chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; un-noticed temperature excursion; This spontaneous report was received from a registered nurse and refers to a 5-year-old male patient. His medical history, concurrent conditions and concomitant therapies were not provided.  On 13-AUG-2024, the patient was vaccinated with a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (recombinant Human albumin), lot #Y004547, expiration date: 19-AUG-2025, administered subcutaneously at right arm for prophylaxis (strength was not provided); after un-noticed temperature excursions (temperature -12 C, time frame 37 minutes, previous temperature excursion: yes). The vaccine was administered before vaccine was cleared by manufacturer. The vaccine was cleared for use (Product storage error). No adverse effects reported.; Sender's Comments:  US-009507513-2409USA005182: US-009507513-2409USA005195: US-009507513-2409USA005205: US-009507513-2409USA005214:
Sex: F
Vaccine: HEP, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; HCP stated patient came in to get their 2nd dose of GARDASIL 9 on September 3rd 2024, at their 2 months schedule but possibly Hepatitis B (HEPLISAV-B) could have been administered instead of GARDASIL 9.; This spontaneous report was received from a nurse practitioner and refers to a 28-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, 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) injection (dose, lot #, expiry date, route of administration and vaccination site were not provided) administered for prophylaxis.  On 03-SEP-2024, the patient came in to get their second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at their 2 months schedule but instead of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) she possibly was administered hepatitis b vaccine rhbsag (yeast) (HEPLISAV B) for prophylaxis (dose, formulation, lot #, expiry date, route of administration and vaccination site were not provided) (wrong product administered). The reporter stated that there was confusion in documentation, so they were not sure if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient. She should have received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The reporter confirmed that no side effects have been reported. Limited information was provided by the reporter. No other information was provided. No additional adverse event (AE) reported (no adverse event). No product quality complaint (PQC) was reported.  Lot # is being requested and will be submitted if received.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; HCP called to report a dose of GARDASIL 9 was administered after its expiration date. Caller verified the product was an initial dose to a patient, no side effects or symptoms have been reported. The product expired 08/09/2024 and was administered to; This spontaneous report was received from registered nurse and refers to a 36-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-SEP-2024, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #u039529, expiration date: 09-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP called to report that a 7 month old male infant had been inadvertently administered a first dose of ROTATEQ, and will age out of being able to complete the series; This spontaneous report was received from an Other Health Professional and refers to a 7-month-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-SEP-2024, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, administered orally for prophylaxis (strength, lot #, and expiry date were not provided). The patient had been inadvertently administered a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), and would age out of being able to complete the series (Inappropriate age at vaccine administration). The patient experienced no additional adverse event (no adverse event).   The relatedness between the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the event was not provided.  Lot # is being requested and will be submitted if received
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; HCP called to report TE where PROQUAD was administered to one patient; This spontaneous report was received from a registered nurse and refers to an 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-SEP-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #Y009348, expiration date: 11-NOV-2025 (route of administration and vaccination site were not provided) administered for prophylaxis. The reporter called to report a temperature excursion (TE) where measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered to one patient (-14C to -10C(-11.7C) for 7 hours 0 minutes 0 seconds - prior; -14C to -10C(-12.5C) for 15 hours 25 minutes 0 seconds - prior; -14C to -10C(-14.3C) for 24 hours 0 minutes 0 seconds - prior; -14C to -10C(-12C) for 9 hours 10 minutes 0 seconds - current) (product storage error). No side effects or symptoms were reported. No Additional information was provided. No additional adverse event (AE) or product quality complaint (PQC) was noted (no adverse event).
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers. Follow up information was received from the registered nurse regarding a 5-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). On 16-AUG-2024,  with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (subcutaneously in her left arm ) for prophylaxis (product storage error).  The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 12-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). On 16-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (subcutaneously in her left arm ) for prophylaxis (product storage error).  The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 12-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). On 16-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (subcutaneously in her left arm ) for prophylaxis (product storage error).  The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 13-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). On 16-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (subcutaneously in the left arm ) for prophylaxis (product storage error).  The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 10-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). On 16-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (subcutaneously in the left arm ) for prophylaxis (product storage error).  The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 7-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (subcutaneously in the right arm ) for prophylaxis (product storage error).  The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 15-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (subcutaneously in the right arm ) for prophylaxis (product storage error).  The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 5-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (subcutaneously in the left arm ) for prophylaxis (product storage error).  The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine inadvertenly administered after after temperature excursion; Confirmed no other AE occurred; This spontaneous report was received from a registered nurse referring to a 13 years old female patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). The temperature excursion of the vaccine was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes and they were storage in clinical practice. No previous excursions were detected.  On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her right arm with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous, lot number y005919, expiration date 13-MAR-2026 (strength, dose, and dose number were not provided) for prophylaxis (product storage error).   It was mentioned that data logger had an excursion but did not alarm and the storage was in clinical practice; additionally it was reported that outage caused the temperature excursion and discovered at time of monthly temperature uploading.   No adverse event was reported and no product quality complaint involved.  This is one of several reports received from the same reporter. This case was initially considered as non valid in absence of patients identifiers.; Sender's Comments:  US-009507513-2409USA000500:
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; Administered after after a temperature excursion; This spontaneous report was received from a registered nurse referring to a 13 years old female patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). The temperature excursion of the vaccine was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes and they were storage in clinical practice. No previous excursions were detected.  On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her left arm with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) Subcutaneous, lot number y005919, expiration date 13-MAR-2026 (strength, dose and dose number were not provided) for prophylaxis (product storage error).   It was mentioned that data logger had an excursion but did not alarm and the storage was in clinical practice; additionally it was reported that outage caused the temperature excursion and discovered at time of monthly temperature uploading.   No adverse event was reported and no product quality complaint involved.  This is one of several reports received from the same reporter. This case was initially considered as non valid in absence of patients identifiers.; Sender's Comments:  US-009507513-2409USA000500:
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; Administered after after a temperature excursion; This spontaneous report was received from a registered nurse referring to a 8 years old male patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). The temperature excursion of the vaccine was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes and they were storage in clinical practice. No previous excursions were detected.  On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in his right arm  with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous, lot lot number y005919, expiration date 13-MAR-2026 (strength, dose and dose number were not provided) for prophylaxis (product storage error).   It was mentioned that data logger had an excursion but did not alarm and the storage was in clinical practice; additionally it was reported that outage caused the temperature excursion and discovered at time of monthly temperature uploading.   No adverse event was reported and no product quality complaint involved.  This is one of several reports received from the same reporter. This case was initially considered as non valid in absence of patients identifiers.; Sender's Comments:  US-009507513-2409USA000500:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; Administered after after a temperature excursion; This spontaneous report was received from a registered nurse referring to a 5 years old female patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). The temperature excursion of the vaccine was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes and they were storage in clinical practice. No previous excursions were detected.  On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her left arm with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous, lot number y005919, expiration date 13-MAR-2026 (strength, dose and dose number were not provided) for prophylaxis (product storage error).   It was mentioned that data logger had an excursion but did not alarm and the storage was in clinical practice; additionally it was reported that outage caused the temperature excursion and discovered at time of monthly temperature uploading.   No adverse event was reported and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially considered as non valid in absence of patients identifiers.; Sender's Comments:  US-009507513-2409USA000500:
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other information provided. No additional AEs or PQC reported.; Caller reported PROQUAD administered to a 17 year old patient; This spontaneous report was received from a nurse and refers to a 17-years-old patient of unknown gender. The patient's medical, concurrent conditions and concomitant therapies were not reported.  On 13-SEP-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant human albumin)) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #Y004546, expiration date: 19-AUG-2025, administered subcutaneously for prophylaxis (Product administered to patient of inappropriate age). No other information provided. No additional adverse events or PQC reported.
Age: 4.0
Sex: U
Vaccine: HEPA, HIBV, MMRV, PNC15
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report a patient inadvertently received one additional dose of VAQTA, PEDVAXHIB, VAXNEUVANCE, and PROQUAD. No side effects reported. HCP reported the patient received additional vaccinations due to unknown vaccination history.; This spontaneous report was received from a nurse and referred to a 4-year-old patient of unknown gender. The patient's medical history, historical conditions, concurrent conditions and concomitant therapies were not reported.  On 17-SEP-2024, due to unknown vaccination history, the patient was vaccinated with one additional dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #Y006122, expiration date: 17-MAY-2025, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided); sterile diluent (STERILE DILUENT) solution for injection/infusion (strength, dose, lot #, expiry date, route of administration, anatomical site of administration and indication were not provided); measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X025820, expiration date: 29-APR-2025, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X026480, expiration date: 12-JAN-2026, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided); and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #X020943, expiration date was reported as 26-MAR-2026 but upon internal validation established as 06-MAR-2026, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided). No side effects reported/No additional information/clarification provided/No additional adverse event (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Nurse calling to report an adverse event regarding an improperly stored and administered dose of PROQUAD.  Nurse stated that the PROQUAD was involved in a Temperature Excursion that occurred on 9/12/2024, and that a dose of PROQUAD was administered o; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 16-SEP-2024, the patient was vaccinated with an improperly stored dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # Y009107, expiration date: 06-NOV-2025, 0.5 milliliter/ two dose series (route of administration and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was involved in a temperature excursion that occurred on 12-SEP-2024 (product storage error). Nurse confirmed that there have been no reports of the patient involved reporting any medical concerns or symptoms after the dose was administered (no adverse event).
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Received Heplisav-B by Accident; Initial report received on 26-Aug-2024 from the Agency.  A consumer reported that a female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while four months pregnant.  No relevant medical history was reported.  No relevant concomitant medications were reported.  On approximately 19-Aug-2024, the patient received a dose of HEPLISAV-B (lot #, expiration date , NDC #, route, and site not reported) while four months pregnant by accident.   No additional information was reported.   At the time of report, the Agency was closed and no longer accepting patients.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Product administration error
Clinical narrative: A shingrix dose was mistakenly given after reconstitution window (after 6 hours).; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug administration error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug administration error (Verbatim: A shingrix dose was mistakenly given after reconstitution window (after 6 hours).). The outcome of the drug administration error was unknown.   Additional Information: GSK receipt date: 12-SEP-2024 A Shingrix dose was mistakenly given after reconstitution window (after 6 hours), which led to drug administration error The reporter asked if the dose be repeated.
Sex: U
Vaccine: VARZOS
Symptoms: Immune system disorder
Clinical narrative: had immunotherapy; This non-serious case was reported by a consumer via call center representative and described the occurrence of immune system disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced immune system disorder (Verbatim: had immunotherapy). The outcome of the immune system disorder was not reported.   It was unknown if the reporter considered the immune system disorder to be related to Shingrix.     It was unknown if the company considered the immune system disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2024 The reporter questioned about Shingrix.  The patient got the first dose and then had immunotherapy. The patient could not get my second dose within 6 months from the first dose. The patient's immunity just got back and can get vaccines now, however, if the patient take the second dose it will be six months late. The patient questioned should he/she restart the series or just simply do the second dose.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: it was warm at touch; itching; redness at injection site; the rash is about the same size; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-SEP-2024, the patient received the 1st dose of Shingrix (intramuscular, left arm). In SEP-2024, less than a day after receiving Shingrix, the patient experienced injection site warmth (Verbatim: it was warm at touch), injection site itching (Verbatim: itching), injection site erythema (Verbatim: redness at injection site) and injection site rash (Verbatim: the rash is about the same size). The outcome of the injection site warmth, injection site itching and injection site erythema were unknown and the outcome of the injection site rash was not resolved.   It was unknown if the reporter considered the injection site warmth, injection site itching, injection site erythema and injection site rash to be related to Shingrix.     It was unknown if the company considered the injection site warmth, injection site itching, injection site erythema and injection site rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-SEP-2024 The reporter was the spouse of the patient. Reporter stated on September 6th, 2024, that a male patient received his 1st dose of Shingrix vaccine on September 3rd, 2024, at a local pharmacy. Customer reported that the injection was given in the left arm. Customer reported that the patient had an 8 to 10 inches round red area from the injection site down to the elbow area. Reporter stated that it was warm at touch, rash, Itching, redness. Reporter stated the symptoms had not gotten worse, and the rash was about the same size. Reporter stated that patient applied ice to the affected area.; Sender's Comments:  US-GSK-US2024111412:2 of 2report
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: hiberix vaccine that were not reconstituted with the diluent; hiberix vaccine that were not reconstituted with the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old male patient who received Hib (Hiberix) (batch number TL3KP) for prophylaxis.   On 30-AUG-2024, the patient received Hiberix. On 30-AUG-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: hiberix vaccine that were not reconstituted with the diluent) and inappropriate dose of vaccine administered (Verbatim: hiberix vaccine that were not reconstituted with the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-SEP-2024 The reporter had a hiberix vaccine that were not reconstituted with the diluent and reached out to vaccine coordinator, and she said that we could call the manufacturer to see if they could send us a diluent for the vaccine.  The reporter had a staff member that gave a distinct diluent and not mixed with the powder of the hiberix and just gave the diluent to a patient, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the first dose at 10 and did not come back in and get the second dose until a year later.; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a child patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (The patient received the first dose at 10). Concurrent medical conditions included asplenia.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: The patient received the first dose at 10 and did not come back in and get the second dose until a year later.). The outcome of the drug dose administration interval too long 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: 11-SEP-2024 The patient who had received 2 doses of Bexsero.  The patient was 11 years old and was categorized as high risk due to asplenia.  The patient received the first dose at 10 and did not come back in and get the second dose until a year later, which led to lengthening of vaccination schedule. Her question was did the patient need another dose and if so, when did the patient need to get the next dose of Bexsero.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: DTAP, DTAPIPV, HEPA, MENB, RV1, UNK
Symptoms: Product storage error
Clinical narrative: Bexsero, Flulaval, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Rotarix (liq) stored at 50.2F x 1hr 55 min.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Rota (Rotarix liquid formulation) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis, Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, HAV (Havrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis.   On 10-SEP-2024, the patient received Rotarix liquid formulation, Infanrix, FluLaval 2024-2025 season, Bexsero, Havrix and Kinrix. On an unknown date, an unknown time after receiving Rotarix liquid formulation, Infanrix, FluLaval 2024-2025 season, Bexsero, Havrix and Kinrix, the patient experienced incorrect storage of drug (Verbatim: Bexsero, Flulaval, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Rotarix (liq) stored at 50.2F x 1hr 55 min.). The outcome of the incorrect storage of drug 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: 11-SEP-2024 CMA requested stability data for Bexsero, Flulaval, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Rotarix (liq) stored at 50.2F x 1hr 55 min. Excursions occurred on September 9, 2024 and September 10, 2024. No prior excursions.  Vaccines (Rotarix (liq), Infanrix, Flulaval, Bexsero, Havrix, Infanrix, Kinrix) were administered on September 10, 2024 to 18 different patients, which led to incorrect storage of drug. Consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave kinrix to a 3 year and 8 month old patient; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 44-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: gave kinrix to a 3 year and 8 month old patient). 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: 11-SEP-2024 and 12-SEP-2024 The reporter reported that they administered kinrix to a 44 month old patient, which led to inappropriate age at vaccine administration. She stated that this dose of Kinrix was supposed to be the patient's 5th dose of DTaP and 4th dose of IPV.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired dose of Fluarix QIV was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 9R2T9, expiry date 30-JUN-2024) for prophylaxis.   On 11-SEP-2024, the patient received Fluarix Quadrivalent 2023-2024 season. On 11-SEP-2024, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced expired vaccine used (Verbatim: expired dose of Fluarix QIV was administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-SEP-2024 The pharmacist reported that the patient received the Fluarix quadrivalent vaccine which was expired,which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.