chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: not experienced any symptoms; 71 years old has received two doses of the GARDASIL 9 vaccine.; This spontaneous report was received from a 71-year-old male patient referring to himself. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 08-APR-2022, 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) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). On 15-JUN-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. The patient had not experienced any symptoms.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product preparation error, Underdose
Clinical narrative: No additional AE reported; the nurse didn't screw the needle tight; the patient got only 1/2 the dose of GARDASIL 9; This spontaneous report was received from a nurse referring to an 11-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 16-JUN-2022, the patient was vaccinated with with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U035286, expiration date: 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The reporter informed that the patient got only 1/2 the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) since the nurse didn't screw the needle tight (underdose and product preparation error). No additional adverse event reported.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Expired vaccine administered to a patient; Prior temperature excursion; This spontaneous report has been received from a nurse referring to a 2-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 16-JUN-2022, the patient was vaccinated expired vaccine of hepatitis a vaccine, inactivated (VAQTA) syringe (lot # T031201 with expiry date 14-JUN-2022) (strength, dose, and route of administration were not provided) for prophylaxis (expired product administered). This vaccine had a prior temperature excursion (product storage error), but there was no information on the matter. There was no additional adverse event (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Customer reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, past drug reactions or allergies, and concomitant therapies were not reported.  On 15-JUN-2022, the patient was vaccinated with one (1) improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme frequency, route of administration, and anatomical site of application were provided; lot # U039948 that has been verified to be a valid lot number with expiration date reported and established as 16-DEC-2023) for prophylaxis.  The administered vaccine experienced the temperature excursion of minus (-) 2.5 degrees Celsius (C) for a timeframe of 5 hours and 6 minutes. There was no previous temperature excursion. No other adverse event (AE) occurred (no adverse event).  This is one of five reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported.; Caller reports that doses of improperly stored vaccines were administered to patients. Additional adverse events 02189027, 02189036, 02189037, 02189038, 02189039 and 02189040 were filed. No further information provided. No other adverse events report; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown gender and age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JUN-2022, the patient was vaccinated with one dose of improperly stored hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, lot #U026792, expiration date: 28-OCT-2022 (both confirmed to be valid), administered for prophylaxis (strength, route and site of administration were not provided) (product storage error). The vaccine was exposed to 47.17 degrees Fahrenheit for 15 minutes. There was no previous temperature excursion. There were no other adverse events reported.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2206USA006061: US-009507513-2206USA006116: US-009507513-2206USA006096: US-009507513-2206USA006272: US-009507513-2206USA006141:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, past drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 09-MAR-2022, the patient was vaccinated with improperly stored and administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (valid lot #U022819, expiration date: 14-JAN-2023) (strength, dose, frequency and route of administration were not reported) for prophylaxis.  The temperature was 0.1 Celsius degrees during 24 hours. Additionally, a previous temperature excursion was reported. No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA007068: US-009507513-2206USA007098: US-009507513-2206USA007094:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no adverse effects or symptoms from this dose; Caller is a medical assistant who reports six expired doses of VAQTA were administered; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 21-JUN-2022, the patient was vaccinated with an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter (lot# T031201, has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA), expiration date not reported, but upon internal validation established as 14-JUN-2022) (dose, anatomical location, and route of administration were not reported) (Expired product administered).  The vaccine did not have any prior temperature excursions and the patient had no adverse effects or symptoms from this dose.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; expired dose of MMR II was administered; vaccine was administered IM instead of the recommended SQ; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 mL, administered intramuscularly (IM) instead of the recommended subcutaneously (SQ) for prophylaxis (lot# T020656, expiration date: 16-JUN-2022; strength was not provided) (expired product administered, incorrect route of product administration). No other information or addition adverse event (AE) was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no additional AE; the dose of VAQTA expired on 14JUN2022 and the patient was administered the dose on 16JUN2022; This spontaneous report was received from an officer administrator referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-JUN-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 injection, administered intramuscularly for prophylaxis (lot #T031202, expiration date: 14-JUN-2022; strength was not provided) (expired product administered). No additional adverse event details were provided.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE reported; Student medical assistant reports that a 12 month old patient was accidently administered both VARIVAX and PROQUAD on Jun 22. 2022.; This spontaneous report has been received from a student medical assistant concerning a 12-month-old patient of unknown gender. The concomitant medications, medical history, drug reactions or allergies, and concurrent conditions were not reported.  On 22-JUN-2022, the patient was accidently administered both measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # U030590, expiration date 29-MAR-2023 (strength, dose, route of administration and anatomical location were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) lot # U028164, expiration date 09-SEP-2023 (strength, dose, route of administration and anatomical location were not provided) for prophylaxis (accidental overdose). No further information was provided. Healthcare professional (HCP) provided consent to be followed up with, and stated if she was not there, could talk to anyone at the doctors' office. No additional adverse event (AE) was reported. No product quality complaints (PQC) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022 and was administered to a patient; This spontaneous report was received from a medical technologist lab manager and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-JUN-2022, the patient was vaccinated improper stored with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W002599, expiration date: 24-JAN-2024, administered for prophylaxis (dose, strength, and route of administration were not provided). The receive by date of the varicella virus vaccine live (oka/merck) (VARIVAX)  was 06-JUN-2022; however, the varicella virus vaccine live (oka/merck) (VARIVAX) was not delivered until 07-JUN-2022. After the varicella virus vaccine live (oka/merck) (VARIVAX) was delivered, it was unpackaged and stored and not administered to the patient until 16-JUN-2022 (product storage error). There was no previous temperature excursion. No additional adverse event reported. No additional information provided.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller who is responsible for vaccine storage reported administered dose of improperly stored PROQUAD.; This spontaneous report was received from office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUN-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, lot #U017140, expiration date: 28-NOV-2022 (strength, and route of administration were not provided) administered for prophylaxis (Product storage error).  This is one of the several reports received from the same reporter (link reports # 2206USA007281, 2206USA007312, 2206USA007639).; Sender's Comments:  US-009507513-2206USA007312:Patient 02191883 US-009507513-2206USA007281:Patient 02191896 US-009507513-2206USA007639:Patient 02191897
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided.; 1 dose of PROQUAD stored outside of recommended range was administered to a patient.; This spontaneous report was received from a medical assistant concerning a 4-year-old male patient. The patient's medical history, drug reactions/allergies, concurrent conditions were not reported. Concomitant medication included sterile diluent (STERILE DILUENT).  On 22-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 1 dose (lot # U030588, expiration date: 29-MAR-2023; route and was not reported) for prophylaxis, which was stored outside of recommended range (product storage error). The details of the improperly stored temperature excursion: temperature minus 10 degrees Celsius up to 8 degrees Celsius (minus 8.8C) for 0 hours 45 minutes 0 seconds; minus 10 degrees Celsius up to 8 degrees Celsius (1.1C) for 0 hours 50 minutes 0 seconds. It was reported that there were no previous temperature excursions. No additional adverse event details (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: dministered dose of improperly stored PROQUAD; This spontaneous report was received from office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUN-2022, the patient was vaccinated with improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, lot # U017140, expiration date: 28-NOV-2022 (strength, and route of administration were not provided) administered for prophylaxis (product storage error).  This is one of the several reports received from the same reporter (link reports # 2206USA007281, 2206USA007312, 2206USA007229).; Sender's Comments:  US-009507513-2206USA007281: US-009507513-2206USA007312: US-009507513-2206USA007229:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; ROTATEQ has been administered to a patient following temperature excursion; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-JUN-2022, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1837116, expiration date reported and validated as 24-MAR-2023, administered orally for prophylaxis (dose and strength was not provided) that experienced a temperature excursion (product storage error). No other event reported.  The vaccine experienced a temperature excursion of 47.7 degrees Fahrenheit (F) for 12 minutes. There was no previous temperature excursion.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007704:
Sex: U
Vaccine: HEP, RV5, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with  a improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of 0.5 milliliter once, lot number T032918 was determined to be valid for vial formulation for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date: 12-NOV-2022 (vaccination scheme, and route of administration were not provided), and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally at a dose of  2ml once, lot number U038864, expiration date: 22-APR-2023 (vaccination scheme was not provided), as prophylaxis following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes (product storage error), there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Sex: U
Vaccine: HEP, RV5, HEP
Symptoms: Extra dose administered, Product storage error
Clinical narrative: the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with  a improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of 0.5 milliliter once, lot number T032918 was determined to be valid for vial formulation for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date: 12-NOV-2022 (vaccination scheme, and route of administration were not provided), and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally at a dose of  2ml once, lot number U038864, expiration date: 22-APR-2023 (vaccination scheme was not provided), as prophylaxis following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes (product storage error), there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with  a improperly stored hepatitis a vaccine, inactivated (VAQTA) at a dose of  0.5ml/once, lot number U031911, expiration date: 11-NOV-2022, as prophylaxis (strength, vaccination scheme, and route of administration were not provided) following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes, there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of 0.5 milliliter once, lot number T032918 was determined to be valid for vial formulation for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date: 12-NOV-2022 (vaccination scheme, and route of administration were not provided) as prophylaxis following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes (product storage error), there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of 0.5 milliliter once, lot number T032918 was determined to be valid for vial formulation for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date: 12-NOV-2022 (vaccination scheme, and route of administration were not provided), and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally at a dose of  2ml once, lot number U038864, expiration date: 22-APR-2023 (vaccination scheme was not provided), as prophylaxis following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes (product storage error), there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with  a improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter once, lot number U034200, expiration date: 21-OCT-2023, prophylaxis (strength, vaccination scheme, and route of administration were not provided) following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes (product storage error), there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of 0.5 milliliter once, lot number T032918 was determined to be valid for vial formulation for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date: 12-NOV-2022 (vaccination scheme, and route of administration were not provided), as prophylaxis following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes (product storage error), there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of  0.5 milliliter once, lot number T032918 was determined to be valid for vial formulation for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date: 12-NOV-2022 (vaccination scheme, and route of administration were not provided), and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally at a dose of  2ml once, lot number U038864, expiration date: 22-APR-2023  (vaccination scheme was not provided), as prophylaxis following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes (product storage error), there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired dose of MMR II administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 01-JUL-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), dose of 0.5 mL administered subcutaneously, lot number: T022310, expiration date: 30-JUN-2022 (dose number and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events (AEs) or product quality complaint (PQC) were reported (no adverse event).
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took the first 3 doses according to schedule and took the final dose on the 11th day after the third dose; A spontaneous report was received from the registered nurse on 23JUN2022. It described an 18-year-old male patient who "took the first 3 doses according to schedule and took the final dose on the 11th day after the third dose" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient received Vivotif from the clinic on 29MAY2022 and started taking the vaccine approximately one week later. Reportedly, the patient took the first three doses according to the schedule on days 0, 2, and 4 and forgot to take the final dose on the scheduled day but took it on the 11th day after the third dose. Additionally, the vaccine was maintained at appropriate temperature in the patient's refrigerator.  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a consumer took the first 3 doses of Vivotif according to schedule and took the final dose on the 11th day after the third dose (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a consumer took the first 3 doses of Vivotif according to schedule and took the final dose on the 11th day after the third dose (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took one dose of Vivotif and then forgot to take it for 5-6 days; A spontaneous report was received from a pharmacist on 24JUN2022. It described a patient (unknown age and gender) who "took one dose of Vivotif and then forgot to take it for 5-6 days" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took one dose of Vivotif and then forgot to take it for next 5 to 6 days.  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a patient took one dose of Vivotif and then forgot to take it for 5-6 days (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient took one dose of Vivotif and then forgot to take it for 5-6 days (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix given to 7 year old; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a child patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's Comment: The reporter wanted to know that, if a dose of Pediarix was inadvertently given to a patient 7 years of age or older, would the Hepatitis B and IPV components count as a dose of Hepatitis B and IPV or would it have to be repeated. Additional Supportive Information: The dose of Pediarix was inadvertently given to a patient 7 years of age or older, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Facial pain, Pain in extremity, Pain of skin
Clinical narrative: skin tenderness on my face and leg; tenderness on face; tenderness on leg; This case was reported by a consumer via interactive digital media and described the occurrence of skin tenderness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced skin tenderness, facial pain and leg pain. On an unknown date, the outcome of the skin tenderness, facial pain and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the skin tenderness, facial pain and leg pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's comments: This case was reported via interactive digital media. The patient had the shots after receiving vaccine stopped the shingles rash but every year still get a skin tenderness on his/her face and leg but did not completely go away.
Sex: F
Vaccine: MEN
Symptoms: Headache
Clinical narrative: horrible headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 25th June 2022, the patient received Meningococcal B vaccine. On 25th June 2022, less than a day after receiving Meningococcal B vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Meningococcal B vaccine.     Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that patient got meningitis B shot and same day horrible headache all day.  The patient said that why should not she get the booster in 6 months. The follow-up would not possible as no contact details were available. Additional Supportive Information: On 25th Jun 2022, the patient had 2nd dose of meningitis vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Product use in unapproved indication, Skin ulcer
Clinical narrative: pain awful/sores minimal; sore's; got shot within a day of shingles diagnosis; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, skin ulcer and product use in unapproved indication. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the skin ulcer was recovering/resolving and the outcome of the product use in unapproved indication was unknown.   It was unknown if the reporter considered the pain and skin ulcer to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine within a day of his/her shingles diagnosis as well as the patient experienced awful pain, but sores were minimal, and never itched. The patient was on week five and had one sore yet to heal over. Additional Supportive Information: The patient received Shingles vaccines within a day of shingles diagnosis, which led to product use in unapproved indication. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel like crap; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th June 2022, the patient received the 2nd dose of Shingles vaccine. On 25th June 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comments:  This case was reported by a consumer via interactive digital media. The patient received second shot a day before reporting and he/she felt like crap on the day of reporting. The reporter reported he/she does have side effect, but worth it if he/ she did not get shingles.
Age: 79.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received their second dose, dose was expired; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 79-year-old patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose on 21st December 2021).   On 21st June 2022, the patient received the 2nd dose of Hepatitis A vaccine. On 21st June 2022, unknown after receiving Hepatitis A vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's Comments: The patient received their second dose of Hepatitis A vaccine; however, the dose was expired. No systemic or local reactogenicities were reported at the time of reporting. Additional Supportive Information: The patient received Hepatitis A vaccine which was expired which led to expired vaccine used. This case had been linked with case US2018117623, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018117623:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: powder vials unmatched adjuvant diluents; Adjuvant only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The pharmacist reported that they found in their stock three Shingrix powder vials unmatched with adjuvant diluents. The patient might had received the diluent only. The reporter gave consent to follow up. Additional supportive Information: The patient might had received the diluent only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is one of 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR099690:Same reporter, Patient 2 US-GLAXOSMITHKLINE-US2022099168:Same Reporter, Patient 1
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: powder vials unmatched adjuvant diluents; Adjuvant only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The pharmacist reported that they found in their stock three Shingrix powder vials unmatched with adjuvant diluents. The patient might had received the diluent only. The reporter gave consent to follow up. Additional supportive Information: The patient might had received the diluent only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is one of 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099168:Same reporter. Patient 1 US-GLAXOSMITHKLINE-US2022AMR099689:Same reporter. Patient 3
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: I had it 7 times, Had shots after 3 times, shingles/suspected vaccination failure; shingles; pain; burning sensation; nerve pain; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation and post herpetic neuralgia. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation and post herpetic neuralgia to be related to Shingles vaccine.  Linked case(s) involving the same patient: US2022AMR100425   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles 7 times. The patient stated that, he/she thought others could only get shingles vaccine once.  The patient had shots after 3 times got shingles.  The patient never got a rash he/she guessed that's what people were saying were internal they give him/her Valacyclovir medication it took the pain and burning away last November. The patient had it and took the medication it went away 3 weeks later, he/she got it again now he/she thinking was it really shingles  he/she get nerve pain with it. The patient had it 3 times on his/her left side on the side, two times on his/her right side and 2 times in his/her left leg on top by waist.  The patient doctor sent him/her to a nerve specialist.  The patient said that, he couldn't test for shingles because he/she had gotten the shingles shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100425:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and, didn't prevent getting 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 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-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingles shot and it did not prevent him/her from getting shingles. However, the doctor said it would had been a lot worse if he/she had not received the shot.  The patient felt it was bad enough. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporters comment: The patient self-reported the case via interactive digital media. The patient received a dose of Shingles vaccine for free from county health department and experienced a mild case of shingle. The reporter stated that he/she would not receive the second dose. Additional Supportive Information: Follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had both doses/ still got a bad case of shingles/ suspected vaccination failure; Still got a bad case of 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had both doses of Shingrix vaccine but still got a bad case of shingles. The patient asked did GlaxoSmithKline anticipate that his/her recovery would be better because he/she was vaccinated. Additional supportive information: This case was considered as suspected vaccination failure as details regarding the 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.