chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19-2, FLUC4
Symptoms: Asthenia, Asthma, COVID-19, Condition aggravated, Deafness unilateral
Clinical narrative: So on 03-JAN-2023 early in the morning I noticed my breath was shallow and a sore throat and my rapid test came back positive immediately as the day progressed I got weak and had trouble walking I got headaches and had trouble hearing in my right ear I got Paxlovid prescribed and started taking immediately I had the metallic taste I had started to get better but was sick for two weeks and after two weeks I got better but about a week after I got sick again had to use my inhaler due to my asthma I had worse headaches and was extremely lethargic on the rebound and had to lay down for several days and was sick again for maybe ten days or so I still have shortness of breath and walking to fast will cause that as well, I was very lethargic and it is getting better little by little.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19-2, FLUC4
Symptoms: Dyspnoea, Gait disturbance, Headache, Hypopnoea, Lethargy
Clinical narrative: So on 03-JAN-2023 early in the morning I noticed my breath was shallow and a sore throat and my rapid test came back positive immediately as the day progressed I got weak and had trouble walking I got headaches and had trouble hearing in my right ear I got Paxlovid prescribed and started taking immediately I had the metallic taste I had started to get better but was sick for two weeks and after two weeks I got better but about a week after I got sick again had to use my inhaler due to my asthma I had worse headaches and was extremely lethargic on the rebound and had to lay down for several days and was sick again for maybe ten days or so I still have shortness of breath and walking to fast will cause that as well, I was very lethargic and it is getting better little by little.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19-2, FLUC4
Symptoms: Malaise, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: So on 03-JAN-2023 early in the morning I noticed my breath was shallow and a sore throat and my rapid test came back positive immediately as the day progressed I got weak and had trouble walking I got headaches and had trouble hearing in my right ear I got Paxlovid prescribed and started taking immediately I had the metallic taste I had started to get better but was sick for two weeks and after two weeks I got better but about a week after I got sick again had to use my inhaler due to my asthma I had worse headaches and was extremely lethargic on the rebound and had to lay down for several days and was sick again for maybe ten days or so I still have shortness of breath and walking to fast will cause that as well, I was very lethargic and it is getting better little by little.
Age: 29.0
Sex: F
Vaccine: MMRV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Product dispensing issue
Clinical narrative: No additional AE.; HCP reported PROQUAD was administered to patients over the age of 13 years old.; Indicate at which point in the process the medication error occured: dispensing; This spontaneous report was received from a physician regarding an unknown number of patients of an unknown age and gender. Their medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates, the patients over the age of 13-year-old were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported.  Follow-up information has been received from the vaccine provider on 08-MAR-2023.   The patient was a 29-year-old female patient. On 24-JAN-2023, she was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot# W030217, expiration date 23-MAY-2025, administered subcutaneously. The reporter considered that the medication error occurred in the dispensing process (Product dispensing issue).   Lot Number W030217 is not valid for PROQUAD, as confirmed by the lot validation team.   This is one of two reports received from the same reporter.   This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid, as patient identifiers were reported.; Sender's Comments:  US-009507513-2303USA003423:
Sex: M
Vaccine: HEP, HPV9
Symptoms: Maternal exposure before pregnancy, Premature delivery, Vaccination error
Clinical narrative: premature delivery; pregnant patient received a dose of GARDASIL 9 as a result of user error; This prospective pregnancy spontaneous report was received from a registered nurse and refers to a male neonate patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The patient's mother became pregnant with the last menstrual period (LMP) on 31-MAY-2022 (conflicting information, also reported as 17-MAY-2022) and estimated date of delivery (EDD) on 07-MAR-2023. At the time of this report, her gestation was 36 weeks and 1 day.  On 08-FEB-2023, the patient's mother received a dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, pre-filled syringe, 1 dose in a right arm, lot #U039529, expiration date: 09-AUG-2024 (strength, and route of administration were not provided) as a result of user error (captured in 2302USA002937). The nurse reported that hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was intended and there was not anything in regards to packaging or labeling that contributed to the error. The patient did receive the intended vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dose in the left arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The patient was born prematurely (gestational age 36 weeks 3 days) (premature baby) (conflicting information, also reported as term birth). His birth weight was 6lbs 8ozs.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. The causal relationship between the event and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown.  This is one of two cases from the same reporter. ; Sender's Comments:  US-009507513-2302USA002937:Mother's Case
Sex: M
Vaccine: HPV9, PPV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: the staff administering the medication only checked the expiration date and did not verify the medication checks; No adverse effects were reported; patient inadvertenly received a dose of PNEUMOVAX 23 (intramuscular) instead of his scheduled GARDASIL 9 injection; This spontaneous report was received from a medical assistant and refers to a 41-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included "possibly" exercise-induced asthma. Concomitant therapies were not reported.  On 01-MAR-2023, the patient inadvertently received a dose of  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, once intramuscularly (IM) administered for prophylaxis (lot #W019533, expiration date: 30-SEP-2023), instead of his scheduled HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection.  The reporter confirmed the patient had not began the series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or ever received it. The caller said the confusion occurred because the staff administering the medication only checked the expiration date and did not verify the medication checks they had in place to avoid medication errors. No adverse effects were reported.
Age: 37.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE.; HCP reported PROQUAD was administered to patients over the age of 13 years old.; This spontaneous report was received from a physician regarding an unknown number of patients of an unknown age and gender. Their medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates, the patients over the age of 13-year-old were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported.  Follow-up information has been received from a registered nurse on 08-MAR-2023.   The patient was a 37-year-old male patient. On 12-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot# W023866, expiration date: 24-JAN-2024, administered intramuscularly on the left arm. It was reported that the patient did no experience any adverse reaction and that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was just administered to an adult.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid, as patient identifiers were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009375:
Age: 1.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: one year old child was accidently administered a dose of unspecified HPV vaccine.; one year old child was accidently administered a dose of unspecified HPV vaccine.; No additional AE reported; This spontaneous report has been received from consumer concerning to an 1-year-old patient of an unknown gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was accidently administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (also reported as unspecified HPV vaccine)(manufacturer unknown) (strengths, lot numbers, expiration dates, anatomical locations, vaccination scheme frequency and routes of administration were not provided) for prophylaxis. The consumer was not able to provide the brand name of the unspecified HPV vaccine (manufacturer unknown) (product origin unknown).  No additional adverse event (AE) reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; to report a temperature excursion.  ROTATEQ was administered.; This spontaneous report was received from other and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-MAR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 time dose, lot #1892784, expiration date: 03-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion. The temperature was reported as 46.4F, time frame was 5 minutes. There was a previous temperature excursion reported as 47.9F for 0 hours 47 minutes and 0 seconds. No additional adverse events (AEs) were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, Oxygen saturation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; DAMAGED THE LUNGS; This spontaneous report received from a consumer concerned a 77-year-old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number was not reported, expiry date: unknown) dose was not reported, 1 total administered at  left arm on 15-APR-2021 for COVID-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 76 years old. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient got COVID (suspected covid-19 infection), and was hospitalized for 10 days on an unspecified date in 2022 for which patient was in physical therapy and had to retire from his job. He also stated that when he got COVID, it knocked his oxygen level down and damaged his lungs. He stayed on oxygen all the way until OCT-2022. Patient stated that it had nothing to do with the Janssen shot. Laboratory data included: Oxygen saturation low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and damaged the lungs was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230320386. Sender's Comments: V0-20230320475-Suspected covid-19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.  V0-20230320475- Damaged the lungs. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Exostosis, Tremor, X-ray abnormal
Clinical narrative: Left arm has tremors
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Stress, Vaccination failure
Clinical narrative: had the shot but got shingles/ Suspected Vaccination Failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot but got shingles/ Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure and shingles were not reported.   It was not reported if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 02-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shot a long time ago but got shingles. The patient reported that, it depends on the person apparently, some get the shot and do okay but there are those that have bad side effects. The patient was told extreme stress could cause shingles. The patient was very upset and stressed out when he/she got shingles. The patient stated that it was hard to know what to do. The follow-up could not be possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: 4 minutes after the injection she felt faint and passed out in the chair-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: With the help of 2 customers we gently placed her on the floor and raised her feet abouve her head.  A customer (RN) from the ER said to put a cold compress on her chest.  She checked her pulse (strong) Patient said that she has fainted before when blood was drawn and when she had a shot as a teenager.  She is not diabetic and stated that she ate before arriving at the store.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Drug ineffective
Clinical narrative: I was employed by Hospital in 1984 at age 21. in providing my immunization records, we believed I had never had chicken pox. I was born in 1964 , I could not remember having the chicken pox and my mother said I did not have it. The hospital health office drew a titer and confirmed I had no immunity to the virus. I was not allowed in rooms with shingles or chicken pox patients. After the chicken pox vaccination became available I received it from my employer, this was approximately 1997 . I was approx. 33 years old at that time. I changed employers in January 2023, and the hospital I moved to drew blood to see what immunizations I would need. My new employer advised me my labs shown that I have no immunity to the chicken pox virus and gave me in the 2 dose, 30 days apart vaccine. I am just sharing this with you because I thought it might be helpful information on the duration and effectiveness of the first chicken pox vaccine that first came out, ( I believe it was new for children and adults in 1995). It did not give me lifelong immunity. I am 58 years old now and have been offered the shingle vaccination, but I feel I should not need it if I have never had the chicken pox virus. thank you.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Peripheral swelling, Pruritus, Rash, Swollen tongue
Clinical narrative: Took Covid-19 Booster through Pfizer, the next few days later had swollen hands, itchy limbs, full body hives, rash, ongoing swollen tongue, uticaria, persistent allergic reaction for over a year now. Had to go to allergist, taking high dosage of antihistamine and xolair to mitigate ongoing side effects.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Took Covid-19 Booster through Pfizer, the next few days later had swollen hands, itchy limbs, full body hives, rash, ongoing swollen tongue, uticaria, persistent allergic reaction for over a year now. Had to go to allergist, taking high dosage of antihistamine and xolair to mitigate ongoing side effects.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, SARS-CoV-2 test, Swelling face
Clinical narrative: Took Covid-19 Booster through Pfizer, the next few days later had swollen hands, itchy limbs, full body hives, rash, ongoing swollen tongue, uticaria, persistent allergic reaction for over a year now. Had to go to allergist, taking high dosage of antihistamine and xolair to mitigate ongoing side effects.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Took Covid-19 Booster through Pfizer, the next few days later had swollen hands, itchy limbs, full body hives, rash, ongoing swollen tongue, uticaria, persistent allergic reaction for over a year now. Had to go to allergist, taking high dosage of antihistamine and xolair to mitigate ongoing side effects.
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Incorrect dose administered
Clinical narrative: I noticed looking at my sons medical history vaccines they gave him 3 rotavirus pentavalent doses(oral). Two were 2ml each and the third one was 1ml. For my understanding they supposed to have 2 doses of 1ml before 24 months. Manufacture code: MSD Manufacture name: Merck and co inc. Looking back at his vaccine history (January 2023) from my computer on XXXX account.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast swelling, Capsular contracture associated with breast implant, Lymphadenopathy, Magnetic resonance imaging normal
Clinical narrative: I received the Pfizer Covid 19 vaccine (2nd shot) in my left arm. two days later I was extremely swollen in my breast, neck and lymph nodes under my arm.  Swelling lasted 13 days, pain continued and worsened.  My left breast became very tense, and pain increased with random swelling.  Many dr. appointments and radiology screenings a Capsular IV contracture was diagnosed on my left Sientra implant.  Pain has never subsided only gotten worse.  When I was required to get a booster covid shot the same reaction happened again, extreme swelling in breast, neck, and under arm lasting 16 days.  Breast implant has hardened even more with daily extreme pain.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram normal, Medical device site induration, Oedema peripheral, Pain, Swelling
Clinical narrative: I received the Pfizer Covid 19 vaccine (2nd shot) in my left arm. two days later I was extremely swollen in my breast, neck and lymph nodes under my arm.  Swelling lasted 13 days, pain continued and worsened.  My left breast became very tense, and pain increased with random swelling.  Many dr. appointments and radiology screenings a Capsular IV contracture was diagnosed on my left Sientra implant.  Pain has never subsided only gotten worse.  When I was required to get a booster covid shot the same reaction happened again, extreme swelling in breast, neck, and under arm lasting 16 days.  Breast implant has hardened even more with daily extreme pain.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Menveo which is a vaccine for meningococcal infection has a 2 vial dose. One with liquid and one with powder. My son only received the liquid portion for the vaccine. The nurse who administered the vaccine realized shortly after that she made the mistake of not giving both vials at once.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion over the weekend were administered to a patient.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reaction/allergies were not reported.  On 13-FEB-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #W021182, expiration date: 27-FEB-2025); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #W026135, expiration date: 31-JAN-2024) for prophylaxis (strength, anatomical site of administration and route of administration were not provided) which temperature excursion over the weekend, temperature above 9 degree Celsius for 2 hours 32 minutes and 0 seconds (product storage error). There's no previous temperature excursion. No additional adverse event (AE) reported (no AE).
Sex: U
Vaccine: PNC15
Symptoms: Crying, Injection site pain
Clinical narrative: excessive crying; pain/burning with injection; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown age. The patient was vaccinated with 3 doses of pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13). The patient's concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (strength, lot #, expiry date and route of administration were not provided).  On an unknown date, the patient experienced excessive crying (crying) and pain and burning with injection (vaccination site pain). At the time of reporting, the outcome of the events was not provided.   The causal relationship between the events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not provided.   This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2303USA002603:same reporter link US-009507513-2303USA002536:same reporter link
Age: 1.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 12 month male patient was administered GARDASIL 9; No additional AE reported; This spontaneous report was received from a nurse and refers to a 12-month-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with 1 dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) in error (strength, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis (Product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash erythematous, Vaccination failure
Clinical narrative: had vaccine and in the middle of second bout/suspected vaccination failure; in the middle of second bout; pain; red streak on cheek; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had vaccine and in the middle of second bout/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: in the middle of second bout), pain (Verbatim: pain) and red rash (Verbatim: red streak on cheek). The outcome of the vaccination failure and pain were not reported and the outcome of the shingles was not recovered/not resolved and the outcome of the red rash was recovered/resolved.   It was not reported if the reporter considered the vaccination failure, shingles, pain and red rash to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure, shingles, pain and red rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by a patient via interactive digital media. The patient had shingles vaccine and he/she was in the middle of his/her second bout shingles patient never really had much pain.  The patient had the vaccine for more than 5 years ago and had a very small red streak on his/her cheek. .  The patient just happened to be in the clinic and asked to see his/her physician assistant.  She knew immediately what it was, called in a script to the medical and by the next morning it was gone.  The reporter stated that patient still finish the medication. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow up would not possible as no contact detail were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Rash pruritic, Vaccination failure
Clinical narrative: suspected vaccination failure had vaccination got shingles/suspected vaccination failure; shingles; had vaccination was 10; strip in chest to backbone itch; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a child male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure had vaccination got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), itchy rash (Verbatim: strip in chest to backbone itch) and inappropriate age at vaccine administration (Verbatim: had vaccination was 10). The outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were not reported and the outcome of the itchy rash was recovered/resolved (duration 5 weeks).   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and itchy rash to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 07-MAR-2023 This case was reported by a patient's grandparent via interactive digital media. The patient had his shingles vaccination which was a school vaccination requirement. He was about 10 when he got the shingles and he had a strip that stretched from in front of his chest to the backbone. The reporter remembered him complaining about the itch, it lasted about five weeks and then it faded away. The patient received the shingles vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had a shot but still got them; Painful burning itch/burning itching; Painful burning itch/Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 86-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had a shot but still got them), itch burning (Verbatim: Painful burning itch/burning itching) and pain (Verbatim: Painful burning itch/Pain). The outcome of the vaccination failure, shingles, itch burning and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, itch burning and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, itch burning and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and still got the shingles, a painful burning itch. The patient too just had weeks of burning itching pain. The reporter thought that he/she had the shot and now not sure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles shot/Suspected Vaccination Failure; Got is again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got shingles shot/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got is again). The outcome of the vaccination failure was not reported and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case  was received from the patient via interactive digital media. The patient got shingles shot several years ago then within 2 weeks caught shingles. The patient took pictures of it. The patient was in small town, the physician was gone but nurse was there, the patient got shingles. The patient stated there was no record and got it again in few months ago still had issue from it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had had a shingles shot and when i got them I had three on my back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had had a shingles shot and when i got them I had three on my back). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case  was received from the patient via interactive digital media. The patient had Shingles shot and when he/she got them  he/she was very fortunate The patient had three on back and that was all. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Blood blister, Herpes zoster, Pain, Pruritus
Clinical narrative: Itching; blisters started to dry out; blisters bleed; blister crack; pain; Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pruritus (Verbatim: Itching), blister (Verbatim: blisters started to dry out), blood blister (Verbatim: blisters bleed), skin cracked (Verbatim: blister crack) and pain (Verbatim: pain). The outcome of the vaccination failure, pruritus, blister, blood blister, skin cracked and pain were not reported and the outcome of the shingles was recovered/resolved (duration 10 days).   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, blister, blood blister, skin cracked and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus, blister, blood blister, skin cracked and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and still experienced shingles. The patient stated that it was a very mild case of shingles on his/her right cheek right under his/her eye and it was lasted about 10 days. The patient reported that other than itching the only pain was when the blisters started to dry out especially when he/she smiled they had crack and bleed. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Skin fissures, Vaccination failure
Clinical narrative: Itching; blisters started to dry out; blisters bleed; blister crack; pain; Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pruritus (Verbatim: Itching), blister (Verbatim: blisters started to dry out), blood blister (Verbatim: blisters bleed), skin cracked (Verbatim: blister crack) and pain (Verbatim: pain). The outcome of the vaccination failure, pruritus, blister, blood blister, skin cracked and pain were not reported and the outcome of the shingles was recovered/resolved (duration 10 days).   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, blister, blood blister, skin cracked and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus, blister, blood blister, skin cracked and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and still experienced shingles. The patient stated that it was a very mild case of shingles on his/her right cheek right under his/her eye and it was lasted about 10 days. The patient reported that other than itching the only pain was when the blisters started to dry out especially when he/she smiled they had crack and bleed. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: got shots and still had a recurrence/ suspected vaccination failure; had a recurrence; internal deep nerve pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shots and still had a recurrence/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had a recurrence) and post herpetic neuralgia (Verbatim: internal deep nerve pain). The outcome of the vaccination failure, shingles and post herpetic neuralgia were not reported.   It was not reported if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient got shots and still had a recurrence but the internal deep nerve pain not the rash. 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 could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; has had shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for an unknown indication.   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, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: has had shingles twice). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient's daughter/son via interactive digital media. The patient had shingles twice in the last 2 months. The patient had 2 shots in 2018, that was. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious 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 Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was not reported if the reporter considered the shingles to be related to Shingles vaccine.     It was not reported if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-03-2013 The patient took the shot within a few days, he/she had shingles. He/she was told that he/she could not do anything about it.  The patient felt someone should pay him/her some money.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Small pox like bumps on arm, chest; very few little pox; Not very itchy; This non-serious case was reported by a consumer and described the occurrence of vesicular rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-MAR-2023, the patient received Shingrix. On 03-MAR-2023, 1 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: Small pox like bumps on arm, chest; very few little pox) and pruritus (Verbatim: Not very itchy). On 06-MAR-2023, the outcome of the vesicular rash was recovered/resolved (duration 3 days). The outcome of the pruritus was not reported.   It was not reported if the reporter considered the vesicular rash and pruritus to be related to Shingrix.     It was not reported if the company considered the vesicular rash and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was submitted by public reporting reference via the online direct entry reporting system. The case was self reported by the patient. The patient received a dose of Shingrix and experienced very few little pox which was not really very itchy. The patient reported that couple on arm and one on chest and stated as a very limited small pox like bumps. On 5th March 2023 the patient received Vaginal estergen concomitantly for dryness.   The patient reported that symptoms were not treated. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: having problems with sleep-flying; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleep disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sleep disorder (Verbatim: having problems with sleep-flying). The outcome of the sleep disorder was not recovered/not resolved.   It was not reported if the reporter considered the sleep disorder to be related to Shingles vaccine.     It was not reported if the company considered the sleep disorder to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shingles vaccination and now had problem with sleep flying. The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received 3 doses; This non-serious case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Received 3 doses). The outcome of the extra dose administered was not reported.   Additional Information: GSK Receipt Date: 01-MAR-2023 The nurse explained to the reporter that the patient received 3 doses of Shingrix.  The patient came in for an appointment and could not recall whether they had received their 2nd dose or not and so they administered a shot and realized later that in fact the patient had already received dose 2. The reporter had no further details about the patient.  The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter had included the office manager's email address so that you could follow up.