chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Secretion discharge
Clinical narrative: In around December 2022, I began coughing up a large amount of mucus every day. This symptom has persisted and continues to this day. I went to my PCP on 3/20/2023. He determined that I had cobblestone throat and nasal passages. He said that my lungs and my ears were clear, however. He prescribed me pantoprazole. He also recommended OTC Claritin and Flonase. He instructed me to take all three medications for 30 days. Sometimes, I feel like there's been an improvement, but sometimes I cough up phlegm until I want to choke. The mucus I cough up now is thick, but usually clear, though it does sometimes have a yellowish tinge.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bronchiolitis, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: I couldn't breathe. I went to the emergency room.  I was there for four days and my final diagnosis was Bronchiolitis
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, Pain, SARS-CoV-2 test positive, Secretion discharge
Clinical narrative: On March 7, 2023, I had aches and pains and different texture in my mucus.  I tested positive for COVID-19, and I began taking Paxlovid on March 10th and then began having symptoms of sinusitis.  I no longer have COVID-1 symptoms, but I do still have sinusitis.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: On March 7, 2023, I had aches and pains and different texture in my mucus.  I tested positive for COVID-19, and I began taking Paxlovid on March 10th and then began having symptoms of sinusitis.  I no longer have COVID-1 symptoms, but I do still have sinusitis.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Adult failure to thrive
Clinical narrative: Pfizer vaccine was administered outside of location - reported by patient  I21.9 ACUTE MI 2/15/2022 FAILURE TO THRIVE SYNDROME, ADULT
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Chronic respiratory failure, Pneumonia, Respiratory failure
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/17/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/13/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE I21.4 ACUTE NON ST ELEVATION MI 4/17/2022 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/13/2022 PNEUMONIA
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Hypotension
Clinical narrative: HYPOTENSION 12/27/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Patient reported extreme exhaustion/fatigue for 3 days following injection Reported swollen lymph nodes for approximately 2 weeks after injection
Age: 75.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Breast cancer female, Breast conserving surgery, Mammogram abnormal, Ultrasound breast abnormal
Clinical narrative: I went to my yearly mammogram in December and it was abnormal. I did a sonogram and it came back as breast cancer in my right breast. I had lumpectomy. I have to do chemo and radiation.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular disorder, Chronic respiratory failure, Dysphagia
Clinical narrative: J96.10 CHRONIC RESPIRATORY FAILURE 12/31/2021 CHRONIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 12/31/2021 DYSPHAGIA FOLLOWING CEREBROVASCULAR DISEASE
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Erythema, Nasal congestion, Peripheral swelling, Pruritus
Clinical narrative: Patient went to Urgent Care due to concern about allergic reaction to MMR vaccine administered at Pharmacy. Signs and symptoms are the following: redness and swelling of the face, hands, and nose. His nasal passages are swollen shut. Intense pruritus. Had shortness of breath. The patient was treated with Diphenhyramine 50 mg IM, famotidine 20 mg IV, dexamethasone 10 mg IV, and epinephrine 0.3 mg IM. The patient was discharge home.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: Patient went to Urgent Care due to concern about allergic reaction to MMR vaccine administered at Pharmacy. Signs and symptoms are the following: redness and swelling of the face, hands, and nose. His nasal passages are swollen shut. Intense pruritus. Had shortness of breath. The patient was treated with Diphenhyramine 50 mg IM, famotidine 20 mg IV, dexamethasone 10 mg IV, and epinephrine 0.3 mg IM. The patient was discharge home.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Suspected COVID-19
Clinical narrative: On 12/28/2022, I started having a tickling in the back of my throat. I suspected COVID-19 because my husband had the same symptom the day before. My symptoms were all in my head. My head was completely stuffed. It took me two weeks for me to test negative for COVID-19. I had a fever the fifth or sixth day of around 101. That lasted only around 24 hours. I treated myself with TYLENOL and lots of fluids. I did a telehealth visit on around the fourth day, after testing positive. He was unable to prescribed me PAXLOVID, but he said that it didn't seem like I needed it anyway since my symptoms were not in my chest. I just mostly rested, and the symptoms were gone within a week.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Throat irritation
Clinical narrative: On 12/28/2022, I started having a tickling in the back of my throat. I suspected COVID-19 because my husband had the same symptom the day before. My symptoms were all in my head. My head was completely stuffed. It took me two weeks for me to test negative for COVID-19. I had a fever the fifth or sixth day of around 101. That lasted only around 24 hours. I treated myself with TYLENOL and lots of fluids. I did a telehealth visit on around the fourth day, after testing positive. He was unable to prescribed me PAXLOVID, but he said that it didn't seem like I needed it anyway since my symptoms were not in my chest. I just mostly rested, and the symptoms were gone within a week.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Diabetes mellitus, Lumbosacral radiculoplexus neuropathy, Respiratory failure
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/28/2021 SECONDARY DM W AMYOTROPHY
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Osteomyelitis, Respiratory failure
Clinical narrative: Pfizer vaccine was administered outside of the clinic - reported by patient  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/5/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/5/2021 OSTEOMYELITIS
Age: 46.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Insomnia, Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Tender and sore in elbow and forearm for 2 weeks. Now it is a high level ache with scorching, searing, ripping feeling pain off and on. Taking ibprofrin, icing, wrapping and anything else I can think of to relieve the pain. Can not bend the elbow ( left), without excruciating pain. Can't sleep, going on 3rd night.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Syncope
Clinical narrative: Patient fainted in lobby. initial BP 74/40 HR 45, patient pale, placed cool wash cloth on patient and offered snacks and water. Vitals retaken at 943 BP 95/61 HR 58, after some minutes patient's color returned to face and patient was transferred to seated position. Vitals 104/67 HR 68. Assisted patient to standing position 108/73 HR 71. PCP aware and patient stated he was feeling back to normal. PCP released patient to leave with parent and educated patient to move slowly and eat/stay hydrated.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy
Clinical narrative: D68.9 COAGULOPATHY, UNSPECIFIED TYPE 8/31/2022 HX OF ACUTE KIDNEY INJURY
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional adverse events reported.; Caller reports that a patient was administered an expired dose of GARDASIL 9 on 19Mar2023. Caller confirmed the dose expired on 15Mar2023; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 19-MAR-2023, the patient was vaccinated with a one expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, frequency, route of administration, anatomical location and dose were not provided) (lot number W007026 has been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), expiration date reported as 15-MAR-2023, but upon internal validation was established as 04-DEC-2024) (expired product administered). It was confirmed by the reporter that the dose was properly stored up through the time of administration. No additional side effects were reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No Additional AEs; that RECOMBIVAX HB was administered to 1 patient following temperature excursion.; This spontaneous report was received from physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-FEB-2023, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dose, lot #W011618, expiration date: 10-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 55.7 degrees Fahrenheit for 3 hours 10 minutes. There was no previous temperature excursion. There was no adverse event reported.
Age: 1.0
Sex: U
Vaccine: MMR, PNC15, VARCEL
Symptoms: Gianotti-Crosti syndrome, Rash, Rash maculo-papular
Clinical narrative: flat, maculopapular, non-blanchable rash on the limbs, buttocks and face; He stated that he believes that the child's rash resembles Gianotti-Crosti syndrome; This spontaneous report was received from a physician and refers to a 1-year-old patient of unknown gender. No medical history, concurrent conditions nor concomitant medications were reported.  On 16-FEB-2023, the patient was vaccinated with dose of varicella virus vaccine live (Oka/Merck) (VARIVAX); dose of pneumococcal 15v conj vaccine (CRM197) prefilled syringe (VAXNEUVANCE) and dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (exact doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) for prophylaxis.  On 13-MAR-2023, the patient experienced flat, maculopapular, non-blanchable rash on the limbs, buttocks and face. The physician stated that the child's rash resembled Gianotti-Crosti syndrome. The patient did not have any other symptoms such as a runny nose, congestion or fever. The patient came back later that day and patient's mother had some questions. They briefly discussed the program and reviewed sample collection and shipping instruction in case the physician decided to submit a sample for PCR testing. The physician reported that he would discuss with patient's mother and contact if he planed on submitting a sample through the program. He additionaly reported that he did not feel that sample collection would be possible without removing a 'chunk' of the patient's skin since it was a flat, maculopapular rash and he did not feel that the rash was varicella. Additional information had been requested. The outcome of the events was reported as not recovered/not resolved. The action taken with suspect vaccines regarding the events was not applicable.  The relatedness between the events and suspect vaccines was reported as unlikely to be related.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; RECOMBIVAX HB was administered to 1 patient following temperature excursion; This spontaneous report was received by customer and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with one dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot# W025778, expiration date: 11-JUN-2023, (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  On 11-APR-2023, administered dose of vaccine was exposed to the temperature excursion of 50.6 degrees Fahrenheit (F) for 4 hours (product storage error). No previous temperature excursion. No additional adverse events (no adverse event).  Lot number W025778 (expiration date: 11-JUN-2023) has been verified to be valid lot number for hepatitis b vaccine (recombinant) (RECOMBIVAX HB).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reports that improperly stored vaccines were administered; No adverse event; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On unknown day, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) rHA (recombinant Human albumin) subcutaneous injection (1 time dose, lot #W028561, expiration date 06-MAR-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On unknown day, the suspect vaccine experienced a temperature excursion of 7.7 degrees Fahrenheit (F) for 8 hours and 54 minutes (product storage error). Previous temperature excursion of 7.7 F for 2 hours and 18 minutes from unknown day was reported. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP reports that improperly stored vaccines were administered. HCP did not have specific detail regarding the administration date. Case Consent to contact was provided. No Additional AEs. No PQCs.          ?    Names of vaccines involved (including; No additional AEs; This spontaneous report was received from Medical assistant and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 time dose, lot #W028561, expiration date: 06-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, HCP reported that improperly stored vaccines were administered (product storage error temperature too high). Vaccine was stored in 7.7 degree Fahrenheit for 8 hours and 54 minutes. Vaccine had previous temperature excursion (7.7 degree Fahrenheit for 2 hours and 18 minutes). HCP did not have specific detail regarding the administration date. Case Consent to contact was provided. No Additional AEs. No PQCs.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: missed second dose of GARDASIL 9.; No additional AEs were reported; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not provided.  On 11-JUL-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # U008316, expiration date 15-AUG-2023; strength, dose and route were unknown) for prophylaxis. On an unknown date, the patient missed the second dose of vaccine. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot but still got shingles / Suspected vaccination failure; Still 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: Got shot but still got shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was 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: 08-APR-2023 This case was reported via interactive digital media. The reporter reported that she knew two people (patients) who got shot but still got shingles. The reporter was wondering why to put this chemical in body, pay for it and then suffer the disease. The reporter also reported that with Polio and measles shot the disease was eradicated. Not so with Shingles or Covid shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination, time to onset and laboratory confirmation of shingles were not provided. The follow up would not be possible as no contact details were provided. This case was linked with US2023AMR037410, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR037410:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles three times after the shot/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.   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: Had shingles three times after the shot/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was 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: 18-MAR-2023 The case was received from the patient interactive digital media. The patient had the shingles six times, three before the shot, three times after the shot.  The reporter stated that shot would not prevent you from having them if you had already had them, but they usually are not as bad after the shot.  The patient stated still, no picnic. 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. This case is linked with US2023AMR052388, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR052388:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got vaccinated and still got shingles/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: Got vaccinated and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was 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: 09-APR-2023 This case was reported from the patient via  interactive digital media. The patient got vaccinated and still got shingles. 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. The case had been linked to US2023AMR053081, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR053081:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Epstein-Barr virus infection
Clinical narrative: Epstein Barr plus other health issues; This serious case was reported by a consumer via interactive digital media and described the occurrence of epstein-barr virus infection 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, an unknown time after receiving Shingles vaccine, the patient experienced epstein-barr virus infection (Verbatim: Epstein Barr plus other health issues) (serious criteria GSK medically significant). The outcome of the epstein-barr virus infection was not resolved.   The reporter considered the epstein-barr virus infection to be possibly related to Shingles vaccine.     The company considered the epstein-barr virus infection to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-APR-2023 This case was reported by the patient via interactive digital media. The patient reported that it could not be worse than going on third year with Epstein Barr from the vaccination. The patient received anti-seizure medication as treatment drug for all the other health issue. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR053239, for the same reporter.; Sender's Comments:  US-GSK-US2023AMR053239:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Epstein-Barr virus infection
Clinical narrative: Epstein Barr plus other health issues; This serious case was reported by a consumer via interactive digital media and described the occurrence of epstein-barr virus infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included seizure.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced epstein-barr virus infection (Verbatim: Epstein Barr plus other health issues) (serious criteria GSK medically significant). The outcome of the epstein-barr virus infection was not resolved.   The reporter considered the epstein-barr virus infection to be possibly related to Shingrix.     The company considered the epstein-barr virus infection to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2023 This case was reported by a consumer via interactive digital media. The patient reported that it couldn't be worse than going on third year with Epstein Barr from the vaccine.  The patient was taking anti seizure medication. They also had all the other health issues. This case had been linked with US2023AMR053230 due to same reporter. The reporter think that the event might have been related to the Product/Device.; Sender's Comments:  US-GSK-US2023AMR053230:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuropathy peripheral, Pain, Skin irritation
Clinical narrative: suspected vaccination failure/had the Shingles vaccine and the virus was aggravated; Neuropathy; widespread shingles; pain, sore, pain over my entire body, painful and aggressive/residuals still flaring up with sores; blistering; irritation; 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/had the Shingles vaccine and the virus was aggravated) (serious criteria GSK medically significant), neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: widespread shingles), pain (Verbatim: pain, sore, pain over my entire body, painful and aggressive/residuals still flaring up with sores), blister (Verbatim: blistering) and skin irritation (Verbatim: irritation). The outcome of the vaccination failure was unknown and the outcome of the neuropathy, blister and skin irritation were not reported 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, neuropathy, shingles, pain, blister and skin irritation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, neuropathy, shingles, pain, blister and skin irritation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-Mar-2023 The case was received from the patient via interactive digital media. The patient was an old and can tell that he/she had been whooped, stabbed, shot and blown up, his/her memory might be fading, however he/she remember no pain and irritation such as given by the shingles. The patient had the Shingles vaccine a few years ago and had a more rare form known as widespread shingles where he/she had sores, blistering and pain over his/her entire body. They said shingles might last for weeks but in his/her case it was 4 1/2 months before he/she started seeing some relief. Here the patient a year later still dealing with the extended damage done, neuropathy and some residuals still flaring up with sores. In the patient's case, apparently the virus was aggravated by the interaction with the Covid vaccine which caused them to manifest in a more painful and aggressive manner, needless to say, the patient 's physician advised him/her not to get any of the boosters for Covid due to possible further complications.  But yes, painful, ugly pain in the ass shingles were. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure/had the Shingles vaccine and the virus was aggravated; Neuropathy; widespread shingles; pain, sore, pain over my entire body, painful and aggressive/residuals still flaring up with sores; blistering; irritation; 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/had the Shingles vaccine and the virus was aggravated) (serious criteria GSK medically significant), neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: widespread shingles), pain (Verbatim: pain, sore, pain over my entire body, painful and aggressive/residuals still flaring up with sores), blister (Verbatim: blistering) and skin irritation (Verbatim: irritation). The outcome of the vaccination failure was unknown and the outcome of the neuropathy, blister and skin irritation were not reported 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, neuropathy, shingles, pain, blister and skin irritation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, neuropathy, shingles, pain, blister and skin irritation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-Mar-2023 The case was received from the patient via interactive digital media. The patient was an old and can tell that he/she had been whooped, stabbed, shot and blown up, his/her memory might be fading, however he/she remember no pain and irritation such as given by the shingles. The patient had the Shingles vaccine a few years ago and had a more rare form known as widespread shingles where he/she had sores, blistering and pain over his/her entire body. They said shingles might last for weeks but in his/her case it was 4 1/2 months before he/she started seeing some relief. Here the patient a year later still dealing with the extended damage done, neuropathy and some residuals still flaring up with sores. In the patient's case, apparently the virus was aggravated by the interaction with the Covid vaccine which caused them to manifest in a more painful and aggressive manner, needless to say, the patient 's physician advised him/her not to get any of the boosters for Covid due to possible further complications.  But yes, painful, ugly pain in the ass shingles were. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Vaccination failure
Clinical narrative: Got both shots and still got the shingles/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.   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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got both shots and still got the shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   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: 19-MAR-2023 The case was received from the patient interactive digital media. The patient got both shots and still got the shingles.  The patient stated that they were on his/her left side. The patient could not wear a bra, still had to wear underwear. The patient stated that he/she hated having shingles. This case was considered as suspected vaccination failure as details regarding 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, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: had 2 shingles shots and had shingles/Suspected vaccination failure; shingles neck and thigh; itchy; 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.   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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had 2 shingles shots and had shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles neck and thigh), pruritus (Verbatim: itchy) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2023 The case was received from the patient interactive digital media. The patient had the 2 Shingles shots and twice within 6 months he/she had shingles in back on my neck and other time was on his/her tight.  The patient stated that it was itchy and some pain but he/she did not had it as bad as other people had it. This case was considered as suspected vaccination failure as details regarding 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: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had gotten both shots & still got shingles/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 male 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had gotten both shots & still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was 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: 19-Mar-2023 The case was received from the patient's wife via interactive digital media. The patient had gotten both shots and still got shingles. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and got the shingles/suspected vaccination failure; Shingles from top of head, down back, below bum; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 85-year-old 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: Got the shot and got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles from top of head, down back, below bum). The patient was treated with ascorbic acid (Vitamin C), benadryl (nos) (Benadryl Oral) and caladryl (nos) (Caladryl). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   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: 19-Mar-2023 The case was received from the patient's children via interactive digital media. The patient got the shot and got the shingles 3 times. The reporter reported that every time from top of patient's head, down his back, to below his bum. The reporter was miserable off the chart. Not down with the shot. The patient got relief with megadose vitamin C (21 thousand mg per day) divided up with 3 low/no carb meals, benadryl oral and caladryl topical applied liberally.  Fortunately the patient was retired and did not had to be very physical, but the first round of them was very hard on his 85 year old body. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: does not work had shot still got shingles/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: does not work had shot still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was 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: 19-Mar-2023 The case was received form the patient via interactive digital media. The patient stated that the shingles vaccine did not work as he or she had the shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took vaccine got shingles/suspected vaccination failure; shingles / shingles on head/ had shingles last year on the right side of my head; 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: took vaccine got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles / shingles on head/ had shingles last year on the right side of my head). The outcome of the vaccination failure was unknown and the outcome of the shingles was 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: 19-Mar-2023 and 20-Mar-2023 The case was received from the patient via interactive digital media. The patient got the shingles vaccine 5 years ago and got shingles last year on the right side of his/her head. The patient stated that you might think you were good. The patient still good, had shingles with the vaccine, nobody in his/her family took the vaccine and never got the shingles except him/her and he/she took the vaccine. No more vaccines for him/her. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Pain, Vaccination failure
Clinical narrative: Two new shots and I still has the Shingles/ suspected vaccination failure; Shingles in left ear; Shingles; Painful; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Zostavax (had many years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Two new shots and I still has the Shingles/ suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Shingles in left ear) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa and shingles were resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster otitis externa, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two new shots Shingles vaccine and still experienced shingles on his or her back and it was very painful. The patient stated that he or she also had shingles several years back on his or left ear and came outside around his or her earlobe ran up side of his or her face and got very close to the left eye. The patient reported that it was very terrible pain ever he or she had. The patient stated that he or she do not wish anyone had shingles and please everyone get the shingles vaccine. 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: Paralysis
Clinical narrative: Was paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis 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 paralysis (Verbatim: Was paralyzed) (serious criteria GSK medically significant). The outcome of the paralysis was not reported.   It was unknown if the reporter considered the paralysis to be related to Shingles vaccine.     It was unknown if the company considered the paralysis to be related to Shingles vaccine.   Additional Information: GSK receipt date:10-April-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she got vaccine and was paralyzed. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles after getting the shots/ 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: Had shingles after getting the shots/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was 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: 19-MAR-2023 This case was reported by a patient friend via  interactive digital media. The reporter reported that his or her friend as suggested received Shingles vaccine and experienced shingles. 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. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR054618:Same Reporter US-GSK-US2023AMR054624:Same Reporter US-GSK-US2023AMR054627:Same Reporter