chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Monocyte count decreased, Monocyte percentage, Nausea, Neck pain, Neutrophil count increased
Clinical narrative: 19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Neutrophil percentage increased, Pain, Photophobia, Platelet count normal, Polymerase chain reaction
Clinical narrative: 19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Prothrombin time prolonged, Pyrexia, Red blood cell count normal, Red cell distribution width normal, Scab
Clinical narrative: 19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Secretion discharge, Skin lesion, Staphylococcus test, White blood cell count increased
Clinical narrative: 19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Back pain, Blood chloride decreased, Blood culture negative, Blood phosphorus decreased, Chills
Clinical narrative: 19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Headache, Injection site rash, Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise
Clinical narrative: 19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Mean platelet volume increased, Nausea, Neck pain, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: 19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Pain, Photophobia, Progressive vaccinia, Pyrexia, Scab
Clinical narrative: 19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Secretion discharge, Skin lesion, Staphylococcus test negative
Clinical narrative: 19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Death, Headache, Intracranial aneurysm, Loss of consciousness, Vomiting
Clinical narrative: Vaccines given 7/26. 7/30 pt awoke with severe headache and vomiting. Went unconscious. Found to have had a cerebellar aneurysm. Pt died 7/31.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Cardiac arrest
Clinical narrative: Pt received MMR 7/29. 8/5/16 presented to ER in asystole.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified multiple patients of unknown age and gender. On unknown dates unspecified number of improperly stored GARDASIL 9 (lot# M011117, expiration date 07-DEC-2017 was given to the multiple unspecified patients. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one several reports received from the same source. Additional information not expected as there is no consent to contact the physician.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt received INFLUENZA in right deltoid, PNEUMOVAX in left deltoid. Provider noted reaction in right arm. Requested ADR be filed to PNEUMOVAX. Redness, swelling, warm to the touch. Diphenhydramine 1 tab at bedtime.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 08-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 15-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 04-AUG-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 05-AUG-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age an gender. On 08-AUG-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received form the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 01-AUG-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified multiple patients of unknown age and gender. on unknown date unspecified number of improperly stored M-M-R II (lot# reported as L036851, therapy type rHA, expiration date 23-SEP-2017) was given to the multiple unspecified patients. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 11-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 19-JUL-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Echocardiogram normal, Joint stiffness, Liver function test normal, Musculoskeletal discomfort
Clinical narrative: 6/5/16 Patient developed shoulder pain, knee discomfort/tightness. 6/15/16 Joint pains spread and arm and leg edema developed. Amlodipine stopped, HCTZ increased, then stopped. Furosemide started. 7/5/16 Rheum eval more labs. Knee fluid aspirated since then patient had also seen a hand specialist for carpal tunnel, infectious disease and renal specialists. Serum sickness is diagnosis. Not fully recovered yet but improving on steroids.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Oedema peripheral, Renal function test normal, Rheumatoid factor, Serum sickness
Clinical narrative: 6/5/16 Patient developed shoulder pain, knee discomfort/tightness. 6/15/16 Joint pains spread and arm and leg edema developed. Amlodipine stopped, HCTZ increased, then stopped. Furosemide started. 7/5/16 Rheum eval more labs. Knee fluid aspirated since then patient had also seen a hand specialist for carpal tunnel, infectious disease and renal specialists. Serum sickness is diagnosis. Not fully recovered yet but improving on steroids.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Ultrasound Doppler normal, Urine analysis normal
Clinical narrative: 6/5/16 Patient developed shoulder pain, knee discomfort/tightness. 6/15/16 Joint pains spread and arm and leg edema developed. Amlodipine stopped, HCTZ increased, then stopped. Furosemide started. 7/5/16 Rheum eval more labs. Knee fluid aspirated since then patient had also seen a hand specialist for carpal tunnel, infectious disease and renal specialists. Serum sickness is diagnosis. Not fully recovered yet but improving on steroids.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 21-JUL-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dyskinesia, Generalised tonic-clonic seizure, Laboratory test normal
Clinical narrative: Patient hadttonic-clonic seizure for about 10 seconds, 10 minutes after vaccines, then continual with jerk, movements for 30 minutes
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash at and around deltoid muscle.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Rash at and around deltoid muscle.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 18-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Malaise, Muscle tightness, Posture abnormal
Clinical narrative: Mom stated patient sat down in waiting room (after vaccine administered) patient stated she did not feel well; once she sat down mom stated her body tensed up and patients head rolled back. -lasting roughly a minute.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Pain
Clinical narrative: The night patient received the vaccine she developed body aches, chills and loss of appetite. No treatment was received.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient reports high fevers following immunization and swelling/redness of arm.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified multiple patients of unknown age and gender. On unknown dates unspecified number of improperly stored M-M-R II (lot# L039551, rHA, expiration date 07-OCT-2017) was given to the multiple unspecified patients. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Unevaluable event
Clinical narrative: Patient waited for 15 mins no reactions
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 07-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Age: 62.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Herpes zoster, Injection site urticaria
Clinical narrative: Inner left arm: hives over bicep area over 36 hours. Inner right arm: Shingles developed rapidly next morning.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema, Oedema peripheral
Clinical narrative: Reaction was reported 7 days after immunization was given, was seen in clinic. Erythema, edema, edema of arm.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling/redness was reported approx. 6 days after actual immunization. Severe swelling/redness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. The patient did not have any concurrent conditions, pertinent medical history or drug reactions or allergies. On 02-AUG-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously on an unspecified arm (lot number and expiry date were not reported). Concomitant therapies included LIPITOR, ONGLYZA and losartan potassium (+) hydrochlorothiazide (manufacturer unknown). On 04-AUG-2016, the patient developed redness and warmth in a circular area around the injection site. The patient sought medical attention with the reporting pharmacist and unspecified treatment was given for the events. No laboratory diagnostic studies were performed. No product quality complain (PQC) was involved. At the reporting time, the outcome of injection site erythema and injection site warmth was reported as not recovered. The reporter did not provided a causality assessment between the events and the ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 22-JUN-2016, the patient received the first dose of ROTATEQ vial (lot # M005733 with an expiry date of 01-OCT-2017 and dose not reported) and then the second dose of vaccine on 19-JUL-2016 (lot # M005733 with an expiry date of 01-OCT-2017 and dose not reported) orally (inappropriate schedule of drug administration). No adverse event was reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. The patients' pertinent medication, drug reactions/allergies and concomitant medication were not reported. From 01-AUG-2016 to 09-AUG-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M003659 with expiration date 20-SEP-2017; dose, dose number and route were not reported). No adverse effect was reported. This is one of several reports from the same reported. Additional information has been requested.
Age: 1.92
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Hypersensitivity, Rash generalised, Vaccination complication
Clinical narrative: Received Varicella vaccine on 7/20/16. On 7/26/16 developed rash all over body. Seen by dermatologist who diagnosed with allergic reaction to varicella.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not provided. On 28-JUL-2016 the patient was vaccinated with a improperly stored dose of VARIVAX 0.5 ml, lot # L043620, expiration date 07-NOV-2017, subcutaneously (anatomical location were not provided). No other suspect or concomitant therapies were reported. Temperature: 7.7 Fahrenheit degrees. Time frame: 40 minutes. Digital data logger was involved (reported as "Yes, log tag"). No prior temperature excursions. No product quality complain was involved. The patient's twin brother was vaccinated at the same time, then, this is one of two reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting and red at injection site.
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 patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 04-AUG-2016, the patient was vaccinated with an improperly stored VARIVAX lot # M006729, expiration date 08-FEB-2018 (concentration, dose and administration route were not reported). The patient's concomitant medication was not provided. No adverse reactions were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Gait disturbance, Pain in extremity, Rash, Streptococcus test negative, Throat tightness
Clinical narrative: Woke 8A with leg pain, some difficulty walking. 730p - developed small bumps mom felt were hives, child said throat tight - given 4 tsp BENADRYL, rash resolved. Spoke with Dr 9:10p, recommended ER, mother called 911. Paramedics felt child fine. No further symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Woke 8A with leg pain, some difficulty walking. 730p - developed small bumps mom felt were hives, child said throat tight - given 4 tsp BENADRYL, rash resolved. Spoke with Dr 9:10p, recommended ER, mother called 911. Paramedics felt child fine. No further symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient over the age of 65. The patient's pertinent medical history, drug allergies and concomitant medications were unknown. Approximately on 05-AUG-2016 (reported as "about a week ago"), the patient was vaccinated with ZOSTAVAX, 1 injection, (lot#, dose and route were unknown). Approximately on 06-AUG-2016 ("1 day after"), the patient developed a big red bump, the size of a silver coin on the injection site. The outcome of the event was unknown. The patient didn't seek medical attention. Additional information is not expected since no contact details was provided.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Low grade fever, headache, raised erythematous area at site of injection (left deltoid).
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Back pain, Pain in extremity, Somnolence
Clinical narrative: On 7/22/2016 I rec'd the shingles vaccine (ZOSTAVAX) from my doctor. Starting on the 25th I became very weak had a hard time staying awake. The 26th my lower legs (from the knees down) became extremely sore. I tried to push myself and ended up with an extremely sore back for a day. Now, 8/13/2016, I am still weak, my legs are still sore.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a 29 year old female patient. There were no patient's concurrent conditions, drug reactions/allergies nor medical history. On 22-JUL-2016, the patient was vaccinated with a dose of VARIVAX subcutaneously (strength and dose were unknown). The lot number was L023587 with expiration date of 26-JUN-2016. Concomitant therapies included CEFDINIR. Subsequently, the patient performed a pregnancy test before a X-ray and, on 26-JUL-2016, she reported to her pharmacist that she was pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) were not known. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 59 year old female patient. The patient's current conditions included non-Hodgkin's lymphoma, pre diabetes and latex allergy. On 14-JUL-2016, the patient was vaccinated with ZOSTAVAX subcutaneously in unspecified arm (strength: 19400 Pre filled units, dose, # lot, dose number unspecified). Concomitant medication included lovastatin. On 15-JUL-2016, the patient developed redness, swelling and blisters at the injection site (injection site erythema, injection site swelling and injection site vesicle) following administration of ZOSTAVAX. The patient sought medical attention and visited nurse practitioner. No treatment was provided for the events. The outcome of the event injection site vesicles, injection site swelling and injection site erythema was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 12 month old patient of unknown gender. Concurrent conditions or pertinent medical history were not reported. On 11-AUG-2016, the patient was vaccinated with an extra dose of ROTATEQ (lot # M004890, expiration date: 10-NOV-2017) orally (dose and frequency were unspecified). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse, concerning about several children of unknown age and gender. The patients' pertinent medical history, allergies/drug reactions or concomitant drugs were not reported. In JUL-2016, the patients were vaccinated with improperly stored VARIVAX, strength, dose and route of administration were not provided. The nurse reported that the vaccine was exposed to a temperature of 21.9 degrees F and 6.6 degrees F during a period of 4 hours since 10:12 and that this was discovered due to a digital data logger. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old patient. In 2013 when the patient was 16 years old he was vaccinated with GARDASIL at his pediatricians office. He then did not received the second dose until April 2016 at the reporters office and then 3rd dose on 07-JUL-2016 intramuscularly. The nurse stated the patient is healthy with no known allergies and no adverse effects from the GARDASIL administration. No other information was provided. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist (R.Ph.), concerning a 64 years old male patient. The patient did not present any pertinent medical history or concurrent conditions at the time of the report. On 05-AUG-2016, the patient was vaccinated with ZOSTAVAX lot # L046896, expiration date 25-FEB-2017, 0.65 ml per subcutaneous route. Concomitant therapies were not provided. The pharmacist reported that on 08-AUG-2016, the patient went in to the pharmacy because he had developed a circular, red rash to an inch and a half above the injection site that was itchy, tender and sore. There were no diagnostic laboratory tests performed and there was no treatment given for the events. The outcome of circular red rash, itchy, tender and sore was not recovered at the time of the report. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Dizziness, Migraine, Nausea, Vomiting
Clinical narrative: Initial unsolicited report received from a pharmacist on 17 November 2015. This case involves a 43-years-old female patient who was vaccinated with a dose of Fluzone QIV (batch number: UI503AA, expiry date: 30 June 2016, dose, dose in series were not reported) intramuscularly in left IM on 16 November 2015. Illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as migraine. Concomitant medications were not reported. On 16 November 2015, four hours following the vaccination (at 20:00 hours), the patient had experienced nausea; dizziness; laid down on the floor, vomited and had migraine. The patient had previously received Fluzone QIV last year. Laboratory data and corrective treatment were not reported. On 17 November 2015 at 23:00 hours, the patient was recovered from the events. List of documents held by sender: none. Follow-up information received from a pharmacist on 21 December 2015. On 16 November 2015 at 12.49 pm the patient was vaccinated with a 0.5 ml dose of Fluzone QIV on left deltoid. Patient's medical history includes migraine, allergy to penicillin, depression, anxiety and stomach acid. On 17 November 2015 the patient was recovered.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 18 November 2015. This case involves a 06 years old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI440AB, Expiry date: 30 June 2016; dose and dose in series were not reported) intramuscularly in the left deltoid on 06 November 2015. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 06 November 2015, following the vaccination, the patient had developed injection site cellulitis (local) and area was warm about 11.5 cm x 12 cm. The patient was previously vaccinated with FLUZONE QIV last year. The patient required ER/doctor visit. Laboratory data and corrective treatment was not reported. The outcomes of the events were unknown. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Diarrhoea, Dizziness, Eye pain
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07-Dec-2015. This case involves a 65-year-old female patient, who was vaccinated with a first dose of Fluzone high dose (batch number: UI428AB, expiration date: 19-Mar-2016) via intramuscular route in left arm on 04-Dec-2015 at 6:00 P.M. It was reported that no illness at the time of vaccination, no allergies and other medical history was not reported. Patient had received Claritin 10 mg daily, Lisinopril or hydrochlorothiazide 10-12.5 daily and Synthroid 88 mcg daily as concomitant medications. On 04-Dec-2015, three hours (at 9:00 P.M) following the vaccination, the patient experienced nausea, convulsions, sore red eyes, high fever, joint aches, body aches, headache, gas, diarrhea, fatigue, throat swelling, heart palpitations, dizziness and weakness. The patient stated that she could hear heart rate banging in her head. Laboratory investigations and corrective treatments were not reported. On an unspecified date, patient recovered from all the events. Upon internal review, the case was considered to be serious due to important medical event: convulsions. List of documents held by sender: none. Sender's Comments: Convulsions are listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with the role of the vaccine. However, investigation results ruling out a concurrent infection would be helpful to further assess this case. Based on the information available, role of the vaccine cannot be assessed.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Flatulence, Headache, Nausea, Ocular hyperaemia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07-Dec-2015. This case involves a 65-year-old female patient, who was vaccinated with a first dose of Fluzone high dose (batch number: UI428AB, expiration date: 19-Mar-2016) via intramuscular route in left arm on 04-Dec-2015 at 6:00 P.M. It was reported that no illness at the time of vaccination, no allergies and other medical history was not reported. Patient had received Claritin 10 mg daily, Lisinopril or hydrochlorothiazide 10-12.5 daily and Synthroid 88 mcg daily as concomitant medications. On 04-Dec-2015, three hours (at 9:00 P.M) following the vaccination, the patient experienced nausea, convulsions, sore red eyes, high fever, joint aches, body aches, headache, gas, diarrhea, fatigue, throat swelling, heart palpitations, dizziness and weakness. The patient stated that she could hear heart rate banging in her head. Laboratory investigations and corrective treatments were not reported. On an unspecified date, patient recovered from all the events. Upon internal review, the case was considered to be serious due to important medical event: convulsions. List of documents held by sender: none. Sender's Comments: Convulsions are listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with the role of the vaccine. However, investigation results ruling out a concurrent infection would be helpful to further assess this case. Based on the information available, role of the vaccine cannot be assessed.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Palpitations, Pharyngeal oedema, Pyrexia, Seizure
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 07-Dec-2015. This case involves a 65-year-old female patient, who was vaccinated with a first dose of Fluzone high dose (batch number: UI428AB, expiration date: 19-Mar-2016) via intramuscular route in left arm on 04-Dec-2015 at 6:00 P.M. It was reported that no illness at the time of vaccination, no allergies and other medical history was not reported. Patient had received Claritin 10 mg daily, Lisinopril or hydrochlorothiazide 10-12.5 daily and Synthroid 88 mcg daily as concomitant medications. On 04-Dec-2015, three hours (at 9:00 P.M) following the vaccination, the patient experienced nausea, convulsions, sore red eyes, high fever, joint aches, body aches, headache, gas, diarrhea, fatigue, throat swelling, heart palpitations, dizziness and weakness. The patient stated that she could hear heart rate banging in her head. Laboratory investigations and corrective treatments were not reported. On an unspecified date, patient recovered from all the events. Upon internal review, the case was considered to be serious due to important medical event: convulsions. List of documents held by sender: none. Sender's Comments: Convulsions are listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with the role of the vaccine. However, investigation results ruling out a concurrent infection would be helpful to further assess this case. Based on the information available, role of the vaccine cannot be assessed.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Ataxia, Decreased eye contact, Eczema, Emotional distress
Clinical narrative: Noted significant decrease in eye contact, smiling, and vocalizations for 4 days following vaccine. Increased Moro response with difficulty calming child. Movement patterns became ataxic. Child had an excema flare on right knee, stomach, and behind ears for several days.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Speech disorder
Clinical narrative: Noted significant decrease in eye contact, smiling, and vocalizations for 4 days following vaccine. Increased Moro response with difficulty calming child. Movement patterns became ataxic. Child had an excema flare on right knee, stomach, and behind ears for several days.