chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient received improperly stored vaccine on 08/26/2021; This spontaneous report was received from a medical assistant, referring to 4-year-old male patient. The patients' historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 26-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live albumin status rHA (recombinant Human albumin)  (PROQUAD) 1 dose, lot# U009262, expiration date 19-SEP-2022, for prophylaxis (strength, dose, route, frequency were not reported).  The temperature excursion was of -3.3 centigrade degrees (°C), for 4 hours 52 minutes. A previous temperature excursion of was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events of multiple outbreaks of herpes zoster and postherpetic neuralgia were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around August 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was considered to be medically significant.  The event of hearing loss was determined to be disabling.
Age: 0.17
Sex: M
Vaccine: HIBV, RV5
Symptoms: Blister, Diarrhoea, Flushing, Irritability, Pruritus
Clinical narrative: flush/diffuse flushing; itch; blister; vomiting; diarrhea; irritability; This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 2-month-old male patient. No information regarding the patient's medical history was provided. His concurrent condition included maculopapular cutaneous mastocytosis (MPCM).  At 6-month visit, the patient's vaccines included 3rd dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP), polio vaccine inact (IPV), pneumococcal vaccine conj (PCV13), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (vaccination date, exact dose, vaccination site, route of administration, lot # and expiration date were not provided for all). The number of lesions at initial visit was greater than 100. His tryptase level was 5.8 micro-g/L. On an unknown date, the patient experienced cutaneous symptoms and signs: flush, itch, blister; and systemic symptoms: vomiting, diarrhea, irritability. Cutaneous reaction location was within prior MPCM lesions, diffuse flushing. Time interval was reported as hours. As a treatment, he received oral antihistamines. The outcome of the events was unknown.  The authors considered the events to be related to the suspect vaccines.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.17
Sex: M
Vaccine: HIBV, RV5
Symptoms: Tryptase, Vomiting
Clinical narrative: flush/diffuse flushing; itch; blister; vomiting; diarrhea; irritability; This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 2-month-old male patient. No information regarding the patient's medical history was provided. His concurrent condition included maculopapular cutaneous mastocytosis (MPCM).  At 6-month visit, the patient's vaccines included 3rd dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP), polio vaccine inact (IPV), pneumococcal vaccine conj (PCV13), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (vaccination date, exact dose, vaccination site, route of administration, lot # and expiration date were not provided for all). The number of lesions at initial visit was greater than 100. His tryptase level was 5.8 micro-g/L. On an unknown date, the patient experienced cutaneous symptoms and signs: flush, itch, blister; and systemic symptoms: vomiting, diarrhea, irritability. Cutaneous reaction location was within prior MPCM lesions, diffuse flushing. Time interval was reported as hours. As a treatment, he received oral antihistamines. The outcome of the events was unknown.  The authors considered the events to be related to the suspect vaccines.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Illness, Malaise, Mobility decreased, Vomiting
Clinical narrative: really sick; deathly suck vomit; Diarrhea sick for 2 days in bed; 2 days in bed; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 63-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (The patient saw her parent go through pain at home for shingles in 2021 age 88 years old).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, vomiting, diarrhea and mobility decreased. On an unknown date, the outcome of the sickness, vomiting and diarrhea were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the sickness, vomiting, diarrhea and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's parent. The patient got the shingle shot at age 63 years this year. She got really sick from the shot. She had side effects including deathly suck vomiting.  The patient also had diarrhea and was sick for 2 days in bed.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: got the first one and had a allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had an allergic reaction. The patient stated that he/ she cannot get the second one.  The patient also enquired about how protected he/ she was.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Feeling abnormal, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: allergic reaction; hives from head to ankles/ I look like a burn victim.; miserable and itches like mad.; anxiety; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's dad and daughter suffered with shingles and it was extremely painful).   In April 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, between 3 and 4 months after receiving Shingles vaccine, the patient experienced allergic reaction, hives, pruritus and anxiety. The patient was treated with antihistamine. On an unknown date, the outcome of the allergic reaction, hives, pruritus and anxiety were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, hives, pruritus and anxiety to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 1st dose of Shingles vaccine in April and the patient had allergic reaction to which the patient was still dealing with at the end of August. It started out in hives from head to ankles and the hives spread out until their edges met and at the time of reporting, the patient looked like a burn victim. The patient stated fortunately, though it looks quite painful it was not but it was absolutely miserable and itched like mad. The patient also mentioned that most days his/her anxiety level from itching was through the roof. The patient used Anti-histamines but they were ineffective. The patient being seen by dermatology but treatments had been ineffective. The patient stated he/she still encouraged folks to get the vaccine. Having a reaction like what patient had was a long shot.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Hurt Worse Than COVID-19 Vaccination; Arm Was Sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 71-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID-19 VACCINE UNKNOWN with an associated reaction of pain (received dose on an unknown date).   On 2nd July 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the 1st shot in 2nd July 2021 and it hurt worse than covid-19 vaccination and the arm was sore for a whole week but the patient believed it was worth it. The patient heard that shingles was no joke, also said that he/she would take 2nd dose in 9th September 2021. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: sore arm/most painful shot; Couldn't hardly lift it; This case was reported by a consumer via  interactive digital media and described the occurrence of injected limb mobility decreased 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, 1 day after receiving Shingles vaccine, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and patient stated that it was the most painful shot he/she had but well worth it. One day after the vaccination the patient had sore arm and did not able to lift arm but it was better 24 hours later. The reporter stated that he/she had heard so many reports about how awful shingles were and patient did not wait to get 2 course vaccine. The reporter stated that did not want darn shingles. For tolerance of 2nd dose of Shingles vaccine, refer case US2021AMR183248 .; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183248:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site joint pain, Peripheral swelling
Clinical narrative: pain / shoulder to elbow, left arm/Injection site shoulder pain; Pain at injection site, radiating from shoulder to elbow; arm is still slightly swollen; This case was reported by a consumer via call center representative and described the occurrence of injection site joint pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 19th March 2021, for tolerance refer case US2021182206).   On 31st July 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2021, 5 hrs after receiving Shingrix, the patient experienced injection site joint pain, pain in elbow and swelling arm. On an unknown date, the outcome of the injection site joint pain, pain in elbow and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site joint pain, pain in elbow and swelling arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient received the 2nd dose of Shingrix in left arm and patient experienced pain which was from shoulder to elbow in left arm. The patient also had slightly swelling on arm. The reporter stated that, she was still having pain since then and also still slightly swollen. The reporter referred her to HCP (Health care professional). The reporter consented to follow up. This case was linked with US2021182206 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021182206:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: sore arm/most painful shot; Couldn't hardly lift it; This case was reported by a consumer via interactive digital media  and described the occurrence of injected limb mobility decreased 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 unknown date, for tolerance refer case US2021AMR183231).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced injected limb mobility decreased and pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 2nd dose of Shingles vaccine and the patient stated that it was the most painful shot he/she had but well worth it. One day after the vaccination, the patient had sore arm and did not able to lift arm but it was better 24 hours later. The reporter stated that he/she had heard so many reports about how awful shingles were and patient did not wait to get 2 course vaccine. The reporter stated that did not want darn shingles. The case was linked with US2021AMR183231 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183231:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: the area had a tiny hot fever; little itch; This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, pain, pruritus and shingles (Family History) (The patient's father had shingles for two years all over and around his entire torso).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site warmth and injection site itching. On an unknown date, the outcome of the injection site warmth and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site warmth and injection site itching to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the dose of Shingles vaccine and the area had a tiny hot fever and was little itchy. The reporter stated that, it was gone within a couple of days verses the shingles over a month. The reporter mentioned you could not get any relief no matter what and stated got a new doctor.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: it made me very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included rash (had rash in eye) and headache (had absolutely horrid nonstop headaches). Concurrent medical conditions included scar.   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 sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The patient was 49 years old and had asked for vaccine before and was told not old enough.  The patient went to emergency room with rash in eye and absolutely horrid nonstop headaches.  The patient had scars on his/her face. The patient got vaccine following year and was very sick 2 days. For tolerance to 2nd dose Shingles vaccine, refer case US2021AMR183340.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183340:Same reporter
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Rash, Scar
Clinical narrative: gave me bad headache; This case was reported by a consumer via  interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included rash (had rash in eye) and headache (had absolutely horrid nonstop headaches). Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date and experienced sickness for tolerance refer case US2021AMR183327). Concurrent medical conditions included scar.   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 headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The patient was 49 years old and had asked for vaccine before and was told not old enough.  The patient went to emergency room with rash in eye and absolutely horrid nonstop headaches.  The patient had scars on his/her face. The patient got second dose of Shingles vaccine and experienced bad headache. The patient went to emergency room.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183327:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: I got mine from a vaccine!/suspected vaccination failure; I got mine; sick; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and sickness were not recovered/not resolved.   The reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles from a vaccine and still had shingles 6 months later and he/she was sick of being sick. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles; High level of stress; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included stress (4 years ago the patient had stressful situation ), difficulty in standing (the patient couldn't stand to wear pants for 6 weeks) and pain. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received single dose of shingles vaccine 8 years ago and experienced shingles).   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 stress. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that 8 years ago the patient had the single vaccine. 4 years ago after a stressful situation the patient came down with shingles around waist and on upper hips. The patient could not stand to wear pants for 6 weeks and could barely stand loose underwear. When the patient recovered the doctor gave a prescription for the 2 shots about 2 months apart. The one shot vaccine was not as effective. The patient got shingles 3 years after taking shingles vaccine. They were so painful.  The patient had received two shingles shots and still experienced shingles. The physician said high level of stress caused flare up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after having the shot/Suspected vaccination failure; Got 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. As per the patient vaccine did not work for everyone. The patient got shingles after had the 2 Shingles shots and hoped better results. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR186902, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shots, 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 a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots and still got the shingles, but they were not severe. The patient stated, if he/she did not get the Shingles shot, they would have been worse. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Visual impairment
Clinical narrative: New and approved vaccine, then got a real bad case/Suspected vaccination failure; got a real bad case that caused her to lose some vision in one eye; Lose some vision in one eye; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received first vaccine on an unknown date and then experienced a mild case of 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), ophthalmic herpes zoster (serious criteria GSK medically significant) and vision decreased. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and vision decreased were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and vision decreased to be related to Shingles vaccine.  Additional details were reported as follows: The patient was the reporter's mother. The age at vaccination was not reported. The physician told the patient hat she needed the new and approved shignles vaccine. The patient then got a real bad case that caused her to lose some vision in one eye. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles in his eye; eye pain; This case was reported by a consumer via media  and described the occurrence of suspected vaccination failure in a male 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), ophthalmic herpes zoster (serious criteria GSK medically significant) and eye pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and eye pain to be related to Shingles vaccine.  Additional details were provided as follows The case was reported for the reporter's brother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles in his eye in terrible pain. 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 of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Not getting 2nd dose, not uncommon due to COVID pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that, the patient never came back for second dose.  The pharmacist had no further details regarding patient or product, She stated that, this was not uncommon due to COVID pandemic, which led to social problem. The reporter consented to follow up. This case had been link with US2021183424, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183424:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get the 2nd dose within 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. 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 of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had it twice I got the Shingles vaccine also/suspected vaccination failure; had it; 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 case was reported by the patient. The age at vaccination was not reported as follows: The patient had the shingles twice and you did not want it, was just awful. The patient got the Shingles vaccine also and then it was not supposed to get shingles more than once but the patient did and it was nasty. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash, Vaccination failure
Clinical narrative: had the two other shots. Again, later! I had shingles/Suspected Vaccination failure; had shingles; rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included rash. Previously administered products included Zostavax with an associated reaction of herpes zoster (within the 3 months, had shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shot when only one was available and within 3 months, the patient had shingles. A couple years later, the patient had the 2 Shingles shots and again later had the shingles. Neither case was terrible or painful, the patient never had blisters either time just the rash. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2 PEOPLE GOT THE SHOT, STILL BROKE OUT WITH SHINGLESsuspected 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 reported as follows: The age at vaccination was not reported. The patient got the Shingles shot and still broke out with shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR186373, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186373:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2 PEOPLE GOT THE SHOT, STILL BROKE OUT WITH SHINGLESsuspected 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 reported as follows: The age at vaccination was not reported. The patient got the Shingles shot and still broke out with shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR186362, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186362:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot later got the ShinglesSuspected 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, 1 month 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 case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and then about a month later got the shingles and would not wish this on the devil. The physician said the shingles was mild. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had vaccine and still had 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 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had vaccine and still had shingles. It did not prevent it. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got SHINGLES way after the shot / 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got Shingles way after the shot. The patient stated hope they had something better out there now. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Got the shot after me 2nd round & they came back about 4 months later / suspect 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shot after 2nd round and they came back about 4 months later. The patient had them 3 times now. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule and laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles twice after the vaccine / 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingles twice after the vaccine. The physician made the new vaccine and no shingles for several years. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.