chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 6 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 27-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 15 month old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 18-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 18 month old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (dose, route, lot and expiration date unknown) for prophylaxis. The details of the storage were two occurrences when the temperature of the freezer reached 29 Fahrenheit degree for 30 minutes on each of the two occasions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1701USA001058: US-009507513-1612USA011816.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot and expiration date unknown) for prophylaxis. The details of the storage were two occurrences when the temperature of the freezer reached 29 Fahrenheit degree for 30 minutes on each of the two occasions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.; Sender's Comments: US-009507513-1612USA011816: US-009507513-1701USA001057:
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site pain, Rash, Rash pruritic
Clinical narrative: Right arm pain in injection site immediately after administered with an itchy rash. Progressively worsened by spreading to Right side of neck, chest and back.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Altered state of consciousness, Blood alcohol, Computerised tomogram head, Drug screen, Fall
Clinical narrative: Pt was sitting on exam table. Received MENACTRA first in (L) arm then TRUMENBA in (R) arm. Right after 2nd vaccine episode of syncope causing Pt to fall onto exam room floor, striking head-leading to altered level of consciousness. Transported via squad to ED.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Full blood count, Haemoglobin, Head injury, Metabolic function test, Syncope
Clinical narrative: Pt was sitting on exam table. Received MENACTRA first in (L) arm then TRUMENBA in (R) arm. Right after 2nd vaccine episode of syncope causing Pt to fall onto exam room floor, striking head-leading to altered level of consciousness. Transported via squad to ED.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urine analysis
Clinical narrative: Pt was sitting on exam table. Received MENACTRA first in (L) arm then TRUMENBA in (R) arm. Right after 2nd vaccine episode of syncope causing Pt to fall onto exam room floor, striking head-leading to altered level of consciousness. Transported via squad to ED.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization coordinator 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 an unknown day in December 2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K002528, expiration date: 18-FEB-2016) (dose, route of administration and injection site were not provided). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 51.1 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The patient's concurrent conditions included hypertension, neck issue with bones and joints and hyperlipidaemia. No information regarding the patient's drug reactions or allergies was provided. On 29-NOV-2016, the patient was vaccinated with ZOSTAVAX subcutaneously, injection, lot # L040445, expiration date 15-JAN-2017 (dose was not reported). On the same day, she received steroid shot (not otherwise specified) for neck issue with bones and joints. Concomitant therapies included ibandronate sodium (BONIVA) 150 mg. On an unknown date in 2016, the patient experienced tingling along spine and feet. The had no visible rash. No treatment was given for the adverse event. No product quality complaint was involved. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified number of patients (reported as about 15) of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M032493, expiration date 06-JUL-2018 for prophylaxis (dose, and route were not reported). No adverse effect reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions /allergies and concomitant medication were not provided. On 24-MAY-2016, the patient was inadvertently vaccinated with and expired dose of PNEUMOVAX 23, expiration date reported as 05-MAY-2016 (strength, dose, route of administration and lot # were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 21-SEP-2016, the patients received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 16 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 20-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 19-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 19-DEC-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 27-SEP-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 21-SEP-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # L050956 with expiry date on 17-DEC-2017; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 15-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 26-SEP-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # L050956 with expiry date on 17-DEC-2017; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:Original Case : 1610USA004609.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 29-SEP-2016, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # L050956 with expiry date on 17-DEC-2017; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported.  This is one of several cases received from the same reporter.   Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA010748: US-009507513-1610USA004609:Original Case : 1610USA004609
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 11-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA004609:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 15-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA004609:
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 18 month old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 16-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA004609:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 18-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA004609:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse who reported that multiple unspecified patients with an unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with multiple doses of improperly stored of multiple doses of PNEUMOVAX 23 Lot # L048265, exp. 10-JUN-2017 (route, anatomical location and dose were not reported) for prophylaxis. No adverse effects were reported.  No other information was provided. Temperature excursion was 33.1 F for 90 minutes as per data logger. As of 27-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA001215: US-009507513-1701USA001216: US-009507513-1610USA006216:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse who reported that multiple unspecified patients with an unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with multiple doses of improperly stored of multiple doses of VAQTA Lot # L045713, expiration date: 14-JAN-2017 (route, anatomical location and dose were not reported) for prophylaxis.  No adverse effects were reported.  No other information was provided. Temperature excursion was 33.1 F for 90 minutes as per data logger. As of 27-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA001214: US-009507513-1610USA006216: US-009507513-1701USA001216:
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report received from a Health Professional via MedImmune representative concerns, female patient. Patient received unknown FluMist Quadrivalent (influenza virus vaccine live, intranasal) on an unknown date. HCP reported that her daughter had flu. The outcome of flu was unknown. The report was considered to be non-serious by company physician.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Abasia, Cellulitis, Chills, Decreased appetite, Dehydration
Clinical narrative: I started getting a headache which eventually led to fever of 101, fatigue, chills, diarrhea, nauseated, vomiting, left arm where I received was beginning to turn red (redness in entire arm) and I was in a lot of pain, and I could not even walk had lots of pain in my legs and whole body. I could not move my left arm due to swelling and redness (turned to cellulitis). I felt paralyzed on the left side where I got my flu and pneuomonia shots. Dehydration. No appetite. Extreme pain.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Hemiplegia
Clinical narrative: I started getting a headache which eventually led to fever of 101, fatigue, chills, diarrhea, nauseated, vomiting, left arm where I received was beginning to turn red (redness in entire arm) and I was in a lot of pain, and I could not even walk had lots of pain in my legs and whole body. I could not move my left arm due to swelling and redness (turned to cellulitis). I felt paralyzed on the left side where I got my flu and pneuomonia shots. Dehydration. No appetite. Extreme pain.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Nausea, Pain, Pain in extremity
Clinical narrative: I started getting a headache which eventually led to fever of 101, fatigue, chills, diarrhea, nauseated, vomiting, left arm where I received was beginning to turn red (redness in entire arm) and I was in a lot of pain, and I could not even walk had lots of pain in my legs and whole body. I could not move my left arm due to swelling and redness (turned to cellulitis). I felt paralyzed on the left side where I got my flu and pneuomonia shots. Dehydration. No appetite. Extreme pain.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia, Urinary tract infection, Vomiting
Clinical narrative: I started getting a headache which eventually led to fever of 101, fatigue, chills, diarrhea, nauseated, vomiting, left arm where I received was beginning to turn red (redness in entire arm) and I was in a lot of pain, and I could not even walk had lots of pain in my legs and whole body. I could not move my left arm due to swelling and redness (turned to cellulitis). I felt paralyzed on the left side where I got my flu and pneuomonia shots. Dehydration. No appetite. Extreme pain.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Neuralgia, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: Parson's Turner Syndrome, numbness and pain in brachial plexus right side.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Acute kidney injury, Blood bilirubin increased, Blood creatinine increased, Blood pressure decreased, Blood smear test normal
Clinical narrative: Time of onset: unknown; flu-like symptoms with myalgias, achiness and intermittent fever up to 102 F. Malaise, chills, and headache started on 12/24/2016; patient unable to eat or drink much, diarrhea started on 12/26/2016, Presented to the ED at 1217 PM hypotensive, Scr 3.07, T bili 2.7; patient admitted, seen by Infectious Disease physician, Internal Medicine, and critical care/pulmonary physicians; given IV fluid - responded to fluids initially; c. diff negative, fever, decrease BP and diarrhea persisted; thrombocytopenic, cefepime and steroids administered (x one dose each); thought to be possible vicerotropic yellow fever reaction -  developed metabolic acidosis, acute kidney injury, likely acute tubular necrosis on CKD stage 3, patient intubated, PEA arrest on 12/28/2016, quick return of circulation with ACLS, pressors restarted, emergent HD; platelets now 23, on bicarbonate for acidosis; mild central pulmonary congestion, peripheral blood smear done, no hemolysis on smear, not suggestive of microangiopathic process, now jaundiced, intubated and on pressors; 12/29/2016 multiorgan failure persisted, developed sinus tachycardia,started on amiodarone for HR and rhythm control,albumin started to support BP.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Cardiac arrest, Chills, Chronic kidney disease, Clostridium test negative, Diarrhoea
Clinical narrative: Time of onset: unknown; flu-like symptoms with myalgias, achiness and intermittent fever up to 102 F. Malaise, chills, and headache started on 12/24/2016; patient unable to eat or drink much, diarrhea started on 12/26/2016, Presented to the ED at 1217 PM hypotensive, Scr 3.07, T bili 2.7; patient admitted, seen by Infectious Disease physician, Internal Medicine, and critical care/pulmonary physicians; given IV fluid - responded to fluids initially; c. diff negative, fever, decrease BP and diarrhea persisted; thrombocytopenic, cefepime and steroids administered (x one dose each); thought to be possible vicerotropic yellow fever reaction -  developed metabolic acidosis, acute kidney injury, likely acute tubular necrosis on CKD stage 3, patient intubated, PEA arrest on 12/28/2016, quick return of circulation with ACLS, pressors restarted, emergent HD; platelets now 23, on bicarbonate for acidosis; mild central pulmonary congestion, peripheral blood smear done, no hemolysis on smear, not suggestive of microangiopathic process, now jaundiced, intubated and on pressors; 12/29/2016 multiorgan failure persisted, developed sinus tachycardia,started on amiodarone for HR and rhythm control,albumin started to support BP.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Endotracheal intubation, Headache, Hypophagia, Hypotension, Influenza like illness
Clinical narrative: Time of onset: unknown; flu-like symptoms with myalgias, achiness and intermittent fever up to 102 F. Malaise, chills, and headache started on 12/24/2016; patient unable to eat or drink much, diarrhea started on 12/26/2016, Presented to the ED at 1217 PM hypotensive, Scr 3.07, T bili 2.7; patient admitted, seen by Infectious Disease physician, Internal Medicine, and critical care/pulmonary physicians; given IV fluid - responded to fluids initially; c. diff negative, fever, decrease BP and diarrhea persisted; thrombocytopenic, cefepime and steroids administered (x one dose each); thought to be possible vicerotropic yellow fever reaction -  developed metabolic acidosis, acute kidney injury, likely acute tubular necrosis on CKD stage 3, patient intubated, PEA arrest on 12/28/2016, quick return of circulation with ACLS, pressors restarted, emergent HD; platelets now 23, on bicarbonate for acidosis; mild central pulmonary congestion, peripheral blood smear done, no hemolysis on smear, not suggestive of microangiopathic process, now jaundiced, intubated and on pressors; 12/29/2016 multiorgan failure persisted, developed sinus tachycardia,started on amiodarone for HR and rhythm control,albumin started to support BP.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Jaundice, Life support, Malaise, Metabolic acidosis, Multiple organ dysfunction syndrome
Clinical narrative: Time of onset: unknown; flu-like symptoms with myalgias, achiness and intermittent fever up to 102 F. Malaise, chills, and headache started on 12/24/2016; patient unable to eat or drink much, diarrhea started on 12/26/2016, Presented to the ED at 1217 PM hypotensive, Scr 3.07, T bili 2.7; patient admitted, seen by Infectious Disease physician, Internal Medicine, and critical care/pulmonary physicians; given IV fluid - responded to fluids initially; c. diff negative, fever, decrease BP and diarrhea persisted; thrombocytopenic, cefepime and steroids administered (x one dose each); thought to be possible vicerotropic yellow fever reaction -  developed metabolic acidosis, acute kidney injury, likely acute tubular necrosis on CKD stage 3, patient intubated, PEA arrest on 12/28/2016, quick return of circulation with ACLS, pressors restarted, emergent HD; platelets now 23, on bicarbonate for acidosis; mild central pulmonary congestion, peripheral blood smear done, no hemolysis on smear, not suggestive of microangiopathic process, now jaundiced, intubated and on pressors; 12/29/2016 multiorgan failure persisted, developed sinus tachycardia,started on amiodarone for HR and rhythm control,albumin started to support BP.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Myalgia, Pain, Platelet count decreased, Pulmonary congestion, Pulseless electrical activity
Clinical narrative: Time of onset: unknown; flu-like symptoms with myalgias, achiness and intermittent fever up to 102 F. Malaise, chills, and headache started on 12/24/2016; patient unable to eat or drink much, diarrhea started on 12/26/2016, Presented to the ED at 1217 PM hypotensive, Scr 3.07, T bili 2.7; patient admitted, seen by Infectious Disease physician, Internal Medicine, and critical care/pulmonary physicians; given IV fluid - responded to fluids initially; c. diff negative, fever, decrease BP and diarrhea persisted; thrombocytopenic, cefepime and steroids administered (x one dose each); thought to be possible vicerotropic yellow fever reaction -  developed metabolic acidosis, acute kidney injury, likely acute tubular necrosis on CKD stage 3, patient intubated, PEA arrest on 12/28/2016, quick return of circulation with ACLS, pressors restarted, emergent HD; platelets now 23, on bicarbonate for acidosis; mild central pulmonary congestion, peripheral blood smear done, no hemolysis on smear, not suggestive of microangiopathic process, now jaundiced, intubated and on pressors; 12/29/2016 multiorgan failure persisted, developed sinus tachycardia,started on amiodarone for HR and rhythm control,albumin started to support BP.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Pyrexia, Renal tubular necrosis, Sinus tachycardia, Thrombocytopenia
Clinical narrative: Time of onset: unknown; flu-like symptoms with myalgias, achiness and intermittent fever up to 102 F. Malaise, chills, and headache started on 12/24/2016; patient unable to eat or drink much, diarrhea started on 12/26/2016, Presented to the ED at 1217 PM hypotensive, Scr 3.07, T bili 2.7; patient admitted, seen by Infectious Disease physician, Internal Medicine, and critical care/pulmonary physicians; given IV fluid - responded to fluids initially; c. diff negative, fever, decrease BP and diarrhea persisted; thrombocytopenic, cefepime and steroids administered (x one dose each); thought to be possible vicerotropic yellow fever reaction -  developed metabolic acidosis, acute kidney injury, likely acute tubular necrosis on CKD stage 3, patient intubated, PEA arrest on 12/28/2016, quick return of circulation with ACLS, pressors restarted, emergent HD; platelets now 23, on bicarbonate for acidosis; mild central pulmonary congestion, peripheral blood smear done, no hemolysis on smear, not suggestive of microangiopathic process, now jaundiced, intubated and on pressors; 12/29/2016 multiorgan failure persisted, developed sinus tachycardia,started on amiodarone for HR and rhythm control,albumin started to support BP.
Age: 73.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Death, Injection site infection
Clinical narrative: Time of onset: unknown; flu-like symptoms with myalgias, achiness and intermittent fever up to 102 F. Malaise, chills, and headache started on 12/24/2016; patient unable to eat or drink much, diarrhea started on 12/26/2016, Presented to the ED at 1217 PM hypotensive, Scr 3.07, T bili 2.7; patient admitted, seen by Infectious Disease physician, Internal Medicine, and critical care/pulmonary physicians; given IV fluid - responded to fluids initially; c. diff negative, fever, decrease BP and diarrhea persisted; thrombocytopenic, cefepime and steroids administered (x one dose each); thought to be possible vicerotropic yellow fever reaction -  developed metabolic acidosis, acute kidney injury, likely acute tubular necrosis on CKD stage 3, patient intubated, PEA arrest on 12/28/2016, quick return of circulation with ACLS, pressors restarted, emergent HD; platelets now 23, on bicarbonate for acidosis; mild central pulmonary congestion, peripheral blood smear done, no hemolysis on smear, not suggestive of microangiopathic process, now jaundiced, intubated and on pressors; 12/29/2016 multiorgan failure persisted, developed sinus tachycardia,started on amiodarone for HR and rhythm control,albumin started to support BP.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling, began 12 hours after injection.
Age: 24.0
Sex: M
Vaccine: FLU4, HEP, MMR
Symptoms: Rash
Clinical narrative: R upper arm and bilateral knee rash.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Alopecia totalis, Pityriasis rosea
Clinical narrative: Pityriasis Rosea; Alopecia Totalis.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of GARDASIL lot # L033347, expiration date 23-JUL-2017 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. Data logger was not used and there were no prior excursions. This is one of several reports received from the same reporter. Follow-up information has been received on 16-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA004014: MERCK 1610USA013021:Mfr number.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This solicited report was received from a 67 year old male patient reporting on himself, as part of a market research program conducted by Research Group. The patient's concurrent conditions included diabetes and bypass (12 years ago). The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for shingles prophylaxis. On an unknown date, it was reported that the patient's arm was sore/aching the day after getting the shot and got a little red at the injection site. The outcome of the event was reported as recovered on an unspecified date in MAY 2016 (also reported as gone after 2 days).  The action taken with ZOSTAVAX was reported as not applicable. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site cellulitis
Clinical narrative: This spontaneous report was received from a 65 year old retired registered female nurse, who refers to herself. The patient's pertinent medical history included seasonal allergies and chronic sinusitis, she was also allergic to penicillin, tetanus and unspecified sulfa drugs. In approximately 1980 (reported as 36 years ago), she received a tetanus shot. A few hours after administration (approximately in 1980), she experienced an itchy rash all over the body similar to poison ivy. The nurse took oral diphenhydramine (BENADRYL reported as BENEDRYL) but the symptoms did not recover. She went to the doctor's office and received a cortisone shot and oral cortisone (manufacturer unknown) to treat the reaction. The nurse reported that the reaction took several days to clear up. On an unknown date in approximately 2013 (reported as 2 to 3 years ago), the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (reported as shingles vaccine) injection, in arm (dose, route of administration, lot# and expiration date were not reported), for shingles prevention. Concomitant therapies included fluticasone propionate (FLONASE), azelastine hydrochloride (ASTELIN), ezetimibe (ZETIA), lisinopril (+) hydrochlorothiazide (manufacturer unknown), fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), alprazolam (XANAX), aspirin (manufacturer unknown) and ascorbic acid (VITAMIN C). On an unknown date after the vaccination, the patient experienced cellulitis in the arm where the vaccine was administrated. The nurse went to the doctor and was given an azithromycin (ZITHROMAX Z-PAK) to treat the infection. Lab diagnostic studies were not performed. Product quality complaint (PQC) was not involved. The outcome of the event was reported as recovered on an unspecified date, about a week later. The relatedness between the event of cellulitis and suspect vaccine was not provided. Upon internal review, the event of cellulitis was determined to be medically significant.  Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 26-SEP-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M010478 with expiration date 01-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 17 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 15-SEP-2016, the patients received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 04-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609.