I've had 2 doses but they were more than 6 months apart; This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 2 doses but they were more than 6 months apart, which led to drug dose administration interval too long.  The physician suggested that he/she did not need another while his/her family physician said had to start over. The reporter was asking if she/she need to start the series again. Follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed 2nd dose, 7 months after 1st; 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 (1st dose received seven months before).   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 to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient missed 2nd shot now by 7 months after 1st dose and asked if it was going to be okay. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I missed 2nd dose by 6 months from1st; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 6 month ago on an unknown date).   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 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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter had a question regarding shingles vaccine that 2nd dose was suppose to be by 6 months from 1st which he/she missed so now. The patient was at 7 months was that ok. The reporter would call hospital. The reporter did not feel comfortable to share the information.
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain
Clinical narrative: ear pain; This case was reported by a consumer via call center representative and described the occurrence of ear pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced ear pain. On an unknown date, the outcome of the ear pain was unknown.   It was unknown if the reporter considered the ear pain 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 dose of Shingrix vaccine and experienced ear pain. The patient asked was it somewhat common to had ear pain when getting a Shingrix vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Fever Blisters; This case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister 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 stated that he/she could still get fever blisters if he/she had got the Shingrix vaccine. The follow-up could not be possible as no contact details were available.
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 self-reported this case. The age at vaccination was not reported. The patient stated he/she got the vaccine and it gave him/her the shingles. The patient stated he/she would never take it again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First shingles shot in 2019, second 2-2-22; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st shot in 2019).   On 2nd February 2022, the patient received the 2nd dose of Shingles vaccine. On 2nd February 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient received a dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccination schedule. The reporter asked does that counts and that if he/she was protected. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Staphylococcal infection, Vaccination failure
Clinical narrative: suspected vaccination failure/had them 4 times, even with the Vax; shingles even with the Vax; painful; secondary infections like staph; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 times ).   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 staphylococcal infection. On an unknown date, the outcome of the vaccination failure, shingles, pain and staphylococcal infection were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and staphylococcal infection to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient had shingles 4 times, even with the Shingles vaccine. The shingles were very painful but did not itch. The patient stated that watch out for secondary infections like staph. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. Note: The event staphylococcal infection was conservatively capture as it was not clear if the patient had experienced this event or not after receiving vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles vaccine, got shingles later/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 self-reported this case.  The age at vaccination was not reported. The patient paid for Shingle vaccine and still got the shingles later and it was very mild case. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she had the shot and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles on left eye; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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), ophthalmic herpes zoster (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster 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 stated he/she got the shot for shingles and at the time of reporting had shingles on his/her left eye, it was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: patient requested administration in thigh / he planned to call the patient to schedule administration; patient requested administration in thigh / he planned to call the patient to schedule administration; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and vaccine administered at inappropriate site. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and vaccine administered at inappropriate site were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, they had a patient that only had one arm and he said he did not do well getting vaccines in his only arm. The reporter stated that, the patient requested administration in thigh.  At time of reporting, the Shingrix had not been administered to patient, but the reporter planned to call the patient to schedule administration, which was the circumstance or information capable of leading to medication error and if vaccine administered in thigh region, it would lead to vaccine administration at inappropriate site.
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: received Trumenba instead of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 27th December 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 28th January 2022, the patient received TRUMENBA. In January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient received inadvertently Trumenba instead of Bexsero as 2nd dose, which led to interchange of vaccine products. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Night blindness, Photopsia, Vision blurred, Visual impairment
Clinical narrative: Vision issue, not clear; Colorful strobe light in eye; vision is not good at night time; irritates her right eye; This case was reported by a consumer via call center representative and described the occurrence of visual disturbance in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2021, the patient received the 1st dose of Shingrix. In November 2021, 3 days after receiving Shingrix, the patient experienced visual disturbance, flashing lights, decreased night vision and eye irritation. On an unknown date, the outcome of the visual disturbance was recovering/resolving and the outcome of the flashing lights, decreased night vision and eye irritation were not recovered/not resolved.   It was unknown if the reporter considered the visual disturbance, flashing lights, decreased night vision and eye irritation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received first dose of Shingrix on the left arm from pharmacy. Three days after the vaccination, the patient had a vision issue, she described it as her vision in the right eye was not clear. The patient went to see her eye doctor to see if her retina was okay, the eye doctor informed that her retina was intact. Then the patient stated that the vision had gotten a little better, but still not back to how it was before the vaccination. Furthermore, the patient stated that the vision was not good at night time. The patient stated that at night, she felt like there was a strand of eye lash in the eye which irritates her right eye, also, she experienced a colorful strobe light effect in corner of right eye. The reporter did not have information about lot/expiry date, dose and route of administration. The reporter stated that she wrote a letter to GlaxoSmithKline via email which included the side effect she experienced. The reporter consented to follow-up with her healthcare professional; however, she did not have a fax number or email address to her healthcare professional. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Dry mouth, Dry throat, Fatigue, Feeling cold
Clinical narrative: injection site swelling; Soreness at the injection site; Chronic Headache / headache; fever of 99.9 F; dry eyes; dry throat; Dry mouth; Not really chills, but feels like I'm gonna have chills; fatigue; muscle pain; stiff neck; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2021).   On 28th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain, chronic headaches, fever, eye dryness, dry throat, dry mouth, feeling cold, fatigue, muscle pain and stiff neck. On an unknown date, the outcome of the injection site swelling, injection site pain, chronic headaches, fatigue, muscle pain and stiff neck were unknown and the outcome of the fever, eye dryness, dry throat, dry mouth and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, chronic headaches, fever, eye dryness, dry throat, dry mouth, feeling cold, fatigue, muscle pain and stiff neck 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 stated, for the Shingrix vaccine, she was on her second dose. The patient stated she was running a fever of 99.9 Fahrenheit, she experienced headache which started 11 hours after taking the vaccine, soreness at the injection site, swelling, stiff neck, chronic headache, muscle pain, fatigue, she did not really had chills, but felt like she was going to have chills. The patient also experienced dry mouth, dry throat, dry eyes but she was drinking and that was it.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: injection site swelling; Soreness at the injection site; Chronic Headache / headache; fever of 99.9 F; dry eyes; dry throat; Dry mouth; Not really chills, but feels like I'm gonna have chills; fatigue; muscle pain; stiff neck; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2021).   On 28th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain, chronic headaches, fever, eye dryness, dry throat, dry mouth, feeling cold, fatigue, muscle pain and stiff neck. On an unknown date, the outcome of the injection site swelling, injection site pain, chronic headaches, fatigue, muscle pain and stiff neck were unknown and the outcome of the fever, eye dryness, dry throat, dry mouth and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, chronic headaches, fever, eye dryness, dry throat, dry mouth, feeling cold, fatigue, muscle pain and stiff neck 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 stated, for the Shingrix vaccine, she was on her second dose. The patient stated she was running a fever of 99.9 Fahrenheit, she experienced headache which started 11 hours after taking the vaccine, soreness at the injection site, swelling, stiff neck, chronic headache, muscle pain, fatigue, she did not really had chills, but felt like she was going to have chills. The patient also experienced dry mouth, dry throat, dry eyes but she was drinking and that was it.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: injection site swelling; Soreness at the injection site; Chronic Headache / headache; fever of 99.9 F; dry eyes; dry throat; Dry mouth; Not really chills, but feels like I'm gonna have chills; fatigue; muscle pain; stiff neck; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2021).   On 28th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain, chronic headaches, fever, eye dryness, dry throat, dry mouth, feeling cold, fatigue, muscle pain and stiff neck. On an unknown date, the outcome of the injection site swelling, injection site pain, chronic headaches, fatigue, muscle pain and stiff neck were unknown and the outcome of the fever, eye dryness, dry throat, dry mouth and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, chronic headaches, fever, eye dryness, dry throat, dry mouth, feeling cold, fatigue, muscle pain and stiff neck 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 stated, for the Shingrix vaccine, she was on her second dose. The patient stated she was running a fever of 99.9 Fahrenheit, she experienced headache which started 11 hours after taking the vaccine, soreness at the injection site, swelling, stiff neck, chronic headache, muscle pain, fatigue, she did not really had chills, but felt like she was going to have chills. The patient also experienced dry mouth, dry throat, dry eyes but she was drinking and that was it.  The reporter consented to follow up.