chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Respiratory tract congestion, Urine analysis normal, Weight decreased
Clinical narrative: The first 2 days I experience congestion and severe arm pain. The following 2 days I experienced fatigue, dizziness when standing up, and the inability to eat. The following day (Wednesday, August 18) I woke up with severe chest pain. The chest pain made it extremely painful to eat or drink anything. I experienced no pain in my esophagus, it was as though the effort to eat or drink intensified the pain I was feeling in my chest. On Thursday I went to my doctors office where an EKG, urine sample, and blood work were done on me, both came back within normal range but I was severely dehydrated. They couldn?t figure out what was wrong, but said if the pain got worse to go to the ER. I woke up on Friday and the pain was worse. I hadn?t eaten in several days and had lost 15 lbs in one week. I went to the ER where they did blood work, a urine sample, an EKG, gave me a IV drip for my dehydration, and X-ray on my chest, and a CAT scan.  The CAT scan relieved I had a blood clot in my lung. I was immediately told to stop taking birth control and I was put on blood thinners, nausea medicine, ulcer medicine (although I didn?t have issues with my through, they just didn?t know what else to do to help with my eating/drinking complications) and blood thinners. I was worried because my current birth control kept me from having my period, so as soon as I was told to stop and put on blood thinners I had my period. Normally I have period that last 7 days and are heavy, but due to the blood thinners my period was extremely heavy flow. Even more than usual.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event reported.  The patient's mother filled out the immunization consent form and screening form.  On both forms mother wrote the date of birth of the patient as 11/16/2008.  Before the pharmacist gave the vaccination, she confirmed the patient's age. Account flagged the account because the patient's actual date of birth through vital records is 11/16/2009.  I tried to call mother several times.  Her voice message is full and I am unable to leave a message.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received at 13 years and 2 months; No other AEs; This spontaneous report was received from a nurse prescriber and refers to a 13-year-old patient of an unspecified gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.      On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route of administration, anatomical location were not reported, dose, lot # and expiration date were unknown) for prophylaxis, at age of 13-year and 2 months old (inappropriate age at vaccine administration). No adverse event (AE) reported (no adverse event). No other information was available.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Dry mouth, Dysgeusia, Dysphagia, Dyspnoea
Clinical narrative: anaphylactic reaction to the vaccine almost immediately and was hospitalized; antihistamines were not working; cellulitis around the injection site; Her left arm felt like it had "snakes crawling underneath it" and was swollen; Her left arm felt like it had "snakes crawling underneath it" and was swollen; fever; This spontaneous report has been received from a 29 years old female consumer referring to herself. The patient did not have any concomitant medication or pertinent medical history.  On 07-NOV-2005, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose detail, route, lot # and expiration date were not reported) in the left arm for chicken pox prophylaxis.   On 07-NOV-2005, almost immediately after vaccination, the patient experienced an anaphylactic reaction to the vaccine and was hospitalized. She reported that her throat closed up, her tongue became swollen, she felt like she couldn't breathe, was unable to swallow, and her mouth became very dry and had a "metallic" taste. It was reported that the back of her throat "looked like Hiroshima", being bright red and her tongue "tripled in size". She had a fever and was sweating for a few days. Her chest turned red and "felt like it was on fire". Her left arm felt like it had "snakes crawling underneath it" and was swollen (vaccination site swelling, vaccination site discomfort). Her armpits and groin "were on fire". She developed cellulitis around the injection site (vaccination site cellulitis). She felt pain behind her eyes and her eyes became red. It was also reported that her lymph nodes were swollen and that she "looked like a Fighting Championship fighter". She reported that antihistamines (unspecified) were not working (drug ineffective). She sought medical attention and there were no lab diagnostics/studies performed. The patient did not receive the 2nd dose of the vaccine due to her reactions. The outcome of drug ineffective to antihistamines was unknown. The outcome of remaining events was recovered on an unknown date (reported as a few weeks afterwards). The reporter considered anaphylactic reaction, vaccination site swelling, vaccination site discomfort, vaccination site cellulitis to be related to varicella virus vaccine live (oka/merck)(VARIVAX). The causality was not provided for other events.   Upon internal review, anaphylactic reaction to the vaccine was determined to be medically significant.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Eye pain, Hyperhidrosis, Lymphadenopathy, Ocular hyperaemia
Clinical narrative: anaphylactic reaction to the vaccine almost immediately and was hospitalized; antihistamines were not working; cellulitis around the injection site; Her left arm felt like it had "snakes crawling underneath it" and was swollen; Her left arm felt like it had "snakes crawling underneath it" and was swollen; fever; This spontaneous report has been received from a 29 years old female consumer referring to herself. The patient did not have any concomitant medication or pertinent medical history.  On 07-NOV-2005, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose detail, route, lot # and expiration date were not reported) in the left arm for chicken pox prophylaxis.   On 07-NOV-2005, almost immediately after vaccination, the patient experienced an anaphylactic reaction to the vaccine and was hospitalized. She reported that her throat closed up, her tongue became swollen, she felt like she couldn't breathe, was unable to swallow, and her mouth became very dry and had a "metallic" taste. It was reported that the back of her throat "looked like Hiroshima", being bright red and her tongue "tripled in size". She had a fever and was sweating for a few days. Her chest turned red and "felt like it was on fire". Her left arm felt like it had "snakes crawling underneath it" and was swollen (vaccination site swelling, vaccination site discomfort). Her armpits and groin "were on fire". She developed cellulitis around the injection site (vaccination site cellulitis). She felt pain behind her eyes and her eyes became red. It was also reported that her lymph nodes were swollen and that she "looked like a Fighting Championship fighter". She reported that antihistamines (unspecified) were not working (drug ineffective). She sought medical attention and there were no lab diagnostics/studies performed. The patient did not receive the 2nd dose of the vaccine due to her reactions. The outcome of drug ineffective to antihistamines was unknown. The outcome of remaining events was recovered on an unknown date (reported as a few weeks afterwards). The reporter considered anaphylactic reaction, vaccination site swelling, vaccination site discomfort, vaccination site cellulitis to be related to varicella virus vaccine live (oka/merck)(VARIVAX). The causality was not provided for other events.   Upon internal review, anaphylactic reaction to the vaccine was determined to be medically significant.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Pharyngeal erythema, Pyrexia, Skin burning sensation, Swollen tongue, Throat tightness
Clinical narrative: anaphylactic reaction to the vaccine almost immediately and was hospitalized; antihistamines were not working; cellulitis around the injection site; Her left arm felt like it had "snakes crawling underneath it" and was swollen; Her left arm felt like it had "snakes crawling underneath it" and was swollen; fever; This spontaneous report has been received from a 29 years old female consumer referring to herself. The patient did not have any concomitant medication or pertinent medical history.  On 07-NOV-2005, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose detail, route, lot # and expiration date were not reported) in the left arm for chicken pox prophylaxis.   On 07-NOV-2005, almost immediately after vaccination, the patient experienced an anaphylactic reaction to the vaccine and was hospitalized. She reported that her throat closed up, her tongue became swollen, she felt like she couldn't breathe, was unable to swallow, and her mouth became very dry and had a "metallic" taste. It was reported that the back of her throat "looked like Hiroshima", being bright red and her tongue "tripled in size". She had a fever and was sweating for a few days. Her chest turned red and "felt like it was on fire". Her left arm felt like it had "snakes crawling underneath it" and was swollen (vaccination site swelling, vaccination site discomfort). Her armpits and groin "were on fire". She developed cellulitis around the injection site (vaccination site cellulitis). She felt pain behind her eyes and her eyes became red. It was also reported that her lymph nodes were swollen and that she "looked like a Fighting Championship fighter". She reported that antihistamines (unspecified) were not working (drug ineffective). She sought medical attention and there were no lab diagnostics/studies performed. The patient did not receive the 2nd dose of the vaccine due to her reactions. The outcome of drug ineffective to antihistamines was unknown. The outcome of remaining events was recovered on an unknown date (reported as a few weeks afterwards). The reporter considered anaphylactic reaction, vaccination site swelling, vaccination site discomfort, vaccination site cellulitis to be related to varicella virus vaccine live (oka/merck)(VARIVAX). The causality was not provided for other events.   Upon internal review, anaphylactic reaction to the vaccine was determined to be medically significant.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site cellulitis, Vaccination site discomfort, Vaccination site swelling
Clinical narrative: anaphylactic reaction to the vaccine almost immediately and was hospitalized; antihistamines were not working; cellulitis around the injection site; Her left arm felt like it had "snakes crawling underneath it" and was swollen; Her left arm felt like it had "snakes crawling underneath it" and was swollen; fever; This spontaneous report has been received from a 29 years old female consumer referring to herself. The patient did not have any concomitant medication or pertinent medical history.  On 07-NOV-2005, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose detail, route, lot # and expiration date were not reported) in the left arm for chicken pox prophylaxis.   On 07-NOV-2005, almost immediately after vaccination, the patient experienced an anaphylactic reaction to the vaccine and was hospitalized. She reported that her throat closed up, her tongue became swollen, she felt like she couldn't breathe, was unable to swallow, and her mouth became very dry and had a "metallic" taste. It was reported that the back of her throat "looked like Hiroshima", being bright red and her tongue "tripled in size". She had a fever and was sweating for a few days. Her chest turned red and "felt like it was on fire". Her left arm felt like it had "snakes crawling underneath it" and was swollen (vaccination site swelling, vaccination site discomfort). Her armpits and groin "were on fire". She developed cellulitis around the injection site (vaccination site cellulitis). She felt pain behind her eyes and her eyes became red. It was also reported that her lymph nodes were swollen and that she "looked like a Fighting Championship fighter". She reported that antihistamines (unspecified) were not working (drug ineffective). She sought medical attention and there were no lab diagnostics/studies performed. The patient did not receive the 2nd dose of the vaccine due to her reactions. The outcome of drug ineffective to antihistamines was unknown. The outcome of remaining events was recovered on an unknown date (reported as a few weeks afterwards). The reporter considered anaphylactic reaction, vaccination site swelling, vaccination site discomfort, vaccination site cellulitis to be related to varicella virus vaccine live (oka/merck)(VARIVAX). The causality was not provided for other events.   Upon internal review, anaphylactic reaction to the vaccine was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Pleural effusion, Pneumonia, Pyrexia
Clinical narrative: pneumonia; pleural effusion; fever; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 01-SEP-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered pneumonia, pleural effusion and fever. As a result of these symptoms, the patient was seen and treated by medical providers and was under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior the using of Zoster Vaccine Live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting in physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, 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 of patient's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and no economic damages.  At the reporting time, the outcome of pneumonia, pleural effusion, and pyrexia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of pneumonia was considered to be medically significant.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additioanl adverse effect reported; pedvaxhib that under a temperature excursion was administratered; This spontaneous report was received from a consumer, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not provided.     On 02-SEP-2021, the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T030707, expiration date 14-APR-2023; strength, dose and route were unknown) for prophylaxis that underwent a temperature excursion was administered (product storage error).         Temperature excursion of this vaccine was above 47 Fahrenheit degrees (54.1 Fahrenheit) for 1 hour 10 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event was reported.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles, including any and all of its sequelae; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a 66-year-old male patient. On 12-APR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administation, lot # and expiration date were not reported) at age of 63 years old (also reported as 66-year-old). As a result of his receipt of zoster vaccine live (ZOSTAVAX), on 21-SEP-2018, patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. Patient is informed and believes and further alleges that patient  will in the future be required to obtain further medical and/or hospital care, attention, and services. The outcome ofthe events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: big old red circles; itching; burning; This case was reported by a consumer via  interactive digital media and described the occurrence of localized erythema 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 localized erythema, localized itching and burning sensation. On an unknown date, the outcome of the localized erythema, localized itching and burning sensation were recovered/resolved.   It was unknown if the reporter considered the localized erythema, localized itching and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine had a reaction both times big old red circles itching and burning. The follow up would not be possible as no contact details were available. For tolerance of 2nd dose refer case US2021AMR186892, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186892:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details provided were as follows; The case was reported by patient's wife. Age at vaccination was not reported. The patient received Shingles vaccine and a week later experienced shingles. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Herpes zoster, Mobility decreased
Clinical narrative: small outbreak; my shoulder still hurts to the touch; 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.   The patient's past medical history included chronic pain (lived with chronic pain for 15 years).   On an unknown date, the patient received the 1st dose of Shingles vaccine. In August 2021, unknown after receiving Shingles vaccine, the patient experienced shingles and shoulder pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and shoulder pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that, having lived with chronic pain for 15 years and about 5 hours of the first Shingles shot, the patient's body felt like it filled with sand, laid in bed and almost cried because he/she felt zero pain, just a pleasant heavy feeling.  The patient said that, he/she could not wait for shot second shingles shot. The patient had another small outbreak a couple weeks ago from the time of reporting and his/her shoulder still hurts to the touch.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt not so great; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2021, the patient received the 1st dose of Shingrix. On 31st August 2021, less than a day after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's wife. Age at vaccination was not reported. The patient got dose 1 of Shingrix on the day of reporting. The patient felt not so great for 3 hours and at the time of reporting, felt great. The patient was expecting the worse but it was not bad. No contact details were available. The case had been linked with US2021AMR187034 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187034:same reporter
Age: 21.0
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose (0.5ml) to a 21 years; pediatric dose in error to a 21 year old; This case was reported by a physician via sales rep and described the occurrence of underdose in a 21-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric .5 ml. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details provided were as follows: The physician reported that a pediatric dose was administered in error to a 21 year old which led to underdose and adult use of a child product. The reporter denied to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shungles twice; 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 the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles twice after receiving one shingles shot. The patient stated that nothing was never.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: outbreak of herpes; This case was reported by a consumer via interactive digital media and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingrix vaccine 4 days ago and experienced an outbreak of herpes.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: allergic to the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine 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 allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was unknown.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient was vaccinated for shingles and was allergic to vaccine. The follow up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: wait until they were vaccinated for Covid before getting their second vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix over one year ago).   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 information was provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix over one year ago. The patient did not receive the 2nd dose of Shingrix till the time of reporting and was told to wait until he was vaccinated for Covid before getting the second Shingrix vaccination.  The pharmacist reported inappropriate schedule of vaccine and inquired if Shingrix series should be restarted. The patient received the full Covid vaccinations over 14 days before the day of reporting.  The reporter did not know exact dates of Shingrix or Covid immunizations. The reporter did not consent to follow up. This case is linked to case US2021188784 reported by same reporter for another patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021188784:Same reporter
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 3rd September 2021, less than 2 years 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. The patient received Shingles vaccine last year from the date of reporting. After receiving Shingles vaccine, the patient got diagnosed with shingles on the date of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 female 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. The action taken with Shingles vaccine was unknown. 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: The case was reported for the reporter's sister. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I've gotten shingles/ in my eye many times; This case was reported by a consumer via 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 ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster 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 in eye many times. 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, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; I've had them; still hurt; 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 pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had been vaccinated several times and it did not prevent shingles for him/her. After receiving Shingles vaccine, the patient got shingles four times. The patient had them in January and it still hurt at the time of reporting. The patient stated that, shingles got worsen every time. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; has them now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles at the time of reporting. 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; He got shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingles vaccine, the patient still 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: suspected vaccination failure; got them 4 times.; 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 still got shingles 4 times. 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: Bedridden, Herpes zoster, Pain in extremity, Scab, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; leisions crusted over; I was right down in bed for a month; leg pain; 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, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, bedridden, leg pain and scab. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, bedridden, leg pain and scab were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, bedridden, leg pain and scab 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. The patient reported that, doctor said anyone over 60 should have the Shingles shot. What they did not tell was that it was 50/50. Three months after receiving Shingles vaccine, the patient got shingles. The patient was right down in bed for a month and had leg pains for 6 weeks after the lesions crusted over.  The patient stated that, it was an awful experience.  The patient would tell everyone who was had chicken pox, do not get the Shingles shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot and got shingles/suspected vaccination failure; 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 details were reported as follows: The case was reported by the patient's relative. The age at vaccination was not reported. The patient had the shot and got shingles 4 times, get really did not work. 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the 2 shots and Got the friggin 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 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) 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 are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got 2 Shingles vaccine shots and had the frigging shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product label confusion
Clinical narrative: Hasn't gotten it in years, got it one time for sure; Supposed to get it every year; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female 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 and product label confusion. On an unknown date, the outcome of the incomplete course of vaccination and product label confusion were unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter stated that, she knows that she was supposed to get it every year, which led to product confusion. The patient got it one time for sure, but is unsure if she actually ever got a second dose. Agent called in an attempt to learn vaccination dates, but could not find any record (locally or system wide) of consumer ever having any prescription filled or vaccine being administered. Agent informed consumer. Gave medical disclaimer.  The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product administration error, Product preparation issue
Clinical narrative: First injection was only saline; First injection was only saline; Administered it incorrectly; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 20th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and drug administration error. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and drug administration error were unknown.  Additional details were provided are as follows: The case was reported by patient for himself. The patient reported that health care professional administered 2nd dose of Shingrix incorrectly which led to drug administration error. The patient stated that he was given 2 injections  and believed he was administered vaccine adjuvant without active component, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered.  Then the patient was given a second administration with the complete Shingrix vaccine. Registered pharmacist reviewed the stored video and stated the 1st injection was only saline. The patient stated he had an appointment to saw his primary care physician on Friday for a annual visit and would follow up with them on how to manage this event. Provided MI phone number for health care professional reference. The reporter consented to follow-up.
Age: 57.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: did not received 3rd dose; waited 5 months and get her second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 28th January 2021).   On 29th June 2021, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 3rd dose of Engerix B. On 29th June 2021, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.  Additional details were provided are as follows: Pharmacist reported that the patient waited 5 months to went back to the pharmacy and get her 2nd dose of Engerix-B later than recommended interval, which led to lengthening of vaccine schedule. Till the time of reporting, the patient did not received 3rd dose of Engerix-B yet, which led to incomplete course of vaccination. The reporter would like to know if they could gave her 3rd dose of vaccine on 31st August 2021, or how did they need to proceed. No further details were provided at the time of the call. The reporter consented to follow-up via phone.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Neuropathy peripheral, Paraesthesia
Clinical narrative: it feels like stepping on wet pad; strange sensation on the sole of the feet; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th August 2021, 4 days after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant) and weird feeling. On an unknown date, the outcome of the peripheral neuropathy and weird feeling were not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy and weird feeling to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix into the muscle on the right deltoid and after about 4 days, he experienced strange sensation on the sole of the feet.  The patient stated that it was difficult for him to elaborate the strange sensation but stated it feels like stepping on wet pad. The symptom was ongoing and not resolved.  The reporter gave a consent to follow-up with health care professional. However, he did not have mailing address, fax number, or an email address to health care professional. He provided his personal email address. The reporter did not have Shingrix lot number, expiry date and dose for the vaccine he received.  The reporter consented to follow up.