chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "had his 3 Pfizer Covid vaccines, then got the Covid 19 virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: he got Covid-19 on New Year's weekend. Caller stated that he got 3 doses of the Pfizer Covid-19 Vaccine. Reaction / Event as Reported by the Primary Source for Translation: had his 3 Pfizer Covid vaccines, then got the Covid-19 virus. Caller stated that on his 1st dose, he experienced tiredness. During his 3rd dose, he experienced pain under left armpit and pain on the glands in his throat. When he consulted with his doctor, they found that his thyroid did not produce enough hormones. Caller stated that he is in a hypothyroid state. Caller is looking into getting his 4th dose. Caller wanted to check if thyroid issues will have an effect with the Pfizer Covid-19 Vaccine. Caller also wanted to check if there is information on the vaccine causing thyroid issues. States his 3rd shot was in Oct2021, and he got Covid-19 on New Years weekend. He has been having lingering symptoms, one of which being his thyroid is not producing enough hormone, so he is hypothyroid. He is hoping that maybe the 4th shot will help that improve. Declined to complete the report. States that he is thinking about getting the 4th shot this weekend but wants to make sure it won't make his thyroid issue worse. Requests to be transferred. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ep6955), on 09Apr2021 as dose 2, single (Lot number: ep6955) and on 28Nov2021 as dose 3 (booster), single (Lot number: fj1620) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. Concomitant medication(s) included: FLUOXETINE. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Apr2022, latency 1 day after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Prior to vaccination, was the patient was no diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ep6955), on 09Apr2021 as dose 2, single (Lot number: ep6955) and on 28Nov2021 as dose 3 (booster), single (Lot number: fj1620) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. Concomitant medication(s) included: FLUOXETINE. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Apr2022, latency 1 day after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Prior to vaccination, was the patient was no diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: lateral abdominal muscular pain preceded URT sympotoms; Abdominal pain; Also I am observing that my periods are preceded with more severe and extended pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2021 at 12:00 as dose 2, single (Lot number: EW0179) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot/Batch number: EW0176, Location: Left arm), administration date: 01May2021, when the patient was 42-year-old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN (disability) with onset May2021, outcome "not recovered"; DYSMENORRHOEA (disability) with onset May2021, outcome "not recovered", described as "Also I am observing that my periods are preceded with more severe and extended pains"; UPPER RESPIRATORY TRACT INFECTION (disability) with onset May2021, outcome "not recovered", described as "lateral abdominal muscular pain preceded URT sympotoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of upper respiratory tract infection, abdominal pain, dysmenorrhoea.  Additional information: patient had lateral abdominal muscular pain for extended period of time which became non-significant over the time. i got exposed to COVID around end of 2021, and lateral abdominal muscular pain preceded URT symptoms. However this time it had not disappeared and most of the mornings I am waking up with this abdominal lateral muscular pain. Also I am observing that my periods are preceded with more severe and extended pains than before taking vaccination. Vaccine had caused permanent damage in my physiology and I am living with low to severe abdominal pains on daily basis. I am worried what else is changed in my body because of Vaccine. Covid was not prior vaccination. Covid was tested post vaccination.  Follow-Up (04May2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200643701 similar report from same reporter
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Dysmenorrhoea, SARS-CoV-2 test, Upper respiratory tract infection
Clinical narrative: lateral abdominal muscular pain preceded URT sympotoms; Abdominal pain; Also I am observing that my periods are preceded with more severe and extended pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2021 at 12:00 as dose 2, single (Lot number: EW0179) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot/Batch number: EW0176, Location: Left arm), administration date: 01May2021, when the patient was 42-year-old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN (disability) with onset May2021, outcome "not recovered"; DYSMENORRHOEA (disability) with onset May2021, outcome "not recovered", described as "Also I am observing that my periods are preceded with more severe and extended pains"; UPPER RESPIRATORY TRACT INFECTION (disability) with onset May2021, outcome "not recovered", described as "lateral abdominal muscular pain preceded URT sympotoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of upper respiratory tract infection, abdominal pain, dysmenorrhoea.  Additional information: patient had lateral abdominal muscular pain for extended period of time which became non-significant over the time. i got exposed to COVID around end of 2021, and lateral abdominal muscular pain preceded URT symptoms. However this time it had not disappeared and most of the mornings I am waking up with this abdominal lateral muscular pain. Also I am observing that my periods are preceded with more severe and extended pains than before taking vaccination. Vaccine had caused permanent damage in my physiology and I am living with low to severe abdominal pains on daily basis. I am worried what else is changed in my body because of Vaccine. Covid was not prior vaccination. Covid was tested post vaccination.  Follow-Up (04May2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200643701 similar report from same reporter
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; Caller stated the PEDVAX HIB was administered after a temperature excursion; This spontaneous report has been received from an unspecified reporter and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions, drug allergies, reactions and concomitant therapies were not reported.  On 15-MAR-2022, the patient was vaccinated with an improperly stored dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) at a dose of 0.5 ml, lot number T030711, expiration date: 15-APR-2023 (vaccination scheme frequency, anatomical location, and route of administration were not provided).  The administered dose of the vaccine experienced temperature excursions on 23-FEB-2022: 48.4 Fahrenheit degree (F) for 2 hours 25 minutes, on 03-MAR-2022: 49.3F for 2 hours 50 minutes, on 08-MAR-2022: 46F for 30 minutes and on 09-MAR-2022: 47.8 for 3 hours 56 minutes. No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information; LPN calling to report expired vaccine administered to patient; This spontaneous report has been received from a Licensed Practical Nurse referring a patient of an unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 04-APR-2022, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) at a dose reported as 1 milliliter (mL) once (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number lot number T034003 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 28-MAR-2022) for prophylaxis (expired product administered).  No additional adverse event (AE) information was provided (no adverse event).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller stated the PEDVAX HIB was administered after a temperature excursion.; This spontaneous report was received from a female consumer worker referring to a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 15-MAR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b, conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) at the dose of 0.5 milliliter (mL), for prophylaxis ,0.5ml, lot #T030711, expiration date: 15-APR-2023, (strength, frequency, anatomical injection site and route of administration and were not provided ; lot number T030711 has been verify to be a valid lot number with an expiration date on 15-APR-2023)).  The haemophilus b, conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was stored on 23-Feb-2022, at a temperature of 46.4 degrees Fahrenheit (°F) for the time frame of 1 hour, and 48.4°F for the timeframe of 2 hours 25 minutes. On 03-MAR-2022, it was stores at 49.3 °F for the time frame of 2 hours 50 minutes. On 08-MAR-2022 it was stored at 46°F for a timeframe of 30 minutes. On 09-MAR-2022 it was stores at 47.8 °F for the time frame of 3 hour 56 minutes. There was no previous temperature excursion. No additional adverse events reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient reported that the last dose they had (which was the second in the series of ) was taken sometime in the "summer of 2019"; No additional AE information reported; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.   On an unknown date and then on an unspecified date in June 2019 (also reported as "sometime in the summer of 2019") the patient was administered with the first and the second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, exact doses, exact frequencies, routes of administration, anatomical injection sites, lot numbers and expiration dates were not reported) as prophylaxis. However, the patient had not received the third dose yet (inappropriate schedule of product administration).  No additional adverse event information reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored vaccine administered; This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 14-MAR-2022, the patient was vaccinated with 1 improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB) (lot number u026217, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 02-NOV-2023) (frequency, route of administration, anatomical location and vaccination scheme were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally either (lot number u026664, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 24-FEB-2023 or lot number 1741817, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 30-JUL-2022) (frequency, anatomical location and vaccination scheme were not reported). The indication for both vaccines was prophylaxis. The administered vaccines experienced a temperature excursion of 34.3F during a time frame of 55 minutes (product storage error). No previous temperature excursion or additional adverse events were reported.
Sex: F
Vaccine: PPV, UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever; This spontaneous report was received from a consumer concerning a 43-year-old female patient.  The patient's medical history and concurrent conditions were not reported. Her concomitant therapies included tozinameran (PFIZER BIONTECH COVID-19 VACCINE).   On 31-MAR-2022, the patient received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, dose number, lot number, expiry date, and route of administration were not provided). Other suspect therapy included adalimumab (HUMIRA), citrate free, administered subcutaneously for moderate to severe hidradenitis suppurativa (strength, frequency, lot number, and expiry date were not provided).    On the same date (31-MAR-2022), the patient experienced fever and vomiting. At the time of reporting, the patient had not recovered from the events.  The action taken with adalimumab (HUMIRA) was reported as unknown.  It was reported that was unknown if the patient was enrolled in a coronavirus disease 2019 (COVID-19) vaccine trial.  The causal relationship between fever, vomiting and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines.; This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 11-MAR-2022, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # U026217 and expiration date 02-NOV-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 34.3 degree fahrenheit (F) for 55 minutes; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 11-MAR-2022, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # U026217 and expiration date 02-NOV-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 34.3 degree fahrenheit (F) for 55 minutes; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines; This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 14-MAR-2022, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # U026217 and expiration date 02-NOV-2023, and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  (dosage regimen was not reported), lot # 1741817 and expiration date 30-JUL-2022, administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 34.3 degree fahrenheit (F) for 55 minutes; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001821: US-009507513-2204USA001816:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 11-MAR-2022, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # U026217 and expiration date 02-NOV-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 34.3 degree fahrenheit (F) for 55 minutes; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001821: US-009507513-2204USA001816:
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; Caller reports an expired vaccine was administered.; This spontaneous report was received from a registered nurse and refers to an 18-year-old patient of unknown gender. There was no information regarding patient's medical history, concurrent conditions or concomitant therapies provided.  On 14-APR-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, lot # S026372, expiration date: 01-APR-2022 (dose number, dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events reported (no adverse event).
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not have any symptoms or adverse effects of administration; Caller is a nurse who reports an expired dose of PROQUAD was given to a patient today.; Information has been received from a nurse regarding a 4-years-old female patient (conflicting information, also reported as 5 years old). Patient's concomitant vaccines included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid(PEDIARIX). The patient's medical history, drug allergies, previously drug reactions and concurrent conditions were not reported.  On 19-APR-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 ml once, for prophylaxis, lot number T032144 with expiration date in 20-MAR-2022, administered by route/site reported as "LOT" which was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot number W000452 with expiration date on 23-JUL-2024, with route/site reported as "ROT" (strength, dose, route of administration, strength and anatomical location not reported) (expired vaccine administered).  It was reported that organization workflow policy was not followed and immunization was missed when checking expired terms. Documentation completed at primary care physician (PCP) site and proper workflow trained was completed again.  It was reported that the patient did not have any symptoms or adverse effects of administration.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: neuropathy; shingles; This initial spontaneous report was received from a lawyer, regarding a case in litigation and referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around October 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for it's intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles and neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of shingles and neuropathy was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter assessed both events to be disabling.  Upon internal review, the event of neuropathy was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored vaccines administered; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.    Since 10-JAN-2022, the vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number u015476, expiration date 13-NOV-2022, had a temperature excursion and was administered on 22-MAR-2022 (dose and route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  No previous temperature excursions were detected.; Sender's Comments:  US-009507513-2205USA000524: US-009507513-2205USA000533: US-009507513-2205USA000544:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Caller is an office manager who reports administration of vaccine following temperature excursion. No adverse effects of administration. No further information provided. No other AE/no PQC.         ?    Names of vaccines involved (including lot/exp; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 21-APR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, lot number U013036, expiration date 23-APR-2023 for prophylaxis (route of administration not reported) (product storage error). The vaccine was reconstituted with sterile diluent that did not experienced any temperature excursion.   no adverse event was reported.  The vaccine underwent a temperature excursion of 14.5 degrees Celsius for 10 hours. No previous temperature excursions were detected.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; Improper storage of product in use; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 05-JAN-2022, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # T028582, expiration date: 04-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided).   The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (Product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown to the reporter. There was no previous temperature excursion. No adverse events (AE) were reported, and no further information was provided.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000533: US-009507513-2205USA000540: US-009507513-2205USA000544: US-009507513-2205USA000564: US-009507513-2205USA000560:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; 0.7 mL were administered; Caller is a nurse who reports an expired dose of VARIVAX was inadvertently administered to a patient today. No adverse effects or symptoms from the administration. No temperature excursions. Vaccine was not supported per post-expiry memo. No other AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 02-MAY-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.7 milliliter (incorrect dose administered), lot number S028923, expiration date 16-SEP-2021 (expired product administered) for prophylaxis (route of administration not reported). The vaccine was reconstituted with 0.7 millilter of sterile diluent. No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; A medical assistant reported that an improperly stored PROQUAD vaccine was administered.  No additional AE's and no PQC's were reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 13-APR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number U022729, expiration date  16-JAN-2023 (dose and route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the vaccine was administered after temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 29-APR-2022, the patient was vaccinated with an improperly stored dose (administered after temperature excursion) of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U026207 with expiration date of 24-AUG-2023 or lot # U029496 21-SEP-2023, for prophylaxis (dose, route of administration and frequency were not reported).         Temperature excursion -9 C; Time frame 1 hour 45 minutes; no temperature excursion  No further information provide.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the vaccine was administered after temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 28-APR-2022, the patient was vaccinated with an improperly stored dose (administered after temperature excursion) of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U026207 with expiration date of 24-AUG-2023 or lot # U029496 with expiration date of 21-SEP-2023, for prophylaxis (dose, route of administration and frequency were not reported).         Temperature excursion -9 C; Time frame 1 hour 45 minutes; no previous temperature excursion.   No further information provide.
Sex: F
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; Chronic Hepatitis; This case was reported in a literature article and described the occurrence of vaccination failure in a 27-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and chronic hepatitis b (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the chronic hepatitis b was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and chronic hepatitis b to be related to Hepatitis B vaccine.     Additional Information: GSK receipt date: 29 April 2022 Author comment: The patient was born in another country and did not receive the HBV vaccination in childhood. The patient reported 2 heterosexual partners in her lifetime. The patient had no history of other sexually transmitted infections, blood transfusions, needlestick injuries, or intravenous drug use. The patient was without pertinent medical history presented with elevated transaminase levels and a positive hepatitis Bsurface antigen (HBsAg) test result. Because of elevated liver enzymes and lack of anti-HBs following vaccination, further serologic testing was performed. At presentation, the patient was asymptomatic. Physical examination findings were unremarkable. This patient's elevated transaminase levels and birth in a country with high HBV prevalence prompted serum HBsAg testing. A false-positive HBsAg test result is unlikely, particularly in the context of the positive IgG anti-HBc and hepatitis B e antibody (anti- HBe) test results. The patient's negative IgM anti-HBc and HBeAg test results, in addition to transaminase levels being below a value that was 2 times the upper limit of "normal" values, supported the diagnosis of chronic inactive HBV infection, characterized by little or no HBVreplication, minimal or no liver inflammation, normal liver enzyme serum levels, absence of HBeAg, presence of anti-HBe, and undetectable or low levels of serumHBVDNA. Resolution of HBV infection is characterized by a negative HBsAg test result with positive anti-HBs and IgG anti-HBc test results and therefore was unlikely in this patient. The patient was informed of her chronic hepatitis B diagnosis and the need for regular monitoring, at least annually, of serum HBV DNA and alanine transaminase levels to assess viral replication and candidacy for HBV treatment. Liver ultrasonography and elastography findings did not show fibrosis or focal masses.  Additional supportive information: This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and time to onset were unknown. This article corresponding to this case is not available for regulatory submission due to copyright restriction.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: first singles shot a year ago, didn't get second because covid; This case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient received 1st dose a year ago of reporting date and did not receive second because of COVID-19. The patient asked whether he/she should get second shot within six months. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Saturday I could hardly move; I had my 2nd shot on Friday was in so much pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd April 2022, the patient received the 2nd dose of Shingles vaccine. In April 2022, less than a day after receiving Shingles vaccine, the patient experienced pain. On 23rd April 2022, the patient experienced mobility decreased. On an unknown date, the outcome of the pain and mobility decreased were recovering/resolving.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had second shingles shot on Friday and was in so much pain and on Saturday, the patient could hardly move. On reporting day, the patient felt much better and went to church as usual. The patient also stated that it took two or three days to feel better. Additional Supportive Information: The follow up was not possible due to no contact details
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Skin warm, Swelling
Clinical narrative: Swelling for 3 weeks.; Warm to touch; Required felt malaise for minimum three days; This case was reported by a other health professional via sales rep and described the occurrence of swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling, skin warm and malaise. On an unknown date, the outcome of the swelling, skin warm and malaise were unknown.   It was unknown if the reporter considered the swelling, skin warm and malaise to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: The patient was reported swelling for 3 weeks and Warm to touch and required felt malaise for minimum three days. The reporter did not give consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache; fever; shivering & amp; muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received the 2nd dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced headache, fever, shivering and muscle pain. On an unknown date, the outcome of the headache, fever, shivering and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, shivering and muscle pain to be related to Shingrix.     Additional Information: GSK receipt date: 27-Apr-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient self-reported this case. The patient had received 2nd dose of Shingrix one day before the reporting and had headaches, fever, shivering and amp and muscle pain. The patient asked that how long did these effects lasted. Did not consent to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received 2 shots but broken out with shingles/suspected vaccination failure; broken out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment:This case was reported by a consumer via interactive digital media. The patient had received 2 shot of shingles but had broken out with shingles again. The patient wanted to know if she/she could receive the vaccine again. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Hot arm; Knot; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site warmth and injection site induration. On an unknown date, the outcome of the injection site warmth and injection site induration were unknown.   It was unknown if the reporter considered the injection site warmth and injection site induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had both the doses over 2 month apart in 2022. The injection site was right arm both times. After the 1st dose, the patient had mild reaction like hot arm and knot. No fever or weakness every time. The patient had no reaction to the 2nd shot and asked if it was still good.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine and still had it super bad/suspected Vaccination failure; still had it super bad, horrible; This case was reported by a consumer via interactive digital media and described the occurrence of 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 recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the vaccine and still had shingles super bad. The patient had them for month and a half. It was horrible. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and still got the Shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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: GSK Receipt Date: 28-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the vaccine and still got the Shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, 2 doses, and still got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by the patient's sibling. The patient received two doses of shingles vaccine and still got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.