chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 4-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 28-AUG-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017 and 26-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017 and 01-AUG-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1709USA012767: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1711USA003158:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 4-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 05-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017, 26-JUL-2017 and 05-SEP-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017 and 01-AUG-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003158: US-009507513-1709USA012767:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. From 25-OCT-2017 through 07-NOV-2017,  the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot # N000175, expiration date 20-SEP-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. The temperature involved was 35 degrees Fahrenheit for 16 hours. There was no previous temperature reported, and a data logger was not involved.; Sender's Comments: US-009507513-1711USA010360: Original Case : 1711USA003934 US-009507513-1711USA010361: Original Case : 1711USA003934.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Impaired work ability, Injected limb mobility decreased, Injection site pain, Local reaction
Clinical narrative: Right arm pain after her PNEUMOVAX injection on November 8, 2017. Her arm was initially just sore.   By suppertime at 6:30 p.m. the pain worsened in her right shoulder. She was unable to move the right arm and needed the assistance of her daughter to help her brush her hair. She rates the pain at a 9/10 on the numeric pain scale and describes the pain as shooting with attempts at moving her arm. From the right shoulder to the right elbow the pain is sharp and constant. From the right elbow to the right wrist, the pain is different. She has tingling in her fingers and she states her hand and fingers feel cold to the touch in comparison to the left side. She also reports numbness in the right arm. She has tried ice and heat, neither helped more than the other. She has also tried ibuprofen and Icy Hot without relief. She reports disrupted sleep due to the pain. Patient is right hand dominant. Work excused provided. At this time, symptoms appear to be localized reaction to the immunization. Five day course of prednisone as prescribed. May use acetaminophen, ibuprofen or Naproxen once course of prednisone is complete. Work on range of motion of the right shoulder and arm. Exercises provided. had follow up visit on 11/15/2017 and released back to work with a restriction to not lift more than 25 lbs. and a tapering dose of prednisone given, and to follow up again in 2 weeks.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: Right arm pain after her PNEUMOVAX injection on November 8, 2017. Her arm was initially just sore.   By suppertime at 6:30 p.m. the pain worsened in her right shoulder. She was unable to move the right arm and needed the assistance of her daughter to help her brush her hair. She rates the pain at a 9/10 on the numeric pain scale and describes the pain as shooting with attempts at moving her arm. From the right shoulder to the right elbow the pain is sharp and constant. From the right elbow to the right wrist, the pain is different. She has tingling in her fingers and she states her hand and fingers feel cold to the touch in comparison to the left side. She also reports numbness in the right arm. She has tried ice and heat, neither helped more than the other. She has also tried ibuprofen and Icy Hot without relief. She reports disrupted sleep due to the pain. Patient is right hand dominant. Work excused provided. At this time, symptoms appear to be localized reaction to the immunization. Five day course of prednisone as prescribed. May use acetaminophen, ibuprofen or Naproxen once course of prednisone is complete. Work on range of motion of the right shoulder and arm. Exercises provided. had follow up visit on 11/15/2017 and released back to work with a restriction to not lift more than 25 lbs. and a tapering dose of prednisone given, and to follow up again in 2 weeks.
Age: 0.92
Sex: F
Vaccine: FLU3
Symptoms: Crying, Decreased appetite, Irritability, Urine output decreased, Vomiting
Clinical narrative: She's been vomiting every day or every other day since receiving the flu shot, at first she had a very good appetite but now she doesn't. It happens early morning from 1 AM - 4 PM. She's throwing up WHILE ASLEEP. She doesn't wake up unless I put her in a tub full of water or I put water on her. She also hardly ever pees, only maybe once a day, the rest is defecation. She's very irritable now and cries much more often than usual also.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray abnormal, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: At 11:00 pm I began having severe chest pain. The pain was so severe I could not draw a deep breath. I went to the ER.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Electrocardiogram, Lung infection
Clinical narrative: At 11:00 pm I began having severe chest pain. The pain was so severe I could not draw a deep breath. I went to the ER.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Hyperhidrosis, Nausea, Visual impairment
Clinical narrative: Patient denoted altered vision (seeing red light briefly), profuse sweating [arms, chest, and face], and feeling nauseous.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: Pt starting having arm pain when she pressed the site on 11/9/17 or 11/10/17. She also felt the pain when lifting something heavy or lifting her arm up.
Age: 71.0
Sex: M
Vaccine: FLUR3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient has been experiencing redness and swelling from the elbow up for almost 4 days. Patient is also stating they have pain in the left arm as well. Patient was concerned since it has been almost 4 days. Advised patient they may want to put some ice on their arm to decrease some of the swelling and that they may want to take some TYLENOL or ibuprofen to help with some pain relief. I also advised patient to contact doctor on Monday if it has not gotten better.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to an adult patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 21-AUG-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB pediatric formulation, intramuscular injection, lot # L044707, expiration date 06-OCT-2018 (also reported as 21-AUG-2017) for prophylaxis. On 02-OCT-2017, the patient was vaccinated with the second dose of RECOMBIVAX HB pediatric formulation, intramuscular injection, lot # L044707, expiration date 06-OCT-2018 (also reported as 21-AUG-2017) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 27-OCT-2017, the patient received an improperly dose of VARIVAX lot # N017397, expiration date 07-JUN-2019 for prophylaxis (dose, anatomical location and route of administration were not reported) reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 3 hours and 41 minutes. The vaccine underwent a previous temperature excursion between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 1 hour and 40 minutes. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter; the additional report was considered as non-valid as there were no patient identifiers.; Sender's Comments: US-009507513-1711USA010765:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 1 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (concentration, route of administration, lot# and expiration date were not reported). On an unknown date, approximately one year after the first dose, the patient was vaccinated with the second dose of GARDASIL 9 (concentration, route of administration, lot# and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist ,refers to a patient of unknown age and gender. No information on the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX injection, lot # N020942, expiry date: 26-OCT-2018, for prophylaxis (route of administration was not reported). It was reconstituted with properly stored sterile diluent (lot# N016189, expiry date: 13-AUG-2019). Administered dose of vaccine underwent the 6- hours temperature excursion 6 Fahrenheit degrees to 14 Fahrenheit degrees (10 Fahrenheit degrees). There was no previous temperature excursions noted. Digital data logger was involved. No adverse effects reported. Product quality complaint was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730: US-009507513-1711USA000697:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721:  US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730: US-009507513-1711USA000697:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA000697: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 2 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA000697: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA000697: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA000697: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA000697: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 5 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA000697: US-009507513-1711USA010729: US-009507513-1711USA010730:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes. A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA000697: US-009507513-1711USA010730.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA000697:
Age: 70.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient has been experiencing redness and swelling from the elbow up for almost 4 days. Patient is also stating they have pain in the left arm as well. Patient was concerned since it has been almost 4 days.  Advised patient they may want to put some ice on their arm to decrease some of the swelling and that they may want to take some Tylenol or ibuprofen to help with some pain relief. I also advised patient to contact doctor on Monday if it has not gotten better.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Medication: Prednisone 20MG.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Mass, Skin swelling, Skin warm
Clinical narrative: Hard lump formed under skin. Red, swollen skin. Very hot to touch. Swollen, red area spread to about 4 in in diameter, in an oblong shape.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain, Swelling, Vaccination site infection
Clinical narrative: PATIENT'S SPOUSE REPORTED THAT THE AREA OF THE VACCINCATION HAD BECOME INFECTED. Patient WAS TAKEN TO THE HOSPITAL AND TREATED WITH AN ANTIBIOTIC. SHE REPORTED PAIN, REDNESS, AND SWELLING 24 HRS POST VACCINATION ADMINISTRATION.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient states that his arm immediately started to hurt after receiving the vaccine. He says his whole shoulder hurts, and it is hard for him to lift his arm to shoulder height. He says he wakes up at night, because he rolls onto his left arm and the pain wakes him up. The pain has not changed or subsided since the end of September. Patient was recently hospitalized for an undisclosed reason, and he forgot to ask about it in the hospital.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Injected limb mobility decreased, Injection site reaction, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient presented to pharmacy 11.20.17 with upper arm pain and complaint of range of movement loss. She could only raise her left arm to a certain point. She mentioned that she thought the immunization location was higher up on the arm than she had been accustomed to. I recommended that she consult with her physician or similar caregiver (express/urgent care) and to please keep me informed as to what was happening and if she got any suggestions/recommendations related to the pain/discomfort. She presented to the pharmacy a second time on 11.24.17 and informed me that she had her arm checked and was told that she had a bacterial infection in her upper arm (between the left shoulder and elbow) and was prescribed cephalexin and prednisone. She has a regular visit with her provider coming up and will keep us abreast of the situation.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Electromyogram, Muscle contractions involuntary, Nervous system disorder, Nuclear magnetic resonance imaging brain
Clinical narrative: Some time after receiving a flu vaccine in October 2015 I started having fasciculations all over my body. Initially i did not know what caused it, and i did not relate it to anything. I have seen a neurologist and had some testing that apparently were normal. After the flu shot in 2016 my fasciculations got worse/ much more frequent. After worsening in my condition I had an EMG test as well. I was diagnosed with benign fasciculation syndrome. I believe  that my neurological condition could be an adverse reaction to the Flu vaccine.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging spinal
Clinical narrative: Some time after receiving a flu vaccine in October 2015 I started having fasciculations all over my body. Initially i did not know what caused it, and i did not relate it to anything. I have seen a neurologist and had some testing that apparently were normal. After the flu shot in 2016 my fasciculations got worse/ much more frequent. After worsening in my condition I had an EMG test as well. I was diagnosed with benign fasciculation syndrome. I believe  that my neurological condition could be an adverse reaction to the Flu vaccine.
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 7 years old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 22-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766:  US-009507513-1709USA012768:
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 11 years old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 22-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
Age: 1.25
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 19 months old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported. On 23-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: The shot was painful when administered. The left arm is now unusually weak and sometimes painful to do things like removing a shirt or lifting anything with that arm. My doctor says it is a rotator cuff injury and now I will need some physical therapy and time for it to get better.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus generalised, Urticaria
Clinical narrative: Pt started having symptoms of puffy hands on both sides on Sunday evening (11-12-17), which worsened on Monday morning. She also started having hives and itching. She called her doctor who prescribed her low dose prednisone for 5 days and recommended OTC allegra/BENADRYL as needed. As of today (11-24-17), she is still experiencing hives and itching all over.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site mass, Injection site pain
Clinical narrative: PATIENT CAME TO PHARMACY 11/24/2017 AND STATED HIS ARM IS STILL HURTING FROM HIS SHOT GIVEN IN SEPTEMBER. HE SAID IT DID NOT SWELL OR WASN'T RED AT THE TIME OF INJECTION BUT IT HURT. HE HAS A SMALL LUMP UNDER THE SKIN AT THE SITE HE SAID THE INJECTION WAS GIVEN.  HE SAID IT HURTS TO PUSH ON THE LUMP.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: Patient had 6 inch diameter rash on right arm at site of injection, upper arm was swollen. Patient reported rash appeared on 11/16/17 but didnt not come into pharmacy until 11/24/17. No treatment provided, recommended to apply cold pack to help with swelling.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain
Clinical narrative: Patient came into the pharmacy over a month and a half later complaining that she still had a bruise and her arm still hurt in the area she had received the vaccination.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Blood test normal, Diet refusal, Dyskinesia, Febrile convulsion
Clinical narrative: After my son received the shot that whole night he was not himself. He began running a high fevers, kept jerking, and would not eat or drink anything. He kept complaining that his legs are hurting and struggled to walk. His fever continued and only came down with medicine. I was alternating TYLENOL and Ibuprofen for fevers. His fevers were a constant 105-106. On Saturday night I checked his temperature and it was 106 I gave him Ibuprofen and he fell asleep so I laid him down were me and my husband were sitting so we can keep a close eye on him because he kept jerking and wasn't himself at all. Within about 15-20 mins later my son woke up and said "mommy" I said we are right here sweetheart, he lifted his head and his head fell back on to the pillow and went unconscious. My husband stayed with him trying everything to get him back up and I ran and grabbed my phone to call 911. EMTs arrived not too long after that and he was taken into hospital. Doctors stated that he had a febrile seizure, they test him for flu and a lot of virus and all test came back negative. The hospital also did a urine test and that as well came back negative. Prior to this my son has never had any types of seizure. After discharge my son continued to have fevers. On Monday I took my son in to his PCP due to the fevers, not eating, and not being himself. He was test again for all types of viruses, flu, and strep all came back negative. On Tuesday I was told by his PCP to take him into hospital to be monitored. Once again at hospital they tested his urine that too showed nothing. They also did more testing and blood work and all came back negative. He received in the hospital IV fluids, TYLENOL, and MOTRIN.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Influenza virus test negative, Injection site pain, Loss of consciousness, Pain in extremity
Clinical narrative: After my son received the shot that whole night he was not himself. He began running a high fevers, kept jerking, and would not eat or drink anything. He kept complaining that his legs are hurting and struggled to walk. His fever continued and only came down with medicine. I was alternating TYLENOL and Ibuprofen for fevers. His fevers were a constant 105-106. On Saturday night I checked his temperature and it was 106 I gave him Ibuprofen and he fell asleep so I laid him down were me and my husband were sitting so we can keep a close eye on him because he kept jerking and wasn't himself at all. Within about 15-20 mins later my son woke up and said "mommy" I said we are right here sweetheart, he lifted his head and his head fell back on to the pillow and went unconscious. My husband stayed with him trying everything to get him back up and I ran and grabbed my phone to call 911. EMTs arrived not too long after that and he was taken into hospital. Doctors stated that he had a febrile seizure, they test him for flu and a lot of virus and all test came back negative. The hospital also did a urine test and that as well came back negative. Prior to this my son has never had any types of seizure. After discharge my son continued to have fevers. On Monday I took my son in to his PCP due to the fevers, not eating, and not being himself. He was test again for all types of viruses, flu, and strep all came back negative. On Tuesday I was told by his PCP to take him into hospital to be monitored. Once again at hospital they tested his urine that too showed nothing. They also did more testing and blood work and all came back negative. He received in the hospital IV fluids, TYLENOL, and MOTRIN.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Streptococcus test negative, Urine analysis normal, Viral test negative
Clinical narrative: After my son received the shot that whole night he was not himself. He began running a high fevers, kept jerking, and would not eat or drink anything. He kept complaining that his legs are hurting and struggled to walk. His fever continued and only came down with medicine. I was alternating TYLENOL and Ibuprofen for fevers. His fevers were a constant 105-106. On Saturday night I checked his temperature and it was 106 I gave him Ibuprofen and he fell asleep so I laid him down were me and my husband were sitting so we can keep a close eye on him because he kept jerking and wasn't himself at all. Within about 15-20 mins later my son woke up and said "mommy" I said we are right here sweetheart, he lifted his head and his head fell back on to the pillow and went unconscious. My husband stayed with him trying everything to get him back up and I ran and grabbed my phone to call 911. EMTs arrived not too long after that and he was taken into hospital. Doctors stated that he had a febrile seizure, they test him for flu and a lot of virus and all test came back negative. The hospital also did a urine test and that as well came back negative. Prior to this my son has never had any types of seizure. After discharge my son continued to have fevers. On Monday I took my son in to his PCP due to the fevers, not eating, and not being himself. He was test again for all types of viruses, flu, and strep all came back negative. On Tuesday I was told by his PCP to take him into hospital to be monitored. Once again at hospital they tested his urine that too showed nothing. They also did more testing and blood work and all came back negative. He received in the hospital IV fluids, TYLENOL, and MOTRIN.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Brachial plexopathy, Bursitis, Cervical radiculopathy, Diarrhoea, Headache
Clinical narrative: 10/31/17 0750 shot administered; headache started within 30 minutes; within 6 hours-left facial numbness/tingling, left 4th and 5th digit parasthesias, severe left arm/shoulder/neck pain; later that evening had severe generalized pain, aches, malaise and 2 loose stools 11/1/17 am-facial parasthesia resolved; severe generealized pain. malaize, continued left hand parasthesias: saw urgent care MD and diagnosed with low grade fever, lymphadenopathy impacting left brachial plexus: by 8pm that evening severe uncontrolled diarrhea started which lasted 72 hours, lost 9 lbs in first 48 hours of onset of diarrhea, diarrhea did not completely stop until 11/9/17 am. Continued LUE pain and intermittent parasthesias. 11/9/17 LUE pain increased with loss of ROM, marked weakness and decreased function 11/12/17 saw urgent care MD diagnosed as left cervical radiculopathy due to adverse reaction of influenza vaccine, started Prednisone 20mg po daily x 5 days and Gabapentin 200mg po titrate to tid.  11/21/17 saw primary MD for continued parasthesia, severe pain and decreased function of LUE-diagnosis serum sickness syndrome with brachial plexopathy and left subdeltoid bursitis as evidenced on ultrasound.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Lymphadenopathy, Malaise
Clinical narrative: 10/31/17 0750 shot administered; headache started within 30 minutes; within 6 hours-left facial numbness/tingling, left 4th and 5th digit parasthesias, severe left arm/shoulder/neck pain; later that evening had severe generalized pain, aches, malaise and 2 loose stools 11/1/17 am-facial parasthesia resolved; severe generealized pain. malaize, continued left hand parasthesias: saw urgent care MD and diagnosed with low grade fever, lymphadenopathy impacting left brachial plexus: by 8pm that evening severe uncontrolled diarrhea started which lasted 72 hours, lost 9 lbs in first 48 hours of onset of diarrhea, diarrhea did not completely stop until 11/9/17 am. Continued LUE pain and intermittent parasthesias. 11/9/17 LUE pain increased with loss of ROM, marked weakness and decreased function 11/12/17 saw urgent care MD diagnosed as left cervical radiculopathy due to adverse reaction of influenza vaccine, started Prednisone 20mg po daily x 5 days and Gabapentin 200mg po titrate to tid.  11/21/17 saw primary MD for continued parasthesia, severe pain and decreased function of LUE-diagnosis serum sickness syndrome with brachial plexopathy and left subdeltoid bursitis as evidenced on ultrasound.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Musculoskeletal disorder, Neck pain, Pain, Pain in extremity
Clinical narrative: 10/31/17 0750 shot administered; headache started within 30 minutes; within 6 hours-left facial numbness/tingling, left 4th and 5th digit parasthesias, severe left arm/shoulder/neck pain; later that evening had severe generalized pain, aches, malaise and 2 loose stools 11/1/17 am-facial parasthesia resolved; severe generealized pain. malaize, continued left hand parasthesias: saw urgent care MD and diagnosed with low grade fever, lymphadenopathy impacting left brachial plexus: by 8pm that evening severe uncontrolled diarrhea started which lasted 72 hours, lost 9 lbs in first 48 hours of onset of diarrhea, diarrhea did not completely stop until 11/9/17 am. Continued LUE pain and intermittent parasthesias. 11/9/17 LUE pain increased with loss of ROM, marked weakness and decreased function 11/12/17 saw urgent care MD diagnosed as left cervical radiculopathy due to adverse reaction of influenza vaccine, started Prednisone 20mg po daily x 5 days and Gabapentin 200mg po titrate to tid.  11/21/17 saw primary MD for continued parasthesia, severe pain and decreased function of LUE-diagnosis serum sickness syndrome with brachial plexopathy and left subdeltoid bursitis as evidenced on ultrasound.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Pyrexia, Serum sickness, Ultrasound scan abnormal, Vaccination complication
Clinical narrative: 10/31/17 0750 shot administered; headache started within 30 minutes; within 6 hours-left facial numbness/tingling, left 4th and 5th digit parasthesias, severe left arm/shoulder/neck pain; later that evening had severe generalized pain, aches, malaise and 2 loose stools 11/1/17 am-facial parasthesia resolved; severe generealized pain. malaize, continued left hand parasthesias: saw urgent care MD and diagnosed with low grade fever, lymphadenopathy impacting left brachial plexus: by 8pm that evening severe uncontrolled diarrhea started which lasted 72 hours, lost 9 lbs in first 48 hours of onset of diarrhea, diarrhea did not completely stop until 11/9/17 am. Continued LUE pain and intermittent parasthesias. 11/9/17 LUE pain increased with loss of ROM, marked weakness and decreased function 11/12/17 saw urgent care MD diagnosed as left cervical radiculopathy due to adverse reaction of influenza vaccine, started Prednisone 20mg po daily x 5 days and Gabapentin 200mg po titrate to tid.  11/21/17 saw primary MD for continued parasthesia, severe pain and decreased function of LUE-diagnosis serum sickness syndrome with brachial plexopathy and left subdeltoid bursitis as evidenced on ultrasound.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Weight decreased
Clinical narrative: 10/31/17 0750 shot administered; headache started within 30 minutes; within 6 hours-left facial numbness/tingling, left 4th and 5th digit parasthesias, severe left arm/shoulder/neck pain; later that evening had severe generalized pain, aches, malaise and 2 loose stools 11/1/17 am-facial parasthesia resolved; severe generealized pain. malaize, continued left hand parasthesias: saw urgent care MD and diagnosed with low grade fever, lymphadenopathy impacting left brachial plexus: by 8pm that evening severe uncontrolled diarrhea started which lasted 72 hours, lost 9 lbs in first 48 hours of onset of diarrhea, diarrhea did not completely stop until 11/9/17 am. Continued LUE pain and intermittent parasthesias. 11/9/17 LUE pain increased with loss of ROM, marked weakness and decreased function 11/12/17 saw urgent care MD diagnosed as left cervical radiculopathy due to adverse reaction of influenza vaccine, started Prednisone 20mg po daily x 5 days and Gabapentin 200mg po titrate to tid.  11/21/17 saw primary MD for continued parasthesia, severe pain and decreased function of LUE-diagnosis serum sickness syndrome with brachial plexopathy and left subdeltoid bursitis as evidenced on ultrasound.
Age: 73.0
Sex: M
Vaccine: PNC, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 73 year old male patient. The patient had no illness at time of vaccination. No pre-existing physician-diagnosed allergies, birth defects, or medical conditions were reported. The Pharmacist reported that on 15-SEP-2015, the patient received a first dose of ZOSTAVAX (strength, dose, route, lot and expiration date not provided). On 27-OCT-2017 the patient was vaccinated with a second dose of ZOSTAVAX (subcutaneously, in the left arm, lot # N025565, expiration date 21-DEC-2018) for prophylaxis.  On the same date, the patient also received a dose of PREVENAR (intramuscularly, in the left arm, lot # S58702). No other concomitant medications were reported. The Pharmacist said that he was administering the ZOSTAVAX and explained that the patient might experience redness or swelling at the injection site, and at that point, the patient said it did not bother him "last time". Then, the Pharmacist finished the vaccine administration and checked the Immunization Registry (IR) and saw the patient had had a previous dose in 2015 at another pharmacy.The patient experienced no adverse event/reactions. Prescription drug treatment was not required. The patient's outcome was reported as "recovered".