chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 17-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. 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: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002983: US-009507513-2104USA002974: US-009507513-2104USA002982: US-009507513-2104USA002973: US-009507513-2104USA002975: US-009507513-2104USA002963: US-009507513-2104USA002985: US-009507513-2104USA002971: US-009507513-2104USA002984: US-009507513-2104USA002972: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 26-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. 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. West Point; manufactureraddress: 770 Sumneytown Pike; manufacturercity: West Point; manufacturerstate: PA; manufacturercountry: UNITED STATES; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002986: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002983: US-009507513-2104USA002974: US-009507513-2104USA002982: US-009507513-2104USA002973: US-009507513-2104USA002975: US-009507513-2104USA002963: US-009507513-2104USA002985: US-009507513-2104USA002971: US-009507513-2104USA002984: US-009507513-2104USA002972: US-009507513-2104USA002988: US-009507513-2104USA002989:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 01-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. 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: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002986: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002987: US-009507513-2104USA002983: US-009507513-2104USA002974: US-009507513-2104USA002982: US-009507513-2104USA002985: US-009507513-2104USA002973: US-009507513-2104USA002975: US-009507513-2104USA002963: US-009507513-2104USA002971: US-009507513-2104USA002984: US-009507513-2104USA002972: US-009507513-2104USA002989:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 08-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. 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: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002986: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002988: US-009507513-2104USA002987: US-009507513-2104USA002983: US-009507513-2104USA002974: US-009507513-2104USA002982: US-009507513-2104USA002985: US-009507513-2104USA002973: US-009507513-2104USA002975: US-009507513-2104USA002963: US-009507513-2104USA002971: US-009507513-2104USA002984: US-009507513-2104USA002972:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 31-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were not provided; frequency-5; lot# was T028139 and expiration date was 15-FEB-2022) involved a temperature excursion for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).               The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.   This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA002470: US-009507513-2104USA003267: US-009507513-2104USA002475: US-009507513-2104USA003268: US-009507513-2104USA003265: US-009507513-0503USA00121:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VAQTA was inadvertently administered on 13 APR202 l after a temperature excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided.  On 13-APR-2021, the patient was inadvertently vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # T033304, expiration date was reported as 23-JUN-2022 but upon internal validation process, it was established as 02-APR-2022 (dose and route of administration were not reported) (Incorrect product storage).  There was no additional adverse effect reported. Administered doses of vaccine was stored in temperature of 9 degrees Celsius for 10 hours and 56 minutes. Data logger was involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA003768: US-009507513-2104USA003667 : US-009507513-2104USA003622 : US-009507513-2104USA003606 :
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: had antibody titers drawn that showed the patient is not protected; This spontaneous report as received from a nurse and refers to a 17-year-old male patient.  His concurrent conditions, medical history and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with all 3 doses of hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) for hepatitis B prevention.  On an unknown date. the patient had antibody titers drawn that showed the patient was not protected. It was not confirmed if the patient was originally vaccinated with hepatitis B vaccine (RECOMBIVAX) or another hepatitis B vaccine, because the reporter did not have the patient's previous records. The patient sought medical attention. He received treatment for the event, he was being revaccinated. No additional information was available. The outcome of the event was reported as not recovered.  The causal relationship between the event and of hepatitis B vaccine (recombinant) (manufacturer unknown) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; administration of expired VAQTA; This spontaneous report was received from a nurse via a company representative and refers to an identifiable patient of unknown age and gender. No information regarding the patient's medical history, drug reaction/allergies or concomitant therapies was provided.  On 16-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), lot # S037574, expiration date was not provided but upon internal review established as 10-APR-2021 (dose and route of administration were not provided) for prophylaxis. No additional adverse events were reported. The reporter was inquiring viability information. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity:devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related conditions; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 20-OCT-2013, the patient was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by healthcare providers for shingles, and other zoster-related conditions.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The outcome of the events was unknown. The reporter considered events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: no additional adverse event; Expired vaccine used; This spontaneous report was received from a pharmacy technician concerning a patient of unknown age. No information about the patient's concurrent condition, medical history or concomitant therapy was reported.   The pharmacy technician reported that the first dose of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (at the dose of 1 dosage form, lot # R005341, expiration date 06-DEC-2020; route was not reported) was administered to the patient on 08-JAN-2021 as prophylaxis (expired product administered). This dose was properly stored. The second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose and route were not reported) was administered to the patient on 08-MAR-2021 as prophylaxis. The pharmacy technician did not have lot/expiration of second dose. No additional adverse events were reported.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Hypersomnia, Increased appetite, Injection site pain, Nausea
Clinical narrative: fainted for 5-10 minutes; he felt pain when it was administered; his whole body began to hurt.; he felt nauseous; He then slept for 12 hours that night; would be slumped/slouching throughout the day; he was very hungry when he had the shot administered.; This spontaneous report was received from the patient's mother and refers to a 14-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-MAR-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injected into left arm (exact dose, route of administration, lot # and expiration date were not provided), as routine vaccination.  On the day of the vaccination, the patient experienced pain when the vaccine was administered and his whole body began to hurt. After a while, he felt nauseous and fainted for 5-10 minutes. He then slept for 12 hours that night and would be slumped/slouching throughout the day. Reported mentioned that the patient was very hungry during the vaccine administration. On an unknown dates in 2021, he recovered from all events.  The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not reported.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pain, Syncope
Clinical narrative: fainted for 5-10 minutes; he felt pain when it was administered; his whole body began to hurt.; he felt nauseous; He then slept for 12 hours that night; would be slumped/slouching throughout the day; he was very hungry when he had the shot administered.; This spontaneous report was received from the patient's mother and refers to a 14-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-MAR-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injected into left arm (exact dose, route of administration, lot # and expiration date were not provided), as routine vaccination.  On the day of the vaccination, the patient experienced pain when the vaccine was administered and his whole body began to hurt. After a while, he felt nauseous and fainted for 5-10 minutes. He then slept for 12 hours that night and would be slumped/slouching throughout the day. Reported mentioned that the patient was very hungry during the vaccine administration. On an unknown dates in 2021, he recovered from all events.  The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not reported.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: No additional AEs; missed dose/ patient received the 4 valent Human Papillomavims Vaccine ( 4 valent) when she was 13 years old, on an unknown date, but did not receive any additional doses until the now 22 year old patient received GARDASIL 9; patient received the 4 valent Human Papillomavims Vaccine ( 4 valent) when she was 13 years old, on an unknown date, but did not receive any additional doses until the now 22 year old patient received GARDASIL 9; This spontaneous report was received from a registered nurse via a company representative and refers to a 22-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported.    On an unknown date, at the age of 13 years, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, route of administration, vaccination site, lot # and expiry date were not provided) for prophylaxis.  The patient did not receive any additional doses until 19-APR-2021, when she was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 mL (route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis (inappropriate schedule of product administration and interchange of vaccine products). No additional adverse events were reported. Product quality complaint was not involved.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Ill-defined disorder, Polymerase chain reaction, Polymerase chain reaction positive, Rotavirus test positive
Clinical narrative: Developed +PCR for rotavirus; developed symptoms (it is unknown to reporter what the symptoms were); This spontaneous report was received from a physician via company representative and refers to a 6-month-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date, at the age of 2 month-old the patient was received first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and on an unknown date in 2021, at the age of 4 months old, the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered, both orally as vaccine (exact dose, lot number and expiration date were not provided), and the patient tolerated those doses without any side effects.  On-09-APR-2021, the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot number and expiration date were not provided) and developed symptoms (it was unknown to reporter what the symptoms were). The patient sought for medical attention. On 15-APR-2021, the patient was seen at urgent care and in the emergency room (ER) on 17-APR-2021, and the patient had a positive the polymerase chain reaction (PCR) for rotavirus in ER.  The outcome of gastroenteritis rotavirus and ill-defined disorder was unknown. The causality assessement was not provided.  Upon internal review, the event of gastroenteritis rotavirus was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/Patient was asymptomatic; temperature excursion of a vaccine which was administered to a patient.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The reporter did not provide information about the patient's pertinent medical history, drug reactions, allergies, and concomitant medications.  On 19-APR-2021, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) which went through a temperature excursion of 12.5 degrees Celsius (C) for a timeframe of 24 minutes (product storage error), lot number S029455, expiration date 19-SEP-2021 (anatomical site of vaccination, route, dose, strength, scheme of vaccination, formulation were not reported), as prophylaxis. There was no previous temperature excursion, and a data logger did detect the temperature excursion.   No additional adverse event (AE), the reporter stated that the patient was (no adverse event).
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: on 20-APR-2021 the patient came for her 3rd dose of GARDASIL 9; the first and second dose were administered back in 2016; no additional adverse events reported; This spontaneous report was received from a nurse and refers to a 23-year-old female patient. There was no information regarding her medical history, current conditions nor concomitant therapies provided.  On unspecified dates in 2016, the patient received the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact doses, route of administration, anatomical location, lot # and expiration dates were not provided) for prophylaxis. Then, she skipped coming back for the third scheduled dose of the series. On 20-APR-2021 (described also as today), she came into the nurse's office for her third dose of the vaccine (outside of prescribed recommendation of scheduling), however it was unknown whether the dose was administered to her. No adverse events were reported.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: pneumonia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to currently approximately 58-year-old patient of an unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 24-DEC-2017, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a providers for the following injury resulting form patient's zoster vaccine live (ZOSTAVAX) use: pneumonia. The outcome of the event of pneumonia was not provided. The reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of pneumonia was determined to be medically significant.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope x2; This case was received via United States FDA VAERS (Reference number: 0958516) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Syncope x2) in an 888-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SYNCOPE (Syncope x2) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Syncope x2) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications reported by the investigator. Treatment of these events were not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Cellulitis; Injection site swelling; This case was received via website (Reference number: 0977305) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.  This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, CELLULITIS (Cellulitis) and INJECTION SITE SWELLING (Injection site swelling) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got the shingles the next year, twice, but a mild case of it; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose of Shingles vaccine one year nad 2nd dose of Shingles vaccine next year and got the shingles the next year, twice but a mild case of it. The reporter said still would get the shot if they have another on available and was worth it. This case was considered as suspected vaccination failure, as information about laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: past 6 months by about 2 weeks. Can I still get my second dose?; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on an unknown date.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: This case was reported by the customer itself. The patient received 1st dose of shingrix on an unknown date. The patient was late by  6 months by about 2 weeks for 2nd dose. Which leads to incomplete course of vaccination. The patient consented to follow up. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: worst shot ever....better than shingles; This case was reported by a consumer and described the occurrence of malaise in a adult 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 malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the consumer itself. The age at vaccination was not applicable for this report.  The patient received shingles vaccine on an unknown date. The patient experienced malaise. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 1st shot of Shingrix in March 2020 / didn´t get the 2nd shot d/t Covid situation; This case was reported by a pharmacist and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated the patient received didn't get the 2nd shot due to Covid situation. The patient asked whether he should get the 2nd shot now or does he have to start the series over again with the 1st shot. Reporter had requested for more information and also confirmed if the patient had COVID-19. Reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got the shot for shingles 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 confirmation was not given. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: Product prescribing error
Clinical narrative: Patient / under 50 years old had a script from a doctor to receive a / dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult 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 intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   It was unknown if the reporter considered the intercepted drug prescribing error to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not applicable for this report. Pharmacist reported that an unknown patient who was under 50 years old had a script from a doctor to receive a dose of Shingrix over a year ago, which led to intercepted drug prescribing error. Health care professional declined to provide information about it. Health care professional disconnected the call so no follow up was done.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Third trimester pregnancy
Clinical narrative: She is in her third trimester, baby is due on 16 AUG 2020; This is a prospective pregnancy case. This 35-year-old female subject was enrolled in an open label study. The subject received Boostrix on 21st July 2020, for prophylaxis. The subject's estimated date of delivery was 16th August 2020. The subject received Boostrix at an unknown time during the pregnancy.   On an unknown date, unknown after receiving Boostrix, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.    Additional details were reported as follows: The patient received Boostrix in her third trimester and was due on 16th August 2020.  The last menstrual cycle unknown.  The patient did not experience an additional adverse event. The reporter did not consent to follow-up. caller does not give permission to contact HCP.   Follow up information was received on 21st April 2021: After completion of all the follow up attempts the case was considered as pregnancy lost to follow up.
Age: 0.67
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: shingrix was administered to an 8 month old baby today; shingrix was administered to an 8 month old baby today; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 8-month-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2021, the patient received Shingrix. On 10th March 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were reported as follows: The shingrix was administered to an 8 month old patient, which led to inappropriate age at vaccine administration and wrong vaccine administration. No additional details were available at the time of reporting. The reporter was an License PR actioner Nurse in the practice requested to speak with GlaxoSmithKline medical information urgently. The reporter consented to follow up.  Note: The event wrong vaccine administered was captured conservatively in case because it seems that patient visit to received another vaccine but instead got shingrix. Clarification has been raised for same.   Follow up information was received from nurse on 21st April 2021: Patient's demographics details was reported. VAERS details was updated.
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received on feb 9th their 3rd dose of pediarix/ On 4/20/2021 received/ engerix; On 4/20/2021 received/ DOSE 1( 4TH DOSE OF DTAP AND POLIO) of kinrix.; On 4/20/2021 received/ DOSE 1( 4TH DOSE OF DTAP AND POLIO) of kinrix.; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 9-month-old male patient who received HBV (Engerix B) (batch number YL2L3, expiry date 14th December 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix).   On 20th April 2021, the patient received the 4th dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 20th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device and not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the extra dose administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 3rd dose of Pediarix on 9th February 2021. The patient received Engerix B, this becames an extra dose of Hepatitis B. The patient received Kinrix as a 4th dose of Dtap and IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reported batch number for Kinrix was YZNZN, which was updated to YZ97N as per sales datasheet. The reporter consented to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Computerised tomogram abnormal, Gait disturbance, Incorrect dose administered, Magnetic resonance imaging
Clinical narrative: scan confirmed a stroke; foot was dragging; nurse forgot to reconstitute with the Shingrix antigen and injected just the Shingrix adjuvant; injected just the Shingrix adjuvant into an unknown arm; This case was reported by a consumer and described the occurrence of stroke in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus and fibromyalgia.   On 13th April 2021, the patient received Shingrix (intramuscular) and the 1st dose of Shingrix. On 13th April 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On 15th April 2021, the patient experienced stroke (serious criteria hospitalization and GSK medically significant) and leg dragging (serious criteria hospitalization). On an unknown date, the outcome of the stroke was not recovered/not resolved and the outcome of the leg dragging, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the stroke and leg dragging to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The caller was the daughter of the patient. On the 1st Shingrix injection, the nurse forgot to reconstitute with the Shingrix antigen and injected just the Shingrix adjuvant, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The Shingrix 1st injection was administered in unknown arm and after realizing her mistake, nurse reconstituted the Shingrix vaccine correctly and injected it into the patient's right arm. On 15th April 2021, the patients foot was dragging and she was transported to the emergency room (ER) and CT scan confirmed a stroke. The reporter was waiting for the results of the MRI that was done on 19th April 2021. The caller reports her mother was nursing home resident and the nurse called the caller to let her know her mother received both an injection of the adjuvant for Shingrix and a Shingrix vaccine.   The reporter does not give permission to contact the HCP.      The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product preparation issue
Clinical narrative: scan confirmed a stroke; foot was dragging; nurse forgot to reconstitute with the Shingrix antigen and injected just the Shingrix adjuvant; injected just the Shingrix adjuvant into an unknown arm; This case was reported by a consumer and described the occurrence of stroke in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus and fibromyalgia.   On 13th April 2021, the patient received Shingrix (intramuscular) and the 1st dose of Shingrix. On 13th April 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On 15th April 2021, the patient experienced stroke (serious criteria hospitalization and GSK medically significant) and leg dragging (serious criteria hospitalization). On an unknown date, the outcome of the stroke was not recovered/not resolved and the outcome of the leg dragging, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the stroke and leg dragging to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The caller was the daughter of the patient. On the 1st Shingrix injection, the nurse forgot to reconstitute with the Shingrix antigen and injected just the Shingrix adjuvant, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The Shingrix 1st injection was administered in unknown arm and after realizing her mistake, nurse reconstituted the Shingrix vaccine correctly and injected it into the patient's right arm. On 15th April 2021, the patients foot was dragging and she was transported to the emergency room (ER) and CT scan confirmed a stroke. The reporter was waiting for the results of the MRI that was done on 19th April 2021. The caller reports her mother was nursing home resident and the nurse called the caller to let her know her mother received both an injection of the adjuvant for Shingrix and a Shingrix vaccine.   The reporter does not give permission to contact the HCP.      The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Incomplete course of vaccination, Influenza like illness
Clinical narrative: Very serious reaction to the first / dose / she was sick; Very serious reaction to the first / dose / she was / with flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on an unknown dates, patient had shingles twice in her lifetime when she was younger). Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received live shingles vaccine on an uknown date and did not have any side effects). Concurrent medical conditions included drug hypersensitivity and chemical sensitivity. Concomitant products included benadryl (nos) (Benadryl).   In August 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced sickness (serious criteria other: Serious as per reporter ) and influenza-like symptoms (serious criteria other: Serious as per reporter). Shingrix was discontinued. On an unknown date, the outcome of the sickness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The patient had both the shingles incidents before she received the Shingrix vaccine. The patient received the live shingles vaccine before she had ever received the first Shingrix dose. The patient reported that she has had a medication/chemical sensitivity condition before she received the first Shingrix dose. It was not a full-blown allergic reaction, but it did have an effect on her. She expanded on this sensitivity by stating that she had a delayed reaction to allergy shots which include flu-like symptoms in the morning and which used to get worse at night.  The patient stated that this sick feeling with flu-like symptoms did not start right after the first Shingrix dose but that it was a delayed reaction. She did not have any anaphylactic shock or hives.  The patient never received her 2nd Shingrix dose because she had a very serious reaction to the 1st dose.  The patient further described this reaction by stating that she was sick with flu-like symptoms for three weeks.  The patient declined to provide her date of birth or her full address and was unable to provide the dosage, lot number or expiration date of the Shingrix dose she received, and the full address, email address, or fax number of her physician.  The reporter consented to follow up.