chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: LOW-GRADE FEVER; HEADACHE; FATIGUE; ACTIVE EPSTEIN BARR INFECTION; CHRONIC BODY ACHES; EVERYDAY ACTIVITIES DIFFICULT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced active epstein barr infection. On APR-2021, the subject experienced chronic body aches. On APR-2021, the subject experienced everyday activities difficult. Laboratory data included: COVID-19 antibody test (NR: not provided) Positive, and Epstein-Barr virus test (NR: not provided) Elevated. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced low-grade fever. Laboratory data included: Body temperature (NR: not provided) 99 to 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and had not recovered from fatigue, low-grade fever, active epstein barr infection, chronic body aches, and everyday activities difficult. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Joint swelling, Lip swelling, Metabolic function test, Pain in extremity
Clinical narrative: Patient had a very bad allergic reaction to her 2nd dose of vaccine of pfizer on 7/6/21 . her reaction occured on 7/7/21 she broke out in bubble hives as well as her feet fingers and eyelids swelling up. today marks 4 days. I did take her to her primary on 7/8/21 he prescribed her benadryl . the next day got worse , so I took her to the hospital on 7/9/21. doctor drew a blood sample to check her organs she said everything  looked ok. So doctor said she was gonna report it and I was to do so as well. Symptons have not gone away and we are going on day 4 so  doctor said it should be gone in 3 days. So if shes not bring her back into hospital. I am very worried, and am up through out the night settting my alarm every 2 hrs to make sure shes not flaring up.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Patient had a very bad allergic reaction to her 2nd dose of vaccine of pfizer on 7/6/21 . her reaction occured on 7/7/21 she broke out in bubble hives as well as her feet fingers and eyelids swelling up. today marks 4 days. I did take her to her primary on 7/8/21 he prescribed her benadryl . the next day got worse , so I took her to the hospital on 7/9/21. doctor drew a blood sample to check her organs she said everything  looked ok. So doctor said she was gonna report it and I was to do so as well. Symptons have not gone away and we are going on day 4 so  doctor said it should be gone in 3 days. So if shes not bring her back into hospital. I am very worried, and am up through out the night settting my alarm every 2 hrs to make sure shes not flaring up.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Hypersensitivity, Peripheral swelling, Swelling of eyelid, Urticaria
Clinical narrative: Patient had a very bad allergic reaction to her 2nd dose of vaccine of pfizer on 7/6/21 . her reaction occured on 7/7/21 she broke out in bubble hives as well as her feet fingers and eyelids swelling up. today marks 4 days. I did take her to her primary on 7/8/21 he prescribed her benadryl . the next day got worse , so I took her to the hospital on 7/9/21. doctor drew a blood sample to check her organs she said everything  looked ok. So doctor said she was gonna report it and I was to do so as well. Symptons have not gone away and we are going on day 4 so  doctor said it should be gone in 3 days. So if shes not bring her back into hospital. I am very worried, and am up through out the night settting my alarm every 2 hrs to make sure shes not flaring up.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: ARM SORENESS; inadvertently administered a dose of MMRlI on 5/29/2021, when the patient "was expecting to get a meningitis; ho is 17 years of age received her first dose of MMRlI at age 1 and the second dose at age 5; inadvertently administered a dose of MMRlI the patient "was expecting to get a meningitis vaccine", specifically MENACTRA; This spontaneous report was received from a pharmacist refers to a 17 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On unknown dates, at age 1 and 5 the patient received first and second dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route, vaccination site and lot# were not provided), for prophylaxis.  On 29-MAY-2021, the patient was vaccinated inadvertently administered  with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter, subcutaneous, lot# T00723, expiration date 27-FEB-2022, for prophylaxis when the patient was expecting to get a meningitis vaccine, specifically  meningococcal vaccine a/c/y/w conj (dip tox)(MENACTRA).  On the same date, the patient experienced some arm soreness (pain in extremity).     At the time of reporting, the reporter recovered from pain in extremity approximately in 2021.   The reporter did not provide a causality assessment betweenpain in extremity and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a dose of V ARlV AX on 2/25/2011 that expired in; no other adverse event; This spontaneous report was received from a registered nurse, concerning a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 25-FEB-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis, lot number reported as 1699Z with an expiration date reported as 1991 (strength and route of administration were not reported). The vaccine was administered at another facility and no additional information was obtained, however, the patient thought the expiration date was entered into the system incorrectly, but they did not have documentation to confirm this. No other adverse event was reported.
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity
Clinical narrative: allergic to VARIVAX; This spontaneous report was received from a consumer referring to a male patient of unknown age. On unknown previous dates, the patient was administered and had experienced separate allergic reactions to amoxicillin, pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) and hib vaccine conj (tet tox) (ACTHIB). The patient's pertinent medical history and concomitant medication were not reported.    On an unknown date, reporter was unable to confirm if patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route, batch/lot# and expiration date were not reported) for prophylaxis or if patient had experienced an allergic reaction to varicella virus vaccine live (oka/merck) (VARIVAX) at call time.   Reporter was requesting information on if varicella virus vaccine live (oka/merck) (VARIVAX) had shared the same inactive ingredients as amoxicillin, pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) and hib vaccine conj (tet tox) (ACTHIB) at call time. Outcome of allergic reaction was unknown. The causality assessment between allergic reaction and varicella virus vaccine live (oka/merck) (VARIVAX) was related.
Age: 58.0
Sex: F
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/ PQC; temperature excursion MMR II (stored in freezer),VARlVAX, and RECOMBIVAX HB.; This spontaneous report was received from a physician who was reporting on 58-year-old female patient. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 21-JUN-2021, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thiomersal free, lot # T035865, expiration date 28-APR-2023, dose of 1 milliliter administered into unspecified body part on left side (strength, route of administration and anatomical location were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion was stored in temperature of 68.7 degrees Fahrenheit for 56 hours and 22 minutes (temperature to high) and 23.3 degrees Fahrenheit for 24 hours and 0 (temperature to low). Data logger was not involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T035865; expirationdate: 28-APR-2023; 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: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; The vaccine was administered after it expired; This spontaneous report was received from registered nurse (RN), concerning a patient of unknown age and gender. No information was provided regarding the patients' pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 28-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) 0.5 milliliter (ml) (lot number R031628 has been verified to be valid, expiration date reported and validated as 01-NOV-2020)) (vaccination scheme frequency, route and anatomical location of administration were not reported) as prophylaxis. Concomitant therapies included the sterile diluent at a dose of 0.5 milliliter (ml) (lot number S008564 has been verified to be valid, expiration reported and validated as 05-AUG-2021). No additional adverse event (AE) reported.
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Exposure to communicable disease, Skin lesion, Varicella virus test positive
Clinical narrative: cheek swab that was positive by PCR testing/ The child was born on 6/23/2021 with redness to the left cheek. On 6/24/2021, the baby developed lesions on the left cheek that tested positive by PCR for varicella.; the patient was exposed to siblings who received the VARIVAX vaccine; This spontaneous report was received from a nurse practitioner and refers to a 1-day-old male patient. He was a full-term newborn. The patient had no history of herpes zoster, herpes zoster ophthalmicus or chickenpox, he had no allergies. There was no information about the patient's concomitant therapies provided.  The patient's mother had varicella as a child and was not immunized. On an unknown date in approximately May 2021 (reported as "about a month before delivery of the baby"), the mother was exposed to someone who had shingles, but she remained asymptomatic, the patient experienced perinatal exposure to shingles.  On 23-JUN-2021, the patient was born with redness to the left cheek. On an unknown date in approximately June 2021, the infant was exposed to his siblings who were fully vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis (also reported as "baby got varicella from his mother").   On 24-JUN-2021, he developed lesions on the left cheek that were tested positive by polymerase chain reaction (PCR) for varicella. On an unknown date in June 2021, the patient experienced also blistered lesions on (approximate numbers): back (8), right cheek (1), left cheek (1), trunk (4) and extremities (6). The patient received acyclovir as a treatment. The outcome of the events was reported as recovered on an unknown date in approximately June 2021. There was no causality assessment provided by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: zoster-related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On 06-MAR-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered at the physician's office (dose, route of administration, anatomical location, lot # and expiration date were not specified) for the long-term prevention of herpes zoster or shingles. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated at the physician's office for shingles or zoster-related injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Incomplete course of vaccination, Off label use
Clinical narrative: 1 dose of Shingrix only should be given to patients fully vaccinated with Zostavax; Dr said that accdg to Agency, 1 dose of Shingrix only should be given to patients fully vaccinated with Zostavax; This case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Zostavax (received on an uknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination and off label use. On an unknown date, the outcome of the incomplete course of vaccination and off label use were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician stated that, acording to Advisory Committee 1 dose of Shingrix only should be given to patients fully vaccinated with Zostavax. Till the time of reporting, the patients did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The physician planned to recall patients after conversation with Medical Science Liaison. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had shot 1 in 2018 but didn't return for the booster / had the first dose a 2nd time in June 2020; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on 2018).   In June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details provided as follows: Age at vaccination was not reported. The patient had enquired about re-vaccination. The patient received 1st dose in 2018 but did not return for booster dose and received first dose a second time in june 2020 which led to drug dose administration interval too long. No further information received.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: late second doses / received his first dose on Dic 2020 / due Covid situation.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, the patients were late for 2nd dose of Shingrix due to covid situation. This case was linked with case US2021142802, reported by same reporter for different patient. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142802:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Had sore arm for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received Shingles vaccine on an unknown date and had sore arm for 3 days but then it was ok. No further information were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had Shingles AFTER having the vaccine; 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 age at vaccination was not reported. The patient had shingles after having the vaccine. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My mom got the vaccine... and then got the worst case of shingles/ Suspected vaccination failure; My mom got the vaccine... and then got the worst case of 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 information was provided as follows: The age at vaccination was not reported. The patient received the vaccine, and then got the worst case of shingles. The patient stated that go ahead and believe these fools. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: couldn't afford the second / My husband also had only one; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown 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 case was reported by patient wife. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR064338, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064338:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Was vaccinated, had shingles twice; 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 reporter was the patient. The age at vaccination was not reported. The patient was vaccinated and had shingles twice. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had shot 2 times & still got them.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the two doses of Shingles vaccine and still got them. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and still got shingles twice/!Suspected Vaccination failure; got shingles twice!!!; 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 information was provided as follows: This case was reported by patient itself. The age at vaccination was not reported. The patient got the shot and still got shingles twice. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation for shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I had my first Shingrix 9 months ago can I still get my second shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, 9 months prior to reporting).   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: This case was reported by the patient himself/ herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination. The reporter enquired if he/ she could still get the second shot or if he/ she needed to start over.
Sex: F
Vaccine: VARZOS
Symptoms: Central nervous system lesion, Death
Clinical narrative: got lesion in her BRAIN... IT KILLED HER...; This case was reported by a consumer via interactive digital media and described the occurrence of brain lesion in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included oral lesion (had lesion on lip).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced brain lesion (serious criteria death). On an unknown date, the outcome of the brain lesion was fatal. The reported cause of death was brain lesion.   It was unknown if the reporter considered the brain lesion to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's relative.(son or daughter). The age at vaccination was not reported. The reporter stated that, the patient had lesion on lip, after getting vaccine, the patient had lesion on her brain and it killed her.; Reported Cause(s) of Death: brain lesion
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Haven't gotten the second shot a year after my first dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose year ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, dose he or she need to start over the vaccine schedule. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: Got / the new two part shots / have the shingles on my arm/Suspected vaccination failure; Have the shingles on my arm; Starting to blister on whole arm; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experiennced severe case of shingles before the original shot). Previously administered products included Shingles vaccine (the original shot).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the original shot as well as the new two-part Shingles shots and after three shots, the patient had the shingles on his/her arm and starting to blister on whole arm. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation for Shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot, got shingles a couple years later/then got shingles again/Suspect vaccination failure; I got the shot, got shingles a couple years later/then got shingles again; 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and got shingles a couple years later, got treated (unspecified) and then got shingles again after a couple more years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and still got shingles going on 4 was they're real bad/Suspect vaccination failure; I had the shot and still got shingles going on 4 was they're real bad; 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles shot and still got shingles going on forth was they were really bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: due covid situation /received / first dose on Sep 4th 2020/ never gets her second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th September 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 age at vaccination was not applicable for this report. The pharmacist was looking for information about a Shingrix late second dose due to covid situation. The patient did not receive 2nd dose due to covid situation. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Off label use
Clinical narrative: HCP is administering just one dose of Shingrix after /received / Zostavax/is not providing the second dose; HCP is not providing the second dose of the Shingrix/nor indicating that / should receive it/ is being done with several patients; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date) and Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination and off label use. On an unknown date, the outcome of the incomplete course of vaccination and off label use were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The vaccines representative reported that, the health care professional was not completing the Shingrix schedule. The health care professional  was administering just one dose of Shingrix after the patient received a complete schedule of Zostavax. The health care professioanl was not providing the second dose of the Shingrix vaccine schedule nor indicating that the patients should receive it, which led to off label use.. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to  incomplete course of vaccination. The health care professional  wished not to be contacted for follow up. The vaccines representative agreed to follow up.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: administered an adult dose of Havrix to a 4 year old patient; administered an adult dose of Havrix to a 4 year old patient; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 4-year-old female patient who received HAV (Havrix 1440 adult) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, she administered an adult dose of Havrix to a 4 year old patient, which led to adult product administered to child and overdose. The reporter consented to follow up via postal address.  No further information was reported.
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of shingrix / of twinrix / 12/2019. does she need to restart / has not gotten any other doses; First dose of shingrix / of twinrix / 12/2019. does she need to restart / has not gotten any other doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019) and Twinrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix, the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination were 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 for this report. The reporter stated that, the patient got the 1st dose of Shingrix and Twinrix, but had not gotten any other doses. Till the time of reporting, the patient did not receive 2nd dose of Shingrix and Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First Shingrix / May of 2020 / received / 2nd vaccination today / One year between the two doses; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2020).   On 30th June 2021, the patient received the 2nd dose of Shingrix. On 30th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows: This case was reported by patient herself. The patient received her 1st dose a year before reporting and got her 2nd dose a year later, received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient wanted to know would that be effective or need to get a 3rd dose in 2 to 6 months. The patient did not know the lot number or expiration date. The reporter consented to follow up.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered
Clinical narrative: Co administration of the Engerix-B and Pediarix on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 7-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9x3t5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) (batch number k329e, expiry date 24th April 2023) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 information was provided as follows: The physician reported that the co administration of a dose of Pediarix and Engerix B to patient on the same day, which led to overdose of hepatitis B antigen. No further events were reported.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000110:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: late second doses / received his first dose on Dic 2020 / due Covid situation.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on December 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 age at vaccination was not applicable for this report. The pharmacist stated that, the patient late for 2nd dose of Shingrix due to covid situation. This case was linked with case US2021AMR143241, reported by same reporter for different patients. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR143241:same reporter
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received a kinrix / in spite that /it is for / 4-6 years old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a kinrix dose in spite that,  prescribing information said that it was for patients from 4 to 6 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: dose of Havrix/ nonviable after a temperature excursion.; This case was reported by a physician via call center representative and described the occurrence of incorrect product storage in a 18-year-old female patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   On 25th June 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.  Additional details were reported as follows: A physician reported that a female patient was given a dose of Havrix on 25th June 2021 that was deemed nonviable after a temperature excursion. No symptoms were reported. The reporter consented to follow up. This case is one of 6 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:Same reporter US-GLAXOSMITHKLINE-US2021142816:Same reporter US-GLAXOSMITHKLINE-US2021142817:Same reporter US-GLAXOSMITHKLINE-US2021142813:Same reporter US-GLAXOSMITHKLINE-US2021142815:Same reporter
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: adult patient received a pediatric dose / on 21-Jan-2021 and a second pediatric dose / in 21-Feb-2021; adult patient received a pediatric dose / on 21-Jan-2021 and a second pediatric dose / in 21-Feb-2021; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 57-year-old female patient who received HAV (Havrix pediatric) for prophylaxis.   On 21st January 2021, the patient received the 1st dose of Havrix pediatric (intramuscular). On 21st January 2021, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were reported as follows: The pharmacist reported that an adult patient received 1st pediatric dose of Havrix on 21st January 2021, which led to underdose and adult use of a child product. The second pediatric dose of Havrix was received on 21st February 2021, refer case US2021AMR143447. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR143447:Same reporter