chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: This initial spontaneous case, was received on 26-Oct-2017, reported by other health professional (pharmacist), concerning a 20-year-old, adult, male patient. The patient had no medical history and had not received any concomitant medications. On 25-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramusuclar, anatomical location: right deltoid, batch number: 195225, expiry date: May-2018). On the following day (26-Oct-2017), after vaccination, the reporter stated that, the patient experienced vomiting 'violently' (reported as throwing up a lot). At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Seizure
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 03-Nov-2017, concerning a 31-year-old adult female patient. The patient had not any medical history and concomitant medications. On 03-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195128, expiry date: Apr-2018). On the same day, after the vaccination, the subject developed dizziness and began to have a seizure and no treatment was taken. It was reported that, the patient refused for any emergency care. The same day, after 1 minute later, the patient was recovered from the events. The reporter assessed the events as non-serious.
Age: 1.17
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received from nurse on 10-Nov-2017, concerning a 14-month-old infant female patient. The patient's medical history and concomitant medications were not reported. On 10-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195211 and expiry date: Mar-2018) under the age of 4 years old (explicitly coded as inappropriate age at vaccine administration). It was reported that, no adverse event was occurred after the vaccination. The reporter assessed the events as non-serious.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Emotional distress, Infection, Injection site pain, Joint fluid drainage, Musculoskeletal pain
Clinical narrative: This spontaneous report as received fro a 71 year old female patient regarding herself. The patient's medical history and concomitant medications were not reported. The patient experienced side effects after administration of PREVNAR 13. The patient's concurrent conditions included rheumatoid arthritis.  On 13-NOV-2017, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, (dose number, lot #, expiry date, route and site of administration were not reported) for prophylaxis. On the same day, few hours later the patient complained of pain in the shoulder area and injection site pain. The patient was told to try TYLENOL. The patient tried extra strength TYLENOL and got no relief. The patient eventually went to the Emergency Room and was prescribed Hydromorphone for the pain the following day. The medication did not seem to help. She then went to another doctor and the fluid was drained from the shoulder. The next day she was prescribed KEFLEX 500mg for an infection. The patient was upset because of the pain. The patient had severe side effect. The pharmacist stated that she followed proper procedures when administering the vaccination. The outcome of the events were unknown. The reporter's causality assessment between the events and the suspect therapy were not reported. Upon internal review, the event fluid was drained from the shoulder was determined to be medically significant. The case was considered serious due to hospitalization.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Insomnia, Joint fluid drainage, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received fro a 71 year old female patient regarding herself. The patient's medical history and concomitant medications were not reported. The patient experienced side effects after administration of PREVNAR 13. The patient's concurrent conditions included rheumatoid arthritis.  On 13-NOV-2017, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, (dose number, lot #, expiry date, route and site of administration were not reported) for prophylaxis. On the same day, few hours later the patient complained of pain in the shoulder area and injection site pain. The patient was told to try TYLENOL. The patient tried extra strength TYLENOL and got no relief. The patient eventually went to the Emergency Room and was prescribed Hydromorphone for the pain the following day. The medication did not seem to help. She then went to another doctor and the fluid was drained from the shoulder. The next day she was prescribed KEFLEX 500mg for an infection. The patient was upset because of the pain. The patient had severe side effect. The pharmacist stated that she followed proper procedures when administering the vaccination. The outcome of the events were unknown. The reporter's causality assessment between the events and the suspect therapy were not reported. Upon internal review, the event fluid was drained from the shoulder was determined to be medically significant. The case was considered serious due to hospitalization.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Tenderness
Clinical narrative: This spontaneous report as received fro a 71 year old female patient regarding herself. The patient's medical history and concomitant medications were not reported. The patient experienced side effects after administration of PREVNAR 13. The patient's concurrent conditions included rheumatoid arthritis.  On 13-NOV-2017, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, (dose number, lot #, expiry date, route and site of administration were not reported) for prophylaxis. On the same day, few hours later the patient complained of pain in the shoulder area and injection site pain. The patient was told to try TYLENOL. The patient tried extra strength TYLENOL and got no relief. The patient eventually went to the Emergency Room and was prescribed Hydromorphone for the pain the following day. The medication did not seem to help. She then went to another doctor and the fluid was drained from the shoulder. The next day she was prescribed KEFLEX 500mg for an infection. The patient was upset because of the pain. The patient had severe side effect. The pharmacist stated that she followed proper procedures when administering the vaccination. The outcome of the events were unknown. The reporter's causality assessment between the events and the suspect therapy were not reported. Upon internal review, the event fluid was drained from the shoulder was determined to be medically significant. The case was considered serious due to hospitalization.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Asterixis, Balance disorder, Eye movement disorder, Fall, Gait disturbance
Clinical narrative: When patient woke up on 12/08/2016, her left eye was cloudy and gray -- not clear like the other.  Her left eye was not moving uniform with her right eye. When her left eye would pass the mid line it would stick toward her nose. There were 3 instances when her eye actually stuck at her nose and did not return for several seconds. Patient began continuously hand flapping and walking on her tip toes which had never occurred before. She began falling down and had trouble keeping her balance. She also started walking with the right side of her body leading ahead and the left of her body trailing behind her. She lost the ability to catch or kick a soccer ball without missing. All of these symptoms lasted for several weeks. Her eye continues to stick to this day when she is overly tired or sick.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Toe walking, Vaccination complication, Vision blurred
Clinical narrative: When patient woke up on 12/08/2016, her left eye was cloudy and gray -- not clear like the other.  Her left eye was not moving uniform with her right eye. When her left eye would pass the mid line it would stick toward her nose. There were 3 instances when her eye actually stuck at her nose and did not return for several seconds. Patient began continuously hand flapping and walking on her tip toes which had never occurred before. She began falling down and had trouble keeping her balance. She also started walking with the right side of her body leading ahead and the left of her body trailing behind her. She lost the ability to catch or kick a soccer ball without missing. All of these symptoms lasted for several weeks. Her eye continues to stick to this day when she is overly tired or sick.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Lip swelling, Swelling, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a 66 year old female patient, reporting on herself. The patient's did not have any pertinent medical history, concurrent conditions, drug reactions or allergies to report. Her concomitant medications included multivitamin, calcium and B12 supplements. The patient informed that on 28-NOV-2017, she was vaccinated with a dose of PNEUMOVAX 23 injection as vaccine for pneumonia (strength, dose, lot number and expiration date were not reported). On 29-NOV-2017, the patient's cheeks and lips became swollen and she also had difficulty swallowing. On the evening of 30-NOV-2017, the patient went to the emergency room, and she was diagnosed with Angioedema. She was treated with dexamethasone, epinephrine and hydroxyzine. She also informed that her blood pressure was elevated, and it was treated with "Visterile". She was also given prednisone. There were no laboratory studies performed. At the time of reporting, the outcome of angioedema and blood pressure elevated was reported as recovered approximately on 13-DEC-2017, as the patient stated that it took about two weeks to recover. The causal relationship between the vaccination with PNEUMOVAX 23 and the events was not provided by the reporter. Upon internal review, angioedema was determined to be a medically significant event.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Angioedema, Blood pressure increased, Dysphagia, Lip swelling, Swelling face
Clinical narrative: This spontaneous report was received from a 66 year old female patient, reporting on herself. The patient's did not have any pertinent medical history, concurrent conditions, drug reactions or allergies to report. Her concomitant medications included multivitamin, calcium and B12 supplements. The patient informed that on 28-NOV-2017, she was vaccinated with a dose of PNEUMOVAX 23 injection as vaccine for pneumonia (strength, dose, lot number and expiration date were not reported). On 29-NOV-2017, the patient's cheeks and lips became swollen and she also had difficulty swallowing. On the evening of 30-NOV-2017, the patient went to the emergency room, and she was diagnosed with Angioedema. She was treated with dexamethasone, epinephrine and hydroxyzine. She also informed that her blood pressure was elevated, and it was treated with "Visterile". She was also given prednisone. There were no laboratory studies performed. At the time of reporting, the outcome of angioedema and blood pressure elevated was reported as recovered approximately on 13-DEC-2017, as the patient stated that it took about two weeks to recover. The causal relationship between the vaccination with PNEUMOVAX 23 and the events was not provided by the reporter. Upon internal review, angioedema was determined to be a medically significant event.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Agitation, Balance disorder, Electrocardiogram normal, Electroencephalogram, Eye movement disorder
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 22 year old male patient. The patient had no pertinent medical history, concurrent conditions or drug reactions or allergies. On 11-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 vaccination series, on the left arm, lot number reported as "N019103" with expiration date 03-FEB-2020, for prophylaxis (route of administration was not provided). There were no concomitant medications. On the same date, after the injection, the patient leaned forward to the ground and appeared dizzy, flushed, shaky, had a rigid arm and his eyes rolled to the back of the head. The patient was unresponsive for a very short time and when he woke up, not knowing what happened, he looked agitated. The whole experience lasted less than 2 minutes. The patient had total of 5 cups of coffee prior to the injection. The patient was already fine at the physician's office but was sent to the hospital emergency room as precautionary measurement. Patient was fully recovered and was discharged on the same day (he was not admitted to the hospital). On 16-JAN-2018, an electroencephalogram (EEG) was performed (result not provided) as a follow up and patient was fine at the time of this report. The patient did not received any treatment for the events. The reporter did not assess the causal relationship between GARDASIL 9 and the events. Upon internal review, the event unresponsive for very short time was determined to be medically significant.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Flushing, Grunting, Malaise, Muscle rigidity, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 22 year old male patient. The patient had no pertinent medical history, concurrent conditions or drug reactions or allergies. On 11-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 vaccination series, on the left arm, lot number reported as "N019103" with expiration date 03-FEB-2020, for prophylaxis (route of administration was not provided). There were no concomitant medications. On the same date, after the injection, the patient leaned forward to the ground and appeared dizzy, flushed, shaky, had a rigid arm and his eyes rolled to the back of the head. The patient was unresponsive for a very short time and when he woke up, not knowing what happened, he looked agitated. The whole experience lasted less than 2 minutes. The patient had total of 5 cups of coffee prior to the injection. The patient was already fine at the physician's office but was sent to the hospital emergency room as precautionary measurement. Patient was fully recovered and was discharged on the same day (he was not admitted to the hospital). On 16-JAN-2018, an electroencephalogram (EEG) was performed (result not provided) as a follow up and patient was fine at the time of this report. The patient did not received any treatment for the events. The reporter did not assess the causal relationship between GARDASIL 9 and the events. Upon internal review, the event unresponsive for very short time was determined to be medically significant.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Scan with contrast normal, Tremor, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 22 year old male patient. The patient had no pertinent medical history, concurrent conditions or drug reactions or allergies. On 11-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 vaccination series, on the left arm, lot number reported as "N019103" with expiration date 03-FEB-2020, for prophylaxis (route of administration was not provided). There were no concomitant medications. On the same date, after the injection, the patient leaned forward to the ground and appeared dizzy, flushed, shaky, had a rigid arm and his eyes rolled to the back of the head. The patient was unresponsive for a very short time and when he woke up, not knowing what happened, he looked agitated. The whole experience lasted less than 2 minutes. The patient had total of 5 cups of coffee prior to the injection. The patient was already fine at the physician's office but was sent to the hospital emergency room as precautionary measurement. Patient was fully recovered and was discharged on the same day (he was not admitted to the hospital). On 16-JAN-2018, an electroencephalogram (EEG) was performed (result not provided) as a follow up and patient was fine at the time of this report. The patient did not received any treatment for the events. The reporter did not assess the causal relationship between GARDASIL 9 and the events. Upon internal review, the event unresponsive for very short time was determined to be medically significant.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Agitation, Dizziness, Electroencephalogram, Eye movement disorder, Flushing
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 22 year old male patient. The patient had no pertinent medical history, concurrent conditions or drug reactions or allergies. On 11-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 vaccination series, on the left arm, lot number reported as "N019103" with expiration date 03-FEB-2020, for prophylaxis (route of administration was not provided). There were no concomitant medications. On the same date, after the injection, the patient leaned forward to the ground and appeared dizzy, flushed, shaky, had a rigid arm and his eyes rolled to the back of the head. The patient was unresponsive for a very short time and when he woke up, not knowing what happened, he looked agitated. The whole experience lasted less than 2 minutes. The patient had total of 5 cups of coffee prior to the injection. The patient was already fine at the physician's office but was sent to the hospital emergency room as precautionary measurement. Patient was fully recovered and was discharged on the same day (he was not admitted to the hospital). On 16-JAN-2018, an electroencephalogram (EEG) was performed (result not provided) as a follow up and patient was fine at the time of this report. The patient did not received any treatment for the events. The reporter did not assess the causal relationship between GARDASIL 9 and the events. Upon internal review, the event unresponsive for very short time was determined to be medically significant.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Muscle rigidity, Tremor, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 22 year old male patient. The patient had no pertinent medical history, concurrent conditions or drug reactions or allergies. On 11-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 vaccination series, on the left arm, lot number reported as "N019103" with expiration date 03-FEB-2020, for prophylaxis (route of administration was not provided). There were no concomitant medications. On the same date, after the injection, the patient leaned forward to the ground and appeared dizzy, flushed, shaky, had a rigid arm and his eyes rolled to the back of the head. The patient was unresponsive for a very short time and when he woke up, not knowing what happened, he looked agitated. The whole experience lasted less than 2 minutes. The patient had total of 5 cups of coffee prior to the injection. The patient was already fine at the physician's office but was sent to the hospital emergency room as precautionary measurement. Patient was fully recovered and was discharged on the same day (he was not admitted to the hospital). On 16-JAN-2018, an electroencephalogram (EEG) was performed (result not provided) as a follow up and patient was fine at the time of this report. The patient did not received any treatment for the events. The reporter did not assess the causal relationship between GARDASIL 9 and the events. Upon internal review, the event unresponsive for very short time was determined to be medically significant.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Pain, Product administered at inappropriate site, Pruritus
Clinical narrative: This spontaneous report was received from a physician, regarding to 62 year old female patient. The patient's concurrent conditions included moderate persistent asthma, hypertension, hyperlipidaemia, osteoarthritis, bilateral shin splints, gastrooesophageal reflux disease (G.E.R.D.), hypothyroidism and postmenopausal flashes. Her concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), cyclobenzaprine hydrochloride(FLEXERIL), aspirin (manufacturer unknown), duloxetine hydrochloride (CYMBALTA), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, lisinopril (manufacturer unknown), levothyroxine sodium (SYNTHROID), pantoprazole sodium (PROTONIX) and albuterol(VENTOLIN (ALBUTEROL)). The physician informed that on 16-JAN-2018, the patient was vaccinated with ZOSTAVAX for prophylaxis, lot #N010494 (strength, dose, frequency, route of administration and expiration date were not reported). Other suspect therapy included sterile diluent (MERCK STERILE DILUENT) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). It was informed that on 19-JAN-2018 the patient started to have symptoms of a 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm and the site was tender to palpation. On 22-JAN-2018, the patient presented to the clinic with this symptoms and it was noted that the the symptoms had improved but they were still present and also a new pinpoint brown area was observed. There were no systemic effects. The patient was treated with ibuprofen and diphenydramine. At the time of reporting, the outcome of 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm  and site was tender to palpation was reported as recovering; and of new pinpoint brown area observed was unknown. The causal relationship between the vaccination with ZOSTAVAX and the events was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin discolouration, Skin warm, Swelling, Tenderness, Wound secretion
Clinical narrative: This spontaneous report was received from a physician, regarding to 62 year old female patient. The patient's concurrent conditions included moderate persistent asthma, hypertension, hyperlipidaemia, osteoarthritis, bilateral shin splints, gastrooesophageal reflux disease (G.E.R.D.), hypothyroidism and postmenopausal flashes. Her concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), cyclobenzaprine hydrochloride(FLEXERIL), aspirin (manufacturer unknown), duloxetine hydrochloride (CYMBALTA), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, lisinopril (manufacturer unknown), levothyroxine sodium (SYNTHROID), pantoprazole sodium (PROTONIX) and albuterol(VENTOLIN (ALBUTEROL)). The physician informed that on 16-JAN-2018, the patient was vaccinated with ZOSTAVAX for prophylaxis, lot #N010494 (strength, dose, frequency, route of administration and expiration date were not reported). Other suspect therapy included sterile diluent (MERCK STERILE DILUENT) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). It was informed that on 19-JAN-2018 the patient started to have symptoms of a 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm and the site was tender to palpation. On 22-JAN-2018, the patient presented to the clinic with this symptoms and it was noted that the the symptoms had improved but they were still present and also a new pinpoint brown area was observed. There were no systemic effects. The patient was treated with ibuprofen and diphenydramine. At the time of reporting, the outcome of 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm  and site was tender to palpation was reported as recovering; and of new pinpoint brown area observed was unknown. The causal relationship between the vaccination with ZOSTAVAX and the events was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report was received from a physician, regarding to 62 year old female patient. The patient's concurrent conditions included moderate persistent asthma, hypertension, hyperlipidaemia, osteoarthritis, bilateral shin splints, gastrooesophageal reflux disease (G.E.R.D.), hypothyroidism and postmenopausal flashes. Her concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), cyclobenzaprine hydrochloride(FLEXERIL), aspirin (manufacturer unknown), duloxetine hydrochloride (CYMBALTA), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, lisinopril (manufacturer unknown), levothyroxine sodium (SYNTHROID), pantoprazole sodium (PROTONIX) and albuterol(VENTOLIN (ALBUTEROL)). The physician informed that on 16-JAN-2018, the patient was vaccinated with ZOSTAVAX for prophylaxis, lot #N010494 (strength, dose, frequency, route of administration and expiration date were not reported). Other suspect therapy included sterile diluent (MERCK STERILE DILUENT) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). It was informed that on 19-JAN-2018 the patient started to have symptoms of a 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm and the site was tender to palpation. On 22-JAN-2018, the patient presented to the clinic with this symptoms and it was noted that the the symptoms had improved but they were still present and also a new pinpoint brown area was observed. There were no systemic effects. The patient was treated with ibuprofen and diphenydramine. At the time of reporting, the outcome of 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm  and site was tender to palpation was reported as recovering; and of new pinpoint brown area observed was unknown. The causal relationship between the vaccination with ZOSTAVAX and the events was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin discolouration, Skin disorder
Clinical narrative: This spontaneous report was received from a physician, regarding to 62 year old female patient. The patient's concurrent conditions included moderate persistent asthma, hypertension, hyperlipidaemia, osteoarthritis, bilateral shin splints, gastrooesophageal reflux disease (G.E.R.D.), hypothyroidism and postmenopausal flashes. Her concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), cyclobenzaprine hydrochloride(FLEXERIL), aspirin (manufacturer unknown), duloxetine hydrochloride (CYMBALTA), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, lisinopril (manufacturer unknown), levothyroxine sodium (SYNTHROID), pantoprazole sodium (PROTONIX) and albuterol(VENTOLIN (ALBUTEROL)). The physician informed that on 16-JAN-2018, the patient was vaccinated with ZOSTAVAX for prophylaxis, lot #N010494 (strength, dose, frequency, route of administration and expiration date were not reported). Other suspect therapy included sterile diluent (MERCK STERILE DILUENT) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). It was informed that on 19-JAN-2018 the patient started to have symptoms of a 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm and the site was tender to palpation. On 22-JAN-2018, the patient presented to the clinic with this symptoms and it was noted that the the symptoms had improved but they were still present and also a new pinpoint brown area was observed. There were no systemic effects. The patient was treated with ibuprofen and diphenydramine. At the time of reporting, the outcome of 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm  and site was tender to palpation was reported as recovering; and of new pinpoint brown area observed was unknown. The causal relationship between the vaccination with ZOSTAVAX and the events was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a physician, regarding to 62 year old female patient. The patient's concurrent conditions included moderate persistent asthma, hypertension, hyperlipidaemia, osteoarthritis, bilateral shin splints, gastrooesophageal reflux disease (G.E.R.D.), hypothyroidism and postmenopausal flashes. Her concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), cyclobenzaprine hydrochloride(FLEXERIL), aspirin (manufacturer unknown), duloxetine hydrochloride (CYMBALTA), fexofenadine hydrochloride (ALLEGRA), hydrochlorothiazide, lisinopril (manufacturer unknown), levothyroxine sodium (SYNTHROID), pantoprazole sodium (PROTONIX) and albuterol(VENTOLIN (ALBUTEROL)). The physician informed that on 16-JAN-2018, the patient was vaccinated with ZOSTAVAX for prophylaxis, lot #N010494 (strength, dose, frequency, route of administration and expiration date were not reported). Other suspect therapy included sterile diluent (MERCK STERILE DILUENT) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). It was informed that on 19-JAN-2018 the patient started to have symptoms of a 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm and the site was tender to palpation. On 22-JAN-2018, the patient presented to the clinic with this symptoms and it was noted that the the symptoms had improved but they were still present and also a new pinpoint brown area was observed. There were no systemic effects. The patient was treated with ibuprofen and diphenydramine. At the time of reporting, the outcome of 4cm x 5cm red, warm, itchy area of induration, with skin breakdown, on the volar aspect of the left forearm  and site was tender to palpation was reported as recovering; and of new pinpoint brown area observed was unknown. The causal relationship between the vaccination with ZOSTAVAX and the events was not provided by the reporter.
Age: 25.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Consciousness fluctuating, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Patient was seen for travel consultation and immunization. Patient was given TYPHIM on the upper left arm. Then was given ADACEL on the lower left arm, separated by 1 inch from TYPHIM injection site. Patient fainted after ADACEL shot. Patient kept going in and out of consciousness for about a minute. Patient regained consciousness within a minute but was sweating. 911 call was made for patient, but patient refused service. Patient was given sugary drink and asked to stay put for further monitoring. Patient stated being dizzy at which point asked to contact family member/friend to pick her up. Patient returned to original state and was able to leave site without further action. Patient returned to site for TWINRIX and was asked to lay down for an injection. Patient did not have a reaction to TWINRIX.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria, hives around vaccine site and across body. No vesicular lesions. Prescribed Lidex 0.05% and Atarax 25mg.
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Second Flu booster given 2 weeks early, per manufactuer  not harmful just that vaccine is not valid. No harm done to the patient. This was administered in the Flu clinic and the process for the flu clinic is we don't get into the patients chart or print MCIRs for the patients we just go by whats on the schedule and administer the immunization. Had the process been to print MCIRs this mistake would have never happened. I have brought the process of the flu clinic to my supervisors attention and hope that changes can be made to how the flu clinic works.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from two Licensed Practical Nurses (LPN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unspecified date in January  2018 after 09-JAN-2018 (which had been previously reported as "between 03-JAN-2018 and 09-JAN-2018"), the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number M036057 (also reported as "N036057"), expiration date 18-MAY-2019 and ROTATEQ lot number N010709, expiration date 05-DEC-2018; (strength, dose, dose number and administration routes were not provided) for prophylaxis.  The vaccines were exposure to a temperature excursion; the data logger registered a temperature of 48 Fahrenheit (F) for 1 hour and 45 minutes. The previous temperature excursion registered was 35 F for 3 hours. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1801USA009769:
Sex: M
Vaccine: HEP, HEPA, HPV9, PPV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23 (lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for varicella virus vaccine live (oka/merck) (VARIVAX) reconstitution was stored properly. Doses of varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), pneumococcal vaccine, polyvalent (23-valent)( PNEUMOVAX23), hepatitis b vaccine (recombinant) (RECOMBIVAX HB), and hepatitis a vaccine, inactivated (VAQTA) were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported.  Follow-up information has been received from the physician on 23-JAN-2018. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with MNSC and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. The following initials are patients who received vaccines that were stored in refrigerator and these patients are being contacted to be re-vaccinated.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1801USA010002: US-009507513-1801USA010003: US-009507513-1801USA010004: US-009507513-1801USA010005: US-009507513-1801USA010006:
Sex: F
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were unknown by reporter. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX 23 intramuscularly, to prevent pneumonia (strength, lot # and expiration date were not reported). The PNEUMOVAX 23 was administered concomitantly with an unspecified influenza virus vaccine, also reported as "Flu ad shot" by reporter. On an unknown date, also reported as after being administered PNEUMOVAX 23, the patient became sick (malaise). The patient was hospitalized at an unknown location for an unknown duration and it was unknown if she received any treatment for the adverse experience or if any laboratory study was performed. The present status of the patient was reported as improved. The causality assessment between the malaise and the vaccination with PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, current conditions and drug reactions/allergies were not provided. On 15-DEC-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX for prophylaxis; route of administration was not reported (lot # N016090, expiration date: 23-AUG-2018). Concomitant therapies included properly stored sterile diluent used for reconstitution. The vaccine underwent a temperature of 6 Fahrenheit degrees (°F) to 14 °F (10.6 °F) for 2 hours 55 minutes. Previous temperature excursions included 6°F to 14°F for 1 hour and 15°F to 46°F (31.9°F) for 14 hours. Digital data logger was involved. No adverse effects were reported
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a 12 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, and concomitant medications. The patient had no drug and allergy history to be reported. Approximately on an unspecified date in December 2017 (reported as 1 month ago), the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration and expiration date were not provided), lot # N013276 for prophylaxis. The reporter stated that on an unknown date, the patient developed a lump at the injection site (injection site mass) that was painful (injection site pain). No treatment was given for the adverse event. No laboratory diagnostic were performed. The outcome of injection site mass and injection site pain was reported as not recovered. The causality between the aforementioned events and GARDASIL 9 was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from two Licensed Practical Nurse (LPN) referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unspecified date in January 2018, after 09-JAN-2018 (which had been previously reported as "between 03-JAN-2018 and 09-JAN-2018"), the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot number M036057 (also reported as "N036057"), expiration date 18-MAY-2019, (strength, dose, dose number and administration routes were not provided) for prophylaxis. The vaccine was exposure to a temperature excursion; the data logger registered a temperature of 48 Fahrenheit (F) for 1 hour and 45 minutes. The previous temperature excursion registered was 35 F for 3 hour. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA003362.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23 (lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for VARIVAX reconstitution was stored properly. Doses of VARIVAX was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of GARDASIL 9, ROTATEQ, PNEUMOVAX 23, RECOMBIVAX HB, and VAQTA were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. Follow-up information has been received from the physician on 23-JAN-2018 referring to a female patient. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with MNSC and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. The following initials are patients who received vaccines that were stored in refrigerator and these patients were being contacted to be re-vaccinated. This is one of several reports received from the same source. Sender's Comments: US-009507513-1801USA010003: US-009507513-1801USA010004: US-009507513-1801USA010005: US-009507513-1801USA010006: US-009507513-1801USA004018.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23 (lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for VARIVAX reconstitution was stored properly. Doses of VARIVAX was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of GARDASIL 9, ROTATEQ, PNEUMOVAX 23, RECOMBIVAX HB, and VAQTA were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. Follow-up information has been received from the physician on 23-JAN-2018 referring to a female patient. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with MNSC and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. She was vaccinated with improperly stored doses of ROTATEQ. The following initials are patients who received vaccines that were stored in refrigerator and these patients are being contacted to be re-vaccinated. This is one of several reports received from the same source. Sender's Comments: US-009507513-1801USA004018.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23(lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for VARIVAX reconstitution was stored properly. Doses of VARIVAX was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of GARDASIL 9, ROTATEQ, PNEUMOVAX 23, RECOMBIVAX HB, and VAQTA were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. Follow-up information has been received from the physician on 23-JAN-2018 referring to a male patient. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with MNSC and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. He was vaccinated with improperly stored doses of ROTATEQ. The following initials are patients who received vaccines that were stored in refrigerator and these patients are being contacted to be re-vaccinated. This is one of several reports received from the same source. Sender's Comments: US-009507513-1801USA004018.