chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 03-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 08-SEP-2021, the patient was vaccinated with an improperly sored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-SEP-2021, the patient was vaccinated with an improperly sored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAXHIB underwent a temperature excursion and then was administered; No additional AEs reported; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 16-SEP-2021, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # T037648 with an expiration date on 20-JUL-2023), at a dose of 0.5 milliliters (strength, anatomical location, and route of administration were not reported) for prophylaxis which underwent a temperature excursion of 31.5 degrees Fahrenheit (°F) during a time frame of 13 hours and 10 minutes (product storage error).  No previous temperature excursions were reported.       No adverse events were reported.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE/PQC was reported; she and her husband received a single dose of PENUMOVAX 23 approximately 6 years ago and were told they needed to receive a second dose, 5 years after receiving the first dose; This spontaneous report was received from a the patient's wife regarding a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.      In approximately August 2015 (reported as 6 years ago), the patient was vaccinated with a single dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot# and the expiration date) for prophylaxis.         He would need to receive a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 5 years after receiving the first dose (approximately in 2020). Caller confirmed her husband had not received a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) yet (inappropriate schedule of product administration).   This is one of two cases reporter by the same consumer. Marrs# 2108USA006307.; Sender's Comments:  US-009507513-2108USA006307:
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; a 4 month old child was inadvertently administered a dose of PROQUAD; This spontaneous report has been received from a medical assistant referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 20-SEP-2021, the patient was vaccinated inadvertently with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (product administered to patient of inappropriate age), at a dose of 0.5 milliliters (ml) (route of administration and anatomical site of vaccination were not reported; lot number T032144 has been verified to be valid, expiration date reported and established as 20-MAR-2022) as prophylaxis. A sterile diluent was used, at a dose of 0.5 milliliters (ml) (lot number U001957 has been verified to be valid, expiration date reported and established as 01-JUN-2023). No additional adverse event was reported.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: No additional adverse event was reported; The reported stated it was unknown if his mother received one or two doses of the ZOSTAVAX; This spontaneous report was received from a consumer refers to his an 87-year-old mother. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapy were not reported.      In approximately 2018 (reported as "approximately 3 years ago"), the patient was vaccinated with one or two doses of zoster vaccine live(ZOSTAVAX) (dose, lot #, expiration date and route were not reported) for prophylaxis (extra dose administered). The reporter stated he "suspects she only received one dose", but he could not be certain since his mother could not remember the doses, the dates, where she received the vaccine. No additional adverse event and no product quality complaint were reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other AE; temperature excursion; This spontaneous report was received from a medical assistant concerning a 6-month-old patient. No concurrent condition, medical history, or concomitant therapy was reported.  On 17-SEP-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was unknown; 1 time dose, lot # 1741377 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 07-MAR-2022) orally for prophylaxis following a temperature excursion (product storage error). Temperature were 35.02 Fahrenheit (F). The time frame was reported as 19 hours. There was no previous temperature excursion. No signs or symptoms were reported. There was no adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot
Clinical narrative: red spot; hot spot; This case was reported by a consumer via interactive digital media and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced localized erythema and feeling hot. On an unknown date, the outcome of the localized erythema and feeling hot were recovered/resolved.   It was unknown if the reporter considered the localized erythema and feeling hot to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient never had chicken pox and his/her sisters and children had them. The patient did not think that he/she needed the Shingles shot but physician gave it and had the reaction of big red hot spot. It lasted about 3 days and was scared that it was shingles but it was not. 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: got the shot  got the shingles/suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, 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. The patient got the shot and got shingles anyway. The patient experienced pain and doctor said it was mild compared to a full on case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: fever 99.3; 3rd day felt 80% better; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced fever and feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever and feeling unwell were recovering/resolving.   It was unknown if the reporter considered the fever and feeling unwell to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got the shingles vaccine and got fever 99.3 degree F, 3rd day patient felt 80 percent better. The patient took Tylenol for 2 days. The patient mentioned that better than the break out what he/she heard. The follow-up would not possible as information was not available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only give the reconstitution, not the vaccine; only give the reconstitution, not the vaccine; This case was reported by a consumer and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, the physician gave only reconstitution and not the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Shingrix 2 years ago; This case was reported by a other health professional via Shingrix GSK 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 2 years ago).   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. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: closed for Covid/ never got second shot.; This case was reported by a consumer and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ill-defined disorder. Previously administered products included Shingrix (1st dose received in March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, got 1st dose in March 2020 and had bad reaction. The reporter stated that, his or her physician's office closed for Covid shortly thereafter, and then she retired, hence never got the second shot, which led to social problem. No additional event details provided via form. Medical Information specialist sent email on 20th September 2021 requesting reporter follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198884:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had my first vaccine in March 20/20, didn't get second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on March 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, 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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination The reporter asked could get 2nd dose now.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: both shots and got shingles / suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In May 2021, 6 weeks after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient received both shots and got shingles 6 weeks after the second in May of 21. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR199553 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199553:same patient, same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: both shots and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of herpes zoster (on an unknown date patient received both shots and got shingles 6 weeks after the second in May of 21, refer case US2021AMR199545).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, between 5 and 6 months after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient received both shots and had shingles now (unspecified date). This was about the 4 to 5 time that the patient had it. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The follow up was not required.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199545:same patient, same reporter
Sex: U
Vaccine: COVID19
Symptoms: Shigella infection
Clinical narrative: suffered Shigella; This case was reported by a consumer via interactive digital media and described the occurrence of shigella infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID19 VACCINE. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced shigella infection (serious criteria GSK medically significant). On an unknown date, the outcome of the shigella infection was unknown.   It was unknown if the reporter considered the shigella infection to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient took the vaccine and suffered Shigella 6 months later. The patient also took the Covid-19 Vaccine this year and so far so good. he patient requested to be careful. The follow up was not required. It was unknown if the reporter considered the shigella infection to be related to COVID19 VACCINE.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingle shot, shingles / suspected vaccination failure; shingles for 3 months; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's sister friend. The age at vaccination was not reported. The patient got the shingle shot and now had shingles for 3 months. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles vaccine and got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the vaccine a few years back and developed shingles 8 months later. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got a shingles shot, few years later got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got a shingles shot and a few years later got shingles. The patient enquired what was with that. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after the shot / Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingles after, getting the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy; This case was reported by a consumer via interactive digital media and described the occurrence of neuropathy 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 neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy was unknown.   The reporter considered the neuropathy to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter knew the patient who had terrible reactions to the shingles shot. The reporter stated that the shots had metal in them and caused neuropathy. One of the patient's friend sued and won her case.  It took 2 years to receive the settlement. This case has been linked with US2021AMR199718, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199718:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis
Clinical narrative: has been on med protocol for MS; This case was reported by a consumer via interactive digital media and described the occurrence of multiple sclerosis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's brother had shingles and lasted for a few months).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced multiple sclerosis (serious criteria GSK medically significant). On an unknown date, the outcome of the multiple sclerosis was unknown.   It was unknown if the reporter considered the multiple sclerosis to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's sibling. The age at vaccination was not reported. The patient took the Shingles vaccine and she was fine although she had been on med protocol for MS (Multiple sclerosis). The reporter stated that everyone would be different and needed to make their own decisions. The follow-up would not possible as no contact details were available. This case was linked with US2021AMR199698 and US2021AMR199709, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199698:Same reporter US-GLAXOSMITHKLINE-US2021AMR199709:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Condition aggravated, Herpes zoster, Laboratory test abnormal, Rash
Clinical narrative: after both doses got shingles\ suspected vaccination failure; Shingles; Rash on right side of stomach front to back and is currently spreading down leg,; Burning rash; Itching rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-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. Previously administered products included Zostavax and COVID-19 VACCINE (received both vaccines approximately 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 7th September 2021, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, generalized rash, burning sensation and itchy rash. The patient was treated with valaciclovir (Valacyclovir) and FLUCONAZOLE (FLUCONAZOLE CREAM). On 15th September 2021, the outcome of the shingles, generalized rash, burning sensation and itchy rash were recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure, shingles, generalized rash, burning sensation and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter states that previously has shingles as a child and received Zostavax vaccine as well. The reporter states received both COVID vaccines approximately 6 months ago. The patient received both doses of Shingrix and now has shingles. The reporter states shingles started with rash on right side of stomach front to back and was currently spreading down leg, complaints of itching and burning with rash. The medical care sought and valacyclovir and fluconazole cream prescribed, and rash was fading away. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Vaccination failure
Clinical narrative: after both doses got shingles\ suspected vaccination failure; Shingles; Rash on right side of stomach front to back and is currently spreading down leg,; Burning rash; Itching rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-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. Previously administered products included Zostavax and COVID-19 VACCINE (received both vaccines approximately 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 7th September 2021, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, generalized rash, burning sensation and itchy rash. The patient was treated with valaciclovir (Valacyclovir) and FLUCONAZOLE (FLUCONAZOLE CREAM). On 15th September 2021, the outcome of the shingles, generalized rash, burning sensation and itchy rash were recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure, shingles, generalized rash, burning sensation and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter states that previously has shingles as a child and received Zostavax vaccine as well. The reporter states received both COVID vaccines approximately 6 months ago. The patient received both doses of Shingrix and now has shingles. The reporter states shingles started with rash on right side of stomach front to back and was currently spreading down leg, complaints of itching and burning with rash. The medical care sought and valacyclovir and fluconazole cream prescribed, and rash was fading away. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: not sure how much the patient got; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 3-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number Z3Mk7, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On 14th September 2021, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete 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 patient received Flulaval quadrivalent in left thigh. The licensed practical nurse called in to reported that, they administered Flulaval to a 3 year old patient getting a booster for new flu season. The reporter ststed tah, the patient moved during administration of vaccine and they were not sure how much of the vaccine the patient got. It leaked out due to patient moving and jerking leg, not due to syringe, which led to  incomplete dose administered. The reporter did not consent to follow up.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 542NY, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra 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 nurse reported that, a patient had been given an expired dose of Flulaval, which led to expired vaccine used. The reporter mentioned that, the patient was male but seemed to be trans so upon follow-up the gender of the patient might change. The reporter consented to follow up  by email.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on March 2020; This case was reported by a pharmacist 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 March 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 registered pharmacist reported that, till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter also reported that this patient was vaccinated at another pharmacy so she did not have any demographic details from patient neither details from 1st dose. The reporter did not consent to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles worse than ever; This case was reported by a consumer and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had multiple cases of reoccurring shingles). Previously administered products included Zostavax (had been previously vaccinated with Zostavax).   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient received Shingrix vaccine and mentioned that in July and in August 2021 he broke out with shingles all over including the lower back, hair line, and head. The stated that this episode was worse than ever. The patient inquired if it was safe for him to receive second dose of Shingrix and if it would have any benefit. The reporter consented to follow up with him and with his health care professional (pharmacist).
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot 2019, is now here for 2nd shot; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th December 2019).   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. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: vaccinated with 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 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th September 2021, unknown after receiving Kinrix and Kinrix 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 are as follows: The health care professional reported that a patient was vaccinated with an expired dose of Kinrix. The vaccine was expired on 31st August 2021. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose years ago, second dose not received; This case was reported by a physician and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st Shingrix dose at pharmacy 4 years ago).   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. At the time of the reporting, it was unknown if the patient received the second dose, which led to incomplete course of vaccination. The reporter was inquiring about administering 2nd dose of Shingrix to patient or restarting series. The reporter consented to follow up. No additional details were available from reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2019, never got second dose; This case was reported by a nurse and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th August 2019, batch number:BX25K, expiry date: 19th November 2021).   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 patient was not immunocompromised and never received second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Oropharyngeal pain, Pruritus, Skin exfoliation
Clinical narrative: dry skin on her forehead, which spread to cheeks, eyes, ears, and neck; "very bad" sore throat; skin started to flake "badly"; her face started itching; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2021, 1 days after receiving Shingrix, the patient experienced dry skin. In September 2021, the patient experienced sore throat, flaking skin, and pruritus facial. On an unknown date, the outcome of the sore throat, flaking skin, pruritus facial, and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, flaking skin, pruritus facial, and dry skin to be related to Shingrix.  Additional details were provided are the case was reported by patient herself. The patient received a dose of Shingrix in right deltoid and next morning, she experienced dry skin on her forehead, which spread to cheeks, eyes, ears, and neck. A couple of days or a day later, her face started itching. She used a moisturizer, but no other new cleansing or moisturizing products. Less than 2 weeks after vaccination, the dry skin got worse, and her skin started to flake badly and also reported a very bad sore throat.  These events had not currently resolved.  The reporter was unable to provide lot or expiration of product. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Severe pain where first dose was given; This case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anemia, diabetes and hypertension. Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix and had severe pain in his right arm where the vaccine was administered. The patient stated that he also received pneumonia vaccine in his left arm on the same day as the Shingrix vaccine and did not had pain in his left arm and the patient did not know the name of the pneumonia vaccine. The arm pain was resolved without intervention. The patient declined to provide health care professional information. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete Course of Vaccination; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd September 2020, by intramuscular in left deltoid).   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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired if he could get his second dose or if he needed to restart the series of vaccination all over. The VAERS details were reported for 1st dose of Shingrix.