chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 2-year-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 07-DEC-2022, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2301USA010889:
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 12-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 07-DEC-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2302USA000400: US-009507513-2301USA010889:
Age: 0.17
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 2-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #1892784, expiration date: 23-DEC-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000456: US-009507513-2302USA000412: US-009507513-2302USA000949:
Age: 0.33
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 4-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 08-DEC-2022, the patient was vaccinated with the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #1892784, expiration date: 23-DEC-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000403:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 15-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000403:
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 3-year 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 08-DEC-2022, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2302USA000400: US-009507513-2301USA010889: US-009507513-2302USA000401: US-009507513-2302USA000947:
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 16-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2302USA000403: US-009507513-2302USA000417: US-009507513-2301USA009943: US-009507513-2302USA000455:
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 6-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2302USA000403: US-009507513-2302USA000417: US-009507513-2301USA009943: US-009507513-2302USA000452:
Age: 0.25
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 4-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-DEC-2022, the patient was vaccinated with the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #1892784, expiration date: 23-DEC-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000403: US-009507513-2302USA000412: US-009507513-2302USA000457:
Age: 0.17
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 2-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 01-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #1892784, expiration date: 23-DEC-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000412: US-009507513-2302USA000456:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: been a year from 2nd shot; No additional AE reported; The spontaneous report has been received from a pharmacist, concerning a patient with unknown age and gender. The patient's medical history, historical drugs, concurrent conditions, drug reaction/allergies and concomitant drugs 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) (dose, lot number, expiration date, route and anatomical location was not provided) for prophylaxis. On an unknown date, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot number, expiration date, route and anatomical location was not provided) for prophylaxis. The patient had not yet been vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) had been a year from the second dose (inappropriate schedule of product administration). No additional adverse event (AE) reported (no adverse event).
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 1-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-DEC-2022,  doses of hepatitis A vaccine, Inactivated (VAQTA) underwent a temperature excursion of 47.9 Fahrenheit degrees for 47 minutes, a data logger was involved.  On 27-DEC-2022, the patient was vaccinated with an improperly stored first dose of hepatitis A vaccine, Inactivated (VAQTA) pre-filled syringe, administered intramuscularly on the left thigh, lot #W017343, expiration date: 13-DEC-2023 (strength and dose were not provided) as prophylaxis (product storage error). No adverse event was reported.  This of one of several cases reported by the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion.; This spontaneous report was received from a healthcare professional concerning a 16-months-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 20-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered intramuscularly in left thigh, lot # W006596, expiration date 11-OCT-2024, for prophylaxis (dose was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009943:
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; administered after a temperature excursion; This spontaneous report has been received from a health care professional (HCP) concerning a 12-month-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 01-DEC-2022, several vaccines underwent a temperature excursion of 47.9 F for 47 minutes. On 14-DEC-2022, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis, intramuscularly (IM) on the patient's right thigh (RT), lot number W023937 with expiration date 06-DEC-2023 (dosage regimen was not provided) (Product storage error). No previous temperature excursions were reported. No additional adverse event was reported (No adverse event).    This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175:
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temperature excursion of 47.9°C for 47 min; This spontaneous report was received from a medical assistant referring to a 2-month-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 01-DEC-2022, doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 47.9°C (Celsius degrees) for 47 minutes which occur as a result of a reading from a digital data logger (product storage error).  On 16-DEC-2022, the patient was vaccinated with previous doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #W006596 with an expiration date on 11-OCT-2024), administered intramuscularly in left thigh for prophylaxis (strength and dose were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1892784 with an expiration date on 03-DEC-2023), administered orally for prophylaxis (strength and dose were not provided).  No adverse events were reported.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; ROTATEQ were administered after a temperature excursion; This spontaneous report has been received from a health care professional (HCP) concerning a 6-month-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unknown date in 2022, the patient was vaccinated with the first and second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered as prophylaxis, taken orally (dosage regimen, lot number and expiration date were not provided). On 01-DEC-2022, the several vaccines underwent a temperature excursion of 47.9 F for 47 minutes. On 27-DEC-2022, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered as prophylaxis, taken orally, lot number 1892784 with expiration date 03-DEC-2023 (dosage regimen was not provided) (Product storage error). No previous temperature excursions were reported. No additional adverse event was reported (No adverse event).    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175:
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temperature excursion of 47.9°C for 47 min; This spontaneous report was received from a medical assistant referring to a 2-month-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 01-DEC-2022, doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 47.9°C (Celsius degrees) for 47 minutes which occur as a result of a reading from a data logger (product storage error).  On 20-DEC-2022, the patient was vaccinated with previous doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #W006596 with an expiration date on 11-OCT-2024), administered intramuscularly in left thigh for prophylaxis (strength and dose were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1892784 with an expiration date on 03-DEC-2023), administered orally for prophylaxis (strength and dose were not provided).  No adverse events were reported.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VAQTA administered after a temperature excursion; This spontaneous report has been received from a medical assistant, concerning a 12-months old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 26-DEC-2023, the patient was vaccinated with improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) intramuscularly on the left thigh (lot number W017343 has been verified to be valid; expiration date reported and established as 13-DEC-2023) (strength and dose were not provided) (product storage error). The administered dose of the vaccine was stored at a temperature of 47.9 degrees Fahrenheit (F), during a time frame of 47 minutes, as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No adverse event; VAQTA, was administered after a temperature excursion.; This spontaneous report was received from a  Health Care Professional and refers to a 4-year-old male. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes . Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.
Age: 0.42
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PEDVAXHIB and ROTATEQ were administered after a temperature excursion; This spontaneous report has been received from a vaccine provider, concerning a 5-month-old female patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 01-DEC-2022, doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number W006596 has been verified to be valid for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date reported and confirmed as 11-OCT-2024); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1892784 has been verified to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 03-DEC-2023 [lot number also reported as "18927884" which is not valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ)]), suffered a temperature excursion of 47.9 degrees Fahrenheit (F) for 47 minutes as a result of a reading from a Data Logger. It was reported that there was no any previous temperature excursion.   On 27-DEC-2022, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 2nd dose (lot number W006596, expiration date 11-OCT-2024), administered intramuscularly at her left thigh; and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2nd dose, (lot number 1892784, expiration date 03-DEC-2023), administered orally; both vaccines were administered as prophylaxis (Product storage error).  No additional adverse event was reported.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PEDVAXHIB administered after a temperature excursion; This spontaneous report was received from a Health Care Professional and refers to a 15-month-old male patient.  Information regarding the patient's medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was not provided.  On 16-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh (LT), lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis (dose was not provided) administered for prophylaxis.   The administered dose of the vaccine had experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were previously stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VAQTA administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 2-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-DEC-2022,  doses of hepatitis A vaccine, Inactivated (VAQTA) underwent a temperature excursion of 47.9 Fahrenheit degrees for 47 minutes, a data logger was involved.  On 28-DEC-2022, the patient was vaccinated with an improperly stored second dose of hepatitis A vaccine, Inactivated (VAQTA) pre-filled syringe, administered intramuscularly on the left thigh, lot #W017343, expiration date: 13-DEC-2023 (strength and dose were not provided) as prophylaxis (product storage error). No adverse event was reported.  This is one of several cases reported by the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VAQTA administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-DEC-2022,  doses of hepatitis A vaccine, Inactivated (VAQTA) underwent a temperature excursion of 47.9 Fahrenheit degrees for 47 minutes, a digital data logger was involved.  On an unknown date in December 2022, the patient was vaccinated with an improperly stored second dose of hepatitis A vaccine, Inactivated (VAQTA) pre-filled syringe, administered intramuscularly on the left thigh, lot #W023937, expiration date: 06-DEC-2023 (strength and dose were not provided) as prophylaxis (product storage error). No adverse event was reported.  This is one of several cases reported by the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:
Age: 1.17
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temperature excursion of 47.9°F for 47 min; This spontaneous report was received from a health care professional and refers to a 14-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-DEC-2022, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, lot number W017343 with expiration date: 13-DEC-2023, administered intramuscularly in right thigh for prophylaxis (strength was not provided). The administered dose of the vaccine experienced a temperature excursion of 47.9 degrees fahrenheit (F) (storage in clinical practice) for 47 min on 01-DEC-2022. (product storage error). Data logger was involved. No information provided regarding a previous temperature excursion. No adverse event was reported.  This is one of several reports received from the same reporter.
Age: 0.5
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temp excursion of 47.9°F for 47 min on Dec. 1st, 2022; This spontaneous report was received from a Health Care Professional and refers to a 6-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) administered orally (lot# 1892784, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and upon internal validation established as 03-DEC-2023) and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), administered intramuscularly in left tight (lot# W006596, has been verified to be a valid lot number for haemophilus b conjugate vaccine [meningococcal protein conjugate][LIQUID PEDVAXHIB], expiration date reported and upon internal validation established as 11-OCT-2024). Both vaccines were given as prophylaxis.  The administered doses of the vaccines experienced a temperature excursion (product storage error) on 01-DEC-2022. The vaccines administered were stored at a temperature excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes.   No adverse event was reported.  This is one of several reports received from the same reporter.
Age: 7.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 7-year 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 01-DEC-2022, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2302USA000400: US-009507513-2301USA010889: US-009507513-2302USA000401: US-009507513-2302USA000445:
Age: 0.17
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 5-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 02-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000412: US-009507513-2302USA000403: US-009507513-2302USA001303: US-009507513-2302USA001304: US-009507513-2302USA000456:
Age: 0.42
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 5-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 02-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000456: US-009507513-2302USA000412: US-009507513-2302USA000403: US-009507513-2302USA000949: US-009507513-2302USA001305:
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care 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 05-DEC-2022, the patient was vaccinated with the third dose Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000456: US-009507513-2302USA000412: US-009507513-2302USA000403: US-009507513-2302USA000949: US-009507513-2302USA001303: US-009507513-2302USA001305:
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4236025-00.  A 52-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BISOLVON AMOXYCILINA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: Blood iron: (Oct2022) Extremely low. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: She had contracted COVID in Dec2022.  The reporter's assessment of the causal relationship of "covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after I got the shots/ suspected vaccination failure; Shingles, two times I had them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 30-JAN-2023 Reporter comment: This case was reported by a patient via interactive digital media. The patient got the shingles after he/she got the Shingles shots two times, he had shingles and before shots no. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Know others who got shots, hubby had them twice/Suspected vaccination failure; Had them 2x on his back; First time said it hurt; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's wife had the shingles all over the front of her stomach), pruritus (Family History) (patient's wife had it) and pain (Family History) (patient's wife had).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's Comment: This case was reported by a patient's wife via interactive digital media. The reporter had the shingles all over the front of her stomach and up and yes it was prickiy and itchy pain wise but was not to bad so not doing the shots. The reporter's husband had the shingles twice on his back first time said it hurt twice and he did not even realize he had it . Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR013561, reported by the same reporter, for a different patients. As per narrative it seems that multiple patient included reporter's husband hence case conservatively kept valid considering patient received shingles vaccine and experienced shingles.; Sender's Comments:  US-GSK-US2023AMR013561:Same reporter. "Others" case
Sex: F
Vaccine: VARZOS
Symptoms: Eye infection, Visual impairment
Clinical narrative: serious eye infection; lost 50 percent of the vision; This case was reported by a consumer via interactive digital media and described the occurrence of eye infection in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pinkeye (history of pink eye).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced eye infection (serious criteria other: serious as per reporter) and partial sight. The patient was treated with medication unknown (Pill (Medication Unknown)) and ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the eye infection and partial sight were not recovered/not resolved.   The reporter considered the eye infection and partial sight to be possibly related to Shingles vaccine.  Additional Information: GSK Receipt Date: 29-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shingles vaccine, no one warned her that if you had a history of pink eye this shot could trigger a serious eye infection. The patient had lost 50 percent of the vision in her eye and after a year he/she was still taking pills and applying eye drops four times a day. The reporter thought that the event might had been related to product/device. Additional Supportive Information: The follow up would not possible as no contact details were available.