chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Smear cervix normal, Ultrasound scan vagina abnormal
Clinical narrative: 10 days after my 1st shot I started having a period and I'm Menopausal I haven't had a period in 18 years. Called my PCP he had me schedule a pap  with Dr for May 18, 2021 pap was normal, Dr scheduled me for a Vaginal Ultrasound  May 20, 2021 and it showed abnormal thickening of the endometrium with internal heterogeneous echogenic foci and cystic appearing components. The findings are nonspecific and my reflect endometrial hyperplasia. Dr scheduled me for an Endometrial Biopsy May 27, 2021 and it also was normal. I was referred to and OBGYN and I saw Dr on August 10, 2021 and I'm scheduled for surgery September 7, 2021, they go in vaginally with a camera and light and do a D&C an this is an outpatient procedure at Hospital.  I have since seeing Dr had ANOTHER Period lasting 6 days it started August 11, 2021 and I also came down with what they thought was Covid on August 11, 2021 but Covid test on August 13, 2021 was negative
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Started hurting in mid of night after day of shot. Woke up to itchy, oval, red, warm to touch, and raised/swollen.  Felt fatigued evening after shot and following day, not sick, just tired. The shot location stayed bothersome, red, swollen, warm all weekend and went away by Monday morning. Following Friday, week to the day of original shot, woke up and arm was itchy, lifted shirt and realized the red, hot circle on my arm was back but took up  larger area. Much bigger than first weekend. So odd that it came back exactly a week later for the entire weekend again. All same symptoms but shot location was much bigger, itchy and hot to touch, swollen and raised. Noticed faint yellowish bruise under skin for up to two weeks after second weekend of swelling. Kind of afraid to see what happens with the second shot, if  the first did this.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Started hurting in mid of night after day of shot. Woke up to itchy, oval, red, warm to touch, and raised/swollen.  Felt fatigued evening after shot and following day, not sick, just tired. The shot location stayed bothersome, red, swollen, warm all weekend and went away by Monday morning. Following Friday, week to the day of original shot, woke up and arm was itchy, lifted shirt and realized the red, hot circle on my arm was back but took up  larger area. Much bigger than first weekend. So odd that it came back exactly a week later for the entire weekend again. All same symptoms but shot location was much bigger, itchy and hot to touch, swollen and raised. Noticed faint yellowish bruise under skin for up to two weeks after second weekend of swelling. Kind of afraid to see what happens with the second shot, if  the first did this.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Exposure during pregnancy, Pyrexia, Vomiting
Clinical narrative: 21 weeks pregnant via IVF. Estimated date of delivery = dec 28th.  Around 11:45pm, developed fever and severe chills with bad indigestion. Proceeded to vomit multiple times.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test abnormal, Decreased appetite, Dry mouth, Pollakiuria
Clinical narrative: The next morning I was very weak.  I  had little or no appetite.  I was urinating approximately 15 times a day. I had cotton mouth and  slept 20 hours two days during the weak.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: The next morning I was very weak.  I  had little or no appetite.  I was urinating approximately 15 times a day. I had cotton mouth and  slept 20 hours two days during the weak.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Myalgia, Pyrexia
Clinical narrative: On 26Aug2021, I received the first dose of the AstraZeneca COVID-19 vaccine at around 11 am. In the afternoon, I experienced myalgia. In the evening, I felt very cold. At around 10 pm, I had fever & chills. I was literally shaking all night. On 27Aug2021, I still had myalgia & chills. I also had a headache. I took paracetamol & naproxen affording relief of the headache & myalgia. By 28Aug2021, the symptoms resolved. I think the adverse events were probably caused by the vaccine.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: On 26Aug2021, I received the first dose of the AstraZeneca COVID-19 vaccine at around 11 am. In the afternoon, I experienced myalgia. In the evening, I felt very cold. At around 10 pm, I had fever & chills. I was literally shaking all night. On 27Aug2021, I still had myalgia & chills. I also had a headache. I took paracetamol & naproxen affording relief of the headache & myalgia. By 28Aug2021, the symptoms resolved. I think the adverse events were probably caused by the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Very large red itchy rash left arm. Lasting at least a week. Cold compress and ice.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Nodule
Clinical narrative: Painful lump on right sub clavicular region. Lump about size of walnut. Movable. Painful and achy to touch. Burning sensation once disturbed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Chills, Fatigue, Muscular weakness
Clinical narrative: Tiredness, muscle soreness, muscle weakness, muscle/joint failure upon walking, shivering, tingly burning sensation on portions of skin, some rash spots, upset stomach.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Paraesthesia, Rash
Clinical narrative: Tiredness, muscle soreness, muscle weakness, muscle/joint failure upon walking, shivering, tingly burning sensation on portions of skin, some rash spots, upset stomach.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AEs reported; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 29-JUL-2021, the patient was vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (1 injection, lot # 1581027, expiration date 03-JUN-2021; strength, route of administration and anatomical site of vaccination were not reported) for prophylaxis (expired product administered). No other adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1581027; expirationdate: 03-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; An expired dose of GARDASIL 9 was administered.; This non-valid spontaneous repot was received from a registered nurse via and refers to an unspecified patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 10-AUG-2021, the patient was vaccinated with the second and an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # R027577 was confirmed to be valid, expiration date 23-JUN-2021, for prophylaxis (route and site of administration were not reported). No additional adverse event was reported.  Follow-up information has been received from  the registered nurse on 18-AUG-2021. The patient was 31-year-old female. The vaccine was administered intramuscularly. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027577; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; administration of improperly stored PROQUAD.; This spontaneous report was received from a physician who refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-AUG-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, recombinant human albumin (rHA) (lot # U006314, expiration date: 24-AUG-2022) (strength and route of administration were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was 45.3 degrees Fahrenheit for a time frame of 17 hours on an unspecified date, without any previous temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster
Clinical narrative: cellulitis; other zoster related injuries; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On unknown date (reported as 41891), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a physician and other healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles, cellulitis and other zoster related injuries. The outcome of these events was unknown.   Upon internal review, cellulitis was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; other zoster related injuries; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On unknown date (reported as 42051), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a physician in the urgent care and other healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): herpes zoster and other zoster related injuries. The outcome of these events was unknown.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster related injuries; Information has been received from a lawyer and an elderly patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 08-OCT-2016 (at 71 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a physician and other healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles and other zoster related injuries. The outcome of these events was unknown.
Sex: U
Vaccine: PPV
Symptoms: Splenectomy
Clinical narrative: Splenectomy; This spontaneous report was received from a pharmacist concerning a currently 59 years old patient of unknown gender. Information regarding the patient's concomitant therapies, current conditions and medical history was not provided.   On an unknown date in 2020, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (strength, route of administration, lot number and expiration date were not provided) for prophylaxis.  On 25-JUN-2021 (confliction information: also reported as 25-JUL-2021, the patient had a splenectomy performed. At the time of the report, the outcome of the splenectomy was unknown.   Causality assessment was not reported.  Upon internal review, the splenectomy was considered to be medically significant.
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Lethargy, Unresponsive to stimuli
Clinical narrative: became unresponsive; lethargic; This spontaneous report was received from a physician and refers to a 2-month-old male patient. No information regarding the patient's concomitant therapies was provided. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date in approximately February 2011 (reported as "when the patient was 2 or 4 months old"), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (formulation, strength, dose, frequency, lot # and expiration date were not reported) for vaccination and with pneumococcal vaccine conj 7v (crm197) (PREVNAR) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported for both). After receiving rotavirus vaccine, live, oral, pentavalent (ROTATEQ),pneumococcal vaccine conj 7v (crm197) (PREVNAR) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), the patient became unresponsive and lethargic. On an unknown date, he sought medical attention, and was taken to an unspecified hospital and released on an unknown date, after an unspecified days later. The outcome of the events was reported as recovered on an unknown date. Relatedness between the events and suspect vaccines was not provided.  Upon internal review, the event of unresponsive was considered to be medically significant.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Menactra was administered as the 2nd dose in a series instead of Bexsero; Menactra was administered as the 2nd dose in a series instead of Bexsero; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate schedule of vaccine administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENACTRA for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and the 2nd dose of MENACTRA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The Menactra was administered as the 2nd dose in a series instead of Bexsero, which led to  inappropriate schedule of vaccine administered and wrong vaccine administered. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: You can still get them. I had 2 shots/ suspected vaccination failure; You can still get them./had the worst case the drs had seen.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had 2 shots still got shingles, had the worst case the doctors had seen. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; All my friends who got that vaccine got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unknown number of patients 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 age at vaccination was not applicable for this report. The reporter stated that all his/her friends who got that vaccine got the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and as details regarding laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Visual impairment
Clinical narrative: got shingles shot and 3 month later I got Shingles/suspected vaccination failure; shingles, almost lost my eyesight; almost lost my eyesight; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and profound vision impairment, one eye (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 profound vision impairment, one eye were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and profound vision impairment, one eye to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got shingles shot and got shingles so bad that almost lost left eyesight and still have problem with left eye at the time of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with case US2021AMR156120 for comment response.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156120:Comment response
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Head and ear Shingles from 1st shot; This case was reported by a consumer via 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, less than 2 weeks 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 dollows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, less than 2 weeks after shot, had got head and ear Shingles. The patient was nervous about getting the 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I got one vaccine do I need more; This case was reported by a consumer via and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, got one vaccine did need more.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had them / had the shingle shot/Suspected vaccination failure; Had them 4 times; 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 reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient had shingles 4 times and had the shingles vaccine. The patient also stated that was not pleasant. 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: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes, Vaccine positive rechallenge
Clinical narrative: Genital herpes outbreaks; Increased genital herpes outbreaks after both doses; This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of genital herpes (1st dose received on an unknown date and experienced increased genital herpes outbreaks). Concurrent medical conditions included genital herpes.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced genital herpes and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown.   It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient experienced increased genital herpes outbreaks after receiving the dose of Shingrix vaccine. The reporter did not had any other information except patient's gender. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176130:Same reporter. Pt1 - 1st dose. US-GLAXOSMITHKLINE-US2021AMR176145:Same reporter. Pt1 - 2nd dose. US-GLAXOSMITHKLINE-US2021AMR176145:Same reporter. Pt1 - 2nd dose. US-GLAXOSMITHKLINE-US2021AMR177309:Same reporter. US-GLAXOSMITHKLINE-US2021AMR176145:Same reporter. Pt1 - 2nd dose. US-GLAXOSMITHKLINE-US2021AMR176130:Same reporter. Pt1 - 1st dose.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Fear, Guillain-Barre syndrome, Immediate post-injection reaction
Clinical narrative: Guillain Barre syndrome; honestly thought she was going to die; This case was reported by a consumer via media and described the occurrence of guillain barre syndrome 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, immediately after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and impending doom. On an unknown date, the outcome of the guillain barre syndrome and impending doom were unknown.   It was unknown if the reporter considered the guillain barre syndrome and impending doom to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by patient's close friend. The age at vaccination was not reported. The patient received shingles shot earlier this reporting year (2021) and immediately developed Guillain Barre syndrome. The patient honestly thought she was going to die. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got theshot and ended up getting it again/suspected vaccination failure; ended up getting it again.; 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) 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 case details were reported as follows: The age at vaccination was not reported. The reporter knew a patient who got the shingles shot and ended up getting the shingles again. The reporter also asked what did you tell about the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. This case is one of 8 case, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166325:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR092424:Same reporter US-GLAXOSMITHKLINE-US2021AMR178106:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter. US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter. US-GLAXOSMITHKLINE-US2021AMR179350:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got theshot and ended up getting it againsuspected vaccination failure; ended up getting it again.; 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) 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 case details were reported as follows: The age at vaccination was not reported. The reporter knew a patient who got the shingles shot and ended up getting the shingles again. The reporter also asked what did you tell about the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. This case is one of 8 case, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166325:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR092424:Same reporter US-GLAXOSMITHKLINE-US2021AMR178101:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter. US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter. US-GLAXOSMITHKLINE-US2021AMR179350:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: shingrix vaccines with the adjuvant only; shingrix vaccines with the adjuvant only; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication 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 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 details were provided as follows: The age at vaccination was not reported. A healthcare provider at the doctor's office gave Shingrix vaccine with the adjuvant only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  They took inventory the day before the day of reporting and had Shingrix antigens was left.  They were not sure which patients received full dose and which patients received the adjuvant only. They stated that, all the patients that received Shingrix during this week would have to get revaccinated.  The doctor's office reported this to CDC.  No other information was available.  This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021177375:same reporter, shingrix US-GLAXOSMITHKLINE-US2021AMR178137:same reporter, shingrix US-GLAXOSMITHKLINE-US2021AMR178146:same reporte
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: shingrix vaccines with the adjuvant only; shingrix vaccines with the adjuvant only; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication 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 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 details were provided as follows: The age at vaccination was not reported. A healthcare provider at the doctor's office gave Shingrix vaccine with the adjuvant only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  They took inventory the day before the day of reporting and had Shingrix antigens was left.  They were not sure which patients received full dose and which patients received the adjuvant only. They stated that, all the patients that received Shingrix during this week would have to get revaccinated.  The doctor's office reported this to CDC.  No other information was available.  This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178136:same reporter, Shingrix US-GLAXOSMITHKLINE-US2021177375:same reporter, Shingrix
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: vaccines with the adjuvant only; vaccines with the adjuvant only; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 details were provided as follows: The age at vaccination was not reported. A healthcare provider at the doctor's office gave with only MenCYW-135 liquid component without reconstituting which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  They took inventory the day before the day of reporting and had MenA lyophilized (powder) was left.  They were not sure which patients received full dose and which patients received the adjuvant only. They stated that, all the patients that received Shingrix during this week would have to get revaccinated.  The doctor's office reported this to CDC.  No other information was available.  This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178136:same reporter US-GLAXOSMITHKLINE-US2021AMR178137:same reporter US-GLAXOSMITHKLINE-US2021AMR178146:same reporter US-GLAXOSMITHKLINE-US2021177375:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: vaccines with the adjuvant only; vaccines with the adjuvant only; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 details were provided as follows: The age at vaccination was not reported. A healthcare provider at the doctor's office gave with only MenCYW-135 liquid component without reconstituting which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  They took inventory the day before the day of reporting and had MenA lyophilized (powder) was left.  They were not sure which patients received full dose and which patients received the adjuvant only. They stated that, all the patients that received Shingrix during this week would have to get revaccinated.  The doctor's office reported this to CDC.  No other information was available.  This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178145:same reporter US-GLAXOSMITHKLINE-US2021AMR178137:same reporter US-GLAXOSMITHKLINE-US2021177375:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had the shot and still put the shingles/suspected vaccination failure; shingles; still having pain; I got another shingle shot; 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 Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said that shingles vaccine did not help because he/she had the shingles shot and still got the shingles. The 2 years later, the patient got another shingle shot, which led to extra dose administered. The patient would see how long it takes to get shingles this time and he/she still had the pain from the shingles and the patient was just did not quit as they said it could last for years and years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. Note: As per the narrative, the pain occurred due to past shingles, hence pain was linked with the 1st suspect of shingle vaccine.
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Dyspnoea, Pulmonary oedema
Clinical narrative: lungs filled up with fluid; trouble breathing; This case was reported by a consumer via interactive digital media and described the occurrence of pulmonary edema in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   In November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received COVID-19 VACCINE. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pulmonary edema (serious criteria hospitalization and GSK medically significant) and difficulty breathing. On an unknown date, the outcome of the pulmonary edema and difficulty breathing were unknown.   It was unknown if the reporter considered the pulmonary edema and difficulty breathing to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the flu shot and have had trouble breathing ever since then.  The patient's lungs filled up with fluid and he/she had to go to the hospital. Till the time of reporting, the patient still seeing a lung doctor.  The patient said that, no more poison for him/her.  The patient reported that, they were no longer giving vaccines, but experimental drugs with MRA in them that destroy your immune system, wake up people. It was unknown if the reporter considered the pulmonary edema and difficulty breathing to be related to Covid vaccine. The follow-up would not possible as no contact details were available. Note: It was unknown if the patient had received Covid vaccine or not, as it was mentioned in source document under product field, hence conservatively captured as suspect. The clarification has been raised for the same.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: shingle shots were more painful; This case was reported by a consumer via and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had shingles by eye, it was very scary had to go to eye specialist 3 times, all good). Previously administered products included Covid-19 (received Covid shots on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got 2 shots of shingles. The patient stated that, he/she thought the 2 shingle shots were more painful than covid shots. For the tolerance of the 2nd dose refer case US2021AMR178267, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178267:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; very painful shingles; This case was reported by a consumer via 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. Shingles vaccine was discontinued. 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 details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the 1st shingle shot and it did not work for him/her. The patient came down with a horrible case of very painful shingles. The patient was asked not to get the second shingles shot due to getting from the first shot. The patient stated that the shot probably worked for thousands of people just not for him/her.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles shot and got shingles less than a (unspecified). The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. Note: In the narrative incomplete information was given regarding  and hence the case was processed conservatively as suspected vaccination failure  aunknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles, both had the SHOT two to 3 weeks prior; This case was reported by a consumer via and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 weeks 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 case details were reported as follows: Age at vaccination was not reported. The reporter knew a  patient with Shingles, who had the shingles shot two to 3 weeks prior from the date of reporting. No contact details were reported. The case had been linked with US2021AMR178300.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178300:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got my shot and then got the shingles/suspected vaccination failure; shingles; very painful; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient never had the shingles got his/her shingle shot and got the shingles. The patient stated that yes it was very painful. 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.