chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram abdomen abnormal, Diarrhoea, Faecal elastase test, Hepatobiliary scan
Clinical narrative: In September 2021, I received my second dose of Pfizer covid 19 vaccine. 12/2021 I had an episode of acute pancreatitis where I experienced severe abdominal pain 10/10 2-3 days in a row for less than an hour. At ER, my lipase levels were in 599. CT of abdomen and pelvis was negative except for a hutch diverticuli on bladder which was found incidentally.   01/2022 I tested positive for Covid 19 with symptoms for the second time (the first time 12/2022). After the episode of acute pancreatitis, I continued to have abdominal discomfort, diarrhea, nausea, chills, and abnormal weight loss (190lbs December 2022 down to 165 August 2022). August 2022, diagnosed with exocrine pancreatic insufficiency. I've been eating healthy, exercising, and maintaining a healthy lifestyle up until this episode of pancreatitis. I had regular blood work done with my PCP and am a registered nurse myself.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lipase increased, Nausea, Pancreatic failure, Pancreatitis acute, SARS-CoV-2 test positive
Clinical narrative: In September 2021, I received my second dose of Pfizer covid 19 vaccine. 12/2021 I had an episode of acute pancreatitis where I experienced severe abdominal pain 10/10 2-3 days in a row for less than an hour. At ER, my lipase levels were in 599. CT of abdomen and pelvis was negative except for a hutch diverticuli on bladder which was found incidentally.   01/2022 I tested positive for Covid 19 with symptoms for the second time (the first time 12/2022). After the episode of acute pancreatitis, I continued to have abdominal discomfort, diarrhea, nausea, chills, and abnormal weight loss (190lbs December 2022 down to 165 August 2022). August 2022, diagnosed with exocrine pancreatic insufficiency. I've been eating healthy, exercising, and maintaining a healthy lifestyle up until this episode of pancreatitis. I had regular blood work done with my PCP and am a registered nurse myself.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound abdomen normal, Weight decreased
Clinical narrative: In September 2021, I received my second dose of Pfizer covid 19 vaccine. 12/2021 I had an episode of acute pancreatitis where I experienced severe abdominal pain 10/10 2-3 days in a row for less than an hour. At ER, my lipase levels were in 599. CT of abdomen and pelvis was negative except for a hutch diverticuli on bladder which was found incidentally.   01/2022 I tested positive for Covid 19 with symptoms for the second time (the first time 12/2022). After the episode of acute pancreatitis, I continued to have abdominal discomfort, diarrhea, nausea, chills, and abnormal weight loss (190lbs December 2022 down to 165 August 2022). August 2022, diagnosed with exocrine pancreatic insufficiency. I've been eating healthy, exercising, and maintaining a healthy lifestyle up until this episode of pancreatitis. I had regular blood work done with my PCP and am a registered nurse myself.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pancreatic failure, Pancreatitis acute, SARS-CoV-2 test, Weight decreased
Clinical narrative: In September 2021, I received my second dose of Pfizer covid 19 vaccine. 12/2021 I had an episode of acute pancreatitis where I experienced severe abdominal pain 10/10 2-3 days in a row for less than an hour. At ER, my lipase levels were in 599. CT of abdomen and pelvis was negative except for a hutch diverticuli on bladder which was found incidentally.   01/2022 I tested positive for Covid 19 with symptoms for the second time (the first time 12/2022). After the episode of acute pancreatitis, I continued to have abdominal discomfort, diarrhea, nausea, chills, and abnormal weight loss (190lbs December 2022 down to 165 August 2022). August 2022, diagnosed with exocrine pancreatic insufficiency. I've been eating healthy, exercising, and maintaining a healthy lifestyle up until this episode of pancreatitis. I had regular blood work done with my PCP and am a registered nurse myself.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: In September 2021, I received my second dose of Pfizer covid 19 vaccine. 12/2021 I had an episode of acute pancreatitis where I experienced severe abdominal pain 10/10 2-3 days in a row for less than an hour. At ER, my lipase levels were in 599. CT of abdomen and pelvis was negative except for a hutch diverticuli on bladder which was found incidentally.   01/2022 I tested positive for Covid 19 with symptoms for the second time (the first time 12/2022). After the episode of acute pancreatitis, I continued to have abdominal discomfort, diarrhea, nausea, chills, and abnormal weight loss (190lbs December 2022 down to 165 August 2022). August 2022, diagnosed with exocrine pancreatic insufficiency. I've been eating healthy, exercising, and maintaining a healthy lifestyle up until this episode of pancreatitis. I had regular blood work done with my PCP and am a registered nurse myself.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles vaccine, had shingles 2 times after vaccine/Suspected vaccination failure; Had shingles 2 times; This case was reported by a physician via sales rep 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: 13-FEB-2023 Reporter's Comment: The physician reported that the patient received a dose of Shingles vaccine but had shingles two times after the vaccine and doctor wanted to know if he starts patient on Nucala and asked could it cause patient to get shingles again. Additional supportive information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. As per narrative Shingles vaccine coded as suspect.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion cumulative duration 19.3 hours; No adverse event; First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration 19.3 hours) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration 19.3 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration 19.3 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration 19.3 hours).    No concomitant medications were reported.   It was reported that, excursion took place on 15-Dec-2022 through 27-Dec-2022 and maximum temperature reached was 46.5F. Excursion cumulative duration was 19.3 hours. First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022 and then following that the vaccines were marked to not use. HCP informed that no reports of side effects had been reported to them.  No treatment details were reported.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temp excursion of 47.9 F for 47 min on 01-DEC-2022; This spontaneous report was received from a health care professional and referring to a 15-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, (lot #W006596, expiration date: 11-OCT-2024; dose and strength were not provided) administered intramuscularly in right thigh for prophylaxis.    The administered dose of the vaccine experienced a temperature excursion since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes (product storage error). Digital data logger was involved. No additionally adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA001029:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion began on 30Jan and experienced severa excursions until 14Feb2023; No Adverse Event; Excursion began on 30Jan and experienced severa excursions until 14Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion began on 30Jan and experienced severa excursions until 14Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Excursion began on 30Jan and experienced severa excursions until 14Feb2023) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Excursion began on 30Jan and experienced severa excursions until 14Feb2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion began on 30Jan and experienced severa excursions until 14Feb2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion began on 30Jan and experienced severa excursions until 14Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Excursion began on 30Jan and experienced severa excursions until 14Feb2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion began on 30Jan and experienced severa excursions until 14Feb2023) and POOR QUALITY PRODUCT ADMINISTERED (Excursion began on 30Jan and experienced severa excursions until 14Feb2023).    No concomitant drug information was provided.   No treatment drug information was provided.  The case corresponding to one of the two adult patients who had received the vaccine on 6Feb2023 as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710558, US-MODERNATX, INC.-MOD-2023-710839 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710558:Master case US-MODERNATX, INC.-MOD-2023-710839:same reporter US-MODERNATX, INC.-MOD-2023-710849:Same reporter
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion took place 15Dec2022 through 27Dec2022; No adverse event; First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022).    No concomitant medications were reported.   It was reported that, excursion took place on 15-Dec-2022 through 27-Dec-2022 and maximum temperature reached was 46.5F. Excursion cumulative duration was 19.3 hours. First time excursion started on 15-Dec-2022. HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022 and then following that the vaccines were marked to not use. HCP informed that no reports of side effects had been reported to them.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given after expiration date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date).    It was unknown receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported as vaccine was given after expiration date (6 months to 5 Years old Moderna).  HCP stated that they do not had any information about patient at the moment since they are not at the office. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient to whom inadvertently administered a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination.  On 10-Feb-2023, the patient received 4th dose at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation: unknown) (lot number: UJ682AAA and expiry date: unknown) via intramuscular route in the left thigh (leg) for Immunization and on the same day inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered), (product storage error).  It was reported. Registered nurse (RN) called for information on how to manage patients who were administered vaccines that had undergone temperature excursion, due to a refrigerator malfunction. This situation is reported as a medication error due to administration to the patient of a vaccine that had exceeded the stability data documented in the local labelling and additional supporting stability data. First time product used : No Still using product : No.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; HCP calling for re-vaccination information for MMR II and VARIVAX administered via IM route on 9/20/22. No further information provided, no additional AEs, no PQCs reported.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age an gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 20-SEP-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5ml/once, administered intramuscularly (Incorrect route of product administration) for prophylaxis (strength, lot #, and expiry date were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml/once, administered intramuscularly (Incorrect route of product administration) for prophylaxis (strength, lot #, and expiry date were not provided) . No further information provided, no additional adverse events, no PQCs reported.  This is a non-valid case due to lack of patient's identifiers.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Intercepted product administration error, No adverse event, Wrong product administered
Clinical narrative: An immunization coordinator is reporting an AE on behalf of a patient. The HBP reports that a nurse in the clinic drew up MMR-II and VARIVAX for a patient but the patient was not scheduled to receive those products. The HBP reports that the nurse cau; An immunization coordinator is reporting an AE on behalf of a patient. The HBP reports that a nurse in the clinic drew up MMR-II and VARIVAX for a patient but the patient was not scheduled to receive those products. The HBP reports that the nurse cau; This spontaneous report has been received from a other reporter and refers to a patient of unknown age.   The patient's concurrent condition, medical history and concomitant therapies were not provided  On 25-JAN-2023, it was reported that a nurse in the clinic drew up measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX) for a patient but the patient was not scheduled to receive those products. It was reported that the nurse caught the mistake prior to administration and administered the correct product to the patient. The reporter  did not know what product the patient was supposed to receive (wrong product administered and intercepted product administration error). No additional adverse event  details were provided . The outcome of wrong product administered and intercepted product administration error was unknown.
Age: 1.58
Sex: F
Vaccine: HEPA, HIBV
Symptoms: No adverse event, Product storage error, Product use issue
Clinical narrative: No additional AE reported; Temp excursion of 47.9 F for 47 min on 01-DEC-2022; third dose of LIQUID PEDVAXHIB at 19 months old (reported as 18); This spontaneous report was received from a health care professional and referring to a 19-month-old (also reported as 18-month-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, (lot #W006596, expiration date: 11-OCT-2024; dose and strength were not provided) administered intramuscularly in left thigh for prophylaxis and the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, (lot #W023937, expiration date: 06-DEC-2023; dose and strength were not provided) administered intramuscularly in left thigh intramuscularly for prophylaxis (product use issue).  The administered doses of the vaccines experienced a temperature excursion since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes (product storage error). Digital data logger was involved. No additionally adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA001021:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE or PQC reported; HCP reported PNEUMOVAX 23 was administered after the expiry date.; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-FEB-2023, the patient vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (expiration date: 14-JAN-2023, strength, dose, frequency, route, and lot # were unknown) for prophylaxis (Expired product administered). No additional AE or PQC reported.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Vaccine administered on 2/3/23 while improperly stored during temperature excursion; This spontaneous report was received from a nurse and refers to a 69-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-FEB-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) formulation not reported however upon internal review established as pre-filled syringe, 50/1.0 u/ml, 1.0 ml, once, lot #W017819, expiration date: 27-DEC-2023 (administration site, and route of administration were not provided) administered for prophylaxis (product storage error). There were multiple temperature excursions on 03-FEB-2023. No additional adverse event was reported (no adverse event).  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004298: US-009507513-2302USA004552:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; RN called to report TE for vaccines and confirms that PROQUAD was administered on 2/10/2023. No additional AEs, no PQCs reported.; This spontaneous report was received from a registered nurse (RN) referring to a 4-years-old (reported as 4 years 5 months) female patient. The patient's concurrent conditions, historical conditions, concomitant therapies, and allergies were not reported.  On 10-FEB-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous Injection, at a dosage of 0.5 milliliters (ml) administered once (strength, vaccination scheme frequency, exact dose number, route of administration and anatomical site of application were not provided; lot number W028568 has been verified to be a valid lot number with an expiration date reported and established as 06-MAR-2024) for prophylaxis (product storage error).  No additional adverse events (AEs) were reported (no adverse event). Details about the temperature excursion were not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reports product that experienced temperature excursion over the weekend was administered to a patient.; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 13-FEB-2023 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # W029899, expiry date 16-MAY-2024, for prophylaxis (dose, route of administration and anatomical location were not provided). The vaccine experienced temperature excursion over the weekend (13.25 degrees of Celsius, time frame: 2 hours 32 minutes and 0 seconds) (product storage error). The vaccive had no previous temperature excursion. No additional adverse event (AE) reported.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: concomitant administration of PROQUAD with VARIVAX in a 12 month old female patient./the patient was intended to receive MMRII and VARIVAX; concomitant administration of PROQUAD with VARIVAX in a 12 month old female patient./the patient was intended to receive MMRII and VARIVAX; no additional AE; This spontaneous report has been received from a nurse concerning to a 12-month-old female patient. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was concomitant vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter (ml), (strength and route of administration were not provided; lot number W028567 that was verified to be valid,expiration date reported  and established as 06-MAR-2024); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter (strength, route of administration, and indication were not provided; lot  number W022294 that was verified to be valid, expiration date reported an established as 13-JUL-2024). Both administered for prophylaxis (wrong product administered) (extra dose administered).  The caller reported that the patient was intended to received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, oral route, indication, lot number and expiration date were not provided) for prophylaxis, and varicella virus vaccine live (oka/merck) (VARIVAX).  The outcome of the events was not provided.  No additional adverse event.
Age: 1.17
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA (w020525 12/14/2023) Temperature: 30F Time; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA (w020525 12/14/2023) Temperature: 30F Time; This spontaneous report was received from a healthcare worker and refers to a 14-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 08-FEB-2023, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) prefilled syringe, 1 dose, lot #W020525, expiration date: 14-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was improperly stored for 3 hours and 15 minutes in temperature of 30 degrees Fahrenheit (F). There was no previous temperature excursion. No adverse events were reported.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional AE's; a pediatric patient was inadvertently administered GARDASIL 9 instead of another scheduled vaccine.; This spontaneous report has been received from a medical assistant concerning to a 12-month-old of an unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not provided.  On 15-FEB-2023, the pediatric patient was administered inadvertently with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, scheme vaccination frequency, lot number, expiration date, and route of administration were not provided)  for prophylaxis instead of another schedule vaccine (wrong product administered). The reporter did not know other vaccine the patient was supposed to received and did not have other details.   No additional adverse event were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Patient was administered and expired PNEUMOVAX 23.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 15-FEB-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U022984 with expiration date 29-JAN-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (expired product administered) No other issues or concerns noted. No product quality complaint or temperature excursion.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; A veterinarian calling for herself to report AE. She reported that she received GARDASIL 9 vaccinations on the following dates: 06/02/2022, 06/23/2022, and 02/16/2023.; This spontaneous report was received from a veterinarian calling for herself, a patient ofunknown age (female). There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  She was vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis on 02-JUN-2022, 23-JUN-2022 and 16-FEB-2023 (Inappropriate schedule of product administration). No additional adverse events were reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Vasovagal syncope; This spontaneous report was received from a pediatrician and refers to an 11-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, administered at the office, (strength, expiry date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis.  On an unknown date [reported as within 15 minutes after the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)], the patient experienced vasovagal syncope. At the time of reporting, the outcome of the event vasovagal syncope was unknown.  The causal relationship between vasovagal syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the event of vasovagal syncope was determined to be medically significant.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: The expired Jynneos vaccine was administered to the patient, intradermally; The expired Jynneos vaccine was administered to the patient, intradermally; Case reference number US-BN-2023-000050 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0057) on 11-Jan-2023 and concerns an adult patient of unknown gender.  The patient's medical history and concomitant medication details were not provided.  On 03-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 19-Dec-2022), at an unknown dose or site of administration, intradermally, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Jan-2023 included the local BN case ID.  This case is linked to cases US-BN-2023-000051, US-BN-2023-000052, US-BN-2023-000053, US-BN-2023-000054 and US-BN-2023-000055 (same reporter).; Reporter's Comments: An adult patient of unknown gender was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.; Sender's Comments: An adult patient of unknown gender  was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: The expired Jynneos vaccine was administered to the patient, intradermally; The expired Jynneos vaccine was administered to the patient, intradermally; Case reference number US-BN-2023-000051 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0058) on 11-Jan-2023 and concerns an adult patient of unknown gender.  The patient's medical history and concomitant medication details were not provided.  On 03-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 19-Dec-2022), at an unknown dose or site of administration, intradermally, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Jan-2023 included the local BN case ID.  This case is linked to cases US-BN-2023-000050, US-BN-2023-000052, US-BN-2023-000053, US-BN-2023-000054 and US-BN-2023-000055 (same reporter).; Reporter's Comments: An adult patient of unknown gender was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.; Sender's Comments: An adult patient of unknown gender was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: The expired Jynneos vaccine was administered to the patient, intradermally; The expired Jynneos vaccine was administered to the patient, intradermally; Case reference number US-BN-2023-000052 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0060) on 11-Jan-2023 and concerns an adult patient of unknown gender.  The patient's medical history and concomitant medication details were not provided.  On 03-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 19-Dec-2022), at unknown dose or site of administration, intradermally, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Jan-2023 included the local BN case ID.  This case is linked to cases US-BN-2023-000050, US-BN-2023-000051, US-BN-2023-000053, US-BN-2023-000054 and US-BN-2023-000055 (same reporter).; Reporter's Comments: An adult patient of unknown gender was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.; Sender's Comments: An adult patient of unknown gender was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: The expired Jynneos vaccine was administered to the patient, intradermally; The expired Jynneos vaccine was administered to the patient, intradermally; Case reference number US-BN-2023-000053 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0059) on 11-Jan-2023 and concerns an adult patient of unknown gender.  The patient's medical history and concomitant medication details were not provided.  On 03-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 19-Dec-2022), at an unknown dose or site of administration, intradermally, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Jan-2023 included the local BN case ID.  This case is linked to cases US-BN-2023-000050, US-BN-2023-000051, US-BN-2023-000052, US-BN-2023-000054 and US-BN-2023-000055 (same reporter).; Reporter's Comments: An adult patient of unknown gender born in 1968 was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.; Sender's Comments: An adult patient of unknown gender was vaccinated with the first dose of expired Jynneos vaccine, at an unknown dose or site of administration, intradermally, for monkeypox, which is considered as expired product administered. No associated adverse events were reported. Intradermal injection and expired product administered are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and expired product administered are not related to Jynneos vaccine, but to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: The expired Jynneos vaccine was administered to the patient, intradermally; The expired Jynneos vaccine was administered to the patient, intradermally; Case reference number US-BN-2023-000054 is a spontaneous case report initially received from other health care professional via Communications (reference number: USBAV23-0061) on 11-Jan-2023 and concerns an adult patient of unknown gender.  The patient's medical history and concomitant medication details were not provided.  On 03-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 19-Dec-2022), at an unknown dose or site of administration, intradermally, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Jan-2023 included the local BN case ID.  This case is linked to cases US-BN-2023-000050, US-BN-2023-000051, US-BN-2023-000052, US-BN-2023-000054 and US-BN-2023-000055 (same reporter).; Reporter's Comments: An adult patient was vaccinated with the first dose of expired Jynneos vaccine intradermally. Intradermal injection and expired product administered are listed by convention. No associated adverse events have been reported. Intradermal injection and expired product administered have been considered not related to the suspect product. The case is non-serious.; Sender's Comments: An adult patient was vaccinated with the first dose of expired Jynneos vaccine intradermally. Intradermal injection and expired product administered are listed by convention. No associated adverse events have been reported. Intradermal injection and expired product administered have been considered not related to the suspect product. The case is non-serious.