chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 16-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004516: US-009507513-1704USA004517.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 21-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004467: US-009507513-1704USA004466: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004517.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 month old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 14-DEC-2016, the patient was vaccinated with the second improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant, concerning a 38 years-old pregnant female patient.The patient did not have medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 11-MAR-2017, the patient had her last menstrual period. Then, on 03-APR-2017, the patient was vaccinated with VARIVAX with lot# L043624 and expiration date of 03-NOV-2017 (dose, route of administration and anatomical location were not provided), for prophylaxis. On 07-APR-2017, the patient notified to the medical assistant that she was pregnant and it was stated that the patient was unaware of the pregnancy status when she received VARIVAX. She had made an appointment with her Obstetrics and Gynecology (OB/GYN). The patient's possible pregnancy due date would be 16-DEC-2017. No adverse effect was reported and no laboratory diagnostics studies were performed. No additional information was provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a multiple unspecified number of patient of unknown age and gender. The patients' medical history, concurrent condition, drug allergies or concomitant medications were not reported. On 12-SEP-2016, VAQTA doses were exposed to 73 degrees Fahrenheit (F) for 4 hours. On 23-NOV-2016 and 20-JAN-2017, patients were vaccinated with improperly stored doses of VAQTA injection (strength and dose were not reported) (lot # L048456, expiration date 06-APR-2016 (also reported as 25-MAY-2017)) for prophylaxis. On 01-MAR-2017, VAQTA doses were exposed to 32 F for 166 hours. 06-MAR-2017 and 10-MAR-2017, patients were vaccinated with improperly stored doses of VAQTA injection (strength and dose were not reported) (lot # L048456, expiration date 06-APR-2016 (also reported as 25-MAY-2017)) for prophylaxis. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA005263: US-009507513-1704USA005264: US-009507513-1703USA010647.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a multiple unspecified number of patient of unknown age and gender. The patients' medical history, concurrent condition, drug allergies or concomitant medications were not reported. On 06-JAN-2017, 23-JAN-2017, 30-JAN-2017 and 10-FEB-2017, patients were vaccinated with improperly stored doses GARDASIL 9 injection (strength and dose were not reported) (lot # L040054, expiration date 26-DEC-2017) for prophylaxis. According to the reporter, on 01-MAR-2017, GARDASIL 9 doses were exposed to 32 degrees Fahrenheit (F) for 166 hours. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010647: US-009507513-1704USA005264: US-009507513-1704USA005262:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a multiple unspecified number of patient of unknown age and gender. The patients' medical history, concurrent condition, drug allergies or concomitant medications were not reported. On 12-SEP-2016, ROTATEQ doses were exposed to the following temperature excursion (reported as 82): 73 degrees Fahrenheit (F) for 4 hours. On 06-JAN-2017, patients were vaccinated with improperly stored doses of ROTATEQ orally (strength and dose were not reported) (lot # L028645, expiration date 25-MAY-2017 (also reported as 06-APR-2016) for prophylaxis. According to the reporter, on 01-MAR-2017, ROTATEQ doses were exposed to the following temperature excursions (reported as 82): 32 degrees Fahrenheit (F) for 166 hours. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA005263: US-009507513-1703USA010647: US-009507513-1704USA005262.
Age: 0.17
Sex: F
Vaccine: DTAP, PNC13, RV5
Symptoms: Agitation, Crying, Diet refusal, Discomfort, Emotional distress
Clinical narrative: My daughter started crying and appeared to be very uncomfortable. Her body was very tense and she appeared to be writhing in pain. She continued like this for approximately 4 hours. She was inconsolable and refused to nurse (this was the only time in her life that this had every occurred). Eventually, after screaming and crying for several hours, she fell asleep. For the remainder of the day, when awake, she was very agitated.
Age: 0.17
Sex: F
Vaccine: DTAP, PNC13, RV5
Symptoms: Pain, Screaming, Tension
Clinical narrative: My daughter started crying and appeared to be very uncomfortable. Her body was very tense and she appeared to be writhing in pain. She continued like this for approximately 4 hours. She was inconsolable and refused to nurse (this was the only time in her life that this had every occurred). Eventually, after screaming and crying for several hours, she fell asleep. For the remainder of the day, when awake, she was very agitated.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, Redness, pain.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 03-APR-2017 from a nurse practitioner (also reported as registered nurse) regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 22-MAR-2017 the child was administered a third dose of VARIVAX (considered inappropriate schedule of vaccine administration). The dates of administration for the first and second doses of VARIVAX that the patient received were unspecified. No adverse effects were reported. Action taken was not applicable and outcome was not provided. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Brachial plexopathy, Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle atrophy
Clinical narrative: This spontaneous report was received from a physician referring to a 24 year old male patient. The patient did not have any concurrent condition, medical history, concomitant medication, drug reaction or allergy. On 14-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular (strength, dose, lot number and expiration date were not reported); on 01-SEP-2016 and on 31-MAR-2017, the patient received the second and the third dose of the hpv GARDASIL 9 (both with a Lot # reported as lot M014929 and expiration date of 27-MAY-2017) intramuscular, in the left deltoid area (strength and dose were not reported) all of them for prevention of human papillomavirus (HPV). On 31-MAR-2017 (also reported as 30-MAR-2017), the patient experienced mild injection site pain at the time of the administration of the third dose of GARDASIL 9. On 10-APR-2017, the patient visited the physician because he had severe left shoulder pain, which was further described as "radicular pain radiating to the left thumb and forefinger," as a result, the patient was unable to elevate or abduct his left arm away from his body. Upon examination, the physician noted that the patient had a weakened rotator cuff and atrophy of the deltoid muscle. The physician stated that the arm pain and inability to move the arm were from a "recent onset", but due to the degree of the deltoid atrophy that he observed, the physician suspected that the atrophy started to occur 2 weeks ago, soon after the administration of the third dose of GARDASIL 9. As a result of those symptoms, the physician reported that he suspected a C5-C6 brachioplexopathy and a brachial neuritis. The physician placed to the patient's arm in a sling and it was considered to start the patient on high-dose of corticosteroids. No laboratories or studies were performed.  Additionally, the physician reported that he had seen brachial neuritis commonly in other unspecified patients after the administration of other unspecified vaccines, including an unspecified influenza vaccine. No additional information provided regarding those other unspecified patients. At the time of reporting the patient had not recovered from vaccination site pain, rotator cuff syndrome, atrophy of the deltoid muscle, C5-C6 brachioplexopathy and brachial neuritis. The reporter considered the events to be significant disability or incapacity. The causal relationship between all the events and the suspect vaccine was not reported. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Musculoskeletal pain, Pain in extremity, Radicular pain, Radiculitis brachial, Rotator cuff syndrome
Clinical narrative: This spontaneous report was received from a physician referring to a 24 year old male patient. The patient did not have any concurrent condition, medical history, concomitant medication, drug reaction or allergy. On 14-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular (strength, dose, lot number and expiration date were not reported); on 01-SEP-2016 and on 31-MAR-2017, the patient received the second and the third dose of the hpv GARDASIL 9 (both with a Lot # reported as lot M014929 and expiration date of 27-MAY-2017) intramuscular, in the left deltoid area (strength and dose were not reported) all of them for prevention of human papillomavirus (HPV). On 31-MAR-2017 (also reported as 30-MAR-2017), the patient experienced mild injection site pain at the time of the administration of the third dose of GARDASIL 9. On 10-APR-2017, the patient visited the physician because he had severe left shoulder pain, which was further described as "radicular pain radiating to the left thumb and forefinger," as a result, the patient was unable to elevate or abduct his left arm away from his body. Upon examination, the physician noted that the patient had a weakened rotator cuff and atrophy of the deltoid muscle. The physician stated that the arm pain and inability to move the arm were from a "recent onset", but due to the degree of the deltoid atrophy that he observed, the physician suspected that the atrophy started to occur 2 weeks ago, soon after the administration of the third dose of GARDASIL 9. As a result of those symptoms, the physician reported that he suspected a C5-C6 brachioplexopathy and a brachial neuritis. The physician placed to the patient's arm in a sling and it was considered to start the patient on high-dose of corticosteroids. No laboratories or studies were performed.  Additionally, the physician reported that he had seen brachial neuritis commonly in other unspecified patients after the administration of other unspecified vaccines, including an unspecified influenza vaccine. No additional information provided regarding those other unspecified patients. At the time of reporting the patient had not recovered from vaccination site pain, rotator cuff syndrome, atrophy of the deltoid muscle, C5-C6 brachioplexopathy and brachial neuritis. The reporter considered the events to be significant disability or incapacity. The causal relationship between all the events and the suspect vaccine was not reported. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Brachial plexopathy, Injection site atrophy, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician referring to a 24 year old male patient. The patient did not have any concurrent condition, medical history, concomitant medication, drug reaction or allergy. On 14-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular (strength, dose, lot number and expiration date were not reported); on 01-SEP-2016 and on 31-MAR-2017, the patient received the second and the third dose of the hpv GARDASIL 9 (both with a Lot # reported as lot M014929 and expiration date of 27-MAY-2017) intramuscular, in the left deltoid area (strength and dose were not reported) all of them for prevention of human papillomavirus (HPV). On 31-MAR-2017 (also reported as 30-MAR-2017), the patient experienced mild injection site pain at the time of the administration of the third dose of GARDASIL 9. On 10-APR-2017, the patient visited the physician because he had severe left shoulder pain, which was further described as "radicular pain radiating to the left thumb and forefinger," as a result, the patient was unable to elevate or abduct his left arm away from his body. Upon examination, the physician noted that the patient had a weakened rotator cuff and atrophy of the deltoid muscle. The physician stated that the arm pain and inability to move the arm were from a "recent onset", but due to the degree of the deltoid atrophy that he observed, the physician suspected that the atrophy started to occur 2 weeks ago, soon after the administration of the third dose of GARDASIL 9. As a result of those symptoms, the physician reported that he suspected a C5-C6 brachioplexopathy and a brachial neuritis. The physician placed to the patient's arm in a sling and it was considered to start the patient on high-dose of corticosteroids. No laboratories or studies were performed.  Additionally, the physician reported that he had seen brachial neuritis commonly in other unspecified patients after the administration of other unspecified vaccines, including an unspecified influenza vaccine. No additional information provided regarding those other unspecified patients. At the time of reporting the patient had not recovered from vaccination site pain, rotator cuff syndrome, atrophy of the deltoid muscle, C5-C6 brachioplexopathy and brachial neuritis. The reporter considered the events to be significant disability or incapacity. The causal relationship between all the events and the suspect vaccine was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large area of erythema warmth pain entire L deltoid extenidn to triceps and down to mid upper arm.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Inflammation, Local swelling, Pyrexia
Clinical narrative: Information was received on 03-APR-2017 from a pharmacist regarding a female patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 31-MAR-2017 the patient received an injection of ZOSTAVAX (dose not specified) (lot # and expiration date not reported) subcutaneous for the indication of herpes zoster prevention. The pharmacist reported that the patient "got a bump, red and inflammation, had a headache and fever". The pharmacist reported that "patient stayed in the pharmacy for 30 minutes afterwards". The patient returned to the pharmacy on 03-APR-2017 and reported she "took something" and her symptoms "resolved over weekend." No additional information was provided. Action taken was not applicable, and the outcome of the adverse events was reported as resolved. The pharmacist did not rate the causal relationship. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2014, the patient was vaccinated with the first dose, on 06-MAR-2017 with the second dose and on 04-APR-2017, the patient was inadvertently vaccinated with the third dose of VARIVAX (dose, frequency, lot # and expiration date were not reported). Additionally, a sterile diluent (manufacturer unknown) was used to reconstitute the vaccines (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 16 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately 2002 (reported as about 15 years ago), the patient was vaccinated with a dose of VARIVAX (dose reported as 1 dose; route of administration, lot # and expiration date were not reported) for prevention of chickenpox. In approximately 2017 (reported as 15 years after receiving VARIVAX), the patient experienced shingles that were localized on the right thigh. The patient sought medical attention via the physician's office visit and received an unspecified treatment for the adverse event. The outcome of the adverse event was unknown. The relatedness between the adverse event and VARIVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medial assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M047658 with expiry date 29-OCT-2017 (exact dose and route of administration were not reported). The dose was exposed to the temperature between 47 and 77 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reaction or allergies were not provided. On unknown dates in 2017 (reported as "on unspecified dates since 12-FEB-2017"), the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot # M032149 with expiry date 18-APR-2019 (exact dose and route af administration were not reported). The doses were exposed to the temperature between 0 and 1 degrees Celsius (0.5 degrees Celsius) for 3 hours and 55 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA005924.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an other source and refers to a 5 year old male child patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On 02-MAR-2017, the patient was vaccinated with improperly stored live PROQUAD (lot # M001150, expiry date: 05-JUL-2017) for prophylaxis. It was reported that, the PROQUAD underwent temperature excursion in February 2017. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA005931: US-009507513-1704USA005932: US-009507513-1704USA005930:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reaction or allergies were not provided. On unknown dates in 2017 (reported as "on unspecified dates since 12-FEB-2017"), the patients were vaccinated with improperly stored doses of ROTATEQ, lot # M016238 with expiry date 07-DEC-2017, orally (exact dose was not reported). The doses were exposed to the temperature between 0 and 1 degree Celsius (0.5 degree Celsius) for 3 hours and 55 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004336.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an other source and refers to a 4 year old female child patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On 02-MAR-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M001150, expiry date: 05-JUL-2017) for prophylaxis. It was reported that, the PROQUAD underwent temperature excursion in February 2017. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004376: US-009507513-1704USA005931: US-009507513-1704USA005932:
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an other source and refers to a 6 year old male child patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On 10-MAR-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M001150, expiry date: 05-JUL-2017) for prophylaxis. It was reported that, the PROQUAD underwent temperature excursion in February 2017. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004376: US-009507513-1704USA005930: US-009507513-1704USA005932:
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal distension, Abdominal pain lower, Diarrhoea, Dysuria, Faeces discoloured
Clinical narrative: Per message from patient: writhing 3 hrs after injection, lower abdominal swelling and inability to urinate, 9 hrs after injection flu-like symptoms in addition to lower abdominal swelling and pain. 72 hrs after injection abdominal swelling subsided and ability to urinate returned, but still in pain and b.m. is loose and of an abnormal color. Pt states he has had 8 tetanus vaccines and is not a typical reaction for him. Patient was traveling and did not see a healthcare provider while he had symptoms, but waited for them to subside. Was mostly concerned of others possibly having this side effect. We have had no other reports of such.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness
Clinical narrative: Per message from patient: writhing 3 hrs after injection, lower abdominal swelling and inability to urinate, 9 hrs after injection flu-like symptoms in addition to lower abdominal swelling and pain. 72 hrs after injection abdominal swelling subsided and ability to urinate returned, but still in pain and b.m. is loose and of an abnormal color. Pt states he has had 8 tetanus vaccines and is not a typical reaction for him. Patient was traveling and did not see a healthcare provider while he had symptoms, but waited for them to subside. Was mostly concerned of others possibly having this side effect. We have had no other reports of such.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site nodule, Pain in extremity
Clinical narrative: Baseball size knot and redness at injection site, pain radiating down arms and fingers, blisters on arm and side of torso.
Age: 1.17
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 04-APR-2017 from a medical assistant concerning a 14 month old male patient. No medical history or concomitant medications were reported. On 31-MAR-2017 the patient inadvertently received a dose of PNEUMOVAX 23 (lot M038359, expires 13-MAY-2018) (dose and route not reported) when the child was "14 months of age." No adverse effects reported. No other information was provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, Incorrect product storage
Clinical narrative: This spontaneous report was received from an other source and refers to 1 year old female patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On 22-MAR-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M043581, expiry date: 20-OCT-2016) (expired vaccine used) for prophylaxis. It was reported that, the VARIVAX underwent temperature excursion in February 2017. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004376: US-009507513-1704USA005930: US-009507513-1704USA005931.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-04-08.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Pt reported he got on airplane in morning, his arm got all red and inflamed all the way down, he stayed in bed for 2 days, then went to hospital.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Feeling hot
Clinical narrative: Employee states she began feeling hot and took her temperature it was 101.4, she took 400mg of Ibuprofen and placed ice packs on her head and neck. Rechecked again at 7:00am 99.3. No further events of elevated temp since then.
Age: 36.0
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Presented to  clinic with complaints of left upper arm tenderness, redness, and swelling around injection site.  No systemic symptoms such as urticarial, SOB, or swelling of lips, tongue or throat.  5/10 complaint of pain in upper arm.  2" wide x 3" long area of redness with little swelling on lateral/posterior aspect of left upper arm. Upon inspection of needlestick site, it was noted that the IM vaccine was given distally and laterally to the deltoid muscle and more likely into the sub q tissue.  The vaccine was administered as an IM injection otherwise.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Periarthritis, X-ray
Clinical narrative: Diagnosed with Frozen Shoulder. Symptoms include shoulder pain radiating down arm and decreased range of motion.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Patient said she got a bruise where the injection was.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV, RV5
Symptoms: Extra dose administered
Clinical narrative: Patient was given a PENTACEL and a Hib Prp-omp in the left leg so he received a double dose of Hib.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Nausea, Throat irritation, Vomiting
Clinical narrative: Itchy throat, nausea, stomach ache; soon after pt had vomiting. Pt's vital signs after vaccine: BP was 90/60, HR 110, RR 16; pt was not having any swelling, color change, wheezing or SOB on exam; ambulance was called for pt to be evaluated in ER for possible severe allergic reaction. Ambulance took pt to the ER.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Pain in extremity, X-ray limb abnormal
Clinical narrative: SEVERE DAILY PERSISTENT ARM PAIN FROM SHOULDER TO ELBOW "LIKE A TOOTHACHE" FOR APPROXIMATELY 3 MONTHS. NO PERSISTENT SWELLING/REDNESS.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: C/O chills and fatigue; Injection sites with painful swelling, erythema, and warm to the touch.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: C/O chills and fatigue; Injection sites with painful swelling, erythema, and warm to the touch.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site cellulitis
Clinical narrative: Cellulitis at vaccine site, lymphadenopathy and axillary pain.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Influenza like illness
Clinical narrative: Chills, flue like symptoms...NO FEVER.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Administered Shingles vaccine IM instead of Sub-Q. No reaction.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Patient woke up with left sided facial numbness and palsy. Treated with Prednisone.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Eye movement disorder, Tremor
Clinical narrative: Mom reported to ER child was down for a nap and body began to shake and eyes rolled back in childs head.  Mom reports woke child from sleep.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient's arm got sore and red below the injection site. The red was hot to the touch and itched.
Age: 22.0
Sex: F
Vaccine: RAB, TYP, RAB, TYP
Symptoms: Amnesia, Migraine, Reading disorder, Speech disorder, Thinking abnormal
Clinical narrative: My symptoms began with visual impairment, then a migraine. I then had memory loss and was unable to remember the name of my street or my roommates. I could not think or speak clearly and had trouble reading.
Age: 22.0
Sex: F
Vaccine: RAB, TYP, RAB, TYP
Symptoms: Visual impairment
Clinical narrative: My symptoms began with visual impairment, then a migraine. I then had memory loss and was unable to remember the name of my street or my roommates. I could not think or speak clearly and had trouble reading.
Age: 22.0
Sex: F
Vaccine: RAB, TYP, RAB, TYP
Symptoms: Headache, Memory impairment, Vision blurred
Clinical narrative: My symptoms began with visual impairment, then a migraine. I then had memory loss and was unable to remember the name of my street or my roommates. I could not think or speak clearly and had trouble reading.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Allergy test, Angioedema, Ear infection, Urticaria
Clinical narrative: Received MMR, Hep A and varicella on 03/10/17. Was also started on AUGMENTIN for an ear infection on 03/10/17. Hives began on 03/19/17 with hives and angioedema. Patient was administered DECADRON and BENADRYL and was given an EPIPEN and ATARAX.
Age: 1.08
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt given adult dose Hep A.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site haematoma, Injection site haemorrhage, Injection site swelling
Clinical narrative: Immediately after injection, the patient began bleeding at the injection site. I applied pressure with a cotton ball and within minutes, the bleeding had stopped but a small hematoma formed under the skin. It was a raised bump, about the diameter of a quarter and was purple under the skin where you could tell blood was pooling. The patient waited about 10 minutes and was feeling fine so I told her she could leave and I will follow up the next day to make sure it was looking better. I instructed her to contact the pharmacy or her MD if it appeared to be getting worse.
Age: 25.0
Sex: M
Vaccine: HEPAB, HPV9, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left leg swelling and erythema at injection site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Patient walked into clinic to report his left arm was swollen and red from recent pneumonia 23 injection received 3/29/17. Patient left arm assessed, visible area of cellulitis radiating from deltoid to antecubital, approximate area of redness 32Lx20W, warm to the touch; no areas of induration or drainage noted. Patient given cephalexin 500 mg TID for 10 days.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Hyperhidrosis, Pallor, Respiratory rate increased, Syncope
Clinical narrative: 1601- Pt. given HPV. Pt. became diaphoretic, increased breathing pale which lead to syncope. Pt. resting on exam table with doctor present. Vitals monitored. 1630- Doctor admin Hep A with no adverse reaction. 1635 Pt cleared by doctor and released -1645.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Peripheral swelling, Rash erythematous
Clinical narrative: Swollen left arm, red rash on whole left arm, warm to touch, pt. went to MD and given ALLEGRA to reduce reaction. Pt. received PREVNAR 13 in 2016 w/no reaction.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Swollen left arm, red rash on whole left arm, warm to touch, pt. went to MD and given ALLEGRA to reduce reaction. Pt. received PREVNAR 13 in 2016 w/no reaction.
Age: 27.0
Sex: U
Vaccine: TDAP
Symptoms: Eating disorder, Eye swelling, Injection site swelling, Migraine, Musculoskeletal pain
Clinical narrative: Pt had swelling of the eyes, throat closed, difficulty eating, migraine, swelling at injection site, pain in neck, shoulder and arm.
Age: 27.0
Sex: U
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity, Throat tightness
Clinical narrative: Pt had swelling of the eyes, throat closed, difficulty eating, migraine, swelling at injection site, pain in neck, shoulder and arm.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Electroencephalogram, Epilepsy, Seizure
Clinical narrative: Seizure 1 month after administration. New onset epilepsy.
Age: 33.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red warm to touch Lt. deltoid. Advised cool compress. Call in 24 hrs if not improved.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Polymerase chain reaction, Rotavirus test positive, Vomiting
Clinical narrative: Severe vomiting and diarrhea requiring multiple clinic visits and ER visit. Patient given ZOFRAN, oral electrolytes, and BACTRIM.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site pruritus
Clinical narrative: The day after receiving a flu vaccine she had discoloration and itching around the injection site. This was about 2 inches in diameter. Required MD visit 3 weeks after vaccine and dermatology visit on 4/5/17.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Asthma, Bipolar disorder, Cytogenetic analysis abnormal, Diarrhoea
Clinical narrative: October 30, 2016 trembling inside, Saturday, November 12 2016 Fever 103.8, head spinning, rash on elbows, hair falling out, diarrhea, eyes and face swelling. With Family Practice November 15, 2016. Place on TAMIFLU. Hives appear on face and neck. Stop taking TAMIFLU. Head spinning sick November asthma, December kidney, diarrhea and rash and hives worsen. January can't go without (hives) infection (attack pituitary). I have been so sick and traumatized that bipolar gene has surfaced. Please help I keep getting this is over my pay grade.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Hypersensitivity, Hypothalamo-pituitary disorder, Infection, Injury
Clinical narrative: October 30, 2016 trembling inside, Saturday, November 12 2016 Fever 103.8, head spinning, rash on elbows, hair falling out, diarrhea, eyes and face swelling. With Family Practice November 15, 2016. Place on TAMIFLU. Hives appear on face and neck. Stop taking TAMIFLU. Head spinning sick November asthma, December kidney, diarrhea and rash and hives worsen. January can't go without (hives) infection (attack pituitary). I have been so sick and traumatized that bipolar gene has surfaced. Please help I keep getting this is over my pay grade.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia, Rash, Renal disorder, Swelling face
Clinical narrative: October 30, 2016 trembling inside, Saturday, November 12 2016 Fever 103.8, head spinning, rash on elbows, hair falling out, diarrhea, eyes and face swelling. With Family Practice November 15, 2016. Place on TAMIFLU. Hives appear on face and neck. Stop taking TAMIFLU. Head spinning sick November asthma, December kidney, diarrhea and rash and hives worsen. January can't go without (hives) infection (attack pituitary). I have been so sick and traumatized that bipolar gene has surfaced. Please help I keep getting this is over my pay grade.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Urticaria, Vertigo
Clinical narrative: October 30, 2016 trembling inside, Saturday, November 12 2016 Fever 103.8, head spinning, rash on elbows, hair falling out, diarrhea, eyes and face swelling. With Family Practice November 15, 2016. Place on TAMIFLU. Hives appear on face and neck. Stop taking TAMIFLU. Head spinning sick November asthma, December kidney, diarrhea and rash and hives worsen. January can't go without (hives) infection (attack pituitary). I have been so sick and traumatized that bipolar gene has surfaced. Please help I keep getting this is over my pay grade.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Fever, Swollen arm, rash, pain.
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Head injury, Loss of consciousness, Syncope, Vomiting
Clinical narrative: Client fainted within 2 minutes of receiving the 3rd vaccine (of 3 administered). Client was unconscious 1-2 minutes and struck head as she was being lowered to floor. Once alert, client vomited and was sent to ER for further evaluation.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Phone call received from school nurse 0900. Pt presented in office with left deltoid pain. Nurse states it is red/warm to the touch. Redness appears "golf ball" sized. Slight elevation. Icepack given to pt for relief.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Altered state of consciousness, Eye movement disorder, Seizure like phenomena, Tremor
Clinical narrative: Pt requested MMR #2 for grad sch. Stated fearful of shots, at 1-2 min after MMR given on exam table pt said "I'm going to pass out". Eyes rolled back, legs shaking - seizure like - at 25-30 sec. Pt alert after 25-30 sec. No incontinence.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Extreme fussiness for >3 hours started approximately 18hrs post vaccination physical exam normal.
Age: 54.0
Sex: M
Vaccine: PPV, TD
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever 101.5 - per patient. Nausea. Chills.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Rash pruritic, Rash pustular
Clinical narrative: Pain at injection within hours of administration. 15 min minor (L) chest pain, about 24 hrs after shot. Itching rash (L) elbow 3/19. Rash noted (R) elbow and hand 3/20. Pustular lesions noted extensor (B) elbows and dorsal (R) hand. No SOB/Fever/chills/sweats/cough/headache.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness and firmness with pain on palpation left deltoid. Cool packs 15 min 9.2 - BENADRYL 25 mg tid x 2 day.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Product deemed to be ineffective due to refrigeration issue. Manufacturer contacted. Patient notified and advised for re-administration of the dose. No adverse effects reported.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Hives around injection area
Age: 66.0
Sex: M
Vaccine: DTP, FLU3
Symptoms: Paraesthesia
Clinical narrative: And tingling (Left Arm).
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: Product deemed to be ineffective due to refrigeration issue. Manufacturer contacted. Patient notified and advised for re-administration of the dose.