chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: 1 month after I had my 4th dose of the Moderna vaccine, I had a stroke and was hospitalized for 2 nights.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, Swollen Arm at Injection site
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Condition aggravated, Fat tissue increased, Fibromyalgia
Clinical narrative: Left arm site injection was painful, warm, red, and swollen 2 days after injection. Developed headaches daily (after Botox injections) 2/9/22. Severe lower back pain after epidural injection for lower back pain 1/28/22. Underlying fibromyalgia aggravated, joint pain in body, stiff neck, pain radiating from back of head, neck to shoulder Developed pain in lower lf wrist, ganglion cyst appeared overnight. Cortisone injection for pain, then an ultrasound on wrist to rule out aneurysm. Developed constant ringing in both ears, watering eyes, runny nose, Mouth - inflamed gums & irritated tongue-in-cheek. April I developed new problems lower back pain &radiating down sciatic, fatty tissue developing at pain joints.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Glossitis, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm site injection was painful, warm, red, and swollen 2 days after injection. Developed headaches daily (after Botox injections) 2/9/22. Severe lower back pain after epidural injection for lower back pain 1/28/22. Underlying fibromyalgia aggravated, joint pain in body, stiff neck, pain radiating from back of head, neck to shoulder Developed pain in lower lf wrist, ganglion cyst appeared overnight. Cortisone injection for pain, then an ultrasound on wrist to rule out aneurysm. Developed constant ringing in both ears, watering eyes, runny nose, Mouth - inflamed gums & irritated tongue-in-cheek. April I developed new problems lower back pain &radiating down sciatic, fatty tissue developing at pain joints.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Lacrimation increased, Musculoskeletal stiffness, Neck pain, Noninfective gingivitis
Clinical narrative: Left arm site injection was painful, warm, red, and swollen 2 days after injection. Developed headaches daily (after Botox injections) 2/9/22. Severe lower back pain after epidural injection for lower back pain 1/28/22. Underlying fibromyalgia aggravated, joint pain in body, stiff neck, pain radiating from back of head, neck to shoulder Developed pain in lower lf wrist, ganglion cyst appeared overnight. Cortisone injection for pain, then an ultrasound on wrist to rule out aneurysm. Developed constant ringing in both ears, watering eyes, runny nose, Mouth - inflamed gums & irritated tongue-in-cheek. April I developed new problems lower back pain &radiating down sciatic, fatty tissue developing at pain joints.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Rheumatoid factor negative, Rhinorrhoea, Sciatica, Synovial cyst
Clinical narrative: Left arm site injection was painful, warm, red, and swollen 2 days after injection. Developed headaches daily (after Botox injections) 2/9/22. Severe lower back pain after epidural injection for lower back pain 1/28/22. Underlying fibromyalgia aggravated, joint pain in body, stiff neck, pain radiating from back of head, neck to shoulder Developed pain in lower lf wrist, ganglion cyst appeared overnight. Cortisone injection for pain, then an ultrasound on wrist to rule out aneurysm. Developed constant ringing in both ears, watering eyes, runny nose, Mouth - inflamed gums & irritated tongue-in-cheek. April I developed new problems lower back pain &radiating down sciatic, fatty tissue developing at pain joints.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Tinnitus, Ultrasound scan
Clinical narrative: Left arm site injection was painful, warm, red, and swollen 2 days after injection. Developed headaches daily (after Botox injections) 2/9/22. Severe lower back pain after epidural injection for lower back pain 1/28/22. Underlying fibromyalgia aggravated, joint pain in body, stiff neck, pain radiating from back of head, neck to shoulder Developed pain in lower lf wrist, ganglion cyst appeared overnight. Cortisone injection for pain, then an ultrasound on wrist to rule out aneurysm. Developed constant ringing in both ears, watering eyes, runny nose, Mouth - inflamed gums & irritated tongue-in-cheek. April I developed new problems lower back pain &radiating down sciatic, fatty tissue developing at pain joints.
Age: 36.0
Sex: F
Vaccine: PNC15
Symptoms: Blood glucose fluctuation, Injected limb mobility decreased, Injection site pain, Injection site warmth, Somnolence
Clinical narrative: About 6 hours after injection, site got very sore and I haven?t been able to lift left arm. Arm is very tender to the touch and warm. I am also very sleepy for past several hours, and my blood sugar has been doing a roller coaster of highs and lows, and there hasn?t been any abnormalities to my eating routine.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed COVID positive; diagnosed COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (003110). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: diagnosed COVID Positive; Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took the five-day Paxlovid (nirmatreivir) treatment package. His symptoms mostly disappeared and felt much better afterward but still tested (on a home test) positive. Where can find information about the experience of others and if something similar happened. Patient was told he could test positive for three months after treatment. Is this normal, patient wants to know. Patient diagnosed COVID positive after Pfizer Covid primary series and both boosters. Initially tested positive after taking 5-day regimen of Paxlovid, but now testing negative. Patient states the product was very, very effective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Customer reported that improperly stored vaccine was administered to 10 separate patients. No additional AE reported; Customer reported that improperly stored vaccine was administered to 10 separate patients. No additional AE reported; This spontaneous report was received from an office manager referring to a 18 months patient, gender unknown. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-APR-2022, the patient was vaccinated with an improperly stored of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # T042013 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 22-JUL-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 11.43° Celsius (C) for 1 hour and 45 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.; Sender's Comments:  US-009507513-2205USA003131:
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; Caller reports that a husband and wife was administered expired doses of MMR II.; This spontaneous report was received from a registered nurse concerning a male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (lot #T016197, has been verified to be valid, expiration date: 11-MAY-2022), administered for prophylaxis (strength, and route of administration were not provided). No further information was provided, and no other adverse events were reported.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2205USA003756:
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; Caller reports that a husband and wife was administered expired doses of MMR II.; This spontaneous report was received from a registered nurse concerning a female patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (lot #T016197, has been verified to be valid, expiration date: 11-MAY-2022), administered for prophylaxis (strength, and route of administration were not provided). No further information was provided, and no other adverse events were reported.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2205USA003749:
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AEs reported; On 17MAY2022, the patient was administered a second dose of VARIVAX, along with a dose of PROQUAD; This spontaneous report was received from a nurse concerning a 35 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.     On 19-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  On 17-MAY-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter for prophylaxis (lot number U025205 was determined to be valid for varicella virus vaccine live (oka/merck), expiration date reported and established as 13-AUG-2023) (strength, route of administration and anatomical location were not provided) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot number U029325 was determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and established as 19-MAR-2023) (strength, route of administration and anatomical location were not provided) (overdose).   No adverse event reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: I got the original shingles shot almost 10 years ago. Turns out it only about 30% effective.; swelling, heat, and pain at the injection site; heat, and pain at the injection site; pain at the injection site; Got the Shingrix shots; This spontaneous report has been received from a female patient of unknown age via social media, reporting on herself. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date in 2012 (reported as "almost 10 years ago"), the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (reported as "original shingles shot") (dosage regimen, lot #, expiration date, route of administration and anatomical location were not provided) as prophylaxis.  According to the reporter, the dose of zoster vaccine live (manufacturer unknown) was only about 30% effective (therapy product effect incomplete); therefore, she was vaccinated with the first and second doses (reported as "it is a two shot deal") of zoster vaccine recombinant, adjuvanted (SHINGRIX) (dosage regimen, frequency, route of administration, lot#, expiration date, and indication were not provided) on an unknown date (extra dose administered), and according to the patient had a higher rate of effectiveness. On an unknown date, the patient and her husband experienced swelling (injection site swelling), heat (injection site warmth) and pain at the injection site (injection site pain). At the time of the report, the outcome of all events were not reported.  The causal relationship between all reported events, zoster vaccine live (manufacturer unknown), and zoster vaccine recombinant, adjuvanted (SHINGRIX) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Nurse reporting VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from a nurse concerning a patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies, and concomitant medications were not provided.  On 28-APR-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml) (valid lot number U022320 [expiration date 15-JUL-2023]) for prophylaxis, after a temperature excursion of -12 degrees Celsius (C) for 24 hours (h) (product storage error) (dose number, vaccination scheme, frequency, route and anatomical location of vaccination were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reporting PROQUAD was administered after a temperature excursion. No additional AE. No PQC.; Nurse reporting PROQUAD was administered after a temperature excursion. No additional AE. No PQC.; This spontaneous report was received from a a registered nurse referring to a patient of unknow age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 03-MAY-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 mL as prophylaxis (route of administration, vaccination scheme frequency, anatomical location were not reported; valid lot number U029321 with expiration date 19-MAR-2023). The administered dose of the vaccine experienced a temperature excursion -12 degrees Celsius (C) for 24 hours. There were no previous temperature excursions before, adverse effects, or product quality complaints (PQC).
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Skull fracture, Syncope
Clinical narrative: fracturing skull; collapses on stage, hits floor; This case was reported by a consumer via other manufacturer and described the occurrence of skull fracture in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced skull fracture (serious criteria GSK medically significant) and syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the skull fracture and syncope were unknown.   It was unknown if the reporter considered the skull fracture and syncope to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: The patient self-reported this case, was a comedian. The patient mocked about having the 3 experimental jabs, plus a shingles and flu vaccine, then instantly collapsed on stage fracturing her skull as she hit the floor. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cyst, Surgery
Clinical narrative: shoulder pain; soft tissue cyst; This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shoulder pain and cyst. On an unknown date, the outcome of the shoulder pain and cyst were unknown.   It was unknown if the reporter considered the shoulder pain and cyst to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments:  The reporter reported that in August 2020 administered the 1st Shingrix vaccine to patient. The reporter called patient after the 2 months waiting period to schedule the 2nd dose and was informed that patient was not going to take it due to having significant shoulder pain. The reporter received a legal notice on 23rd May 2022 that the patient had less than 2 years after vaccination developed a soft tissue cyst that had to be surgically removed. The reporter asked was this a problem that had previously noted with this product.
Sex: F
Vaccine: TDAP
Symptoms: Induration, Panniculitis
Clinical narrative: panniculitis; severe induration; This case was reported by a nurse via sales rep and described the occurrence of panniculitis in a adolescent female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix with an associated reaction of panniculitis (received 1st dose of and experienced Panniculitis, refer case US2022082817).   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced panniculitis (serious criteria GSK medically significant) and induration. Rechallenge with Boostrix was positive. On an unknown date, the outcome of the panniculitis and induration were unknown.   It was unknown if the reporter considered the panniculitis and induration to be related to Boostrix.     Linked case(s) involving the same patient:  US2022082817   Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: The reporter stated that the patient received second dose of Boostrix on unknown arm and very soon after developed severe induration and panniculitis No further details provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022082817:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: had the shingles shot and now has Gillian Bare; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received Shingles vaccine. In May 2022, less than 3 weeks after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-May-2022 Reporter's comment: The case was received from the patient's son/ daughter via interactive digital media. The reporter' father just had the shingles shot 3 weeks ago and now he has had guillain barre syndrome. The reporter want people to knew that you can get it from the shot . Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and has had shingles/Suspected vaccination failure; had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for 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: GSK Receipt Date: 21-MAY-2022 Reporters comment:  The case was reported by the patient's son/daughter via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles twice. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccination and got shingles/Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for 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: GSK Receipt Date: 21-MAY-2022 Reporters comment: The case was reported by the patient's son/daughter via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and has been with shingles/Suspected vaccination failure; has been with shingles; she has been in bed wth shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for 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 bedridden. On an unknown date, the outcome of the vaccination failure, shingles and bedridden were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and bedridden to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-MAY-2022 Reporters comment:  The case was reported by the patient's neighbor via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles on her face and she had been in bed with shingles for days at the time of reporting. The patient asked her doctor why she got shingles if she was vaccinated for it and he said that it happens. The reporter stated that, the shot did not stop you from getting shingles. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot, got shingles/Suspected vaccination failure; got shingles; This 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, 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: GSK Receipt Date: 21-MAY-2022 Reporters comment:  The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Only a slight sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-MAY-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient received Shingles vaccine and experienced only a slight sore arm. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.  Note: Case kept conservatively valid since no contact details available for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I had side effects, very very painful arm stayed painful for months; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received the dose of Shingles vaccine and had side effects such as very painful arm which stayed painful for months.  Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Rash
Clinical narrative: couple of places, rash formed; feeling cruddy; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash and feeling unwell. On an unknown date, the outcome of the rash and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the rash and feeling unwell to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR083958   Additional Information: GSK Receipt Date: 21-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The Shingles vaccine had a pretty high rate of side effects.  The patient had a few hours of feeling cruddy with the first dose and a couple of places where a rash formed. Additional Supportive Information: For tolerance of 2nd dose of Shingles vaccine, refer linked case US2022AMR083958, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083958:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: I had the vaccine and still got them/Suspected vaccination failure; still got them; still having nerve pain; This 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, less than 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-MAY-2022 Reporters comment:  The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, you were correct, 3 months after receiving Shingles vaccine, he/she was still having nerve pain till the time of reporting Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: 10 days later got shingles; Worst pain i ever had; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had worst pain. The patient ever had got the new vaccination and 10 days later got Shingles. Additional supportive information:  Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Influenza like illness, Lymphadenopathy
Clinical narrative: ill for almost 3 days; Felt like I had the flu; enlarged lympnodes on side of body where the shot; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of rash (1st dose received on an unknown date and experienced rash, refer linked case US2022AMR083947).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness, influenza-like symptoms and enlargement of lymph nodes. On an unknown date, the outcome of the illness, influenza-like symptoms and enlargement of lymph nodes were recovered/resolved.   It was unknown if the reporter considered the illness, influenza-like symptoms and enlargement of lymph nodes to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR083947   Additional Information: GSK Receipt Date: 21-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The Shingles vaccine had a pretty high rate of side effects.  The patient was ill for almost 3 days  The patient felt like he/ she had the flu, enlarged lymph nodes on the side of body where he/ she had the shot.  Even with all that patient would do it all over again. Shingles was so much worse. Additional Supportive Information: Follow up would not be possible since no contact details were reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083947:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus, Vertigo
Clinical narrative: I've been vertigo; I've been ringing in my ears; This case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vertigo and ringing in ears. On an unknown date, the outcome of the vertigo and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the vertigo and ringing in ears to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had been experiencing vertigo and ringing in ears since taking first dose of Shingrix vaccine. The patient asked if he/she should still get a second dose of Shingrix vaccine. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: mildly sore arm for a day or two; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced mildly sore arm for a day or two, just as he/she would have from any other vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Electric shock sensation, Herpes zoster, Vaccination failure
Clinical narrative: going through this now after getting 2nd shot/Suspected vaccination failure; going through this now after getting 2nd shot; it's like electrical shocks; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria medically significant), shingles and electric shock sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and electric shock sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and electric shock sensation to be related to Shingrix and Shingrix.     Additional Information: Receipt Date: 22-MAY-2022 Reporters comment:  The case was reported by the patient's brother or sister via interactive digital media and described the occurrence of suspected vaccination failure. The patient received 2nd dose of Shingrix and 4th booster dose of Covid 19 vaccine together. After receiving Shingrix and Covid booster vaccine, the patient was going through shingles at the time of reporting. The reporter stated that, did not know why doctor suggested both the vaccines at same time. The patients told the reporter that, it was like electrical shocks. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR083986   Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's Comments: The patient self-reported this case via interactive digital media.  The patient received 1st dose of Shingles vaccine on an unknown date and experienced no effects other than slightly sore arm. The patient was so relieved that he/she got it. Much better than having shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR083986, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083986:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: sore arm; red area; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2022AMR083982).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and erythema. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR083982   Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced sore arm and red area. The patient was so relieved that he/she got it. The patient further stated it was much better than having shingles. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083982:Same reporter