chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a heath care worker and refers to a 28 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. It was reported that on an unspecified date, an unspecified 28 year old patient was vaccinated with GARDASIL 9, (dosage, route, lot number and expiration not reported) for prophylaxis. No adverse event was reported. No additional information was received. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Dizziness, Fatigue, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 17-year-old female patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date, the patient was diagnosed with Lyme disease by a Western Blot test administered by her mother. The patient's physician did not recognize the patient's unspecified symptoms as being related to Lyme disease. The patient's parents were also diagnosed with Lyme disease on unknown dates and aware of the unspecified symptoms. The patient's physician prescribed unspecified antibiotics after the result of Western blot test. The Lyme disease was dormant prior to the patient's GARDASIL 9 vaccination. On an unknown date in November 2015, the patient received her first dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported) for prevention of human papilloma virus (HPV). On unknown dates, after the vaccine administration, the patient began to experience memory, loss brain fog, partial paralysis, eye sensitivity, swollen glands and nausea. The other symptoms included extreme fatigue, muscle pain, feeling dizzy and a feeling of general unwellness. The patient was also hospitalized on an unknown date for pneumonia. Therapy with GARDASIL 9 was discontinued. The patient received treatment for the events. The outcome of the events was reported as not recovered at the time of reporting. The primary reporter stated that her daughter was unable to function as she wanted and needed care from an anonymous psychiatrist. The patient has also missed school because of not feeling well on unspecified dates. There was no further information regarding the physician's course of treatment. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of pneumonia and partial paralysis were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy, Malaise, Myalgia, Nausea, Paralysis
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 17-year-old female patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date, the patient was diagnosed with Lyme disease by a Western Blot test administered by her mother. The patient's physician did not recognize the patient's unspecified symptoms as being related to Lyme disease. The patient's parents were also diagnosed with Lyme disease on unknown dates and aware of the unspecified symptoms. The patient's physician prescribed unspecified antibiotics after the result of Western blot test. The Lyme disease was dormant prior to the patient's GARDASIL 9 vaccination. On an unknown date in November 2015, the patient received her first dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported) for prevention of human papilloma virus (HPV). On unknown dates, after the vaccine administration, the patient began to experience memory, loss brain fog, partial paralysis, eye sensitivity, swollen glands and nausea. The other symptoms included extreme fatigue, muscle pain, feeling dizzy and a feeling of general unwellness. The patient was also hospitalized on an unknown date for pneumonia. Therapy with GARDASIL 9 was discontinued. The patient received treatment for the events. The outcome of the events was reported as not recovered at the time of reporting. The primary reporter stated that her daughter was unable to function as she wanted and needed care from an anonymous psychiatrist. The patient has also missed school because of not feeling well on unspecified dates. There was no further information regarding the physician's course of treatment. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of pneumonia and partial paralysis were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Photophobia, Pneumonia
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 17-year-old female patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date, the patient was diagnosed with Lyme disease by a Western Blot test administered by her mother. The patient's physician did not recognize the patient's unspecified symptoms as being related to Lyme disease. The patient's parents were also diagnosed with Lyme disease on unknown dates and aware of the unspecified symptoms. The patient's physician prescribed unspecified antibiotics after the result of Western blot test. The Lyme disease was dormant prior to the patient's GARDASIL 9 vaccination. On an unknown date in November 2015, the patient received her first dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported) for prevention of human papilloma virus (HPV). On unknown dates, after the vaccine administration, the patient began to experience memory, loss brain fog, partial paralysis, eye sensitivity, swollen glands and nausea. The other symptoms included extreme fatigue, muscle pain, feeling dizzy and a feeling of general unwellness. The patient was also hospitalized on an unknown date for pneumonia. Therapy with GARDASIL 9 was discontinued. The patient received treatment for the events. The outcome of the events was reported as not recovered at the time of reporting. The primary reporter stated that her daughter was unable to function as she wanted and needed care from an anonymous psychiatrist. The patient has also missed school because of not feeling well on unspecified dates. There was no further information regarding the physician's course of treatment. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of pneumonia and partial paralysis were considered to be medically significant. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18 month old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient might have been vaccinated with a dose of GARDASIL 9 lot # M024261, expiration date 30-JUL-2017 (dose, route of administration were not reported), for prophylaxis. The concomitant medication included hepatitis A vaccine (manufacturer unknown) administered on an unknown date. The nurse reported that the patient's medical record indicated that a dose of Hepatitis A vaccine (manufacturer unknown) was administered, but the recorded lot number and expiration date "seemed to correspond to GARDASIL 9". No adverse reactions were reported. No product quality complaint (PQC) was involved. 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 nurse, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB whit Lot # M034189 and an expiration date of 23-OCT-2019 (strength, dose and route were not reported) for prophylaxis. It was confirmed that all the vaccines were reconstituted with sterile diluent (lot # and expiration date were not reported) which was stored in correct temperature range. No adverse effects were reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit degrees (°F) to 77 °F range, for a time frame of 3 hours and 30 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002379: US-009507513-1705USA002378:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to an unspecified patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. The nurse reported that the patient inadvertently received two doses of ZOSTAVAX. The first dose of ZOSTAVAX was given on 17-JAN-2017(strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis and the second dose of ZOSTAVAX was given on 28-APR-2017 (strength, dose, frequency, route of administration) were not provided (lot M037653, expiration 29-NOV-2017) for prophylaxis. No adverse effects reported. No further details provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a nurse via pother company letter (Pfizer) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23. The reporter was enquiring that if a patient reacted to PPSV23, what are the contraindications to receive PREVNAR13. The outcome of the event was unknown. The causality of the event was reported as related to PNEUMOVAX23. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test abnormal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, CD8 lymphocytes decreased
Clinical narrative: Information has been received from the author of a literature article titled as stated above referring to a 60 year-old female patient diagnosed with multiple sclerosis (MS) at age 44. She presented with a history of multiple episodes of bronchitis, pneumonia, and sinusitis in addition to hypothyroidism. CD3+ total T cells and CD3+CD8+ subsets were both low. CH50, IgG, and IgA were within normal limits but IgM was decreased (30 - 33 mg/dL) with a poor pneumococcal vaccine (manufacturer unknown) (dose, lot # and expiration date not reported) response as well as a decreased response to in vitro tetanus recall antigen despite intact tetanus antibody titers. The outcome of the event was unknown. The causality between pneumococcal vaccine (manufacturer unknown) and the event was related. A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same literature  (linked MARRS # 1705USA002635). Additional information has been requested. Literature Report: Sender's Comments:  US-009507513-1705USA002635:
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Complement factor normal, Selective IgM immunodeficiency, T-lymphocyte count decreased
Clinical narrative: Information has been received from the author of a literature article titled as stated above referring to a 60 year-old female patient diagnosed with multiple sclerosis (MS) at age 44. She presented with a history of multiple episodes of bronchitis, pneumonia, and sinusitis in addition to hypothyroidism. CD3+ total T cells and CD3+CD8+ subsets were both low. CH50, IgG, and IgA were within normal limits but IgM was decreased (30 - 33 mg/dL) with a poor pneumococcal vaccine (manufacturer unknown) (dose, lot # and expiration date not reported) response as well as a decreased response to in vitro tetanus recall antigen despite intact tetanus antibody titers. The outcome of the event was unknown. The causality between pneumococcal vaccine (manufacturer unknown) and the event was related. A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same literature  (linked MARRS # 1705USA002635). Additional information has been requested. Literature Report: Sender's Comments:  US-009507513-1705USA002635:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of M-M-R II which had Lot number M034856 with an expiration date of 27-JUL-2018, lot # reported as M002073 with an expiration date of 19-APR-2018 and lot # reported as M020073 with an expiration date of 19-APR-2018 (strength, dose and route were not reported) for prophylaxis. It was confirmed that all the vaccines were reconstituted with sterile diluent (lot # and expiration date were not reported) which was stored in correct temperature range. No adverse effects were reported. It was reported that the vaccines were exposed to temperature of >-15 centigrade degrees (°C) but <-10 °C range, for a time frame of 1 hour. The temperature excursion was not recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002377: US-009507513-1705USA002376:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The patients received unspecified doses of LIQUID PEDBAXHIB that were improperly stored; This spontaneous report was received from a nurse, concerning unspecified patients of unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates between 05-APR-2017 and 01-MAY-2017, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose, frequency and route were not reported) lot # M045206 with expiration date of 27-JUN-2019, for prophylaxis. The temperature excursion of the LIQUID PEDVAXHIB was 35 °F for a time frame of 44 minutes and 48.7 °F for a time frame of 1 hour and 15 minutes; no previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA001160:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning unspecified patients of unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates between 05-APR-2017 and 01-MAY-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency and route were not reported) lot # M037770 with expiration date of 01-JUN-2019, for prophylaxis. The temperature excursion of the GARDASIL 9 was 35°F for a time frame of 44 minutes and 48.7°F for a time frame of 1 hour and 15 minutes; Also, a previous temperature excursion occurred at 35.2°F for a time frame of 362 minutes (6 hours and 2 minutes). No adverse effects were reported. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001159.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history or concomitant medication were not reported. On 02-MAY-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 with lot # L029113 and an expiration date of 27-MAR-2017. There was no adverse event was 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 referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. It was reported that, LIQUID PEDVAXHIB, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002381: US-009507513-1705USA002380: US-009507513-1705USA002383: US-009507513-1705USA002382: US-009507513-1705USA002384:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of PROQUAD which had Lot number M018637 with an expiration date of 11-OCT-2017 and lot # M038862 with an expiration date of 13-MAR-2018 (strength, dose and route were not reported) for prophylaxis. It was confirmed that all the vaccines were reconstituted with sterile diluent (lot # and expiration date were not reported) which was stored in correct temperature range. No adverse effects were reported. It was reported that the vaccines were exposed to temperature of >-15 centigrade degrees (°C) but <-10°C range, for a time frame of 1 hour. The temperature excursion was not recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002377: US-009507513-1705USA001145.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX which had Lot number L030158 with an expiration date of 11-AUG-2017, lot # L048465 with an expiration date of 02-DEC-2017 and lot # M034583 with an expiration date of 27-JUL-2018 (strength, dose and route were not reported) for prophylaxis. It was confirmed that all the vaccines were reconstituted with sterile diluent (lot # and expiration date were not reported) which was stored in correct temperature range. No adverse effects were reported. It was reported that the vaccines were exposed to temperature of >-15 centigrade degrees (°C) but <-10 °C range, for a time frame of 1 hour. The temperature excursion was not recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001145: US-009507513-1705USA002376:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 with Lot # M037770 and an expiration date of 01-JUN-2019 (strength, dose and route were not reported) for prophylaxis. It was confirmed that all the vaccines were reconstituted with sterile diluent (lot # and expiration date were not reported) which was stored in correct temperature range. No adverse effects were reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit degrees (°F) to 77°F range, for a time frame of 3 hours and 30 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002379: US-009507513-1705USA000300.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of PNEUMOVAX23 whit Lot # M022086 and an expiration date of 09-OCT-2017 and lot # M023460 and expiration date of 12-NOV-2017 (strength, dose and route were not reported) for prophylaxis. It was confirmed that all the vaccines were reconstituted with sterile diluent (lot # and expiration date were not reported) which was stored in correct temperature range. No adverse effects were reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit degrees (°F) to 77 °F range, for a time frame of 3 hours and 30 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000300: US-009507513-1705USA002378:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis.        It was reported that, M-M-R II, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002384: US-009507513-1705USA002382: US-009507513-1705USA002383: US-009507513-1705USA001712: US-009507513-1705USA002381:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. It was reported that, RECOMBIVAX HB, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001712: US-009507513-1705USA002380: US-009507513-1705USA002383: US-009507513-1705USA002382: US-009507513-1705USA002384:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally (lot number and expiration date were not provided) for prophylaxis. It was reported that, ROTATEQ, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA002381: US-009507513-1705USA002380: US-009507513-1705USA002383: US-009507513-1705USA001712: US-009507513-1705USA002384:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. It was reported that, GARDASIL 9, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested. Sender's Comments: US-009507513-1705USA002381: US-009507513-1705USA002380: US-009507513-1705USA001712: US-009507513-1705USA002382: US-009507513-1705USA002384.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis.        It was reported that, VAQTA, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002381: US-009507513-1705USA002380: US-009507513-1705USA002383: US-009507513-1705USA002382: US-009507513-1705USA001712:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Fatigue, Pain
Clinical narrative: Experienced dizziness, tiredness, weakness, achy, tingly legs, low fever and almost passed out a couple times in school. She went to the school nurse. I picked her up from school and she came home and slept for a little while. Symptoms continued throughout the afternoon and early evening. I called her doctor and the nurse said to keep an eye on her to see if it gets worse.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Experienced dizziness, tiredness, weakness, achy, tingly legs, low fever and almost passed out a couple times in school. She went to the school nurse. I picked her up from school and she came home and slept for a little while. Symptoms continued throughout the afternoon and early evening. I called her doctor and the nurse said to keep an eye on her to see if it gets worse.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pharyngeal oedema, Presyncope, Pyrexia
Clinical narrative: Fever, 101.7, Headache, throat swelling, near syncope.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Allergy test, Anxiety, Asthma, Blood test, Computerised tomogram
Clinical narrative: My daughter received the GARDASIL vaccination and within 4 hours was screaming with her head hurting. From this day until present she has had 30 episodes of fainting, severe migraines, fatigue, body aches, missed 25 days of school, contracted pneumonia, the flu, viruses, and had sinus surgery. The syncope has worsened so that she stays home, absent from dance and swimming, battles with asthma, and has an immune disorder. This all began after that shot and has been downhill ever since. My daughter has developed anxiety, and depression due to the change in lifestyle.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Depression, Fatigue, Headache, Immune system disorder, Immunology test
Clinical narrative: My daughter received the GARDASIL vaccination and within 4 hours was screaming with her head hurting. From this day until present she has had 30 episodes of fainting, severe migraines, fatigue, body aches, missed 25 days of school, contracted pneumonia, the flu, viruses, and had sinus surgery. The syncope has worsened so that she stays home, absent from dance and swimming, battles with asthma, and has an immune disorder. This all began after that shot and has been downhill ever since. My daughter has developed anxiety, and depression due to the change in lifestyle.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Influenza, Loss of personal independence in daily activities, Migraine, Nuclear magnetic resonance imaging, Pain
Clinical narrative: My daughter received the GARDASIL vaccination and within 4 hours was screaming with her head hurting. From this day until present she has had 30 episodes of fainting, severe migraines, fatigue, body aches, missed 25 days of school, contracted pneumonia, the flu, viruses, and had sinus surgery. The syncope has worsened so that she stays home, absent from dance and swimming, battles with asthma, and has an immune disorder. This all began after that shot and has been downhill ever since. My daughter has developed anxiety, and depression due to the change in lifestyle.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pneumonia, Screaming, Sinus operation, Syncope, Viral infection
Clinical narrative: My daughter received the GARDASIL vaccination and within 4 hours was screaming with her head hurting. From this day until present she has had 30 episodes of fainting, severe migraines, fatigue, body aches, missed 25 days of school, contracted pneumonia, the flu, viruses, and had sinus surgery. The syncope has worsened so that she stays home, absent from dance and swimming, battles with asthma, and has an immune disorder. This all began after that shot and has been downhill ever since. My daughter has developed anxiety, and depression due to the change in lifestyle.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Platelet count decreased
Clinical narrative: PATIENT HAD LABS DRAWN THAT WERE NOT DUE TO VACCINE BUT NOTED TO HAVE A DECREASED PLATELET COUNT. CONTINUED TO HAVE DECREASING PLATELET COUNT FOR TWO MORE DRAWS.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Injection site swelling, Irritability
Clinical narrative: Patient developed a red rash down the left leg 3 hours after vaccine given. Left foot also became swollen and purple at the same time. Rash spread up to lower abdomen on left side. Fever developed approximately 6 hours after vaccine administered. No treatment sought. Rash remained for several days, patient had increased fussiness x 1 week.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Patient developed a red rash down the left leg 3 hours after vaccine given. Left foot also became swollen and purple at the same time. Rash spread up to lower abdomen on left side. Fever developed approximately 6 hours after vaccine administered. No treatment sought. Rash remained for several days, patient had increased fussiness x 1 week.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: Swelling and pain to touch.
Sex: M
Vaccine: MENB
Symptoms: Axillary pain, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old male patient of unspecified race/ethnicity received on an unspecified date TRUMENBA at 0.5 ml single dose in the left arm for immunization. Medical history and concomitant medications were not reported. Day after the administration, the patient went to ER with a red line around the left arm below the administration site. The patient reported also pain around the red line and below armpit. Outcome was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates between 06-MAR-2017 and 10-APR-2017, the multiple unspecified patients were vaccinated with improperly stored doses (also reported as doses were administered before temperature excursion) of VARIVAX (lot # L046887, expiration date 23-NOV-2017, dose, strength, route of administration were not provided). Sterile diluent used to reconstituted vaccines was properly stored. No adverse effects were reported. No product quality complain was involved. The vaccines were stored in the temperature between 6 and 14 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000161: US-009507513-1705USA000160:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Concomitant therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 03-APR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M037096, expiration date 23-AUG-2018; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measured a temperature range from 47 degrees Fahrenheit (F) to 77 degrees F for a total time frame of 15 minutes. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012786:
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Acute febrile neutrophilic dermatosis, Biopsy skin abnormal, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased
Clinical narrative: This literature marketed report was received from the authors. RATIONALE: Manifestations of immune dysregulation in common variable immunodeficiency (CVID) included granulomatous disease, autoimmunity, chronic lung disease, enteropathy, among others. Sweet's syndrome, or acute febrile neutrophilic dermatosis, was a hypersensitivity reaction characterized by fever, neutrophilia, and cutaneous eruptions. Few reports existed describing Sweet's syndrome in association with primary immunodeficiencies. METHODS: The authors herein presented a child with idiopathic, refractory Sweet's syndrome with extracutaneous manifestations and a subsequent diagnosis of CVID. RESULTS: A 9-year-old male developed fever, neutrophilia, mucocutaneous lesions, and tracheobronchial inflammation. Skin biopsy histopathology revealed a dense dermal neutrophilic infiltrate, and bronchoalveolar lavage fluid had a predominance of neutrophils. He was diagnosed with idiopathic Sweet's syndrome, ultimately well-controlled on tocilizumab and lenalidomide. His immune evaluation was unremarkable at diagnosis. Over 15 months, he had declining immunoglobulin levels and protective vaccine responses. Immunoglobulin G (IgG) declined from 536 to 290 mg/dL, IgM from 36 to <25 mg/dL, and IgA from 108 to 16 mg/dL. He received pneumococcal conjugate and polysaccharide vaccines (manufacturer unknown) (dose, lot # and expiration date not reported) and had unsustained responses. He had normal B-cell number and cellular immune evaluation. He clinically developed upper and lower respiratory tract infections. With these findings in mind, the patient was diagnosed with CVID and started on immunoglobulin replacement therapy. CONCLUSIONS: Immune dysregulation was common in CVID. Sweet's syndrome was an inflammatory skin condition generally associated with autoimmune disease and malignancies. This is one of few cases reporting Sweet's syndrome in the setting of CVID. This case should encourage providers to screen Sweet's syndrome patients for underlying primary and acquired immunodeficiencies. The outcome of the event was unknown. The causality between the event and pneumococcal conjugate and polysaccharide vaccines (manufacturer unknown) was related. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Bronchoalveolar lavage abnormal, Immunodeficiency common variable, Immunoglobulin therapy, Lower respiratory tract infection, Neutrophilia
Clinical narrative: This literature marketed report was received from the authors. RATIONALE: Manifestations of immune dysregulation in common variable immunodeficiency (CVID) included granulomatous disease, autoimmunity, chronic lung disease, enteropathy, among others. Sweet's syndrome, or acute febrile neutrophilic dermatosis, was a hypersensitivity reaction characterized by fever, neutrophilia, and cutaneous eruptions. Few reports existed describing Sweet's syndrome in association with primary immunodeficiencies. METHODS: The authors herein presented a child with idiopathic, refractory Sweet's syndrome with extracutaneous manifestations and a subsequent diagnosis of CVID. RESULTS: A 9-year-old male developed fever, neutrophilia, mucocutaneous lesions, and tracheobronchial inflammation. Skin biopsy histopathology revealed a dense dermal neutrophilic infiltrate, and bronchoalveolar lavage fluid had a predominance of neutrophils. He was diagnosed with idiopathic Sweet's syndrome, ultimately well-controlled on tocilizumab and lenalidomide. His immune evaluation was unremarkable at diagnosis. Over 15 months, he had declining immunoglobulin levels and protective vaccine responses. Immunoglobulin G (IgG) declined from 536 to 290 mg/dL, IgM from 36 to <25 mg/dL, and IgA from 108 to 16 mg/dL. He received pneumococcal conjugate and polysaccharide vaccines (manufacturer unknown) (dose, lot # and expiration date not reported) and had unsustained responses. He had normal B-cell number and cellular immune evaluation. He clinically developed upper and lower respiratory tract infections. With these findings in mind, the patient was diagnosed with CVID and started on immunoglobulin replacement therapy. CONCLUSIONS: Immune dysregulation was common in CVID. Sweet's syndrome was an inflammatory skin condition generally associated with autoimmune disease and malignancies. This is one of few cases reporting Sweet's syndrome in the setting of CVID. This case should encourage providers to screen Sweet's syndrome patients for underlying primary and acquired immunodeficiencies. The outcome of the event was unknown. The causality between the event and pneumococcal conjugate and polysaccharide vaccines (manufacturer unknown) was related. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Skin lesion, Tracheal inflammation, Upper respiratory tract infection
Clinical narrative: This literature marketed report was received from the authors. RATIONALE: Manifestations of immune dysregulation in common variable immunodeficiency (CVID) included granulomatous disease, autoimmunity, chronic lung disease, enteropathy, among others. Sweet's syndrome, or acute febrile neutrophilic dermatosis, was a hypersensitivity reaction characterized by fever, neutrophilia, and cutaneous eruptions. Few reports existed describing Sweet's syndrome in association with primary immunodeficiencies. METHODS: The authors herein presented a child with idiopathic, refractory Sweet's syndrome with extracutaneous manifestations and a subsequent diagnosis of CVID. RESULTS: A 9-year-old male developed fever, neutrophilia, mucocutaneous lesions, and tracheobronchial inflammation. Skin biopsy histopathology revealed a dense dermal neutrophilic infiltrate, and bronchoalveolar lavage fluid had a predominance of neutrophils. He was diagnosed with idiopathic Sweet's syndrome, ultimately well-controlled on tocilizumab and lenalidomide. His immune evaluation was unremarkable at diagnosis. Over 15 months, he had declining immunoglobulin levels and protective vaccine responses. Immunoglobulin G (IgG) declined from 536 to 290 mg/dL, IgM from 36 to <25 mg/dL, and IgA from 108 to 16 mg/dL. He received pneumococcal conjugate and polysaccharide vaccines (manufacturer unknown) (dose, lot # and expiration date not reported) and had unsustained responses. He had normal B-cell number and cellular immune evaluation. He clinically developed upper and lower respiratory tract infections. With these findings in mind, the patient was diagnosed with CVID and started on immunoglobulin replacement therapy. CONCLUSIONS: Immune dysregulation was common in CVID. Sweet's syndrome was an inflammatory skin condition generally associated with autoimmune disease and malignancies. This is one of few cases reporting Sweet's syndrome in the setting of CVID. This case should encourage providers to screen Sweet's syndrome patients for underlying primary and acquired immunodeficiencies. The outcome of the event was unknown. The causality between the event and pneumococcal conjugate and polysaccharide vaccines (manufacturer unknown) was related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates between 06-MAR-2017 and 10-APR-2017, the multiple unspecified patients were vaccinated with improperly stored doses (also reported as doses were administered before temperature excursion) of PROQUAD (recombinant human albumin (rHA)) injection (lot# M018636, expiry date 11-OCT-2017, dose and route of administration were not reported). Sterile diluent used to reconstituted vaccines was properly stored. No adverse effects were reported. No product quality complain was involved. The vaccines were stored in the temperature between 6 and 14 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA005927: US-009507513-1705USA000161.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates between 06-MAR-2017 and 10-APR-2017, the multiple unspecified patients were vaccinated with improperly stored doses (also reported as doses were administered before temperature excursion) of ZOSTAVAX injection (lot# M036297, expiry date 14-NOV-2017, dose, route of administration). Sterile diluent used to reconstituted vaccines was properly stored. No adverse effects were reported. No product quality complain was involved. The vaccines were stored in the temperature between 6 and 14 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Digital data logger was involved.  This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA005927: US-009507513-1705USA000160:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M040269, expiration date on 28-APR-2018 (Strength, dose number and anatomical location were not provided). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature of 48°F (Fahrenheit degrees) with a time frame of 10 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002375.