chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second shot; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 1 year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comments: The reporter was a  healthcare provider. A patient received first dose of Shingrix and never got the 2nd dose. The reporter asked should they start the 2 dose series over. The reporter stated that he/she would not like to disclose more than at this time. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: have all these side effects: pain at the injection site; have all these side effects: swelling at the injection site; have all these side effects: redness at the injection site; have all these side effects: muscle pain; have all these side effects: tiredness; have all these side effects: shivering; have all these side effects: headache; have all these side effects: fever; have all these side effects: upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2022, the patient received the 2nd dose of Shingrix. In April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, shivering, headache, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, shivering, headache, fever and upset stomach were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, shivering, headache, fever and upset stomach to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had Shingrix vaccine last night. The patient had all these common side effects were pain, redness , swelling at injection site, muscle pain, tiredness, headache, fever, shivering, upset stomach. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: have all these side effects: pain at the injection site; have all these side effects: swelling at the injection site; have all these side effects: redness at the injection site; have all these side effects: muscle pain; have all these side effects: tiredness; have all these side effects: shivering; have all these side effects: headache; have all these side effects: fever; have all these side effects: upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2022, the patient received the 2nd dose of Shingrix. In April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, shivering, headache, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, shivering, headache, fever and upset stomach were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, muscle pain, tiredness, shivering, headache, fever and upset stomach to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had Shingrix vaccine last night. The patient had all these common side effects were pain, redness , swelling at injection site, muscle pain, tiredness, headache, fever, shivering, upset stomach. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and she got shingles twice/Suspected vaccination failure; Got shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Apr-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient got the vaccine and then she got shingles twice. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR071761, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR071761:Same reporter.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Movement disorder, Pain
Clinical narrative: difficulty moving arms; painful; This case was reported by a consumer via interactive digital media and described the occurrence of movement disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE (TRADE NAME UNKNOWN)) for prophylaxis.   On 28th April 2022, the patient received Shingles vaccine and PNEUMONIA VACCINE (TRADE NAME UNKNOWN). On 28th April 2022, less than a day after receiving Shingles vaccine, the patient experienced movement disorder and pain. On an unknown date, the outcome of the movement disorder and pain were unknown.   It was unknown if the reporter considered the movement disorder and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media The patient received shingles shot and pneumonia shot on reporting day. Now he/she was having difficulty in moving arm and very painful. Additional Supportive Information:Less than a day, after receiving pneumonia shot , the patient experienced mobility decreased and pain. It was unknown if reporter considered mobility decreased and pain to be related to pneumonia shot. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Got it in her eyes from the shot/Suspected vaccination failure; Got it in her eyes; Losing her sight, something similar to macular degeneration; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and loss of vision (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and loss of vision were not recovered/not resolved.   The reporter considered the vaccination failure, ophthalmic herpes zoster and loss of vision to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: This case was received from patient's parent via interactive digital media. The patient got shingles in her eyes from the stinking shingle shot and she was losing her sight. The patient now had something similar to macular degeneration.  The patient had been getting injections in both eyes to stop it (over 2 years now) but it was not helping. The reporter stated that of course, patient could not get help with the cost of trying to save her sight. Additional Supportive Information: 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, Pain
Clinical narrative: TOOK SHINGLES ANYWAYS; hurt me so bad; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient reported that shingles hurt so bad. The patient got the 1st shingles shot and took shingles anyways. The patient heard that the 2nd shot would better and need to get it.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  It was reported that, for additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  For additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  It was reported that, for additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  It was reported that, for additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  It was reported that, for additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Herpes zoster, Vaccination failure
Clinical narrative: Got vaccine & still got Shingles/Suspected vaccination failure; Bells Palsy; Got Shingles on right-side of my face and head; 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), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, bell's palsy and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, bell's palsy and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got shingles vaccine and still got shingles on right-side of his/her face and head along with bell's palsy. Additional Supportive Information: 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 possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Have another round 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.   The patient's past medical history included shingles (had 4 rounds of internal shingles since 2019).   On an unknown date, the patient received Shingles vaccine. In April 2022, less than 2 years 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: 28-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got the Shingrix vaccines last year from the reporting date and now, had another round of shingles, it was very miserable. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: multiple outbreaks of shingles, had 3 Shingrex vaccines; shingles; had 3 Shingrex vaccines; 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 and Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, Shingrix and Shingrix, 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, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient requested Glaxosmithkline (GSK) to do more research and develop a vaccine that works for the immune compromised. The patient reported that this was such a terrible infection.  The patient too had multiple outbreaks of shingles. The patient had 3 Shingrix vaccines and was very thankful because he/she knew that it had lessened severity but keep working to find maybe a MAB that could work better for the huge group of immune compromised.  The patient thanked heaven to had this now.  Additional Supportive Information: The patient received 3 doses of Shingrix vaccine, which led to extra dose administered. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got over a case of these, got the vaccine years ago/Suspected vaccination failure; agonizing pain, painful; got a case of these, on hip and stomach; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingles vaccine years ago.  The patient guessed that, shingles would have been worse without it.  The patient experienced agonizing pain.  The patient had shingles on his/her hip and part of his/her stomach.  The patient stated that, shingles lasted for 3 weeks and they were really painful. The patient stated that, just got over a case of these shingles.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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: Hypersensitivity
Clinical narrative: severe allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 documented times starting at Age 6), cancer and shingles (had after cancer treatment). Previously administered products included Covid vaccine with an associated reaction of hypersensitivity (received first and only Covid Vaccine on 26th April 2021 and had a severe allergic Reaction to it).   On 20th April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient's medical history included severe allergic reaction to the 1st and only Covid Vaccine. The Doctors and Allergist said the patient could not have any More, it would be a Medical Liability if they gave him/her any more. The patient had shingles 4 documented times starting at Age 6, the next time after cancer treatment. The patient stated that they had a medication to Shorten the life shingles but must start it right away, pure Lavender oil helps the symptoms. The patient had first shot of the Shingles Vaccine on 20th April 2022 and had a severe allergic reaction to the vaccine, to it's Ingredients and could not have the 2nd shot; the patient further stated not everyone can get vaccinated because of medical reasons. The patient stated he/she would get fully vaccinated if he/she could but doctors did not want to give him/her anymore vaccinations because of the severity of his/her allergic reactions to them. The patient stated it was not always the patient's choice but a matter of Safety and medical liability. The patient just stays at home and mask up when in public situations.  Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: rash which would clear up and then reappear on different parts; pain at the injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th April 2022, the patient received the 1st dose of Shingrix. On 5th April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 6th April 2022, the patient experienced injection site erythema. On 19th April 2022, the patient experienced rash. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: Reporter was patient who called in to get more information on Shingrix side effects.  The patient received her first dose of Shingrix and that same day after vaccination she experienced some pain at the injection site which lasted 2 to 3 days and resolved.  The following day, the patient noticed redness at injection site and that lasted a week and had resolved.  Patient noted that 2 weeks post vaccination she began to develop a rash which would clear up and then reappear on different parts of her body.  She noted it appeared initially on her stomach, then behind her knee and now arm.  The rash had not resolved.  Provided medical advise disclaimer.  Provided info per package insert (PI) on side effects. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number X2E93, expiry date 6th May 2023) for prophylaxis.   On 25th April 2022, the patient received the 1st dose of Shingrix. On 25th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: The reporter reported that, he accidentally administer only the adjuvant portion of Shingrix as a didn't reconstitute the vaccine. The patient called this afternoon to inquire about Shingrix. She did not provide any other details on the adverse event case but did state to this agent the location of the pharmacy. The patient confirmed her birthdate and initials as documented in the adverse event. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, he accidentally administered only the adjuvant portion of Shingrix as a didn't reconstitute the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Injection site rash, Injection site reaction, Myalgia
Clinical narrative: Pain at injection site; large raised rash injection site, 2-3 inches; large raised rash injection site, 2-3 inches; slight fever; light muscle pain; light body pain; severe lower back pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 22nd April 2022 11:30, the patient received the 2nd dose of Shingrix. On 22nd April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site rash, raised rash, fever, muscle pain, general body pain and low back pain. On an unknown date, the outcome of the injection site pain, fever, muscle pain, general body pain and low back pain were unknown and the outcome of the injection site rash and raised rash were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site rash, raised rash, fever, muscle pain, general body pain and low back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix. Later that evening, between 6 pm-7 pm the patient started having pain at the injection site, slight fever, light body and muscle pain. The patient stated that those were the normal side effects but what really bothered her was the severe lower back pain and large raised rash around injection site. The rash was raised about 2-3 inches, rash was still present but was resolving. The patient needed no further information regarding adverse event. The adverse event was reported to healthcare professional. The consent to follow up was given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash papular
Clinical narrative: Pain at injection site; large raised rash injection site, 2-3 inches; large raised rash injection site, 2-3 inches; slight fever; light muscle pain; light body pain; severe lower back pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 22nd April 2022 11:30, the patient received the 2nd dose of Shingrix. On 22nd April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site rash, raised rash, fever, muscle pain, general body pain and low back pain. On an unknown date, the outcome of the injection site pain, fever, muscle pain, general body pain and low back pain were unknown and the outcome of the injection site rash and raised rash were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site rash, raised rash, fever, muscle pain, general body pain and low back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix. Later that evening, between 6 pm-7 pm the patient started having pain at the injection site, slight fever, light body and muscle pain. The patient stated that those were the normal side effects but what really bothered her was the severe lower back pain and large raised rash around injection site. The rash was raised about 2-3 inches, rash was still present but was resolving. The patient needed no further information regarding adverse event. The adverse event was reported to healthcare professional. The consent to follow up was given.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension
Clinical narrative: Patient experienced hypotension/blood pressure was 80/50/the hypotension lasted all day; This case was reported by a other health professional via sales rep and described the occurrence of hypotension in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced hypotension. On an unknown date, the outcome of the hypotension was recovered/resolved.   It was unknown if the reporter considered the hypotension to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2022 Reporter's Comment: The reporter stated that, a patient experienced hypotension after her Shingrix.  The patient was also a physician in the reporter's office.  She received Shingrix at an unknown pharmacy in the afternoon (date unknown).  The next morning when she woke up her blood pressure was 80/50 mmHg.  The hypotension lasted all day and the patient had to be taken home. She had since recovered and her normal blood pressure is 120/80 mmHg. The reporter did not know batch number and expiration date.  The reporter did not know the office fax or email number. The reporter consented to follow up.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Chromaturia, Drug screen negative, Laboratory test, Pain in extremity
Clinical narrative: Arm was sore; Urine was dark, almost a brown color; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received the 2nd dose of Shingrix. On 27th April 2022, 1 days after receiving Shingrix, the patient experienced pain in arm and dark urine. On an unknown date, the outcome of the pain in arm and dark urine were unknown.   It was unknown if the reporter considered the pain in arm and dark urine to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-Apr-2022 Reporter's Comments: The patient received shingrix and noticed that, the patient's urine was dark as well as arm was sore on reporting day. On vaccination day, the patient had drug test which showed urine was fine. The consent to follow up was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered reconstituted with non approved diluent; administered reconstituted with non approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent .  They were trying to figure out which patients received an incomplete dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered, reconstituted with non approved diluent; Administered, reconstituted with non approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent .  They were trying to figure out which patients received an incomplete dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered, reconstituted with non approved diluent; Administered, reconstituted with non approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent .  They were trying to figure out which patients received an incomplete dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Mobility decreased
Clinical narrative: Weak/Today he is so weak he can not get out of bed.; Wobbly; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 26th April 2022, less than a day after receiving Shingrix, the patient experienced weakness and unsteadiness. On an unknown date, the outcome of the weakness and unsteadiness were not recovered/not resolved.   It was unknown if the reporter considered the weakness and unsteadiness to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The patient's wife reported that patient was received his second Shingrix dose. The patient was weak and wobbly last evening and  patient could not get out of bed. The reporter give consent to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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: 27-APR-2022 Reporter's Comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  Registered nurse did not have a specific amount of patients when spoke to her so could not confirm. It was reported that, for additional information, please reach out to the healthcare professional. Additional Supportive Information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: bruising; injection site became swollen; injection site became hot; injection site became red; malaise; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2022, the patient received the 1st dose of Shingrix. On 22nd April 2022, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, injection site erythema and malaise. On 27th April 2022, the patient experienced contusion. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were unknown and the outcome of the malaise was recovered/resolved and the outcome of the contusion was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema, malaise and contusion to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The case was reported by the patient. The patient stated that, she experienced malaise for three day.  The patient stated that, the injection site became swollen, hot, and red and five days after her arm was showing bruising. The reporter was given medical disclaimer and referred to healthcare professional. Spoke per package insert and content. Provided medical information phone number for health care professional reference. The reporter consented to follow up. Additional Supportive Information: The case had been linked to US2022070818, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070818:Same reporter