chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Sore arm only; Arm discomfort only; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 17Mar2021 08:30 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021, outcome "recovering", described as "Sore arm only"; LIMB DISCOMFORT (non-serious) with onset 17Mar2021, outcome "recovering", described as "Arm discomfort only". Therapeutic measures were not taken as a result of pain in extremity, limb discomfort.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient did not have COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Abscess drainage, Angiogram abnormal, Ankle brachial index, Arteriosclerosis, Blue toe syndrome
Clinical narrative: Starting in end of may of 2021 beginning with headaches along right side of face originating from my ear along the trigeminal nerve. Was treated for ear infections with success. Had MRI and was seen by my ENT without improvement. then week of thanksgiving my csection became abscessed and opened draining purulent drainage followed by a purple to right 4th toe with pain. Have seen PCP, foot specialist, and now a vascular surgeon. Had more labs, MRI with contrast, ABI, and CTA with contrast which shows large amount of plague buildup with lipid panel within normal. left lower leg has no circulation and right lower leg is limited.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Ear infection, Ear pain, Facial pain, Headache
Clinical narrative: Starting in end of may of 2021 beginning with headaches along right side of face originating from my ear along the trigeminal nerve. Was treated for ear infections with success. Had MRI and was seen by my ENT without improvement. then week of thanksgiving my csection became abscessed and opened draining purulent drainage followed by a purple to right 4th toe with pain. Have seen PCP, foot specialist, and now a vascular surgeon. Had more labs, MRI with contrast, ABI, and CTA with contrast which shows large amount of plague buildup with lipid panel within normal. left lower leg has no circulation and right lower leg is limited.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Laboratory test, Lipids normal, Magnetic resonance imaging, Neuralgia, Pain in extremity
Clinical narrative: Starting in end of may of 2021 beginning with headaches along right side of face originating from my ear along the trigeminal nerve. Was treated for ear infections with success. Had MRI and was seen by my ENT without improvement. then week of thanksgiving my csection became abscessed and opened draining purulent drainage followed by a purple to right 4th toe with pain. Have seen PCP, foot specialist, and now a vascular surgeon. Had more labs, MRI with contrast, ABI, and CTA with contrast which shows large amount of plague buildup with lipid panel within normal. left lower leg has no circulation and right lower leg is limited.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Poor peripheral circulation, Postoperative abscess, Purulent discharge, Scan with contrast, Scan with contrast abnormal
Clinical narrative: Starting in end of may of 2021 beginning with headaches along right side of face originating from my ear along the trigeminal nerve. Was treated for ear infections with success. Had MRI and was seen by my ENT without improvement. then week of thanksgiving my csection became abscessed and opened draining purulent drainage followed by a purple to right 4th toe with pain. Have seen PCP, foot specialist, and now a vascular surgeon. Had more labs, MRI with contrast, ABI, and CTA with contrast which shows large amount of plague buildup with lipid panel within normal. left lower leg has no circulation and right lower leg is limited.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Wound
Clinical narrative: Starting in end of may of 2021 beginning with headaches along right side of face originating from my ear along the trigeminal nerve. Was treated for ear infections with success. Had MRI and was seen by my ENT without improvement. then week of thanksgiving my csection became abscessed and opened draining purulent drainage followed by a purple to right 4th toe with pain. Have seen PCP, foot specialist, and now a vascular surgeon. Had more labs, MRI with contrast, ABI, and CTA with contrast which shows large amount of plague buildup with lipid panel within normal. left lower leg has no circulation and right lower leg is limited.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Very sore and painful injection site with delayed onset and continues through several days
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Sensitive skin, Skin lesion, Urticaria
Clinical narrative: Since 25 December she has complained of recurrent episodes of generalized hives which typically occur at sites where she is scraped, scratched, or exposed to pressure (such as the straps of her backpack or waistband of her pants). Lesions last less than 24 hours, spare palms and soles, and resolve without post-inflammatory changes. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 14 December, 11 days prior to onset of her symptoms. She was seen in the ER on 26 December where she received oral H1 and H1 antihistamines and prednisone. She has used oral antihistamines with benefit. She reports a single episode of lip and mild throat swelling, but otherwise denies laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. She denies fever/chills, night sweats, unexplained weight loss, and painful/swollen joints.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Laryngeal discomfort, Pain in extremity, Pharyngeal swelling, Rash
Clinical narrative: Since 10 December he has complained of near-daily recurrent episodes of rashes described as flat to raised, red, itchy spots and whelts which can occur anywhere on his body but typically occur at sites of pressure or where his skin is scraped or scratched. He also notes lesions occur after hot showers. Lesions last less than 24 hours and resolve without post-inflammatory changes. He notes involvement of his palms; palmar lesions described as painful and burning. He endorses daily transient laryngeal symptoms (throat swelling) without clear food triggers. He denies pulmonary, GI, neurologic, and cardiovascular symptoms outside of two interval episodes of loose stools and a single episode of vomiting not associated with cutaneous symptoms or clear trigger. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his COVID19 vaccine booster dose on 27 November, 13 days prior to onset of symptoms. He has used oral antihistamines with partial control of symptoms. He received a single oral corticosteroid course with limited benefit. He denies constitutional symptoms.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic, Skin burning sensation, Skin lesion, Urticaria
Clinical narrative: Since 10 December he has complained of near-daily recurrent episodes of rashes described as flat to raised, red, itchy spots and whelts which can occur anywhere on his body but typically occur at sites of pressure or where his skin is scraped or scratched. He also notes lesions occur after hot showers. Lesions last less than 24 hours and resolve without post-inflammatory changes. He notes involvement of his palms; palmar lesions described as painful and burning. He endorses daily transient laryngeal symptoms (throat swelling) without clear food triggers. He denies pulmonary, GI, neurologic, and cardiovascular symptoms outside of two interval episodes of loose stools and a single episode of vomiting not associated with cutaneous symptoms or clear trigger. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his COVID19 vaccine booster dose on 27 November, 13 days prior to onset of symptoms. He has used oral antihistamines with partial control of symptoms. He received a single oral corticosteroid course with limited benefit. He denies constitutional symptoms.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Since 10 December he has complained of near-daily recurrent episodes of rashes described as flat to raised, red, itchy spots and whelts which can occur anywhere on his body but typically occur at sites of pressure or where his skin is scraped or scratched. He also notes lesions occur after hot showers. Lesions last less than 24 hours and resolve without post-inflammatory changes. He notes involvement of his palms; palmar lesions described as painful and burning. He endorses daily transient laryngeal symptoms (throat swelling) without clear food triggers. He denies pulmonary, GI, neurologic, and cardiovascular symptoms outside of two interval episodes of loose stools and a single episode of vomiting not associated with cutaneous symptoms or clear trigger. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his COVID19 vaccine booster dose on 27 November, 13 days prior to onset of symptoms. He has used oral antihistamines with partial control of symptoms. He received a single oral corticosteroid course with limited benefit. He denies constitutional symptoms.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Approximately two to three weeks after date of vaccination, itchy hives developed all over body. Oral antihistamine Zyrtec 10mg pill was taken and relieved by the symptoms for approximately 24-36 hours. Afterwards, dermatographia has developed and now persists until another dose of Zyrtec is taken.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: I have a rash iitching all over My body, since the next day of my vacunation, third dosis on January 10, 2022.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; administered improperly stored PNEUMOVAX 23 Syringe; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 02-JAN-2021 (reported as night before last), the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T022294, expiration date 26-MAR-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No adverse event (AE) or product quality complaint (PQC) was reported. No product quality complaint (PQC) was reported. Current temperature excursion was 60.57 Fahrenheit degrees for 6 hours and 39 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after temparature excursion; No additional AEs; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, drug reactions or allergies and concomitant therapies were not provided.   On 21-DEC-2021 the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous, 0.5 milliliter(ml), after temperature excursion (product storage error) (lot number U019286, expiration date 15-DEC-2022 ; vaccination scheme, and anatomical site of vaccination were not reported) for prophylaxis.    The vaccine underwent a temperature excursion of 6.8 Fahrenheit (F) for 8 hours 5 minutes. There was no previous temperature excursion.   No additional adverse events (no adverse event) or product quality complaints were reported.
Sex: M
Vaccine: MMR
Symptoms: Blood glucose increased, Type 1 diabetes mellitus
Clinical narrative: Type 1 diabetes; This spontaneous report was received from a male patient of unknown age referring to a himself. The patient's relevant medical history, drug reactions or allergies, and concomitant medications were none. patient stated that no one have diabetes in his family      Onan unknown date in 2006, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) (lot number, expiration date, dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for immunization.  The consumer reported that after received measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) vaccine, he diagnosed with Type 1 Diabetes in 2012. He states that, he was not diagnosed until 2012 but believes he had it for a couple of years before being diagnosed. The consumer also states that, he received 4 to 5 other vaccines when he received measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II), possibility the TDAP (he could not recall the names during the call). Patient went to hospital because his blood sugar was 900. The patient stated that he was diagnosed with diabetes and mentioned that, he got it from measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) vaccine. . He states that there was scientific proof that the rubella virus can cause diabetes and prescribing information used to state that measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live(M-M-R II) vaccine can cause diabetes. The event treated with insulin and IV drip.  The outcome of type 1 diabetes mellitus was reported as unknown.     The reporter considered type 1 diabetes mellitus to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).  The event was considered to be serious because it led to hospitalization.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: was caused to suffer pain as a result of  Shingles, including any and all of its sequelae.; Information has been received regarding a case in litigation and refers to a 76 years old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-JAN-2018, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, route of administration, anatomical location, lot# and expiration date were not provided) for prophylaxis. Subsequently, in August 2018, the pt was caused to suffer shingles, including any and all of its sequelae. As a result of the foregoing acts and omissions, the pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The outcome of the event shingles was considered to be not recovered. The causality was related.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired MMRII vaccine used; Information has been received from the physician assistant, concerning a 1-year-old patient (gender not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 13-JAN-2022, the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (first dose, lot # and expiration date were not provided), Hepatitis A Vaccine, Inactivated (VAQTA) (first dose, lot # and expiration date were not provided), and an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (first dose, lot # T001215, and expiration date on 12-JAN-2022).  This is one from two cases receved from the same reporter.; Sender's Comments:  US-009507513-2201USA003103:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No other AE occurred; expired ROTATEQ administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1742457, expiration date reported as 16-JAN-2022, but upon internal validation stablished as 06-JAN-2022) (strength, dose and frequency not provided) orally (PO) for prophylaxis (Expired product administered).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no reported side effects; Expired dose of ROTATEQ was administered; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age or gender.   The patient's concurrent condition, medical history and concomitant medications were not provided.  On 17-JAN-2022, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (strength, dose, dose number were not provided) (lot#: 1742457, expiration date reported as: 16-JAN-2022, but upon internal validation established as: 06-JAN-2022) (expired product administered). It was reported that the patient had no reported side effects and the vaccine administered had no temperature excursions. No further information was provided.
Age: 29.0
Sex: F
Vaccine: HEP, HEPAB
Symptoms: Incomplete course of vaccination, Wrong product administered
Clinical narrative: Engerix-b as a tird dose for a Hep A-B; Received an Engerix-B instead of Twinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 29-year-old female patient who received HBV (Engerix B) (batch number 2793Z, expiry date 12th May 2022) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2021, the patient received the 3rd dose of Engerix B. On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving Engerix B and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received an Engerix-B dose as a third dose for a Hepatitis A-B vaccination instead of a Twinrix dose which led to wrong vaccine administration. Till the time of reporting, the patient did not receive a dose of Hepatitis A vaccine, hence incomplete course of vaccination was captured for Hepatitis A. The reporter consented to follow up. Note:It was unknown if patient received Hepatitis A vaccine dose till the time of reporting, hence incomplete course of vaccination was captured for Hepatitis A conservatively.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product supply issue
Clinical narrative: received first dose 6/21; This case was reported by a consumer and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. Vaccination facility details were provided for 1st dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as it was not available, which led to product supply issue. The patient was now in another country until July again but there was no Shingrix available. The patient asked if it was possible for it to be available in different country. The consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had Shingrix and got shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingrix shot for shingles and got shingles about 4 months later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Three times for me; Pain was unbelievable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the suspected vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the suspected vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingle three times and had two shots. Pain was unbelievable. So the patient suggested to get the shot. The patient further stated that he/she amazed the doctor. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available. This case has been linked to US2022AMR009087, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR009087:same reporter, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Illness, Influenza like illness, Joint range of motion decreased, Mobility decreased
Clinical narrative: reactions similar to the flu; chills; soreness; feel sick; Couldn't raise arm; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms 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 influenza-like symptoms, chills, pain, mobility decreased and sickness. On an unknown date, the outcome of the influenza-like symptoms, chills, pain, mobility decreased and sickness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, pain, mobility decreased and sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR009112  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had reactions to the shingles shot similar to the flu, chills and soreness.  Could not raise his/ her arm for a week.  Still got the second shot and same thing happened.  The patient figured it was better to feel sick than to deal with shingles. The follow-up would not possible as no contact details were available. The case had been linked with US2022AMR009112, reported by the same reporter for 2nd dose of same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR009112:Same patient/reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: reactions similar to the flu; chills; soreness; feel sick; Couldn't raise arm; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms 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 influenza-like symptoms, chills, pain, mobility decreased and sickness. On an unknown date, the outcome of the influenza-like symptoms, chills, pain, mobility decreased and sickness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, pain, mobility decreased and sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR009112  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had reactions to the shingles shot similar to the flu, chills and soreness.  Could not raise his/ her arm for a week.  Still got the second shot and same thing happened.  The patient figured it was better to feel sick than to deal with shingles. The follow-up would not possible as no contact details were available. The case had been linked with US2022AMR009112, reported by the same reporter for 2nd dose of same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR009112:Same patient/reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot a year ago, missed 2 to 6 month window; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient self reported the case and mentioned that, he/she missed the 2 to 6 month window for the 2nd shot, which led  incomplete course of vaccination. The patient asked should he/she get the 2nd shot now.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: because of pandemic did not receive second dose; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report.  The patient received one dose of the Shingrix vaccine and because of the pandemic the 2nd dose was not received within 6 months interval. It had now been 1 year and 4 months since the first dose.
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: had both Shingles shots, shingles/ suspected vaccination failure; shingles; rash on his right chest; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE for covid-19 prophylaxis.   Previously administered products included Shingles vaccine (several years ago the patient took the one shot).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and COVID-19 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 rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's husband. The age at vaccination was not reported. The patient got both Shingles shots and after taking the two Covid shots, he had a rash on his right chest.  The reporter thought it looked like shingles.  The doctor confirmed it.  The shingles were not very bad.  The reporter believed it was caused by Covid shots. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient stated hope you feel good tomorrow, his/her first shot made him/her sick the next day. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shots and still got them internally/ Suspected vaccination failure; still got them internally; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported he/she had the Shingles shots and still got shingles internally. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had both shingle shots and still got shingles. The patient further stated that anyone could get shingles after vaccine. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/get the shot, came down with a bad case of shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient decided to get the shot and came down with a bad case of shingles. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and  laboratory test confirmation 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: Crying, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; have them now; I still hurt; Cried; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In January 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles, pain and crying. On an unknown date, the outcome of the vaccination failure and crying were unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the suspected vaccination failure, shingles, pain and crying to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient had two shingles vaccinations and had shingles at the time of reporting. The patient had them for 2 weeks now and they were still so bad, under doctors care and everything. The patient stated it still hurt like the dickens and had even cried. The patient stated he/she wouldn't want his/her worst enemy to have them. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had all three shots(old one too) and still got shingles; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included SHINGLES VACCINE (old vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had all three shots (old one too) and still got shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: had the shingle vaccine / Dealing with them now/ Suspected vaccination failure; shingles worse; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle vaccine and still got shingles. The patient was dealing with them at the time of reporting and was absolutely miserable. They were worse since had the vaccine than they were before the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; almost continuous shingles on head; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles vaccine and had almost continuous shingles on his/her head ever since. The patient stated it was awful and that he/she would not take the Covid vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and I still got shingles; Shingles; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and shingles. The patient was treated with gabapentin. On an unknown date, the outcome of the suspected vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure, shingles and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had the vaccine and still got shingles but not very bad and then got it again a year later but not very bad. The patient further stated Gabapentin really did help. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had his/her first shot and ended up with shingles.  The patient was due for the second shot. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected  vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient got shingles after vaccination. The patient was sure that other had shingles too. 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. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine / get slight cases/ suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included abnormal vision (almost went blind from shingles), herpes zoster (they were in hair and face) and pain (took forever to ease the pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles vaccine and now he/she only gets slight cases when nervous about anything, stated that was tolerable. The patient stated one should get vaccinated. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.