chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Joint swelling, Pain, Pain in extremity, Ultrasound scan normal
Clinical narrative: Moderate to severe radiating right leg pain since late May, 2021, w/ no known cause. Recent swelling and stiffness in right knee. OTC meds for pain and cyclobenzaprine. Physical Therapy.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased activity, Headache, Myalgia, Pyrexia
Clinical narrative: severe headache, fever overnight 100F, chills, shivering, overall muscle aches, lasted about 24hrs, first 12hrs worst, very challenging to perform any sustained activity during course of symptoms.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Hyperhidrosis
Clinical narrative: 1st shot received at 09am on 07/02, around 0130am on 07/03, I experienced severe sweating, shivering, chills, severe stomach pains, nausea, severe diarrhea, ringing in my ears, extreme weakness, which lasted until around 5am.  Afterward the diarrhea, chills and nausea continued until around 10am.  Currently, a week later, the right side of my face has broken out with some pustules, some are large, some small-however, they are all on the right side of my face. I received the vaccine in my right arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pustule, Tinnitus
Clinical narrative: 1st shot received at 09am on 07/02, around 0130am on 07/03, I experienced severe sweating, shivering, chills, severe stomach pains, nausea, severe diarrhea, ringing in my ears, extreme weakness, which lasted until around 5am.  Afterward the diarrhea, chills and nausea continued until around 10am.  Currently, a week later, the right side of my face has broken out with some pustules, some are large, some small-however, they are all on the right side of my face. I received the vaccine in my right arm.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No AE reported; report a temperature excursion on ROT ATEQ and product administered to 6 patients; This spontaneous report has been received from a medical assistant referring to a 6 month old patient (unknown gender). No information was provided regarding the patient's medical history, concurrent conditions, drug/allergy history or concomitant medications.  On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) single dose, orally,  lot # T033812, expiration date 29-DEC-2021 (strength and dose were not provided) for prophylaxis.  The doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) were exposed to a temperature excursion of 47°Fahrenheit (°F) during a time frame of 1 hour, which was not detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports from the same reporter (MARRS#2106USA004039, MARRS#2106USA004087,MARRS#2106USA003971, MARRS#2106USA004106, MARRS#2106USA004335); Sender's Comments:  US-009507513-2106USA004106: US-009507513-2106USA004039: US-009507513-2106USA004087: US-009507513-2106USA003971: US-009507513-2106USA004335:
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: that a patient due for her second dose of VARIVAX and was accidently administered PROQUAD instead; that a patient due for her second dose of VARIVAX and was accidently administered PROQUAD instead; that a patient due for her second dose of VARIVAX and was accidently administered PROQUAD instead; no adverse event; This spontaneous report was received from a medical assistant and refers to a 25 year old female patient. The patient's concurrent conditions, concomitant therapies and historical conditions were not provided.  On an unknown date, the patient was due for her second dose of varicella virus vaccine live (oka/merck)(VARIVAX) and was accidently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T021301, expiration date 19-DEC-2021, 0.5 milliliter (route was not provided), for prophylaxis, instead of varicella virus vaccine live (oka/merck)(VARIVAX).
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: the patient inadvertenly recieved the thir dose; interchange of vaccine products; wrong product administered; no adverse event; This spontaneous report as received from a the patient's grandfather, and refers to an approximately 12 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.          It was reported that the patient received on 24-AUG-2020, either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) which have a valid lot # S020254 with expiration date on 09-DEC-2021, (formulations, exact doses, routes of administration, vaccination scheme frequency, anatomical locations were not reported). The reporter states a second dose was administered on 25-MAY-2021, and a third dose was administered today, 25-JUN-2021.  The patient was supposed to receive only two doses but the pediatrician's office who administered the vaccine did not record the administration of the 2nd dose, and therefore the patient inadvertently received a third dose only one month after administration of the second dose. No additional adverse events or product quality complaints were reported.  Lot number S020254 is an invalid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020254; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine used; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date in 2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml administered orally (lot#: 1684154, expiration date: 24-JUN-2021) for prophylaxis (expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine used; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 28-JUN-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml orally (lot#: 1684163, expiration date: 26-JUN-2021) as prophylaxis (expired product administered). The product had no prior temperature excursions. No additional adverse events were reported.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No AE/ PQC reported at this time.; improperly stored temperature excursion; patient date of birth: 8/12/2007; This spontaneous report has been received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 24-JUN-2021, the patient was vaccinated with an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose, route of administration, vaccination scheme, anatomical site of vaccination were not reported, lot number T027112 has been verified to be valid, expiration date 07-FEB-2022) as prophylaxis (product administered to patient of inappropriate age).   The vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number T027112, expiration date 07-FEB-2022) was exposed to the temperature excursion of 10 Fahrenheit degrees during a time frame of 7 hours. It was reported a previous temperature excursion of 6.10 Fahrenheit degrees during a time frame of 1 hour and 30 minutes. These temperature excursions were not detected by a data logger.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA000296:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/PQC reported at this time; PROQUAD was involved in a prior excursion and was administered to five patients; This spontaneous report was received from a medical assistance regarding a 4-year-old patient whose gender was not specified.   Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided.  On 01-JUN-2021, a Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) was improperly stored at a temperature of 6 degrees to 14 degrees Fahrenheit (10 degrees Fahrenheit) for 7 hours. There was a previous temperature excursion from 6 to 14 degrees Fahrenheit (6.10 degrees Fahrenheit) for 1 hour and 30 minutes.   On 21-JUN-2021, the patient was vaccinated with the improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (dose and vaccination scheme frequency were unknown by the reporter; route and anatomical location of administration were not provided; with lot number T027112 and expiration date 07-FEB-2022, which were verified to be valid) for prophylaxis (product storage error). No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA000174: US-009507513-2107USA000121: US-009507513-2106USA008058: US-009507513-2106USA008067:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired dose administered of VAQTA administered; This spontaneous report as received from a pharmacist refers to an identifiable patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were provided.     On 30-JUN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (1 ml, intramuscular, lot # S037821 expiration date 07-JAN-2021) for prophylaxis.  No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiovascular disorder, Flank pain, Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; postherpetic neuralgia; flank pain; a cardiovascular event; hearing problems; Information has been received from a lawyer regarding a case in litigation and referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 09-DEC-2011, the patient was administered the zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot#, expiration date were not reported) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by health providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX): herpes zoster, postherpetic neuralgia, flank pain, a cardiovascular event and hearing problems. The outcome of these events was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Ill-defined disorder
Clinical narrative: Bell's Palsy; Other zoster-related conditions; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In 2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster) and zoster-related conditions.   On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: bell's palsy and other zoster-related conditions (ill-defined disorder). At the reporting time, the outcome of the events was unknown.   The reporter considered the events of bell's palsy and other zoster-related conditions (ill-defined disorder) to be related to zoster vaccine live (ZOSTAVAX).
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Ill-defined disorder
Clinical narrative: Hearing Loss; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation concerning a currently 70 years old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.    On 07-JUL-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose number, route, lot# and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unspecified date, the patient was treated by a health care professional at medical office for hearing loss and other zoster-related conditions. The outcome of deafness and Ill-defined disorder was not provided.   Causality with deafness and Ill-defined disorder with zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, the event deafness was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: She denied further AE.; a patient was administered VARlVAX that expired on 20MAY2021; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.     On 07-JUL-2021, the patient was vaccinated an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot # S015463 and expiration date of 20-MAY-2021, 0.5 milliliter (route of administration was unknown) for prophylaxis. There was no adverse event reported. The vaccine had no any temperature excursions.
Sex: U
Vaccine: FLUN4
Symptoms: Myalgia, Nasal discomfort
Clinical narrative: PHYSICIAN REPORTING THAT WHEN GIVING FLUMIST IN THE PAST PATIENTS HAVE EXPERIENCED IENCED MYALGIA AND NASAL IRRITATION; PHYSICIAN REPORTING THAT WHEN GIVING FLUMIST IN THE PAST PATIENTS HAVE EXPERIENCED IENCED MYALGIA AND NASAL IRRITATION; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 15-FEB-2019, the patient experienced not applicable physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation (preferred term: Myalgia) and not applicable physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation (preferred term: Nasal discomfort).     The outcome of the event(s) of physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation and physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: M
Vaccine: COVID19, UNK
Symptoms: Brain scan normal, Contusion, Device breakage, Fall, Humerus fracture
Clinical narrative: briefly Blacked out; Fell; Broke his right proximal humerus; Bruised his right knee; Split open his upper lip; Dental bridge was also broken in the fall; This is a spontaneous report from a non-contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-061722), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (briefly Blacked out), FALL (Fell) and HUMERUS FRACTURE (Broke his right proximal humerus) in 79-year-old male patient who received apixaban (Eliquis) for an unknown indication. The occurrence of additional non-serious events is detailed below Product or product use issues identified: DEVICE BREAKAGE (Dental bridge was also broken in the fall) on 14-Apr-2021. On an unknown date, the patient started Eliquis (unknown route). On 14-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), FALL (seriousness criterion medically significant), HUMERUS FRACTURE (seriousness criterion medically significant), CONTUSION (Bruised his right knee) and LIP INJURY (Split open his upper lip). The patient was treated with Physical therapy for Humerus fracture. The action taken with Eliquis (Unknown) was unknown. At the time of the report, LOSS OF CONSCIOUSNESS, FALL, HUMERUS FRACTURE, CONTUSION and LIP INJURY outcome was unknown. Patient was taking Eliquis at the time he fell and broke his arm. He had been gardening and was wearing old, worn sneakers when they went to a hardware store for some supplies. At one point he slipped and fell forward to the floor. He broke his right proximal humerus, bruised his right knee, and split open his upper lip, and briefly 'blacked out'. A dental bridge was also broken in the fall. When the attending ER physician learned that he was taking Eliquis he was taken for brain scans to look for hemorrhages. His arm did not require surgery or casting. He wore a sling for several weeks and slept in a recliner until 19-Jun-2021. He's been undergoing physical therapy for almost four weeks and has regained almost 9000 mobility in that arm. There were no specific treatments received for the knee. He received his second Pfizer Covid vaccination on 12-Apr-2021 DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan brain: No bleeding was present. For Eliquis(Unknown), the reporter did not provide any causality assessments.; Sender's Comments: BMS Medical Evaluation Comment: This 79-year-old patient had multiple events after receiving apixaban therapy. Based on the nature of the reported event, loss of consciousness which could have led to fall leading to humerus fracture in this elderly patient, they are considered as not related to apixaban therapy.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Lip injury, Loss of consciousness
Clinical narrative: briefly Blacked out; Fell; Broke his right proximal humerus; Bruised his right knee; Split open his upper lip; Dental bridge was also broken in the fall; This is a spontaneous report from a non-contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-061722), license party for apixaban (ELIQUIS).  This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (briefly Blacked out), FALL (Fell) and HUMERUS FRACTURE (Broke his right proximal humerus) in 79-year-old male patient who received apixaban (Eliquis) for an unknown indication. The occurrence of additional non-serious events is detailed below Product or product use issues identified: DEVICE BREAKAGE (Dental bridge was also broken in the fall) on 14-Apr-2021. On an unknown date, the patient started Eliquis (unknown route). On 14-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), FALL (seriousness criterion medically significant), HUMERUS FRACTURE (seriousness criterion medically significant), CONTUSION (Bruised his right knee) and LIP INJURY (Split open his upper lip). The patient was treated with Physical therapy for Humerus fracture. The action taken with Eliquis (Unknown) was unknown. At the time of the report, LOSS OF CONSCIOUSNESS, FALL, HUMERUS FRACTURE, CONTUSION and LIP INJURY outcome was unknown. Patient was taking Eliquis at the time he fell and broke his arm. He had been gardening and was wearing old, worn sneakers when they went to a hardware store for some supplies. At one point he slipped and fell forward to the floor. He broke his right proximal humerus, bruised his right knee, and split open his upper lip, and briefly 'blacked out'. A dental bridge was also broken in the fall. When the attending ER physician learned that he was taking Eliquis he was taken for brain scans to look for hemorrhages. His arm did not require surgery or casting. He wore a sling for several weeks and slept in a recliner until 19-Jun-2021. He's been undergoing physical therapy for almost four weeks and has regained almost 9000 mobility in that arm. There were no specific treatments received for the knee. He received his second Pfizer Covid vaccination on 12-Apr-2021 DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan brain: No bleeding was present. For Eliquis(Unknown), the reporter did not provide any causality assessments.; Sender's Comments: BMS Medical Evaluation Comment: This 79-year-old patient had multiple events after receiving apixaban therapy. Based on the nature of the reported event, loss of consciousness which could have led to fall leading to humerus fracture in this elderly patient, they are considered as not related to apixaban therapy.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose of Heplisav-B was Administered; Initial Report Received on 26-May-2021  A nursing supervisor reported that a 20 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Relevant medical history included scoliosis. The patient had no known allergies.   No relevant concomitant medications were reported.  On 26-May-2021, the patient received a dose of HEPLISAV-B (Lot # 933094, expiration date 17-Apr-2021, NDC # unknown, serial number 977676332283) in the right deltoid from a medical doctor's office. A tetanus, diphtheria and acellular pertussis (Tdap) vaccine was administered in the left deltoid during the same visit. The patient also received a purified protein derivative (PPD) skin test. At the time of reporting, no adverse symptoms were reported.  No additional information was provided.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Product dose omission issue, Social problem
Clinical narrative: first / vaccine November 2019 / unable to get the 2nd vaccine because of COVID; This case was reported by a other health professional via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   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 patient was unable to get the 2nd dose of Shingrix because of Covid. The reporter asked if the patient should repeat that and get both vaccines or if just take the 2nd vaccine now.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product dose omission issue, Social problem
Clinical narrative: Initial shot a couple of years ago / due to various things including the pandemic / unable to get the second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose two years ago, from the day of 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: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient had the initial shot a couple of years ago but, due to various things including the pandemic, he or she was unable to get the second shot.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient was quite sure it was Shingrix vaccine but did not know for sure. The reporter was asking if they should start over and get two shots or just get the second shot. The follow-up would not possible as no contact details were available. The case had been linked with the case- US2021AMR145801, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR145801:Same reporter. Master case for "We"
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Initial shot a couple of years ago / due to various things including the pandemic / unable to get the second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot two years ago, from the day of 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: 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 as per the vaccination schedule, which led to incomplete course of vaccination. The patients had the initial shot a couple of years ago but, due to various things including the pandemic, they were unable to get the second shot.  The reporter was asking if they should start over and get two shots or just get the second shot. The case is linked with the case- US2021AMR145748, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR145748:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Because of the Covid epidemic, I just got my 2nd Shingrix shot. But the time between shots was 2 years.; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years before the 2nd dose).   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 case was reported by the patient himself/herself. The age at vaccination was not reported The patient stated that he/she received the 2nd dose of Shingrix 2 years later due to Covid epidemic. The reporter stated the time between shots was 2 years and also stated that his/her doctor said that patient should get a 'third' shot because of the time elapsed between the first two. The reporter asked did he/she need another shot in 4-6 months and also asked was there any time that was preferred in the 2 to 6 month time-frame to get your second shingrix shot. It was stated that the patient was advised to talk to his/her healthcare provider about that guidance and patient's individual situation.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: Because of the Covid epidemic, I just got my 2nd./time between shots was 2 years.; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date 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 social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. Because of the Covid epidemic, the patient just got 2nd Shingrix shot but the time between shots was 2 years. The patient enquired if he/she need another shot in 4 to 6 months.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm hurt for a week after each vaccination shot; 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 the 1st dose of 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 provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that after every Shingle shot, his/her arm hurts for a week. The patient stated that he/she could not imagine how painful shingles were. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose, refer link case US2021AMR149445.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR149445:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Varicella post vaccine
Clinical narrative: Vaccinated and still got them / Suspected Vaccination failure; Vaccinated and 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product complaint, Product preparation issue
Clinical narrative: Powder component /without liquid component. Not sure if product was given incorrectly; Powder component /without liquid component. Not sure if product was given incorrectly; Powder component /without liquid component./if this is a QA issue.; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter mentioned that, there was a powder component in box without liquid component and it was not sure if product was given incorrectly or not, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered. The reporter was not sure if it was a QA issue. The reporter consented to follow-up.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: received the vaccine when she was 13 weeks and 6 days pregnant; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 9HT27, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Tetra 2020-2021 season at day 97 of the pregnancy. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   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 reported as follows: The reporter was the patient.  She was a physician resident. The patient received the vaccine when she was 13 weeks and 6 days pregnant which led to vaccine exposure during pregnancy. The reporter consented to follow up.   Follow-up information received on 05th July 2021: After completion of all the follow up attempts the case was considered as pregnancy lost to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: pt. received only the diluent portion of Menveo on 7/2/2021; pt. received only the diluent portion of Menveo on 7/2/2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 2nd July 2021, the patient received Menveo. On 2nd July 2021, unknown after receiving Menveo, 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 age at vaccination was not reported. The patient received only diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No side effects were reported. The reporter consented to follow up.  Note: Patient initials were kept as it is, as no query response was available yet.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a late second dose of Shingrix, first dose on 5Jul2018 and second on 21Apr2021; This case was reported by a physician via call center representative 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 on 5th July 2018).   On 21st April 2021, the patient received the 2nd dose of Shingrix. On 21st April 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 details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: late for the second dose / has not yet been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 38-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 2nd March 2020, batch number 2573g, expiry date 28th May 2022).   On an unknown date, the patient received the 2nd dose of Engerix B and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Engerix B at primary reporter's facility. The pharmacist reported that the patient was late for the second dose of Engerix-b and had not yet been given till the time of reporting, which led to incomplete course of vaccination.  No adverse event was reported. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Received her 2nd dose / on 01Jul2021 and the needle leaked; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 1st July 2021, the patient received the 2nd dose of Shingrix. On 1st July 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The pharmacy student reported that a patient received her dose of Shingrix and the needle leaked, which led to incomplete dose administered. The reporter did not mention if the leakage touched the patient or the health care professional. The health care professional did not have the lot number or expiry date at the time of reporting. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose / (expiration date: 3/2021) was administered to a / patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA354A, expiry date 31st March 2021) for prophylaxis.   On 24th June 2021, the patient received Menveo. On 24th June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: Office Manager reported that an expired dose of Menveo was administered to a patient which led to expired vaccine used.  At the time of the report the patient has not reported any issues.  The lot was expiry only for the powder component.  The liquid component of the vaccine was still in date. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity, Sleep disorder
Clinical narrative: First dose / on 12/09/2020 / still did not receive second dose; Had a sore arm / after first dose; Had trouble sleeping for about 8 days after first dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, difficulty sleeping and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm and difficulty sleeping were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The age at vaccination was not applicable for this report for 2nd dose. The patient received Shingrix had sore arm and trouble sleeping for about 8 days. The patient still did not receive second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up. The reporter was referred to the health care professional. Limited information obtained.
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: administration of less than the recommended dose / due to a syringe malfunction the vaccine leaked during the administration / did not know how many milliliters the patient received; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 272F3, expiry date 1st October 2022) for prophylaxis.   On 8th July 2021, the patient received Shingrix. On 8th July 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the administration of less than the recommended dose of the Shingrix vaccine.  The HCP claimed that due to a syringe malfunction the vaccine leaked during the administration and the reporter did not know how many milliliters the patient received, which led to accidental underdose. The vaccine was administrated on the same day of the call.  No further events were reported.  The reporter consented to follow up.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: was administered an expired dose / expiration date: 7/5/2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 38-year-old male patient who received HAV (Havrix) (batch number D94MK, expiry date 5th July 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th July 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Pharmacist reported that, the patient was administered an expired dose of HAVRIX vaccine, which led to expired vaccine used. No further details were provided at the time of the call. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: do not remember whether they got the 1 and/or 2 doses of the vaccine/they got vaccinated was 3-4 years ago; do not remember whether they got the 1 and/or 2 doses of the vaccine/they got vaccinated was 3-4 years ago; This case was reported by a other health professional via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received doses 3 to 4 years ago of reporting date, did not remember dose number 1 or 2).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and extra dose administered were unknown.  Additional details were reported as follows: The case was reported by the patient's for himself. The age at vaccination was not applicable for this report. Health care professional (also patient) reported that he wanted to have, it might be a 3rd dose of Shingrix. The patient did not remember whether he got the 1st and/or 2 doses of the vaccine, which was the circumstance or information capable of leading to medication error and if had already received 2 doses, this dose would result in extra dose administered. The reporter asked when was he vaccinated and the patient told that they got vaccinated was 3 to 4 years ago. The reporter called to have more data regarding getting re-vaccinated. The reporter consented to follow up. The case had been linked with  US2021149599 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149599:Same reporter