chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; a 19 month old male child received both PROQUAD and VARIVAX; This spontaneous report was received from a registered nurse referring to a 19 month old male patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided.   On 30-APR-2019, the patient was vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R020675, expiry date on 15-JAN-2020, for prophylaxis and varicella virus vaccine live (oka/merck) (VARIVAX) lot #R026547, expiri date on 17-SEP-2020. Both vaccines were properly stored without any prior temperature excursion and were reconstituted with properly stored sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 04-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 05-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: The patient had negative titers to rubella; This spontaneous report was received from a pharmacist and refers to a 47-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  It was reported that the patient might or might not have been administered 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (unknown lots and expiration dates) on two separate dates when he was a child. On an unknown date, (reported as couple of years ago) the patient attended to his doctor's office and the doctor drew a bloodwork which showed that the patient had negative titers to rubella and was encouraged to get revaccinated, however, the patient did not at that time.  On 05-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # R028523, expiration date on 04-OCT-2020, subcutaneously (strength, dose, frequency, route of administration, and anatomical location were not reported) to protect against measles, mumps and rubella (prophylaxis).  The relatedness between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 10-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 10-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 11-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 11-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221 : US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 11-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 11-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002770: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769:
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 12-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 12-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 12-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 12-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: a patient who is pregnant received GARDASIL 9; This spontaneous prospective pregnancy report was received from a company representative and refers to a female patient of unknown age. The patient's relevant medical history, concomitant medications, concurrent conditions and allergies were unknown.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were unknown).       The patient became pregnant on an unknown date and then received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exposure during pregnancy). The last menstrual period LMP and estimated date of delivery EDD were not known. The pregnancy outcome was unknown.The outcome of exposure during pregnancy was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Arthritis, Condition aggravated, Rotator cuff syndrome, Tendonitis
Clinical narrative: tendonitis/tendonitis aggravated; shoulder impingement/shoulder impingement aggravated; arthritis aggravated; This case was reported by a other health professional via call center representative and described the occurrence of tendonitis exacerbated in a 63-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included chickenpox (but no shingles at the time of reporting). Previously administered products included Zostavax (received few years ago). Concurrent medical conditions included tendonitis, impingement syndrome shoulder and arthritis (which were well managed at the moment).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tendonitis exacerbated, impingement syndrome shoulder and arthritis aggravated. On an unknown date, the outcome of the tendonitis exacerbated, impingement syndrome shoulder and arthritis aggravated were unknown.   It was unknown if the reporter considered the tendonitis exacerbated, impingement syndrome shoulder and arthritis aggravated to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  The age at vaccination was not reported. After vaccination with Influenza vaccine Quadrivalent unspecified season, the pre-existing condition of the patient was easily aggravated for months following vaccinations in either shoulder. The patient's orthopedist recently at the time of reporting, confirmed this to be not uncommon.  He suggests, in the future, the patient would ask for such vaccinations below the belt (in the buttocks or thigh), so as not to exacerbate the shoulder issues.  According to the reporter's internist the patient should receive Shingrix.  He asked, administration procedures suggest Shingrix should be injected in the Deltoid.  The patient asked, could Shingrix be injected elsewhere with equal or near equal effectiveness.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms; Pain; Headache; trouble breathing; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain, headache and difficulty breathing. On an unknown date, the outcome of the influenza-like symptoms, pain, headache and difficulty breathing were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, pain, headache and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient had very bad achy pains and very flu like symptoms. The patient had headaches and was having trouble breathing. The patient had these problems for over a week and a half and they were just beginning to settle down. The patient was wondering if she should take the 2nd shot what would be the problems with not taking the second shot. This case has been linked to US2019GSK081836, reported by the same reporter for patient's husband.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: this case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 69-year-old female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, several months after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received both shots of SHINGRIX but several months later had a singles recurrence. This case was considered as vaccination failure since laboratory confirmation was unknown at the time of reporting.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Hypersensitivity, Swelling, Type III immune complex mediated reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of arthus reaction in a 16-month-old male patient who received INFANRIX (batch number PT2RK, expiry date 7th July 2019) for prophylaxis. On 15th September 2017, the patient received INFANRIX On an unknown date, unknown after receiving INFANRIX, the patient experienced arthus reaction (serious criteria GSK medically significant), swelling, hypersensitivity and erythema. On an unknown date, the outcome of the arthus reaction, swelling, hypersensitivity and erythema were unknown. It was unknown if the reporter considered the arthus reaction, swelling, hypersensitivity and erythema to be related to INFANRIX. Additional details were provided as follows: The patient had experienced hypersensitivity, after receiving INFANRIX in 2017. Allergist was trying to narrow down ingredients to determine allergy.
Sex: F
Vaccine: FLUX
Symptoms: Neuritis, Systemic lupus erythematosus
Clinical narrative: This is a serious literature case, initially received on 29-Apr-2019, concerning an adult female patient of an unspecified age (reported as in her late twenties). The objective of the article was that a variety of environmental risk factors can trigger the onset of rheumatic disorders. Vaccines stand next to antibiotics as a nineteenth-century medical breakthrough impacting the human evolution and survival. Evidently, an age-old process of conferring immunity without active infection, practiced in civilizations, introduced and advocated in modern medicine at the time of renaissance by prominent physicians. Vaccines tend to stimulate both the humoral and cellular immunity depending on the type of antigenic stimulation. As with any other medical-intervention, even vaccines sometimes result in adverse events. Vaccine-related side effects were increasing exponentially with higher availability, awareness, and reporting. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On an unspecified date after vaccination (reported as close proximity to immunization), the patient developed systemic lupus erythematosus initially manifesting with lupus neuritis presenting as classical fortification spectra permeated by the diversity of different colours. It was reported that the disease remained chronic, required continuous standard treatment. The outcome of the events was not reported. It was reported that the vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart and this might direct towards slightly altered pathologic mechanisms directed at vaccine-related phenomena (related). This case (201903242) is third of the 3 cases linked due to same reporter (author). The reporter concluded that although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, they might be able to find the at-risk groups and lower the incidence.; Reporter's Comments: An adult female patient of unknown age developed systemic lupus erythematosus initially manifesting with lupus neuritis presenting as classical fortification spectra permeated by the diversity of different colours, after administration of INN Flu Vaccine (reported as close proximity to immunization). Considering the plausible temporal relationship between vaccination and reported event and lack of any underlying conditions or alternative more plausible causes, the company conservatively assessed the event as possibly related to suspect vaccine. The company assessed the case as serious (medically significant).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Headache, generalized muscle soreness, loss of appetite, fever (low grade 99.3), malaise began about 4-6 hours after injection.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Abnormal behaviour, Croup infectious, Decreased appetite, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate redness, swelling, and irritation at injection site of MMR. Hard, warm lump under skin. Painful to touch. Overall child was irritable, not himself. High fever 103.8°F 2 days following injects.  Developed respiratory symptoms of Croup 2 days after vaccination. Extremely clingy, inconsolable, not his typical behavior. No appetite for solid foods, vomiting.  Wednesday may 8th he was seen by physician who prescribed oral prednisone for the croup like symptoms.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site irritation, Injection site mass, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Immediate redness, swelling, and irritation at injection site of MMR. Hard, warm lump under skin. Painful to touch. Overall child was irritable, not himself. High fever 103.8°F 2 days following injects.  Developed respiratory symptoms of Croup 2 days after vaccination. Extremely clingy, inconsolable, not his typical behavior. No appetite for solid foods, vomiting.  Wednesday may 8th he was seen by physician who prescribed oral prednisone for the croup like symptoms.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Respiratory symptom, Vomiting
Clinical narrative: Immediate redness, swelling, and irritation at injection site of MMR. Hard, warm lump under skin. Painful to touch. Overall child was irritable, not himself. High fever 103.8°F 2 days following injects.  Developed respiratory symptoms of Croup 2 days after vaccination. Extremely clingy, inconsolable, not his typical behavior. No appetite for solid foods, vomiting.  Wednesday may 8th he was seen by physician who prescribed oral prednisone for the croup like symptoms.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Nausea, Sensation of foreign body, Urticaria
Clinical narrative: Patient developed symptoms within 2 hours of receipt of IIV. Recalls severe HA, nausea, diarrhea, wheezing, and globus sensation. Also developed urticarial rash on one arm. She self-treated with Benadryl and Albuterol and felt better within an hour. She did not seek urgent care evaluation, but did follow up with her PCM 2 days later to report AEFI.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Patient developed symptoms within 2 hours of receipt of IIV. Recalls severe HA, nausea, diarrhea, wheezing, and globus sensation. Also developed urticarial rash on one arm. She self-treated with Benadryl and Albuterol and felt better within an hour. She did not seek urgent care evaluation, but did follow up with her PCM 2 days later to report AEFI.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: I gave patient a high dose flu vaccine instead of a regular flu vaccine.  She did not have any adverse events.  This was a vaccine error on my part.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Joint and body aches, chills, tiredness, redness and swelling at injection site Responded partially to ibuprofen during 1st 36 hours.  Symptoms still present at 48 hours but improved.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: Flu like symptoms; Pain; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and pain. On an unknown date, the outcome of the influenza-like symptoms and pain were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms and pain to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported this case. The age at vaccination was not reported. The patient had very bad achy pains and very flu like symptoms. The patient had these problems for over a week and a half and they were just beginning to settle down. The patient was wondering if the patien should take the 2nd shot and what would be the problems with not taking the second shot. This case has been linked to US2019AMR073800, reported by the same reporter for herself.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 30th April 2020) for prophylaxis.   On 21st April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st April 2019, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the right deltoid. The reporter was unsure whether the patient had attempted to treat the headache with anything.
Sex: F
Vaccine: FLUX
Symptoms: Rheumatoid arthritis, Vaccination complication
Clinical narrative: This is a serious literature case, initially received on 29-Apr-2019, concerning an adult female patient of an unspecified age (reported as middle-aged healthy woman). The objective of the article was that a variety of environmental risk factors can trigger the onset of rheumatic disorders. Vaccines stand next to antibiotics as a nineteenth-century medical breakthrough impacting the human evolution and survival. Evidently, an age-old process of conferring immunity without active infection, practiced in civilizations, introduced and advocated in modern medicine at the time of renaissance by prominent physicians. Vaccines tend to stimulate both the humoral and cellular immunity depending on the type of antigenic stimulation. As with any other medical-intervention, even vaccines sometimes result in adverse events. Vaccine-related side effects were increasing exponentially with higher availability, awareness, and reporting. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On an unspecified date, after vaccination (reported as close proximity to immunization), the patient developed rheumatoid arthritis. It was reported that the disease remained chronic, required continuous standard treatment. The outcome of the event was not reported. It was reported that the vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart and this might direct to-wards slightly altered pathologic mechanisms directed at vaccine-related phenomena (related). This case is original case 201903240 and is one of the 3 cases linked due to same reporter (author). The reporter concluded that although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, they might be able to find the at-risk groups and lower the incidence.; Reporter's Comments: A middle-aged female patient developed rheumatoid arthritis, after administration of INN Flu Vaccine (reported as close proximity to immunization). Considering the plausible temporal relationship between vaccination and reported event and lack of any underlying conditions or alternative more plausible causes, the company conservatively assessed the event as possibly related to suspect vaccine. The company assessed the event 'rheumatoid arthritis' as serious (medically significant).
Sex: F
Vaccine: FLUX
Symptoms: Rheumatoid arthritis
Clinical narrative: This is a serious literature case, initially received on 29-Apr-2019, concerning an adult female patient of an unspecified age (reported as middle-aged healthy woman). The objective of the article was that a variety of environmental risk factors can trigger the onset of rheumatic disorders. Vaccines stand next to antibiotics as a nineteenth-century medical breakthrough impacting the human evolution and survival. Evidently, an age-old process of conferring immunity without active infection, practiced in civilizations, introduced and advocated in modern medicine at the time of renaissance by prominent  physicians. Vaccines tend to stimulate both the humoral and cellular immunity depending on the type of antigenic stimulation. As with any other medical-intervention, even vaccines sometimes result in adverse events. Vaccine-related side effects were increasing exponentially with higher availability, awareness, and reporting. The patient's current condition included palindromic rheumatism since an unspecified date for which the patient was being treated. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [dose: 0.5 ml (reported as standard dose), route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On an unspecified date after vaccination (reported as close proximity to immunization), the patient developed rheumatoid arthritis. It was reported that the disease remained chronic, required continuous standard treatment. The outcome of the event was not reported. It was reported that the vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart and this might direct to-wards slightly altered pathologic mechanisms directed at vaccine-related phenomena (related). This case (201903241) is second of the 3 cases linked due to same reporter (author). The reporter concluded that although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, they might be able to find the at-risk groups and lower the incidence.; Reporter's Comments: An adult female patient of unknown age with current condition (palindromic rheumatism) developed rheumatoid arthritis, after administration of INN Flu Vaccine (reported as close proximity to immunization). Considering the plausible temporal relationship between vaccination and reported event and lack of any underlying conditions or alternative more plausible causes, the company conservatively assessed the event as possibly related to suspect vaccine. The company assessed the event 'rheumatoid arthritis' as serious (medically significant).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Face oedema, Flushing, Nausea
Clinical narrative: 4-19-19 Had Shingrix #2 @ 9AM. Then between 7-8 PM chills, increased fever nausea felt like going to pass out face edematous flushed felt "like run over by truck " the whole next day". Took OTC. meds. Thrus "felt entirely different no SX".