chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Biopsy stomach abnormal, Disseminated cytomegaloviral infection, Granuloma skin, Histoplasmosis, Inflammation
Clinical narrative: non-necrotizing skin granuloma; diffuse neutrophil inflammation (DNI-type) gastrointestinal tract granuloma; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 12 year old patient of unknown gender with hemophagocytic lymphohistiocytosis (HLH). On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, the patient experienced non-necrotizing (M-type) skin granuloma. On an unknown date, the patient also experienced diffuse neutrophil inflammation (DNI-type) gastrointestinal tract granuloma. The patient had sustained small jejunal perforations; disseminated cytomegalovirus (CMV) and Histoplasma spp. infections were identified in addition to RuV. Predominant RVC+ cells were neutrophils and well-formed granulomas with clearly defined macrophage or neutrophil cores as present in skin biopsies were not observed. Nasopharyngeal swab was positive for iVDRV and gastrointestinal biopsies were positive for rubella virus capside (RVC). The patient was treated with antibiotics, antifungals, and oral steroids with no effect. The patient was also treated with intravenous immunoglobulins and received hematopoietic cell transplantation. At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (2201USA004372, 2202USA004885, 2202USA004887, 2202USA004888 and 2202USA004889).; Sender's Comments:  US-009507513-2201USA004372:
Sex: U
Vaccine: MMR
Symptoms: Jejunal perforation, Rubella, Stomach granuloma
Clinical narrative: non-necrotizing skin granuloma; diffuse neutrophil inflammation (DNI-type) gastrointestinal tract granuloma; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 12 year old patient of unknown gender with hemophagocytic lymphohistiocytosis (HLH). On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, the patient experienced non-necrotizing (M-type) skin granuloma. On an unknown date, the patient also experienced diffuse neutrophil inflammation (DNI-type) gastrointestinal tract granuloma. The patient had sustained small jejunal perforations; disseminated cytomegalovirus (CMV) and Histoplasma spp. infections were identified in addition to RuV. Predominant RVC+ cells were neutrophils and well-formed granulomas with clearly defined macrophage or neutrophil cores as present in skin biopsies were not observed. Nasopharyngeal swab was positive for iVDRV and gastrointestinal biopsies were positive for rubella virus capside (RVC). The patient was treated with antibiotics, antifungals, and oral steroids with no effect. The patient was also treated with intravenous immunoglobulins and received hematopoietic cell transplantation. At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (2201USA004372, 2202USA004885, 2202USA004887, 2202USA004888 and 2202USA004889).; Sender's Comments:  US-009507513-2201USA004372:
Sex: U
Vaccine: MMR
Symptoms: Autologous haematopoietic stem cell transplant, Dermatitis, Granuloma skin, Immunoglobulin therapy, Skin lesion
Clinical narrative: necrotizing epithelioid (M(n)-type) skin granuloma; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 1 year old patient of unknown gender with hemophagocytic lymphohistiocytosis (HLH). On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, soon after vaccination, the patient experienced non-necrotizing (M-type) skin granuloma. Skin biopsy was positive for iVDRV. The patient was treated with antibiotics with no effect. The patient was also treated with topical steroid with improvement. Additionally the patient was treated with intravenous immunoglobulins with no effect and with nitazoxanide with a result of fewer new lesions. Hematopoietic cell transplantation was performed (outcome not provided). At the time of the report, the patient's outcome was recovering.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (MARRS 2201USA004372, 2202USA004885, 2202USA004886, 2202USA004888 and 2202USA004889).; Sender's Comments:  US-009507513-2201USA004372:
Sex: U
Vaccine: MMR
Symptoms: Biopsy skin abnormal, Blood immunoglobulin M, Dermatitis, Granuloma, Granuloma skin
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to an 11 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, the patient experienced necrotizing neutrophilic (N-type) skin granuloma. Skin biopsy was positive for iVDRV. Rubella serology showed persistent RuV IgM antibody. The patient was treated with oral steroids with no improvement. Additionally, the patient underwent hematopoietic cell transplantation but did not survive to the procedure. The patient's outcome regarding necrotizing neutrophilic (N-type) skin granuloma was not recovered.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (MARRS 2201USA004372, 2202USA004885, 2202USA004886, 2202USA004887 and 2202USA004889).; Sender's Comments:  US-0209507513-2201USA004372:
Sex: U
Vaccine: MMR
Symptoms: Biopsy skin abnormal, Granuloma skin, Immunodeficiency
Clinical narrative: non-necrotizing (M-type) skin granuloma; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to an 11 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, the patient experienced non-necrotizing (M-type) skin granuloma. Skin biopsy of right index finger was positive for iVDRV, M-type granuloma. At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (MARRS 2201USA004372, 2202USA004885, 2202USA004886, 2202USA004887 and 2202USA004888).; Sender's Comments:  US-009507513-2201USA004372:
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 83-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was unknown. The reporter stated that the patient never had shingles in her life. The patient got the shingles shot and got shingles and suffered horribly. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I only got one shingle on my lower back; Was very painful; 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 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case The age at vaccination was not reported. A year after the patient got the shingles shot and the patient got shingles. The patient only got one shingles on his/her lower back.  The patient further stated that if patient had not got the shot, he/she would of have more shingles and that one was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Blister, Extra dose administered, Herpes zoster
Clinical narrative: Gotten it 8 times, vaccinated/suspected vaccination failure; shingles; lots of pain; I where my age is up where it is in the hip and the back it's a terrible pain; I where my age is up where it is in the hip and the back it's a terrible pain; Can barely move; bad blister; Extra dose administered; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included operation nos (had operation on an unknown date) and shingles (had got shingles every year, got shingles 8 times).   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and less than 9 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pain in hip, back pain, mobility decreased, blister and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles, pain, pain in hip, back pain, mobility decreased and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pain in hip, back pain, mobility decreased and blister to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had got shingles every year, got shingles 8 times. The patient was vaccinated three times the first one a year ago and the current two ones 7 months ago after his/her operation, which led extra dose administered. Two weeks that the patient went through a rush and he/she still with a lot of pain and could barely move where his/her age was up where they was in the hip and the back it's a terrible pain and a very bad blister that was shingles and that was only cured with medicine from the physician or staying in the house a lot to everything they used in the hospital when they performed an operation on CD or there were some mistakes. But it was the microphone when one said the things sorry that hope that he/she could saw it was not that which he/she got operated on but when his/her friends more thanks was very good they disinfect for whoever wants to use it if they did not went to their physician. This case was considered as suspected vaccination failure as details regarding the laboratory test confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mobility decreased, Pain, Vaccination failure
Clinical narrative: Gotten it 8 times, vaccinated/suspected vaccination failure; shingles; lots of pain; I where my age is up where it is in the hip and the back it's a terrible pain; I where my age is up where it is in the hip and the back it's a terrible pain; Can barely move; bad blister; Extra dose administered; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included operation nos (had operation on an unknown date) and shingles (had got shingles every year, got shingles 8 times).   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and less than 9 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pain in hip, back pain, mobility decreased, blister and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles, pain, pain in hip, back pain, mobility decreased and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pain in hip, back pain, mobility decreased and blister to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had got shingles every year, got shingles 8 times. The patient was vaccinated three times the first one a year ago and the current two ones 7 months ago after his/her operation, which led extra dose administered. Two weeks that the patient went through a rush and he/she still with a lot of pain and could barely move where his/her age was up where they was in the hip and the back it's a terrible pain and a very bad blister that was shingles and that was only cured with medicine from the physician or staying in the house a lot to everything they used in the hospital when they performed an operation on CD or there were some mistakes. But it was the microphone when one said the things sorry that hope that he/she could saw it was not that which he/she got operated on but when his/her friends more thanks was very good they disinfect for whoever wants to use it if they did not went to their physician. This case was considered as suspected vaccination failure as details regarding the laboratory test confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Large red area on arm; Large painful area on arm; This case was reported by a consumer via sales rep and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were unknown.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown, but patient's age was about over 50 year. The patient received Shingrix in an unknown arm. After receiving Shingrix, the patient had a large red painful area from shoulder to almost elbow and it was unknown on which arm. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Chapped lips, Chills, Herpes zoster, Injection site swelling
Clinical narrative: sores in nose, mouth; sores in nose, mouth; sore throat; chapped peeling lips; chapped peeling lips; pimple type spot close to his/her lip; chills; suspected vaccination failure; slight outbreak; injection site swollen; 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), shingles, injection site swelling, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips, papular rash and chills. On an unknown date, the outcome of the vaccination failure, shingles, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips and chills were unknown and the outcome of the injection site swelling was recovered/resolved and the outcome of the papular rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site swelling, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips, papular rash and chills to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she just recently had the second vaccination and asked if anyone had what may appear to be a slight outbreak from it. The patient stated he/she ended up having sores in his/her nose, mouth, sore throat, very chapped peeling lips and a pimple type spot close to his/her lip that came and went away and then came back again. The patient had chills the day after and the injection site stayed swollen for 4 days. The patient stated he/she did not have a cold to cause these problems. The patient was just curious if anyone else had this and he/she was okay if it was; it was much better than getting full-blown shingles for sure. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation regarding shingles was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Lip exfoliation, Nasal ulcer, Oropharyngeal pain, Rash papular, Stomatitis
Clinical narrative: sores in nose, mouth; sores in nose, mouth; sore throat; chapped peeling lips; chapped peeling lips; pimple type spot close to his/her lip; chills; suspected vaccination failure; slight outbreak; injection site swollen; 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), shingles, injection site swelling, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips, papular rash and chills. On an unknown date, the outcome of the vaccination failure, shingles, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips and chills were unknown and the outcome of the injection site swelling was recovered/resolved and the outcome of the papular rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site swelling, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips, papular rash and chills to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she just recently had the second vaccination and asked if anyone had what may appear to be a slight outbreak from it. The patient stated he/she ended up having sores in his/her nose, mouth, sore throat, very chapped peeling lips and a pimple type spot close to his/her lip that came and went away and then came back again. The patient had chills the day after and the injection site stayed swollen for 4 days. The patient stated he/she did not have a cold to cause these problems. The patient was just curious if anyone else had this and he/she was okay if it was; it was much better than getting full-blown shingles for sure. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation regarding shingles was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: sores in nose, mouth; sores in nose, mouth; sore throat; chapped peeling lips; chapped peeling lips; pimple type spot close to his/her lip; chills; suspected vaccination failure; slight outbreak; injection site swollen; 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), shingles, injection site swelling, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips, papular rash and chills. On an unknown date, the outcome of the vaccination failure, shingles, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips and chills were unknown and the outcome of the injection site swelling was recovered/resolved and the outcome of the papular rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site swelling, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips, papular rash and chills to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she just recently had the second vaccination and asked if anyone had what may appear to be a slight outbreak from it. The patient stated he/she ended up having sores in his/her nose, mouth, sore throat, very chapped peeling lips and a pimple type spot close to his/her lip that came and went away and then came back again. The patient had chills the day after and the injection site stayed swollen for 4 days. The patient stated he/she did not have a cold to cause these problems. The patient was just curious if anyone else had this and he/she was okay if it was; it was much better than getting full-blown shingles for sure. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation regarding shingles was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles from the vaccine, the 2 nd shot did it/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- medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   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 by the patient. The age at vaccination was not reported. The patient got shingles from the vaccine and he/she had taken the 2nd shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Note: Vaccine Shinquis was conservatively considered a typo error and coded in the present case as Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Psoriasis, Rash
Clinical narrative: Psoriasis; Bilateral rash / rash; This case was reported by a consumer via sales rep and described the occurrence of psoriasis in a 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 .5 ml. On an unknown date, 1 month after receiving Shingrix, the patient experienced psoriasis and rash. The patient was treated with dermatologicals nos (Lotion). On an unknown date, the outcome of the psoriasis and rash were not recovered/not resolved.   The reporter considered the psoriasis and rash to be possibly related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that 1 month after 2nd dose she experienced bilateral rash that was later diagnosed as psoriasis.  The reporter was still treating 3 years later with medication and lotions.  The reporter felt rash was related to vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got one dose in 2020, now wants another dose; This case was reported by a other health professional 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 of Shingrix in 2020).   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 age at vaccination was not applicable for this report. The reporter reported that a patient got one dose of Shingrix in 2020 and was back at the time of reporting for another dose, asked if the patient required a 3rd dose in the 2-6 months time frame. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination.
Sex: F
Vaccine: MENB
Symptoms: Induration, Pyrexia
Clinical narrative: Fever; Induration; This case was reported by a physician via sales rep and described the occurrence of fever in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 7 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever and induration. On an unknown date, the outcome of the fever and induration were unknown.   It was unknown if the reporter considered the fever and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient had fever at day 7 and not sure if it was related to the vaccine or not. The patient also had induration at day 9.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: dose in 2021 received another dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number N254C, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Boostrix with an associated reaction of exposure during pregnancy (received 1st dose during pregnancy, refer linked case US2022016944).   On 29th January 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 29th January 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Medical Assistant reported that, a pregnant patient received a dose of Boostrix in September 2021 and delivered on 14th November 2021.  The patient returned for her postpartum visit on 29th January 2022 and received another dose of Boostrix, which led to extra dose administered. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016944:Same reporter and patient
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Injection site nodule, Injection site swelling
Clinical narrative: administered an expired dose; Knot in arm at the site of injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a female patient who received Men B NVS (Bexsero) (batch number ABXAB2AZ, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. In February 2022, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the expired vaccine used was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Medical assistant reported that she inadvertently administered an expired dose of Bexsero to a patient on unknown arm, which led to expired vaccine used. The reporter also stated that the mother called in to the clinic on the date of reporting and stated that she had a knot in her arm at the site of injection and she did not knew the date of onset but claimed that it was unresolved. As per reporter information, the lot was ABXAB2AZ on the vial but was unable to verify lot in system. The reporter claimed that the expiration date was 30th January 2022, but she did disposed of the vial and original packaging. The patient's demographics were not able to be provided only that she was a female patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Feeling abnormal, Injection site swelling
Clinical narrative: bump at spot where injected/ local swelling on the injected arm; felt "funny", didn't feel quite right; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 83-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included open heart surgery (had 3 years before reporting and now had prosthetic heart valves) and injection site swelling (on arm, after Covid shots). Previously administered products included pneumococcal vaccine with an associated reaction of peripheral swelling (whole injected arm swelled up, 4 years ago after having Pneumococcal booster and  had to go on prednisone for 5 days). Concurrent medical conditions included systemic lupus erythematosus (diagnosed 4 years ago). Concomitant products included hydroxychloroquine.   On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a day after receiving Influenza vaccine, the patient experienced injection site swelling and feeling abnormal. On an unknown date, the outcome of the injection site swelling and feeling abnormal were recovered/resolved.   The reporter considered the injection site swelling and feeling abnormal to be related to Influenza vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient had many vaccinations during his life. The patient mentioned that he had been getting the influenza/flu shot for years but a few times (not with every flu shot) he had local swelling on the injected arm or felt a bump at the spot where it had been injected and or he had felt "funny" did not feel quite right the next day. These events were so minor (and they self-resolved) that he did not even report them to his doctor. The patient did not provide any specific brand name of flu shot. The reporter did not want to involve the health care professional. The reporter did not consent to follow-up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered a dose that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, a medical assistant administered an expired dose of Bexsero, which led to expired vaccine used. The Vaccine administration facility was the same as Primary reporter. The Healthcare professional did not have the patient's identifiers. The reporter did not consent to follow up.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Kinrix prior to 4 years of age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2M, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received Kinrix prior to the recommended 4 years of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case is linked with US2022027796 and US2022004256, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022027796:Same reporter US-GLAXOSMITHKLINE-US2022004256:Same reporter
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Kinrix prior to 4 years of age.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th December 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received Kinrix prior to the recommended 4 years of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case is linked with US2022027794 and US2022004256, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022027794:Same reporter US-GLAXOSMITHKLINE-US2022004256:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: received dose in the glutes; This case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter requested information about a patient that probably received a Shingrix dose in the glutes muscles, which led to vaccine administered at inappropriate site.
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Twinrix, which led to expired vaccine used.  The reporter consented to follow up. This case had been linked with case US2021247319, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021247319:Same reporter
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received HAB (Twinrix) (batch number dk23d, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Twinrix in left deltoid. The patient was inadvertently administered an expired dose of Twinrix, which led to expired vaccine used. Expiration date was from Company. The reporter did not consent to follow up.