chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004634: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case: 1802USA002182 US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On unknown dates (reported as " from 24-JAN-2018 until 6-FEB-2018), the patients were vaccinated with an improperly stored dose of GARDASIL 9 with lot # N010497, expiration date on 15-JAN-2020; (Strength, route, dose, frequency, and anatomical location were unknown) and an improperly stored dose of PEDVAXHIB lot # N003698, expiration date on 31-OCT-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 0 C to 1 C (1.4C) degrees Celsius for 30 min. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported.
Age: 46.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Back pain, Burning sensation, Chest pain, Injection site swelling, Pain
Clinical narrative: This spontaneous report was received from a 46 year old female patient, who was reporting on herself. The patient's pertinent medical history, was not provided but reported that she had a flu shot in past years. Concurrently, the patient had diabetes, a thyroid disorder and had a drug reaction/allergy to codeine products. Concomitant therapies included metformin, glipizide, lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 03-JAN-2018, the patient was seen at a local clinic where she was vaccinated with a first dose of PNEUMOVAX23 0.5 ml, intramuscularly in the left upper arm, as immunization for the prevention of pneumococal disease (strength, lot # and expiration date were not reported) and with an influenza virus vaccine (unspecified). The patient stated that later at evening, on this same date, her left arm swelled at the injection site and pain travelled/radiated into my chest and back. The patient also stated that it felt like fireballs were inside her arm. After to contact a clinic provider, the patient was advised to ice the injection site and to take unspecified over the counter anti-inflammatory medications, for the pain and swelling; no laboratory studies were performed. The patient stated that, on 07-FEB-2018, her arm looked that there was no anything unusual on the outside of it, but she still had pain in her arm when she move it in certain way. She said that was so painful and she could fall to the floor because of the intense pain. At the reporting time, the outcome of burning sensation, injection site swelling and pain was unknown. The causality assessment between the events and vaccination with PNEUMOVAX23 and influenza virus vaccine (unspecified) was not provided.
Age: 46.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a 46 year old female patient, who was reporting on herself. The patient's pertinent medical history, was not provided but reported that she had a flu shot in past years. Concurrently, the patient had diabetes, a thyroid disorder and had a drug reaction/allergy to codeine products. Concomitant therapies included metformin, glipizide, lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 03-JAN-2018, the patient was seen at a local clinic where she was vaccinated with a first dose of PNEUMOVAX23 0.5 ml, intramuscularly in the left upper arm, as immunization for the prevention of pneumococal disease (strength, lot # and expiration date were not reported) and with an influenza virus vaccine (unspecified). The patient stated that later at evening, on this same date, her left arm swelled at the injection site and pain travelled/radiated into my chest and back. The patient also stated that it felt like fireballs were inside her arm. After to contact a clinic provider, the patient was advised to ice the injection site and to take unspecified over the counter anti-inflammatory medications, for the pain and swelling; no laboratory studies were performed. The patient stated that, on 07-FEB-2018, her arm looked that there was no anything unusual on the outside of it, but she still had pain in her arm when she move it in certain way. She said that was so painful and she could fall to the floor because of the intense pain. At the reporting time, the outcome of burning sensation, injection site swelling and pain was unknown. The causality assessment between the events and vaccination with PNEUMOVAX23 and influenza virus vaccine (unspecified) was not provided.
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 2 month old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 06-FEB-2018, the patient was vaccinated with an expired dose RECOMBIVAX HB (route, dose, frequency, and anatomical location were unknown) with lot # L048849 and expiration date 04-FEB-2018 for prophylaxis. No adverse effects were reported.
Age: 1.17
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 14 month old patient with a cochlear implant. On 26-DEC-2017, the patient received a dose of PREVNAR 13. The patient's drug reactions/allergies and concomitant medications were not reported. On 31-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 lot number: N030111 (expiration date: 21-APR-2019), for prophylaxis (strength, route and dosage schedule date were not reported). No side effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received an improperly stored dose of VARIVAX from lot # N022977 with expiration date 23-AUG-2019 or Lot # N023958 with expiration date 01-SEP-2019, for prophylaxis, (strength, dose, frequency and route of administration were unknown); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature was reported as 6 to 14 degrees Fahrenheit (F) for a time frame of 180 minutes. There was a previous temperature excursion of 6 to 14 degrees Fahrenheit (F) for 222 minutes. Digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004551: US-009507513-1802USA004552: US-009507513-1801USA005336:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received an improperly stored dose of VARIVAX from lot # N022977 with expiration date 23-AUG-2019 or Lot # N023958 with expiration date 01-SEP-2019, for prophylaxis, (strength, dose, frequency and route of administration were unknown); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature was reported as 6 to 14 degrees Fahrenheit (F) for a time frame of 180 minutes. There was a previous temperature excursion of 6 to 14 degrees Fahrenheit (F) for 222 minutes. Digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1801USA005336: US-009507513-1802USA004552: US-009507513-1802USA004550:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received an improperly stored dose of VARIVAX from lot # N022977 with expiration date 23-AUG-2019 or Lot # N023958 with expiration date 01-SEP-2019, for prophylaxis, (strength, dose, frequency and route of administration were unknown); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature was reported as 6 to 14 degrees Fahrenheit (F) for a time frame of 180 minutes. There was a previous temperature excursion of 6 to 14 degrees Fahrenheit (F) for 222 minutes. Digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004551: US-009507513-1801USA005336: US-009507513-1802USA004550:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA002182: US-009507513-1802USA004634: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692: US-009507513-1802USA004616.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA002182: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004692: US-009507513-1802USA004686:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA002182: US-009507513-1802USA004692: US-009507513-1802USA004686: US-009507513-1802USA004673: US-009507513-1802USA004671: US-009507513-1802USA004663: US-009507513-1802USA004658 : US-009507513-1802USA004654 : US-009507513-1802USA004647 : US-009507513-1802USA004641 : US-009507513-1802USA004636:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004634: US-009507513-1802USA002182: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004634: US-009507513-1802USA004636: US-009507513-1802USA002182: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA002182: US-009507513-1802USA004692: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA002182: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case: 1802USA002182: US-009507513-1802USA004654: US-009507513-1802USA002182: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 01-FEB-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N013886, expiry date: 09-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case: 1802USA002182: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA002182: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from the patient's "spouse" referring to a currently 31 year old patient of unknown gender, via Novartis. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis. The reporter mentioned that the patient had been experiencing allergic reactions to the pneumonia vaccine on unspecified dates. At the reporting time the outcome of the event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-DEC-2017, the patient was vaccinated with an improperly storage dose of PROQUAD, lot # N023967, expiration date 28-FEB-2019, (dose number, dose, and route were not reported), for prophylaxis. Other suspect therapies included sterile diluent (MERCK), (Lot number N027626 Expiration date 20-MAY-2019). The PROQUAD and the sterile diluent (MERCK) was on a temperature excursion from 6 to 14 Fahrenheit Degrees during 1 hour and 18 minutes; and from 15 to 46 Fahrenheit Degrees during 34 hours and 29 minutes. Both products had multiple previous temperature excursions. The digital data logger was involved. No adverse effects or reactions had been reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA005276.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 27-DEC-2017, the patient was vaccinated with an improperly storage dose of PROQUAD, lot # N023967, expiration date 28-FEB-2019, (dose number, dose, and route were not reported), for prophylaxis. Other suspect therapies included sterile diluent (MERCK), (Lot number N027626 Expiration date 20-MAY-2019). The PROQUAD and the sterile diluent (MERCK) was on a temperature excursion from 6 to 14 Fahrenheit Degrees during 1 hour and 18 minutes; and from 15 to 46 Fahrenheit Degrees during 34 hours and 29 minutes. Both products had multiple previous temperature excursions. The digital data logger was involved. No adverse effects or reactions had been reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA005276.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 28-DEC-2017, the patient was vaccinated with an improperly storage dose of PROQUAD, lot # N023967, expiration date 28-FEB-2019, (dose number, dose, and route were not reported), for prophylaxis. Other suspect therapies included sterile diluent (MERCK), (Lot number N027626 Expiration date 20-MAY-2019). The PROQUAD and the sterile diluent (MERCK) was on a temperature excursion from 6 to 14 Fahrenheit Degrees during 1 hour and 18 minutes; and from 15 to 46 Fahrenheit Degrees during 34 hours and 29 minutes. Both products had multiple previous temperature excursions. The digital data logger was involved. No adverse effects or reactions had been reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA005276.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 29-DEC-2017, the patient was vaccinated with an improperly storage dose of PROQUAD, lot # N023967, expiration date 28-FEB-2019, (dose number, dose, and route were not reported), for prophylaxis. Other suspect therapies included sterile diluent (MERCK), (Lot number N027626 Expiration date 20-MAY-2019). The PROQUAD and the sterile diluent (MERCK) was on a temperature excursion from 6 to 14 Fahrenheit Degrees during 1 hour and 18 minutes; and from 15 to 46 Fahrenheit Degrees during 34 hours and 29 minutes. Both products had multiple previous temperature excursions. The digital data logger was involved. No adverse effects or reactions had been reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA005276.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 30-DEC-2017, the patient was vaccinated with an improperly storage dose of PROQUAD, lot # N023967, expiration date 28-FEB-2019, (dose number, dose, and route were not reported), for prophylaxis. Other suspect therapies included sterile diluent (MERCK), (Lot number N027626 Expiration date 20-MAY-2019). The PROQUAD and the sterile diluent (MERCK) was on a temperature excursion from 6 to 14 Fahrenheit Degrees during 1 hour and 18 minutes; and from 15 to 46 Fahrenheit Degrees during 34 hours and 29 minutes. Both products had multiple previous temperature excursions. The digital data logger was involved. No adverse effects or reactions had been reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA005276.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 11-JAN-2018, the patient was vaccinated with a dose of improperly stored VARIVAX lot number N001527, expiration date 13-JAN-2019 for prophylaxis (frequency and route of administration were not reported). The sterile diluent (MERCK) used for reconstitution was properly stored. On unknown dates, the doses of VARIVAX underwent temperature excursions of 6 degrees Fahrenheit (°F) to 14 °F for 69 hours 2 minutes, 15 °F to 46 °F for 36 hours 14 minutes. A previous temperature excursion of 15 °F to 46 °F for 60 hours was reported. Temperature excursions were detected by the data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1801USA010690: US-009507513-1801USA010882: US-009507513-1802USA004843.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 23-JAN-2018, the patient was vaccinated with a dose of improperly stored GARDASIL 9 lot number N017697, expiration date 21-JAN-2020 for prophylaxis (frequency and route of administration were not reported). On unknown dates, the dose of GARDASIL 9 underwent temperature excursions of below 32 degrees Fahrenheit (°F) for 9 hours 6 minutes and 32 °F up to 35 °F 19 hours 11 minutes, which were detected by the data logger. No previous temperature excursions were reported. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1801USA010690: US-009507513-1802USA004842: US-009507513-1801USA010882.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Dysphagia, Lip swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient received her first doses of TRUMENBA (Lot Number: S26985, Expiry date: 31Jan2019) at 0.5mL single IM injection left deltoid at 1:30 PM on 24Jan2018 as Prevention of meningitis B; HAVRIX (Manufacturer: GlaxoSmithKline, Lot Number: ZK374, Expiry date: 19Mar2020) at 0.5mL IM injection in right deltoid at 1:30 PM on 24Jan2018 as prevention of hepatitis A; GARDISIL 9 (Manufacturer: Merck, Lot Number: N010497, Expiry date: 15Jan2020) at 0.5mL IM injection in left deltoid at 1:30 PM on 24Jan2018 as Prevention of HPV; and her second dose of MENACTRA (Manufacturer: Sanofi Pasteur, Lot Number: U5839AA, Expiry date: 05Mar2019) at 0.5ml IM injection in right deltoid at 1:30 PM on 24Jan2018 as Prevention of meningitis A. Medical history included: allergic to bee venom (no other allergies). Patient received her first dose of MENACTRA. Concomitant medications were none. On 24Jan2018 at 1:30 PM, the patient received her vaccines. She stayed for a 15 minute waiting period and left the office at 1:45PM. At 7: 02 pm parent called reporting patient had significant upper lip swelling and some difficulty swallowing on 24Jan2018. Went to ER who noted significant upper lip swelling, throat and airway looked good; oxygen was 100%; tongue was not enlarged. When patient got to the ER, an IV was started and she was given SOLU-MEDROL, PEPCID, and BENADRYL by IV, (dosages for any of the medications that the patient received in the ER was unknown). She was observed for 1 hour in ER and nothing deteriorated but patient still complained of swelling. She was given another half dose of IV BENADRYL and oral dose of VISTARIL at that time. Patient had improvement so discharged home on oral Prednisone and ATARAX. She was fine the next day. Patient was not admitted overnight, she was discharged from the ER by 10:30PM 24Jan2018. The office followed up with the patient by phone the next day. She was not exhibiting any symptoms, so they did not request that she come to the office. Reporter did verify that the meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w conj (dip tox) were given in different extremities. Events outcome was recovered on 25Jan2018.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Angioedema, Dysphagia, Dyspnoea, Lip swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient received her first doses of TRUMENBA (Lot Number: S26985, Expiry date: 31Jan2019) at 0.5mL single IM injection left deltoid at 1:30 PM on 24Jan2018 as Prevention of meningitis B; HAVRIX (Manufacturer: GlaxoSmithKline, Lot Number: ZK374, Expiry date: 19Mar2020) at 0.5mL IM injection in right deltoid at 1:30 PM on 24Jan2018 as prevention of hepatitis A; GARDISIL 9 (Manufacturer: Merck, Lot Number: N010497, Expiry date: 15Jan2020) at 0.5mL IM injection in left deltoid at 1:30 PM on 24Jan2018 as Prevention of HPV; and her second dose of MENACTRA (Manufacturer: Sanofi Pasteur, Lot Number: U5839AA, Expiry date: 05Mar2019) at 0.5ml IM injection in right deltoid at 1:30 PM on 24Jan2018 as Prevention of meningitis A. Medical history included: allergic to bee venom (no other allergies). Patient received her first dose of MENACTRA. Concomitant medications were none. On 24Jan2018 at 1:30 PM, the patient received her vaccines. She stayed for a 15 minute waiting period and left the office at 1:45PM. At 7: 02 pm parent called reporting patient had significant upper lip swelling and some difficulty swallowing on 24Jan2018. Went to ER who noted significant upper lip swelling, throat and airway looked good; oxygen was 100%; tongue was not enlarged. When patient got to the ER, an IV was started and she was given SOLU-MEDROL, PEPCID, and BENADRYL by IV, (dosages for any of the medications that the patient received in the ER was unknown). She was observed for 1 hour in ER and nothing deteriorated but patient still complained of swelling. She was given another half dose of IV BENADRYL and oral dose of VISTARIL at that time. Patient had improvement so discharged home on oral Prednisone and ATARAX. She was fine the next day. Patient was not admitted overnight, she was discharged from the ER by 10:30PM 24Jan2018. The office followed up with the patient by phone the next day. She was not exhibiting any symptoms, so they did not request that she come to the office. Reporter did verify that the meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w conj (dip tox) were given in different extremities. Events outcome was recovered on 25Jan2018.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Headache, Lymphadenopathy, Malaise
Clinical narrative: Right arm pain. Right arm temperature extremely warm. Oral fever 103 degrees F. Malaise. Headache. Swollen lymph nodes right arm.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Right arm pain. Right arm temperature extremely warm. Oral fever 103 degrees F. Malaise. Headache. Swollen lymph nodes right arm.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding a 13 year old female patient. No information was provided regarding medical history and concomitant medications of the patient. Concurrent condition included seasonal allergy. The patient had no illness at the time of the vaccination. On 07-NOV-2017, the clinic refrigerator had a temperature excursions of 39/48 degrees Fahrenheit (F), on 08-NOV-2017 was 39/48 degrees F, on 13-NOV-2017 was 40/48 degrees F and 14-NOV-2017 was 37/47 degrees F. There was no temperature excursion in December 2017. On 22-DEC-2017, the state representative was notified. On 03-JAN-2018, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # N017697 expiration date 21-JAN-2020) (dose, units and frequency was not reported) intramuscularly for prophylaxis at a public health clinic/hospital with private funds. On 04-JAN-2018, the manufacturer was notified who stated it would be ok to continue to use. On 03-JAN-2018, temperature was within the range 40/43 degrees F. The patient received immunization at a well check appointment and had no adverse event or complications were noted. It was reported that possibly a temperature excursions occurred as a result of reading from a Digital Data Logger.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-FEB-2018, the patient was vaccinated with expired ZOSTAVAX lot# N014942 with expiry date of 02-FEB-2018 for prophylaxis (dose and route of administration was not reported). The nurse reported that the ZOSTAVAX did not have any temperature excursion prior to administration. No adverse event was reported. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a consumer (patient's father) refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with 4th dose of GARDASIL 9. It could not be confirmed if the patient had an adverse effect. The outcome of the events was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 21 year old female patient. The patient had no medical history, concurrent conditions, drug reactions/allergies and concomitant therapy. On an unspecified date in 2008, the patient completed the vaccination series with GARDASIL, intramuscular for HPV vaccination. Reporter stated that approximately in December 2017, the patient got a Papanicolaou (PAP) smear done at the physician's office and it was clear. On 29-JAN-2018, she again had a PAP smear done at the same physician's office. The patient received her results on 06-FEB-2018 that were positive for HPV. She required medical attention. No treatment was provided for the adverse event. Outcome of the event was reported as not recovered. Reporter stated that the patient also scheduled for a biopsy on 13-FEB-2018 at the same physician's office. Causality assessment was not provided.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood lactic acid increased, Body temperature increased, Cardiac discomfort, Mobility decreased
Clinical narrative: This spontaneous report was received from a 67 year old female patient regarding herself. Current conditions included Chiari malformation type 1, fibromyalgia, myofascial pain disorder and migraines. Patient had drug reactions/allergies to LAMICTAL and DAYPRO. Concomitant medication included ZETIA. On 22-JAN-2018 (around at noon), the patient started therapy with PNEUMOVAX 23 lot# N030847 with expiry date of 09-JUN-2019 for prevention on Pneumococcal disease. On 22-JAN-2018 at 5:00 pm, the patient experienced top of left arm soreness and it progressively got worse and the patient could not lift the arm. Patient also had explosive pain in the shoulder joint. At 10:00 pm, the patient called insurance company nurse line and they told her to go to the emergency room as her temperature was 102 F. On 23-JAN-2018 (reported as after midnight), the patient was admitted to hospital. The hospital told the patient that her white blood cell count and lactic acid levels were too high. Her heart felt funny but the hospital said that was fine. The patient had horrendous pain and couldn't breathe without pain. Patient was started on IV. The patient was kept in the hospital. Next morning (23-JAN-2018), the repeat blood work to see if the white blood cell count and lactic acid levels had come down. The patient was discharged that afternoon around 5:00 pm on 23-JAN-2018. The patient still had pain and couldn't lay on that side. The patient reported that the PNEUMOVAX 23 injection was given in the muscle but very high up in her arm, like about an inch down from her shoulder. Consumer reported that this was her second PNEUMOVAX 23 and she had received the first injection when she was 65 year old (date not specified). The patient had received treatment for the events. Outcome of the events White blood cell count increased and Blood lactic acid increased was considered to be recovering. Outcome of the other events was reported as not recovered. Causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Painful respiration, White blood cell count increased
Clinical narrative: This spontaneous report was received from a 67 year old female patient regarding herself. Current conditions included Chiari malformation type 1, fibromyalgia, myofascial pain disorder and migraines. Patient had drug reactions/allergies to LAMICTAL and DAYPRO. Concomitant medication included ZETIA. On 22-JAN-2018 (around at noon), the patient started therapy with PNEUMOVAX 23 lot# N030847 with expiry date of 09-JUN-2019 for prevention on Pneumococcal disease. On 22-JAN-2018 at 5:00 pm, the patient experienced top of left arm soreness and it progressively got worse and the patient could not lift the arm. Patient also had explosive pain in the shoulder joint. At 10:00 pm, the patient called insurance company nurse line and they told her to go to the emergency room as her temperature was 102 F. On 23-JAN-2018 (reported as after midnight), the patient was admitted to hospital. The hospital told the patient that her white blood cell count and lactic acid levels were too high. Her heart felt funny but the hospital said that was fine. The patient had horrendous pain and couldn't breathe without pain. Patient was started on IV. The patient was kept in the hospital. Next morning (23-JAN-2018), the repeat blood work to see if the white blood cell count and lactic acid levels had come down. The patient was discharged that afternoon around 5:00 pm on 23-JAN-2018. The patient still had pain and couldn't lay on that side. The patient reported that the PNEUMOVAX 23 injection was given in the muscle but very high up in her arm, like about an inch down from her shoulder. Consumer reported that this was her second PNEUMOVAX 23 and she had received the first injection when she was 65 year old (date not specified). The patient had received treatment for the events. Outcome of the events White blood cell count increased and Blood lactic acid increased was considered to be recovering. Outcome of the other events was reported as not recovered. Causality of the events was not reported.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Pleuropericarditis
Clinical narrative: This spontaneous report was received from a nurse refers to a 54 year old male patient. Patient's pertinent medical history included Lyme associated arthritis, elevated triglycerides, thyroid issues, and high blood pressure. The patient had no drug reactions/allergies. Concomitant therapies included a lot of medications (unspecified). On 11-DEC-2017, the blood cholesterol levels was performed. On 15-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, lot number and expiration date were not reported) intramuscularly for prophylaxis (vaccination). On an unknown date in 2018, the patient developed pleural pericarditis (hospitalization, medically significant, disability and life threatening). On 21-JAN-2018, the patient was hospitalized and was discharged on 31-JAN-2018, and was again readmitted on 02-FEB-2018. Currently the patient was hospitalized. The nurse stated that she was not sure whether the pleural pericarditis was related to the PNEUMOVAX 23. The patient received treatment to treat the adverse event. The patient sought medical attention (was hospitalized). The outcome of pleural pericarditis was reported as not recovered/not resolved. The relationship between event pleural pericarditis and PNEUMOVAX 23 was not provided. There was no product quality complaint (PQC) reported. The event pleural pericarditis was considered to be life-threatening by the reporting nurse. Upon internal review, pleural pericarditis was considered to be serious due be medically significant.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peau d'orange, Peripheral swelling
Clinical narrative: Patient experienced swelling and redness in arm the day following vaccine administration. She went to the ER and the doctor prescribed BENADRYL and an antibiotic (she did not have the name available). Patient is feeling better and taking the medication as prescribed. Doctor diagnosis was cellulite according to the patient.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Groin pain, Headache, Hypersomnia
Clinical narrative: According to the patient: "I just wanted to let you know that I had a reaction to the shingles vaccine. I woke up in the middle of the night shivering, and running a fever. I had a headache, a sore throat, and every joint in my body hurt. I could not even turn sideways because I could not stand the pain in my knee. I slept the whole day Saturday (2/10/18), as I had a fever the whole day. I woke up Sunday (2/11/18) much better, but my left knee is still hurting today, and the pain goes up my inner thigh to my groin."
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: According to the patient: "I just wanted to let you know that I had a reaction to the shingles vaccine. I woke up in the middle of the night shivering, and running a fever. I had a headache, a sore throat, and every joint in my body hurt. I could not even turn sideways because I could not stand the pain in my knee. I slept the whole day Saturday (2/10/18), as I had a fever the whole day. I woke up Sunday (2/11/18) much better, but my left knee is still hurting today, and the pain goes up my inner thigh to my groin."