chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took both Shingrix last year, got a mild case of Shingles this year (a year later)/suspected vaccination failure; Got a mild case of Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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, 1 year 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 Information: GSK receipt date: 03-Sept-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient took both Shingrix vaccinations (shots) last year (in 2021) and got a mild case of shingles this year (a year later). Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of 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, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had both shots, got shingles/Suspected vaccination failure; Shingles/got shingles 3 months ago; Very painful; This case was reported by a contact via interactive digital media and described the occurrence of 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, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 04-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots and got shingles 3 months ago (in 2022), very painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of 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, VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/had shingles 4 times, also had the shingles shot 4 times; had shingles 4 times; had shingles shot 4 times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 4th dose of Shingles vaccine, the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were 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, Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 03-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shingles shot 4 times and have had shingles for 4 times. The patient was not one of the lucky ones. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Baes upon the narrative, 4 suspects were coded considering all 4 were potential GSK product and linked with events accordingly.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the vaccine and still got shingles/Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK receipt date: 05-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine and still got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and today I have shingles/Suspected vaccination failure; I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 5th September 2022, 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 Information: GSK receipt date: 05-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot and on the day of reporting he/she had shingles so it was not a shul. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got it after both shingrix doses/Suspected vaccination failure; Got it in arm; Hurts like a bugger; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), 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 Shingrix and Shingrix.     Additional Information: GSK receipt date: 05-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got them in his/her arm after getting both Shingrix vaccines. The patient stated that hurts like a bugger but could be much worse. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of 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, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I tuck two shots and then shingles/suspected vaccination failure; Bad case of Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK receipt date: 05-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took two shots and then had a bad case of shingles. The patient so stated that he/she thought their shots were worthless. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome, Therapeutic response unexpected
Clinical narrative: received shingles shot and died; received shingles shot and it triggered GBS; had cancer, received shingles shot, cancer free; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included cancer.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and unexpected therapeutic effect. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the guillain barre syndrome and unexpected therapeutic effect were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death and unexpected therapeutic effect to be related to Shingles vaccine. The reporter considered the guillain barre syndrome to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-SEP-2022 Reporter's comment: The patient's relative reported this case via interactive digital media. The reporter reported that the patient received Shingles shot and it triggered GBS (Guillain Barre syndrome) and he died cancer free. Additional supportive information: The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: redness and swelling at the injection site.; swelling at the injection site; upset stomach; Headache; low-grade fever of 100; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, upset stomach, headache and low grade fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, upset stomach, headache and low grade fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, upset stomach, headache and low grade fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter wife got her second dose of Shingrix the day before reporting. The reporter wife had redness and swelling at the injection site, upset stomach, headache and low-grade fever of 100.  The reporter wanted to know how long these adverse effects would last. Additional supportive information: The follow-up could not be possible as no contact details were available. This case has been linked to the case US2022AMR124918 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR124918:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: soreness at injection site; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced injection site pain and headache. On an unknown date, the outcome of the injection site pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Aug-2022 Reporter's Comment:  The reporter was husband. The patient received the second dose of Shingrix vaccine on yesterday. The reporter stated that the patient was experiencing raised soreness at injection site and headache. The reporter want to know how long these adverse events would last. The reporter consent to follow up. Additional Supportive Information:  This case had been linked with US2022124934, reported by same reporter.; Sender's Comments:  US-GSK-US2022124934:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Cough
Clinical narrative: Painful coughing; debilitating side effect; This case was reported by a consumer via interactive digital media and described the occurrence of painful cough in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included soy allergy.   In August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced painful cough and debility. On an unknown date, the outcome of the painful cough was not recovered/not resolved and the outcome of the debility was unknown.   It was unknown if the reporter considered the painful cough and debility to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comment: This case was received from patient via interactive digital media. The patient received the Shingrix 1st dose on 3 days ago from reporting and had debilitating side effect, the patient stated that all but one were included on GSK list and in addition the patient was struggling with painful coughing which usually happens when the patient exposed to soy products. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Dermatitis contact, Rash
Clinical narrative: Poison ivy; has experienced a rash on her elbows/ she developed rash somewhere in the middle after 1st dose not just arm all over body; This case was reported by a consumer via call center representative and described the occurrence of poison ivy rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced poison ivy rash and generalized rash. The patient was treated with prednisone. On an unknown date, the outcome of the poison ivy rash and generalized rash were unknown.   It was unknown if the reporter considered the poison ivy rash and generalized rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022125564, US2022125565   Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's comments: The patient had reported that she had got her 1st dose of Shingrix on May 2022. The patient said that she had developed rash somewhere in the middle after 1st dose on her elbow, not just arm, but all over the body and had no clue if it was due to shingles. Elbow first and was treated for poison ivy with prednisone and topical did not go away. Also a biopsy was done. No other details were available. The reporter had consented to follow-up. Additional supportive information: For Tolerance of 2nd dose refer case US2022125564.; Sender's Comments:  US-GSK-US2022125565:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles, single line under left breast, 2 days later; Painful; Rash; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles, pain and rash. On an unknown date, the outcome of the shingles, pain and rash were unknown.   It was unknown if the reporter considered the shingles, pain and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingrix vaccine. The reporter stated that after 2 days received Shingrix vaccine the patient experienced rash and Shingles appears in a single line under left breast and it was painful. The patient asked she/he wanted to know she had shingles and how long the shingles last. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 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 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 Information: GSK Receipt Date: 28-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient just got his/her final shingles shot. The patient had experienced hurt like hell but was glad he/she had done. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Chest Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got reaction from shingles vaccine.  The patient got chest rash. The patient asked if he/she was allergic to shingles vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain getting worse; This case was reported by a consumer via interactive digital media and described the occurrence of exacerbation of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles during the 2 weeks to flatten the curve). Concurrent medical conditions included pain (still had).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced exacerbation of pain. On an unknown date, the outcome of the exacerbation of pain was not recovered/not resolved.   It was unknown if the reporter considered the exacerbation of pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had been vaccinated for shingles now, but he/she was starting to feel like the pain was getting worse.  The patient stated that, hope shingles was not coming back. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Up at midnight, over 104 fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine (On an unknown date 1st dose received.).   On 26th August 2022, the patient received the 2nd dose of Shingles vaccine. On 26th August 2022, less than a day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK receipt date :27-AUG-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received shingle vaccine and was up at midnight with over 104 degree F fever it was horrible. The patient stated that he heard that shingles was very painful, so he/she got his/her shingles vaccine. Additional Supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced difficulty breathing. On an unknown date, the outcome of the difficulty breathing was not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine. The reporter stated that after received Shingles vaccine the patient experienced difficulty breathing. The patient asked to the agent that how long the difficulty breathing last. The agent advised to patient if you are having difficulty breathing then contact your health care provider. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: given past the expiration date; This case was reported by a nurse and described the occurrence of expired vaccine used in a adult female patient who received HAB (Twinrix) (batch number unknown, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 29th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-AUG-2022 Reporter's comment: The patient was 47 years old. The nurse asked that she would like to know the recommendations if a Twinrix vaccine was given past the expiration date.  The reported request for advise. The reporter consented to follow up. Additional supportive information: The patient had received an expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: administration of products since onset of temperature excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in an unspecified number of patients 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.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comments: The health care professional (HCP) called for evaluation of temperature excursion and reported the administration of other company products that were administered since onset of excursion on 10th August 2022,  IPOL (Sanofi) and Bexsero (GlaxoSmithKline).  The reporter reported that they just discovered excursion on the day of reporting. No further information, additional adverse events and product quality complaint were provided. Additional supportive information: The vaccine was administered after temperature excursion of Bexsero to the patients, which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Rash pustular
Clinical narrative: bumps, pussy; small red bumps; small red bumps; chicken pox; rash, small red bumps, ankles and feet; itching around both ankles and tops of both feet; This case was reported by a consumer and described the occurrence of chickenpox in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox).   On 22nd July 2022, the patient received the 1st dose of Shingrix. On 25th July 2022, 3 days after receiving Shingrix, the patient experienced chickenpox, rash, pruritus, papular rash and red rash. On 26th July 2022, the patient experienced pustular rash. On an unknown date, the outcome of the chickenpox, rash, pruritus, pustular rash, papular rash and red rash were unknown.   It was unknown if the reporter considered the chickenpox, rash, pruritus, pustular rash, papular rash and red rash to be related to Shingrix.     Additional Information: GSK receipt date: 31-Aug--2022 Reporters comment:  The patient developed a rash (small red bumps) and itching around both ankles and tops of both feet.  The next day, the patient emailed his/her doctor because some of those bumps had grown and looked a bit pussy. The  doctor said he/she had chicken pox and should quarantine until the bumps were not pussy. What she could not tell him/her was whether should get the second dose of the Shigrix vaccine. Chicken pox was not listed as a possible side effect of the vaccine and yet had them. The reporter attached pictures at the end. The reporter wanted to know did the first dose had the desired effect. Should attempt to get the second dose with the possibility that he/she would develop chicken pox again and need to quarantine.     .
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: bumps, pussy; small red bumps; small red bumps; chicken pox; rash, small red bumps, ankles and feet; itching around both ankles and tops of both feet; This case was reported by a consumer and described the occurrence of chickenpox in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox).   On 22nd July 2022, the patient received the 1st dose of Shingrix. On 25th July 2022, 3 days after receiving Shingrix, the patient experienced chickenpox, rash, pruritus, papular rash and red rash. On 26th July 2022, the patient experienced pustular rash. On an unknown date, the outcome of the chickenpox, rash, pruritus, pustular rash, papular rash and red rash were unknown.   It was unknown if the reporter considered the chickenpox, rash, pruritus, pustular rash, papular rash and red rash to be related to Shingrix.     Additional Information: GSK receipt date: 31-Aug--2022 Reporters comment:  The patient developed a rash (small red bumps) and itching around both ankles and tops of both feet.  The next day, the patient emailed his/her doctor because some of those bumps had grown and looked a bit pussy. The  doctor said he/she had chicken pox and should quarantine until the bumps were not pussy. What she could not tell him/her was whether should get the second dose of the Shigrix vaccine. Chicken pox was not listed as a possible side effect of the vaccine and yet had them. The reporter attached pictures at the end. The reporter wanted to know did the first dose had the desired effect. Should attempt to get the second dose with the possibility that he/she would develop chicken pox again and need to quarantine.     .
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pruritus
Clinical narrative: Shoulder ache; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient got over acute shingles about a year ago after losing 2 months out of his/her life). Concurrent medical conditions included pruritus (the patient had some minor itching at times).   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 shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.  Linked case(s) involving the same patient:US2022AMR127392   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient still had some minor itching at times. About a month after the acute phase he/she got the first shingles vaccination.  The patient stated that, all the vaccinations he/she had for overseas travel, etc.  The patient stated that, it was the worst. The patient took about 2 weeks before his/her shoulder did not ache.  The patient stated that, still far better than getting shingles. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR127392; Sender's Comments:  US-GSK-US2022AMR127392:2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Slight sore arm; 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.   Previously administered products included Shingrix (1st dose received 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingles vaccine and experienced only a slight sore arm. The patient highly recommended this vaccine to all those 50 and older. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Lymph node pain
Clinical narrative: Lymph node tenderness; This case was reported by a consumer via interactive digital media and described the occurrence of lymph node tenderness 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 lymph node tenderness. On an unknown date, the outcome of the lymph node tenderness was unknown.   It was unknown if the reporter considered the lymph node tenderness to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter asked if lymph node tenderness was a side of Shingrix vaccine. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comments: This case was received from consumer vi interactive digital media. The reporter just wanted to know if he/she allowed to take ibuprofen after his/her Shingrix shot for the soreness in arm. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: accidentally gave Shingrix subcutaneously; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter reported this case via interactive digital media. The patient accidentally received the dose of Shingrix subcutaneously. The reporter asked what would they need to watch the patient for. Additional supportive information: The patient accidentally received the dose of Shingrix subcutaneously, which led to Intramuscular formulation administered by other route.  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Vaccine positive rechallenge
Clinical narrative: Shoulder ache, second shot, and it was even worse; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient got over acute shingles about a year ago after losing 2 months out of his/her life). Previously administered products included Shingles vaccine with an associated reaction of arthralgia (Received 1st dose on an unknown date, for tolerance of 1st dose, refer case US2022AMR127330). Concurrent medical conditions included pruritus (the patient had some minor itching at times).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced shoulder pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR127330   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient still had some minor itching at times. The patient stated that, all the vaccinations he/she had for overseas travel, etc.  The patient experienced shoulder pain again after 2nd dose.  The patient stated that he/she waited 6 months for the second shot of shingles vaccine and it was even worse. The patient stated that, still far better than getting shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR127330:1st dose
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site pain
Clinical narrative: Pain at injection site; severe Stomach pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 592RY, expiry date 31st August 2023) and (batch number 5392T, expiry date 31st August 2023) for prophylaxis.   On 16th June 2022, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In June 2022, less than a day after receiving Shingrix, the patient experienced stomach pain. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and stomach pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain and stomach pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022126895   Additional Information: GSK Receipt Date: 01-SEP-2022 and 02-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced pain at the injection site and stomach pain. Less than a day after vaccination the patient experinced stomach pain.  The patient reported stomach pain began in the middle of the night and lasted approximately 3 days. The reporter consented to follow-up. For tolerance of 2nd dose refer case US2022126895; Sender's Comments:  US-GSK-US2022126895:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter just wanted to know if he/she allowed to take ibuprofen after his/her Shingrix shot for the soreness in arm. The follow-up could not be possible as no contact details were available.
Age: 15.0
Sex: U
Vaccine: HEPAB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 YO patient got TWINRIX in error; This case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 15-year-old patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter reported that, a 15 year old patient got Twinrix in error when the recommended age was 18 years and older.  No additional adverse event reported.  No PQC (Product quality complaint) was reported.  No further information was provided. Additional Supportive Information: The reporter reported that, a 15 year old patient got Twinrix in error when the recommended age is 18 years and older, which led to inappropriate age at vaccine administration.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: Kinrix mixed up with another vaccine; Kinrix mixed up with another vaccine; received Kinrix, child is 11 years old; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The reporter reported that the 11 years old patient received Kinrix vaccine which was mixed up with another vaccine and it was outside the indication. No adverse reaction occurred, just need to know what to be done. The reporter agrees to follow up from GlaxoSmithKline. Additional supportive information: The reporter gave Kinrix vaccine mixed up with another vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter reported that 11 years patient received Kinrix vaccine which is out of recommended age, which led to Inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Injection site pruritus, Injection site reaction, Rash vesicular
Clinical narrative: vesicular lesions at the site of injection; Lesions were uncomfortable; lesion, pruritic; lesion, mildly painful, stinging sensation; vesicular lesions at the site of injection; This case was reported by a physician and described the occurrence of injection site reaction in a adult 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, 2 weeks after receiving Shingrix, the patient experienced injection site reaction, injection site discomfort, injection site pruritus, injection site pain and vesicular eruption. On an unknown date, the outcome of the injection site reaction, injection site discomfort, injection site pruritus, injection site pain and vesicular eruption were recovered/resolved.   It was unknown if the reporter considered the injection site reaction, injection site discomfort, injection site pruritus, injection site pain and vesicular eruption to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR127528   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's comment: The patient received Shingrix vaccine and approximately 2 weeks after the vaccination experienced vesicular lesions at the site of injection. The lesions were uncomfortable (pruritic and mildly painful and had stinging sensation). After the 1st dose of shingles it took more than 2 weeks for the lesions to fully resolved. The reporter consented to follow-up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR127528; Sender's Comments:  US-GSK-US2022AMR127528:Same reporter