chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Immune complex level increased, Joint swelling, Malaise, Nausea, Protein urine present
Clinical narrative: Woke up the day following the vaccination (Saturday, 16 March 2019) with exacerbation of joint pain, exhaustion, malaise, lack of appetite. By afternoon developed fever of 103.2 degrees (could not control fever with acetaminophen). Went to Emergency Department (high/urgent severity) in the evening and once there developed, nausea, vomiting and numbness in arms. Received normal saline and ondansetron IV, continued vomiting and received IV COMPAZINE. Was discharged at 6:30 AM on Sunday, 17 March 2019, and went home. Once home around 12:00 PM (noon) fever returned with maximum of 101.9, while dosing with acetaminophen and ibuprofen. That evening (Sunday 17 March 2019) from 16:00 PM to 4:30 AM the next day, experienced extreme nausea, with violent vomiting, rigor, chills, and delirium. At 09:00 AM on Monday 18 March 2019 returned to Emergency Department with exacerbation of fever, nausea, chills, shortness of breath, joint pain and malaise and was admitted to hospital. In the hospital between Monday 18th to Thursday 21st March continued to experience fever, nausea, chills and rigors, and sweating that worsened throughout the evening and into the night, as well as joint pain and swelling, lack of appetite, weakness, dizziness, fatigue and malaise which were treated with hydromorphone, acetaminophen, ondansetron, COMPAZINE, diclofenac, and tramadol. Started prednisone 20 mg QD on Thursday, 21 March 2019. Abnormal labs tests for serum creatinine and urine protein led to Nephrology consult and recommendation for kidney biopsy. Abnormal CBC and differential lab tests showed blasts in peripheral blood led to Hematology consult and additional flow cytometric analyses and recommendation for bone marrow biopsy. All laboratory testing during Emergency Department visits on 16-17 March and on 18 March then throughout the 5 days of hospitalization suggested cytokine release syndrome and RBC lyses and hemoglobin drop. Laboratory test also identified elevated C-reactive protein, sedimentation rate, circulating immune complexes, and extreme elevations in anti-nuclear antibody titers and complement depletion.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Red blood cell analysis abnormal, Red blood cell sedimentation rate increased, Vomiting
Clinical narrative: Woke up the day following the vaccination (Saturday, 16 March 2019) with exacerbation of joint pain, exhaustion, malaise, lack of appetite. By afternoon developed fever of 103.2 degrees (could not control fever with acetaminophen). Went to Emergency Department (high/urgent severity) in the evening and once there developed, nausea, vomiting and numbness in arms. Received normal saline and ondansetron IV, continued vomiting and received IV COMPAZINE. Was discharged at 6:30 AM on Sunday, 17 March 2019, and went home. Once home around 12:00 PM (noon) fever returned with maximum of 101.9, while dosing with acetaminophen and ibuprofen. That evening (Sunday 17 March 2019) from 16:00 PM to 4:30 AM the next day, experienced extreme nausea, with violent vomiting, rigor, chills, and delirium. At 09:00 AM on Monday 18 March 2019 returned to Emergency Department with exacerbation of fever, nausea, chills, shortness of breath, joint pain and malaise and was admitted to hospital. In the hospital between Monday 18th to Thursday 21st March continued to experience fever, nausea, chills and rigors, and sweating that worsened throughout the evening and into the night, as well as joint pain and swelling, lack of appetite, weakness, dizziness, fatigue and malaise which were treated with hydromorphone, acetaminophen, ondansetron, COMPAZINE, diclofenac, and tramadol. Started prednisone 20 mg QD on Thursday, 21 March 2019. Abnormal labs tests for serum creatinine and urine protein led to Nephrology consult and recommendation for kidney biopsy. Abnormal CBC and differential lab tests showed blasts in peripheral blood led to Hematology consult and additional flow cytometric analyses and recommendation for bone marrow biopsy. All laboratory testing during Emergency Department visits on 16-17 March and on 18 March then throughout the 5 days of hospitalization suggested cytokine release syndrome and RBC lyses and hemoglobin drop. Laboratory test also identified elevated C-reactive protein, sedimentation rate, circulating immune complexes, and extreme elevations in anti-nuclear antibody titers and complement depletion.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Head banging, Injection site pain, Injection site rash, Myalgia
Clinical narrative: Next day: Significant arm pain at site of injection; headache, joint pain, slight nausea,  myalgia. Two days after: Red rash on arm near site of injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Rash erythematous
Clinical narrative: Next day: Significant arm pain at site of injection; headache, joint pain, slight nausea,  myalgia. Two days after: Red rash on arm near site of injection.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness/Swelling/Warmth near injection site
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012981:
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction; Injection site swelling; Injection site redness; Injection site itching; Injection site warmth; This spontaneous report as received from a other health professional refers to a 75 year old female patient with hypertension.    On 25-APR-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R024025, intramuscular for prophylaxis.    Concomitant therapies included losartan(LOSARTAN) and vitamins (unspecified)(VITAMINS (UNSPECIFIED)).   On 25-APR-2019, 1 day after onset of therapy the patient experienced injection site reaction, injection site swelling, injection site warmth, injection site erythema and injection site pruritus.    The outcome of injection site reaction, injection site warmth, injection site pruritus, injection site erythema and injection site swelling was reported as not recovered/not resolved.   The reporter considered injection site reaction, injection site swelling, injection site warmth, injection site erythema and injection site pruritus to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Sex: U
Vaccine: HPV9
Symptoms: Hypoaesthesia
Clinical narrative: numbness in the arm/patient could not feel touch, as with a pinch, but could feel a pin prick; Information has been received from a physician via a field employee referring to a 12 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported.   On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, lot# and expiration date unknown) for prophylaxis.   On the same date, following the injection, the patient experienced numbness in the arm, while still in the physician's office. The physician informed the field employee that patient could not feel touch, as with a pinch, but could feel a pin prick, performed by the physician. No treatment was given to the patient. The outcome of the event was unknown.   The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: A titer showed a "suboptimal response" to the M-M-R II vaccination.; On an unknown date during childhood, a patient received a dose of M-M-R II, then on 08/29/2017, the patient received another dose of M-M-R II. Then on an unknown date after that, the patient received another dose of M-M-R II.; On an unknown date during childhood, a patient received a dose of M-M-R II, then on 08/29/2017, the patient received another dose of M-M-R II. Then on an unknown date after that, the patient received another dose of M-M-R II.; This spontaneous report was received from a pharmacist and refers to a currently 53 year old female patient. The patient's concomitant medications included levothyroxine and olopatadine hydrochloride (PATADAY). The patient's concurrent conditions included hypothyroidism and seasonal allergies. The patient's pertinent medical history and drug allergies were not reported. On an unknown date during childhood, the patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously for vaccination against measles, mumps, and rubella (dose, lot # and expiration date were not reported).  On 29-AUG-2017, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously lot # M006544, expiration date 03-FEB-2018 for vaccination against measles, mumps, and rubella (dose was not reported). Then on an unknown date after that, a titer showed a "suboptimal response" to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination (antibody test negative). On 05-MAR-2019, the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously, lot # N023150, expiration date 24-AUG-2019 for vaccination against measles, mumps, and rubella (dose was not reported) (extra dose administered). The outcome of the occurred events was not reported. The causal relationship between the event antibody test negative and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the patient was inadvertently adrninistered an expired dose of MMRII; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) subcutaneously (lot # N013281, expiration date: 28-APR-2019, dose was not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent. No adverse effects or temperature excursion were reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No known adverse effects; patient received a dose of M-M-R II via the intramuscular route in error; This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 03-MAY-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency were not reported) (lot # R030812, expiry date: 24-OCT-2020) via intramuscular route in error for prophylaxis (incorrect route of product administration). Other suspect therapies included sterile diluent(STERILE DILUENT) (dose, frequency were not reported) (lot # S005008, expiry date: 27-SEP-2021). No adverse effect was reported. No product quality complaint was involved.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse reaction; Expired dose administered; This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) 0.5 milliliter, subcutaneously, lot # N009168, expiry date 20-MAR-2019 (site of administration was not reported) for prophylaxis. There was no temperature excursion. No adverse effects were reported.
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 16-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-009507513-1905USA002753: 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-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002762: 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 16-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-009507513-1905USA002753: 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-009507513-1905USA002770: 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 16-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-009507513-1905USA002753: 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-009507513-1905USA002765: 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 16-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-009507513-1905USA002753: 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-009507513-1905USA002770: 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 16-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-009507513-1905USA002753: 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-009507513-1905USA002767: 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 22-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-009507513-1905USA002753: 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-009507513-1905USA002768: 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 23-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-009507513-1905USA002769: US-009507513-1905USA002770: US-009507513-1905USA002753:
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 23-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-009507513-1905USA002753: 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-009507513-1905USA002770:
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-009507513-1905USA002749: 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:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; The patient was inadvertently admnistered one dose of expire M-M-R II; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 06-MAY-2019, the patient was inadvertently administered one dose of expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (expired product administered) rHA, lot number N013866, expiration date 04-MAY-2019 for prophylaxis (dosage schedule, route, and anatomical site were not reported). The sterile diluent used to reconstituted Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) one dose,  lot number N012922, and expiration date 15-OCT-2019, was not expired. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Bronchiectasis
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. Information regarding the patient's pertinent medical history and concomitant drugs was not provided. The patient was allergic to sulfites. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown), reported as "shingles vaccine, (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 06-MAY-2019, the patient was diagnosed with bronchiectasis. The outcome of bronchiectasis, as well as, the causality between the event and therapy with zoster vaccine live (manufacturer unknown) were unknown. Upon internal review the event bronchiectasis was considered to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; the patient inadvertently received an expired dose of PNEUMOVAX 23; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.   On 07-MAY-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # N030111, expiration date 21-APR-2019, for prophylaxis. No adverse effects were reported.
Age: 29.0
Sex: M
Vaccine: MMR, UNK
Symptoms: Injection site pain
Clinical narrative: the patient said that "it hurt; patient received one dose of MMR II via the intramuscular route on an unspecified injection site; This spontaneous report was received from a pharmacist and refers to a 29 year old male patient. The patient had no pertinent medical history nor drug reactions or allergies. It was unknown if the patient had any concomitant medications.      On 08-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N025891 with an expiration date in 019-SEP-2019), intramuscular route of administration, for prophylaxis (strength, dose and frequency were not provided).  Other suspect therapies included sterile diluent.      On the same date, the patient said that "it hurt" (injection site pain). Moreover, it was  also reported that the patient did not seek for medical attention, no treatment was given for the experienced event and no laboratories were performed to the patient.        At the time of reporting, the outcome of injection site pain was reported as resolved on an unknown date in May 2019.    The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II),  sterile diluent and the reported event was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Systemic lupus erythematosus
Clinical narrative: This spontaneous report was received from  a Nurse via company representative refers to an adult (also reported as in her 20's) female patient of unknown age. The patients' medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency, lot number, anatomical location and expiration date unknown) for prophylaxis. It was reported that right after receiving the vaccine the patient got sick and was hospitalized. The patient was diagnosed with lupus (systemic lupus erythematous). The outcome of systemic lupus erythematosus was unknown. The causality assessement between GARDASIL and lupus was not reported. Upon internal review the event lupus was determined to be medically significant. There was no product quality complaint associated with this report.
Age: 64.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects.; a 64 year old patient received a dose of PROQUAD; Information has been received from a administrator referring to a 64 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 08-MAY-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (1 dosage form, strength, frequency, lot#, therapy type and expiration date were unknown) subcutaneously for prophylaxis (inappropriate age at vaccine administration).  No known adverse effects.
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a nurse via company representative regarding a male patient of an unknown age. The patient's relevant medical history, current conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 (strength, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient had a seizure shortly after vaccination. It was unknown if patient sought for any medical attention or received treatment for the event. The outcome of seizure was unknown. Causality assessment was not reported. No product quality complaint (PQC) was involved. Upon internal review, seizure was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administered intramuscular instead of subcutaneous; no adverse effect; This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R031628, expiry date 01-NOV-2020) intramuscularly instead of subcutaneous for prophylaxis. No adverse effects were reported. No product quality compliant was filed.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On 07-MAY-2019, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration and anatomical location were unknown) (lot # R020949 and expiry date 04-MAY-2021) for prophylaxis (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 35.72 Fahrenheit (F) for a time frame of 5 hours and 5 minutes on 06-MAY-2019. There was previous temperature excursion reported as 31.28 Fahrenheit (F) for a time frame of 5 hours and 7 minutes on 03-MAY-2019, 32.68 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019, 31.26 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the four reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005070: US-009507513-1905USA005068: US-009507513-1905USA005069:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On 07-MAY-2019, the patient was vaccinated with improperly stored hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose, frequency, route of administration and anatomical location were unknown) (lot # R034340 and expiry date 23-NOV-2019) for prophylaxis (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 35.72 Fahrenheit (F) for a time frame of 5 hours and 5 minutes on 06-MAY-2019. There was previous temperature excursion reported as 31.28 Fahrenheit (F) for a time frame of 5 hours and 7 minutes on 03-MAY-2019, 32.68 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019, 31.26 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the four reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004979: US-009507513-1905USA005069: US-009507513-1905USA005070:
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On 07-MAY-2019, the patient was vaccinated with improperly stored rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, dose, frequency, route of administration and anatomical location were unknown) (lot # R016790 and expiry date 20-APR-2020) for prophylaxis (product storage error) and hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, frequency, route of administration and anatomical location were unknown) (lot # R013540 and expiry date 21-MAR-2021) for prophylaxis. No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 35.72 Fahrenheit (F) for a time frame of 5 hours and 5 minutes on 06-MAY-2019. There was previous temperature excursion reported as 31.28 Fahrenheit (F) for a time frame of 5 hours and 7 minutes on 03-MAY-2019, 32.68 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019, 31.26 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the four reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004979: US-009507513-1905USA005070: US-009507513-1905USA005068:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On 06-MAY-2019, the patient was vaccinated with improperly stored hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose, frequency, route of administration and anatomical location were unknown) (lot # R034340 and expiry date 23-NOV-2019) for prophylaxis (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 35.72 Fahrenheit (F) for a time frame of 5 hours and 5 minutes on 06-MAY-2019. There was previous temperature excursion reported as 31.28 Fahrenheit (F) for a time frame of 5 hours and 7 minutes on 03-MAY-2019, 32.68 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019, 31.26 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the four reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004979: US-009507513-1905USA005068: US-009507513-1905USA005069:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; a patient was administered a dose of VARIVAX that was improperly stored; This spontaneous report as received from a nurse prescriber refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 07-MAY-2019 the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R019235, expiry date: 04-JUL-2019) subcutaneously for prophylaxis.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of 44.4 degree Fahrenheit (F) for 1 hour. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2019, the patient received the 1st dose of Shingrix. On 8th April 2019, 1 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported this case for herself. The patient received Shingrix in her left arm. The patient experienced diarrhea seven times at the night.  That was the only time she experienced symptoms and she did not seek medical attention for this. The patient consented to follow up.