chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Reports feeling depressed; Feels a little "out of it"; Could not sleep for a couple of days; Light chills which became stronger that night; Low grade fever (100-101F),102F fever; Severe knee pain; Neck aches that felt like her "neck was going to break if she moved it".; Did not eat much for 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck aches that felt like her "neck was going to break if she moved it".), DECREASED APPETITE (Did not eat much for 2 days), DEPRESSION (Reports feeling depressed), MALAISE (Feels a little "out of it") and INSOMNIA (Could not sleep for a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression. Concomitant products included METOPROLOL for Heart rate.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced NECK PAIN (Neck aches that felt like her "neck was going to break if she moved it".) and PYREXIA (Low grade fever (100-101F),102F fever). 16-Mar-2021, the patient experienced DECREASED APPETITE (Did not eat much for 2 days), INSOMNIA (Could not sleep for a couple of days), CHILLS (Light chills which became stronger that night) and ARTHRALGIA (Severe knee pain). On 19-Mar-2021, the patient experienced DEPRESSION (Reports feeling depressed) and MALAISE (Feels a little "out of it"). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever and Pain, at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and CALAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (CALADRYL [CALAMINE;DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Mar-2021, NECK PAIN (Neck aches that felt like her "neck was going to break if she moved it".) and ARTHRALGIA (Severe knee pain) had resolved. On 18-Mar-2021, DECREASED APPETITE (Did not eat much for 2 days), INSOMNIA (Could not sleep for a couple of days) and PYREXIA (Low grade fever (100-101F),102F fever) had resolved. At the time of the report, DEPRESSION (Reports feeling depressed), MALAISE (Feels a little "out of it") and CHILLS (Light chills which became stronger that night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 122/73 (Inconclusive) BP at 122/73. On 16-Mar-2021, Body temperature: 100 (High) low grade fever (100-101F) and 102 (High) 102 F. On 16-Mar-2021, Heart rate: 85-10 (Inconclusive) Resting heart rate is now85-90 BPM.         Concomitant medication include unknown antidepressant.  Treatment medications include Advil, Hydrocortisone cream, Caladryl (calamine lotion)   This case was linked to MOD-2021-051947 (Patient Link).
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: No PQC or additional AEs reported.; 20yo patient received RECOMBIVAX 5mcg dose; This spontaneous report was received from a medical assistant referring to a 20 years old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 15-JUL-2021, the patient received hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength: 5 micrograms, dose: 0.5 milliliter, lot # T022800, expiration date: 19-NOV-2022) intramuscularly for prophylaxis (inappropriate dose of vaccine administered). No additional adverse events reported.  combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T022800; expirationdate: 19-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT received the first dose of VARIVAX at 12 months of ae and now wants the second dose at age 17 years; No other AE reported; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On an unknown date (reported as "at age 12 months"), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient was now 17 years old and wanted the second dose (Inappropriate schedule of vaccine administered). No other adverse event reported.
Age: 35.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine used; This spontaneous report was received from a medical assistant referring to a 35-year old patient of unknown gender.  The patient's medical history, concurrent condition and concomitant medication were unknown.  On 16-JUL-2021, the patient was accidentally given an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (first dose, lot # S021924, expiration date 15-JUL-2021; route, strength and dose were unknown) in the right arm for prophylaxis (Expired vaccine used). The patient had no adverse events after receiving the expired varicella virus vaccine live (oka/merck) (VARIVAX). The medical assistant was calling to see if the patient needed to be revaccinated, or if this effected the time line for a second dose of the varicella virus vaccine live (oka/merck) (VARIVAX).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: patient received an Expired VARlVAX (S021928, 7/15/2021); This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 10-AUG-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021928 was confirmed to be valid, expiration date 15-JUL-2021, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Lip swelling, Paraesthesia oral, Pruritus
Clinical narrative: Eye irritation; Eye pruritus; Lip swelling; Paraesthesia oral; Pruritus; Swelling of eyelid; Urticaria; This case was received via United States FDA VAERS (Reference number: 0917887) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of EYE IRRITATION (Eye irritation), EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PARAESTHESIA ORAL (Paraesthesia oral) and PRURITUS (Pruritus) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Jan-2021, the patient experienced EYE IRRITATION (Eye irritation), EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PARAESTHESIA ORAL (Paraesthesia oral), PRURITUS (Pruritus), SWELLING OF EYELID (Swelling of eyelid) and URTICARIA (Urticaria). At the time of the report, EYE IRRITATION (Eye irritation) and PARAESTHESIA ORAL (Paraesthesia oral) had resolved and EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PRURITUS (Pruritus), SWELLING OF EYELID (Swelling of eyelid) and URTICARIA (Urticaria) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Urticaria
Clinical narrative: Eye irritation; Eye pruritus; Lip swelling; Paraesthesia oral; Pruritus; Swelling of eyelid; Urticaria; This case was received via United States FDA VAERS (Reference number: 0917887) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of EYE IRRITATION (Eye irritation), EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PARAESTHESIA ORAL (Paraesthesia oral) and PRURITUS (Pruritus) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Jan-2021, the patient experienced EYE IRRITATION (Eye irritation), EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PARAESTHESIA ORAL (Paraesthesia oral), PRURITUS (Pruritus), SWELLING OF EYELID (Swelling of eyelid) and URTICARIA (Urticaria). At the time of the report, EYE IRRITATION (Eye irritation) and PARAESTHESIA ORAL (Paraesthesia oral) had resolved and EYE PRURITUS (Eye pruritus), LIP SWELLING (Lip swelling), PRURITUS (Pruritus), SWELLING OF EYELID (Swelling of eyelid) and URTICARIA (Urticaria) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: shot made me very sick for 2 months; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The reporter mentioned that Shingles shot was awful and made him/her very sick for 2 months.
Sex: U
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 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, less than 2 weeks 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 had reported the case for himself/herself. The age at vaccination was not reported. The patient reported that he/she received first dose of Shingles shot 2 weeks ago and got Shingles, it was horrible. The patient would get second shot in mid September.
Sex: U
Vaccine: VARZOS
Symptoms: Ageusia, Chills, Condition aggravated, Eye disorder, Headache
Clinical narrative: now I have serious side effects / pain where the shot was injected; now I have serious side effects / Loss of arm muscle about 15 - 20 percent; now I have serious side effects / eyes are blurry / Blurry Eyes. Eyes changing daily; now I have serious side effects / shivers / Uncontrolled Shivering; now I have serious side effects / headache; vomiting; loss of taste for 1 week; This case was reported by a consumer and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (in August 2020), loss of smell, taste loss, influenza-like symptoms, labored breathing (took approximately 10 to 12 weeks to be able to work again), difficulty breathing, transient ischemic attack (same exact time in the morning), transient ischemic attack (same exact time in the morning), covid-19 (in February 2020'), loss of smell, taste loss and influenza-like symptoms. Concurrent medical conditions included allergy to chemicals (severe allergy to THC, can not breath).   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, immediately after receiving Shingrix, the patient experienced shivers (serious criteria other: Serious as per reporter), headache (serious criteria other: Serious as per reporter), vomiting (serious criteria other: serious as per reporter), taste loss (serious criteria other: serious as per reporter) and blurred vision (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced injection site pain (serious criteria other: Serious as per reporter) and muscle wasting (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the shivers, headache, vomiting, blurred vision, injection site pain and muscle wasting were not recovered/not resolved and the outcome of the taste loss was recovered/resolved.   The reporter considered the shivers, headache, vomiting, taste loss, blurred vision, injection site pain and muscle wasting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Covid-19 symptoms in February 2020.The symptoms were loss of smell, loss of taste and flu like symptoms before Covid-19 was confirmed. The patient had Covid-19 in August 2020 and had same symptoms but much worse. Breathing was heavier and took Approx 10 to 12 weeks to be able to work again. The patient had serious side effects of Shingrix. Immediate, side effects were shivers, headache, vomiting, loss of taste for 1 week, eyes are blurry, etc.    As of today, August 8 2021. The patient still had pain where the shot was injected, loss of arm muscle about 15 to 20 percent, blurry eyes and uncontrolled Shivering. The patient wrap in blankets when the patient was at home. The patient had blurry eyes. Eyes changing daily. The patient was due for the second shot in October but the patient was very scared the side effects might be much worse. The patient asked for advice.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Muscle atrophy, Vision blurred, Vomiting
Clinical narrative: now I have serious side effects / pain where the shot was injected; now I have serious side effects / Loss of arm muscle about 15 - 20 percent; now I have serious side effects / eyes are blurry / Blurry Eyes. Eyes changing daily; now I have serious side effects / shivers / Uncontrolled Shivering; now I have serious side effects / headache; vomiting; loss of taste for 1 week; This case was reported by a consumer and described the occurrence of shivers in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (in August 2020), loss of smell, taste loss, influenza-like symptoms, labored breathing (took approximately 10 to 12 weeks to be able to work again), difficulty breathing, transient ischemic attack (same exact time in the morning), transient ischemic attack (same exact time in the morning), covid-19 (in February 2020'), loss of smell, taste loss and influenza-like symptoms. Concurrent medical conditions included allergy to chemicals (severe allergy to THC, can not breath).   In April 2021, the patient received the 1st dose of Shingrix. In April 2021, immediately after receiving Shingrix, the patient experienced shivers (serious criteria other: Serious as per reporter), headache (serious criteria other: Serious as per reporter), vomiting (serious criteria other: serious as per reporter), taste loss (serious criteria other: serious as per reporter) and blurred vision (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced injection site pain (serious criteria other: Serious as per reporter) and muscle wasting (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the shivers, headache, vomiting, blurred vision, injection site pain and muscle wasting were not recovered/not resolved and the outcome of the taste loss was recovered/resolved.   The reporter considered the shivers, headache, vomiting, taste loss, blurred vision, injection site pain and muscle wasting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Covid-19 symptoms in February 2020.The symptoms were loss of smell, loss of taste and flu like symptoms before Covid-19 was confirmed. The patient had Covid-19 in August 2020 and had same symptoms but much worse. Breathing was heavier and took Approx 10 to 12 weeks to be able to work again. The patient had serious side effects of Shingrix. Immediate, side effects were shivers, headache, vomiting, loss of taste for 1 week, eyes are blurry, etc.    As of today, August 8 2021. The patient still had pain where the shot was injected, loss of arm muscle about 15 to 20 percent, blurry eyes and uncontrolled Shivering. The patient wrap in blankets when the patient was at home. The patient had blurry eyes. Eyes changing daily. The patient was due for the second shot in October but the patient was very scared the side effects might be much worse. The patient asked for advice.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; mild case of shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (before the shot).   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 mild case of shingles. The patient was glad, he/she got the Shingles shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirmation were not provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I still get them; I have taken three shots; 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.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and 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 three shots of Shingles vaccine which led to extra dose administered. 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 were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed the window (2-6 months); This case was reported by a consumer via 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 (first dose of shingrix vaccine received on 12th November 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 reported as follows: The age at vaccination for this case was not applicable. The patient received first dose of shingrix and missed the window period of second dose (2 to 6 months), which led to incomplete course of vaccination. The patient enquired about to get second shot now to complete the series or must start over.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My Aunt / got the 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.   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 reporter had reported for her//his aunt. 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 were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; herpes zoster; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received both Shingrix doses last year from the date of reporting. After receiving Shingrix, the patient had herpes zoster again at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Off label use
Clinical narrative: First shot got Shingles /Still have some shingles; Got second shot. Still have some shingles from first shot; 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.   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, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and off label use. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine and experienced shingles. The patient also got second dose of shingles vaccine when still had some shingles from first shot, which led to off label use. Nurse stated that some people had them for a couple of years.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR169586:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Muscle fatigue
Clinical narrative: muscle fatigue; feeling exhausted; This case was reported by a consumer via media and described the occurrence of muscle fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced muscle fatigue and exhaustion. On an unknown date, the outcome of the muscle fatigue and exhaustion were unknown.   It was unknown if the reporter considered the muscle fatigue and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received Shingrix first dose and felt exhausted and extreme muscle fatigue. The patient wanted to know how long did this last. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in oct 2020 / never got my second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 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 are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient wanted to know that did he/she start over. The patient had only few minutes and was hoping for a quick answer regarding 2nd dose and would need to try again call when he/she had more time. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: "A couple" / received / first dose / 30AUG2018 / have not / received the next; This case was reported by a pharmacist via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 30th August 2018).   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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter declined to provide further adverse events details or information.  No additional adverse events reported.  No additional information reported. This case had been linked with US2021AMR170420, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170420:Same reporter. Patient 2/2.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: "A couple" / received / first dose / 30AUG2018 / have not / received the next; This case was reported by a pharmacist via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 30th August 2018).   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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter declined to provide further adverse events details or information.  No additional adverse events reported.  No additional information reported. This case had been linked with US2021AMR170406, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170406:Same reporter. Patient 1/2.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot /still got/ Shingles/suspected vaccination failure; bad case of Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot and still got shingles. The patient stated that according to her/his doctor it was a bad case of Shingles. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Know someone who has Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure 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 age at vaccination was not reported. The reporter knew someone who had shingles at the time of reporting after receiving Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bell's palsy, Herpes zoster, Vaccination failure
Clinical narrative: still with Bell's Palsy symptoms; shingles / still with / active shingles; Suspected vacination failure; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In July 2021, between 7 and 9 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the bell's palsy and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, bell's palsy and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received both Shingrix doses and developed shingles 3 weeks before the date of reporting and she was still with Bell's Palsy symptoms and active shingles. Less than 9 months after receiving Shingrix, the patient experienced Bell's Palsy symptoms.  Patient was planning to travel on November 2021. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting.  The reporter consented to follow up by fax.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose / exp 08/01/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old male patient who received HAV (Havrix) (batch number BE5554, expiry date 1st August 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2021, the patient received the 1st dose of Havrix (intramuscular) and Havrix Pre-Filled Syringe Device. On 5th August 2021, unknown after receiving Havrix and Havrix 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 detials were provided as follows: The patient received dose of Havrix in the left thigh. The reporter stated that, the patient received expired vaccine of Havrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: it feels inflamed; itching / at injection site; redness / at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included renal disease.   On 6th August 2021, the patient received the 1st dose of Shingrix. On 6th August 2021, less than a day after receiving Shingrix, the patient experienced injection site inflammation, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site inflammation and injection site itching were unknown and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site inflammation, injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient reported that, she received her first Shingrix shot on Friday.  She experienced redness and itching at the injection site and stated that it felt inflamed.  The patient did not provide a lot number or expiration date. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Deafness
Clinical narrative: LOSS OF HEARING; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (amikacin allergy).   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Flu vaccine.  Additional details were provided as follows: The case was reported by the mother of the patient. The age at vaccination was not reported. The patients mother stated that, the patient was allergic to amikacin.  The reporter inquiring about amikacin in the flu shot currently.  The reporter stated that, her daughter received the flu shot (by unknown manufacturer) previously and loss her hearing due to the daughter's allergy to amikacin. The reporter wanted to know if amikacin would be in the flu shot presently. The reporter did not provide time frame or timeline when the flu shot was administered to her daughter previously.  The reporter did not provide any specific details about the flu shot such as vaccine name, dosage details, lot number, expiration date, etc.  No additional patient information related to patient. The reporter abandoned the call before further details were obtained. The reporter did not provide permission to follow up with doctor.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Now has active shingles; Painful rash on back, rash on head and face; Painful rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles for most of in her adulthood).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. On an unknown date, the outcome of the vaccination failure, shingles, rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The patient stated that, she had received both the doses of Shingrix around 4 years before the date of reporting.  The patient stated that, she now had active shingles with a painful rash on back, rash on head and face, referred her to health care professional. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administrated /batch recall on March 29 2021/ recall 10feb2021; administrated /batch recall on March 29 2021/ recall 10feb2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th September 2022) for prophylaxis.   On 29th March 2021, the patient received Shingrix. On 29th March 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: Health care professional reported that the patient was administered with recalled Shingrix vaccine lot, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This is 1 of the six cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169132:Same reporter. US-GLAXOSMITHKLINE-US2021169133:Same reporter US-GLAXOSMITHKLINE-US2021169134:Same reporter US-GLAXOSMITHKLINE-US2021169135:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Pt received engerix-b / later realized she wanted pt to get twinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a patient who received HBV (Engerix B) for prophylaxis.  Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.  On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 age at vaccination was not reported. The patient received Engerix B vaccine and later realized that patient wanted to get Twinrix, which led to wrong vaccine administered. The reporter wanted to know could Twinrix be used as dose 2 and 3 of the series or must patient receive separate Engerix plus Havrix at this point. The reporter did not consented to follow up. The reporter disconnected the chat before providing credentials or additional information.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, HEP, HEPA, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Several patient were administrated with below freezing vaccines; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Menveo. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 applicable. Several patients were administered with below freezing vaccines, which led to incorrect storage of drug. At time of report health care practitioner was unware of number of vaccines, which vaccine and when or to who it was administered no patient's identifiers provided, no batch number and expiration date provided no vaccination date provided. No adverse event was reported. The reporter consented to follow up.