chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Around 6 pm I got a severe headache, very bad body aches, trouble breathing, and a very fast heart rate. I felt faint and had cold sweats so I went to ER after work. The ER doctor gave me fluids, a vial of tylenol through IV, and just observed me to make sure my heart rate and blood pressure came down. They said it sounded like a normal reaction. Fever of 101. I am getting a MRI of my brain on Tuesday 3/9/21 for continued severe headaches.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain, Pyrexia
Clinical narrative: Around 6 pm I got a severe headache, very bad body aches, trouble breathing, and a very fast heart rate. I felt faint and had cold sweats so I went to ER after work. The ER doctor gave me fluids, a vial of tylenol through IV, and just observed me to make sure my heart rate and blood pressure came down. They said it sounded like a normal reaction. Fever of 101. I am getting a MRI of my brain on Tuesday 3/9/21 for continued severe headaches.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Event: Arm around injection site developed a reaction/rash that was warm to the touch, red and raised. Area starred small then grew to cover entire shoulder Treatment: benadryl and rest
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Experienced slightly swollen and sore arm, headache and muscle aches after the initial injection for approx. 48 hours.  No fever.  8 days after the injection I experienced a swollen, sore red patch on my arm and muscle aches and headache again.  Today is day 3 of the delayed reaction and the redness and swelling has subsided.  I am still feeling achy and tired, along with shakiness and nausea.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: Experienced slightly swollen and sore arm, headache and muscle aches after the initial injection for approx. 48 hours.  No fever.  8 days after the injection I experienced a swollen, sore red patch on my arm and muscle aches and headache again.  Today is day 3 of the delayed reaction and the redness and swelling has subsided.  I am still feeling achy and tired, along with shakiness and nausea.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Injection site hypoaesthesia, Nausea
Clinical narrative: Patient became lightheaded and nauseous approximately 15 minutes after receiving her vaccine. She also complained of having numbness that radiated from her neck to her fingers in the arm that had received the injection. Patient stated that she typically has low blood pressure usually in the 90/60 range. During the incident patient's blood pressure range from 108/74 to 123/69 with heart rates from 61 to 66 to BPM.  Oxygen levels remained normal. Patient took one puff of albuterol inhaler that she had with her at 1311 because she felt ?a little tight?. At 1325 patient stated nausea had subsided and that lightheadedness had transitioned to fatigue. Patient was A&OX4. Patient stated she felt well enough to drive home and be observed by spouse.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swelling, warm to the touch
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: At 10pm (12 hours after the injection), I began to experience chills, muscle aches and pains, joint pain, and a low-grade fever that rose to a high of 101.4 at 8:30 the following morning.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: low grade fever, body ache, hive rash,  severe pain in left arm
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Depressed level of consciousness, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Became diaphoretic, pale, clammy, faint B/P 111/71, HR= 50  Stated feeling dizzy, ringing in ears, unable to remain alert/focused. LOC intermittently for several seconds for about 10 minutes total time
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Tinnitus
Clinical narrative: Became diaphoretic, pale, clammy, faint B/P 111/71, HR= 50  Stated feeling dizzy, ringing in ears, unable to remain alert/focused. LOC intermittently for several seconds for about 10 minutes total time
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: Pt feels dizzy, hot, headache.  VS BP 122/80, HR 75, RR 18, Osat 98% Left arm numb from elbow down.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine given outside of age parameters.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis
Clinical narrative: blood pressue 96/42. patient sweating. feeling dizzie like he was about to pass out. provided food/water and constant monitoring until symptoms resolved
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Rash
Clinical narrative: Fatigue (daily, ongoing) Headache (daily, ongoing) Nausea (comes and goes, but worse over time) Shivers and uncontrollable shuddering (started 4 days ago, worse at night, no fever) Rash on belly (in the last few days)
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Fatigue (daily, ongoing) Headache (daily, ongoing) Nausea (comes and goes, but worse over time) Shivers and uncontrollable shuddering (started 4 days ago, worse at night, no fever) Rash on belly (in the last few days)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever lasted about 24 hours.  Between 99-102 degrees.  Treated with alternating Tylenol and Ibuprofen.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Palpitations, Throat irritation
Clinical narrative: Itchy throat, palpitations, sweating. Lasted < 1 hour after Benadryl 50mg administered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Rectal bleed
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt reported dizziness to EMT at 1200. EMT assessed pt. BP: 110/80. Pt reported hx of allergic reactions to bees and peanuts. Pt offered Diphenhydramine at 1220. Pt denied diphenhydramine. Pt advised to wait an extra 15 minutes for observation. Pt's symptoms resolved within 15 minutes. Pt left facility at 1235 with steady gait.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Swollen tongue, Throat irritation
Clinical narrative: Scatchy throat, affected voice, swollen tongue
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: Patient received first dose of Pfizer COVID 19 vaccine at 0845.  Patient mentioned history of mast cell activation syndrome as well as history of several anaphylactic events to the vaccinator.  Patient related that she had her personal Epi-pen with her on site.  Vaccinator elected to have patient wait  recommended 30 minutes.  At 15 minutes post vaccination, patient stated that she was experiencing the sensation of throat and facial swelling, elaborating that this is typical for her anaphylactic reactions.  Patient was addressed by the PA-C on site.  Upon exam, some edema of the brow bones were noted.  No edema noted in the oropharynx.  Dermatographia noted on the patient's tattoos, however, no generalized rash or injection site reaction noted.  Heart rate and rhythm regular.  Pulse 60bpm, strong.  BP 118/72.  Bilateral lungs clear to auscultation in all fields.  No wheezing or stridor noted.  Patient denied presence of cramping abdominal pains, nausea, and vomiting.  Patient was provided with  10mg Claritin ODT and 25mg PO Benadryl.  Patient related that she had famotidine at home that she normally takes when such events occur.  At 30 minutes post po  meds, Patient related she felt better and did not feel the need to be transported by EMS, though it was offered.  Discussed at length with patient regarding follow up care and low initiation threshold for emergency response.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash, swelling and itching at injection site- still present on 3/5/21
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently administered 1st dose of Moderna cov 19 vaccine to under age 18. Patient administered 2nd dose of Moderna cov 19 vaccine on 3/5/2021 after approval.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Malaise, Nasopharyngitis, Vomiting
Clinical narrative: Cold during the night and today went to lunch and does not feel well at all and threw up and has a tempurature of 100.4
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient's husband reported the patient had a  104.8  degree fever. This occurred around 24 hours after receiving the first dose of the Moderna vaccine. It was recommended the patient take tylenol or ibuprofen. The patient's PCP was notified.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Patient started to itch on left arm and showed slight redness. Gave 25mg of diphenhydramine liquid for 1 dose
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: Really bad headache, fatigue, I was throwing up, I was running about 100 fever but it didn't go higher than that. Those symptoms lasted about a week and a half.  Talked to healthcare provider with video chat - put me on bedrest. I had a positive pregnant test about three days after the first dose of COVID vaccine. And went to the Hospital about 1 week and 1/2 after finding out.  I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy.  Had the second dose of vaccine, I think of February 9, 2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Copious vomiting for about 5 hours, headache, chills, fever = 100.7. Treated in ED with IV fluids, antiemetic, IV Toradol, and sumatriptan to cover for possible migraine. Released from ED after about 3 hours; moderately recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: A 24 yo with hx of headaches received moderna vaccine at  1:14 pm.  Experienced mild headache at 2:12pm.   Took tylenol  own  tylenol 500mg at 2:14 pm.  Headache resolved at 2:36pm.  Pt  states" I'm ok now, I can go home."  Pt discharged.
Age: 68.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PPSV23 administered less than a year after the administration of PCV 13; This initial spontaneous report (split from legal case MARRS # 2008USA010988) was received from an other health professional and refers to a 68-year-old female patient. The patient's medical history included white blood cell count increased, herpes zoster, and pain. Her historical vaccines included influenza virus vaccine (unspecified), zoster vaccine live (ZOSTAVAX), and diphtheria toxoid (+) tetanus toxoid. The patient's concurrent conditions included Janus kinase 2 mutation and myeloproliferative neoplasm.  On 23-MAR-2015, the patient was vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR), 0.5 mL in the left deltoid, lot # L13524, expiration date reported as 01-SEP-2016, for prophylaxis (strength and route of administration not provided).  On 10-MAR-2016, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, 0.5 mL in the right deltoid, lot # L040181, expiration date reported as 18-AUG-2017 and confirmed to be valid (strength, route of administration not provided) for prophylaxis (inappropriate schedule of product administration, as according to the Centers for Disease Control and Prevention guidelines, the patients of or above 65 years of age should receive a dose of 23-valent pneumococcal vaccine at least 1 year after a dose of 13-valent pneumococcal vaccine; herein, it was less than a year).  This is one of two reports concerning the same patient. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: L040181; expirationdate: 18-AUG-2017; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA005522: US-009507513-2008USA010988:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 2 dose shingles vaccine 2 years ago and I broke out in a small area; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient had the 2nd dose Shingles vaccine 2 years ago. However the patient broke out in a small area last fall. This case was considered as suspected vaccination failure since the details regarding lab test confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; 6 weeks later shingles on torso & back, under arms, neck; this time more painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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, 6 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient had shingles around torso, awful experience.  The physician prompted the patient for 2nd year to get the vaccine. The patient could not afford it. Third year, the patient got vaccinated. Six weeks later, the patient had shingles again on torso, back, up under arms, neck and this time more painful than the 1st go around. The reporter stated that sometimes it would reoccur with or without the shot. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection were unknown. The reporter did not consent to follow up. This case has been linked to US2021AMR015360, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR015360:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shingles shot / got shingles/Suspected Vaccination failure; I had the shingles shot / got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included radiation therapy. Concurrent medical conditions included cancer and decreased immune responsiveness.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had shingles shot but had radiation for cancer so his or her system went down and as a result he or she got shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Vaccination failure
Clinical narrative: Suspected vaccination failure; Developed shingles on injection site arm; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in an unknown arm. After receiving Shingrix, the patient developed shingles on injection site arm. The patient went to the dermatologist and followed up with the dermatologist regarding the outcome. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization schedule, time to onset for event and laboratory confirmation were not provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles many years ago. The patient also got the shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had the Shingrix / two years ago / got Shingles; had the Shingrix / two years ago / I got COVID; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Two years ago, from the date of reporting the patient received Shingrix. The patient experienced COVID and Shingles.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles in January 25, 2021; Drug dose administration interval too long; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2018, the patient received the 2nd dose of Shingrix. In November 2017, the patient received the 1st dose of Shingrix. In June 2018, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule.  The physician stated that, the patient came to the practice with shingles on 25th January 2021.  This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The patient had shingles twice once before Shingles vaccine and once after. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Had the shot and still got them / mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and got mild case shingles. The patient went right to physician.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Never had shingles UNTILL after, I got the shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient stated that the patient never had shingles until got the shot. This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site swelling, Pain, Pyrexia, Temperature intolerance
Clinical narrative: suspected vaccination failure; got the Shingles shot / got Shingles again; swelling at the site of injection; fever; pain/residual pain; extremely sensitive to heat in that area; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Neurontin.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site swelling, fever, pain and heat sensitivity. On an unknown date, the outcome of the vaccination failure, shingles, injection site swelling, fever, pain and heat sensitivity were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injection site swelling, fever, pain and heat sensitivity to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received the Shingles shot and experienced shingles, swelling at the site of injection, fever and pain. At the time of reporting, the patient had residulal pain and that area was extremely sensitive to heat. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; got the Shingles shot / got Shingles again; swelling at the site of injection; fever; pain/residual pain; extremely sensitive to heat in that area; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Neurontin.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site swelling, fever, pain and heat sensitivity. On an unknown date, the outcome of the vaccination failure, shingles, injection site swelling, fever, pain and heat sensitivity were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injection site swelling, fever, pain and heat sensitivity to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received the Shingles shot and experienced shingles, swelling at the site of injection, fever and pain. At the time of reporting, the patient had residulal pain and that area was extremely sensitive to heat. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: My sister got them with the shot/suspected vaccination failure; My sister got them with the shot; Few and small amount of pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. After receiving shingles vaccine, the patient experienced shingles, which went away in a few weeks and only had a few and small amount of pain which she does not have afterward. The reporter stated believe me you would rather have them with the shot than without.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had shingles / I had the shot; SHINGLES; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingrix and experienced shingles which hurted. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 6 months later / shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient for self. The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. When the vaccine became available, patient was one of the first in line. About 6- months later, the patient  developed Shingles on his/her tail bone. The patient thank God for the vaccine. It kept the infection from being more than a small nuisance. The patient rarely recommend any vaccine but highly recommend this vaccine. The patient's mother had a horrible case of shingles. The nerve damage was pretty horrendous. This case was considered as suspected vaccination failure as details regarding vaccination schedule was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles 2 years ago and even had the shots!; pain remained for 2 years; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Patient rceived the shots of Shingles vaccine 2 years ago and had shingles and pain. In December patient put wires in head to stop the pain. It was reported that the shingles and pain recovered but patient had head and a battery by left shoulder blade. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles / Feel them starting to come back / Suspected vaccination failure; Shingles / Feel them starting to come back; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had several times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received the Shingles vaccine but occasionally he/she felt shingles starting to come back and immediately he/she take Valtrex and they go right away. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; small flare-up 1 year later; Shingles are very failure; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient had the vaccine 3 years ago. The patient had small flare-up 1 year after the vaccination. The patient stated shingles were very painful. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: still got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the shot and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash, Vaccination failure
Clinical narrative: I had shingles even though I had the vaccine against it!!/ Suspected vaccination failure; I had shingles even though I had the vaccine against it!!; The rash was not as extensive; The nerve ending pain was horrible / lasted for several months; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash and nerve pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and nerve pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced shingles even though he/she had the vaccine against it. The patient's doctor said patient had a lighter case because he/she had the shot a few years before getting it and patient told him that he/she was surely glad that it was a lighter case, because did not know if he/she could have stood a full case of it. The patient experienced rash which was not as extensive but had horrible nerve ending pain, and lasted for several months. This case was considered as suspected vaccination failure, as information about completion of primary vaccination schedule and laboratory test confirmation for shingles infection was unknown. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and then had a light case/ suspected vaccination failure; I had the shot and then had a light case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient had the shot and then had a light case, he/she stated it was not fun. This case was considered as suspected vaccination failure as details regarding vaccination schedule and time to onset for target disease were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Now I have "after shingles" / I got two shots of the shingle vaccine; I have the pain but no blisters / still have the pain; This case was reported by a consumer via and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (when the patient was little) and measles (twice).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient had chicken pox when the patient was little. The patient also had measles twice. The patient got two shots of the shingle vaccine and  experienced shingles and had pain but no blisters.  At the time of reporting the patient still had the pain. The patient advised to get the shingle vaccine.  This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin ulcer, Vaccination failure
Clinical narrative: suspected vaccination failure; Got it right now; Sores; This case was reported and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and skin ulcer. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and skin ulcer were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and skin ulcer to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that he/she had shinges at the time of reporting even after having the vaccines. The patient stated that there was no muscle pain, just the sores and that they were clearing up. This case was considered as suspected vaccination failure as laboratory test confirmation and time to onset for the event was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Mobility decreased, Pain, Vaccination failure
Clinical narrative: Had shot and then still got the darn stuff /Suspected vaccination failure; Had shot and then still got the darn stuff / First time in my face / 4 years ago it came back on my torso; Very painful; 4 years ago it came back on my torso / That put me to bed..... For 2 weeks at least; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and bedridden. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and bedridden to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received the Shingle vaccine and then still got the shingles and was very painful. The patient had it 1st time on his/her face and often then 4 years ago it came back on his/her torso, that put the patient to bed for at least 2 weeks. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.