chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Blood urea normal, Blood urine present, C-reactive protein increased, CSF culture negative, CSF glucose normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: CSF immunoglobulin, CSF protein normal, CSF red blood cell count positive, CSF white blood cell count negative, Carbon dioxide normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Culture urine negative, Diarrhoea, Eosinophil count decreased
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Eosinophil percentage decreased, Glucose urine absent, Haematocrit normal, Haemoglobin normal, Headache
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Human chorionic gonadotropin negative, Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin concentration normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count decreased, Monocyte percentage increased
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Mononucleosis heterophile test negative, Neutrophil count normal, Neutrophil percentage increased, Nitrite urine absent, Platelet count normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Protein total normal, Protein urine absent, Red blood cell count normal, Red cell distribution width normal, Seizure
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Smear site unspecified normal, Specific gravity urine normal, Streptococcus test negative, Syncope, Urine ketone body present
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Urine leukocyte esterase, Urobilinogen urine, Urticaria, White blood cell count normal, pH urine normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Basophil percentage decreased, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood culture negative, Blood glucose normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Blood lactic acid normal, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Borrelia test negative, C-reactive protein increased, CSF culture negative, CSF glucose normal, CSF protein normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: CSF red blood cell count positive, CSF white blood cell count negative, Carbon dioxide normal, Chest X-ray normal, Computerised tomogram head normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Culture throat negative, Culture urine negative, Differential white blood cell count, Dizziness, Eosinophil count decreased
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Haematocrit normal, Haemoglobin normal, Headache, Human chorionic gonadotropin negative, Lymphocyte count decreased
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin increased, Mean cell volume normal, Mean platelet volume increased
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Monocyte count increased, Monocyte percentage decreased, Neutrophil count normal, Neutrophil percentage increased, Nitrite urine absent
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Platelet count normal, Protein total normal, Red blood cell count normal, Red blood cells urine positive, Seizure
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Specific gravity urine normal, Streptococcus test negative, Syncope, Urine ketone body absent, Urine ketone body present
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Urobilinogen urine, White blood cell count normal, White blood cells urine negative, pH urine normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Headache, Injection site erythema
Clinical narrative: I received the FLUZONE QUAD wyr 2016-17 inj from the pharmacy. Since then the injection site has a big red mark about 1/2 a fist size, swelling,pain and severe headaches. I'm sleepy all the time, loss of appetite, diarrhea, and ikky tummy. Its been 3 days and its not getting better..ive gotten the flu shot every year..the only difference was this time I got the shot early instead of waiting like i usually do. Was this a bad batch or what?
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Somnolence
Clinical narrative: I received the FLUZONE QUAD wyr 2016-17 inj from the pharmacy. Since then the injection site has a big red mark about 1/2 a fist size, swelling,pain and severe headaches. I'm sleepy all the time, loss of appetite, diarrhea, and ikky tummy. Its been 3 days and its not getting better..ive gotten the flu shot every year..the only difference was this time I got the shot early instead of waiting like i usually do. Was this a bad batch or what?
Sex: F
Vaccine: HPV4
Symptoms: Death, Encephalitis
Clinical narrative: Information has been received from a gynecologist via a company representative referring to multiple female patients of unknown age. Information regarding concomitant therapy, concurrent condition and medical history was not reported. On unknown dates, the patients were vaccinated with GARDASIL 0.5 ml injection (lot # and expiration date were not reported; 0.5ml) intramuscularly. It was reported that the patients experienced encephalitis and died (date not reported). It was unknown if autopsy was performed. The causality between encephalitis and the vaccine was unknown. Upon internal review, the event encephalitis was considered to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, LYME
Symptoms: Facial paralysis, Pyrexia, Vomiting
Clinical narrative: Given the first GARDASIL shot 8/2/16. 8/6/16-ran a small fever-99. 8/8/16-took her to urgent care. 8/11/16-took her to her primary doctor bc of her face.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, LYME
Symptoms: Acoustic stimulation tests normal, Borrelia test, Computerised tomogram normal, Facial paralysis, Pyrexia
Clinical narrative: Given the first GARDASIL shot 8/2/16. 8/6/16-ran a small fever-99. 8/8/16-took her to urgent care. 8/11/16-took her to her primary doctor bc of her face.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Neurological examination normal, Tinnitus
Clinical narrative: Information has been received from a male patient of unknown age concerning himself. The patient's concurrent condition included asthma. The patient's medical history and concomitant medication were not reported. On 15-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were unknown). About 15 minutes after receiving the ZOSTAVAX, the patient experienced a headache and ringing in his ears. The patient had contacted a physician for medical attention by unspecified way and received treatment, however, the event did not improve. The outcome of the headache and ringing in ears was reported as not recovered at the reporting time. The causal relationship between the headache and ringing in ears and ZOSTAVAX was unknown. Additional information is not expected as there was no consent to contact the reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Tinnitus
Clinical narrative: Information has been received from a male patient of unknown age concerning himself. The patient's concurrent condition included asthma. The patient's medical history and concomitant medication were not reported. On 15-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were unknown). About 15 minutes after receiving the ZOSTAVAX, the patient experienced a headache and ringing in his ears. The patient had contacted a physician for medical attention by unspecified way and received treatment, however, the event did not improve. The outcome of the headache and ringing in ears was reported as not recovered at the reporting time. The causal relationship between the headache and ringing in ears and ZOSTAVAX was unknown. Additional information is not expected as there was no consent to contact the reporter.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Mobility decreased, Periarthritis, Rotator cuff syndrome
Clinical narrative: Patient received a FLUZONE HD vaccination at 10:30 am 9/7/16-She returned to the pharmacy at 4:00 pm and complained of arm shoulder/pain that started at 2pm and was not relieved by Ibuprofen/Ice pack treatment-She was referred to her physician for advice/treatment- She had an apt 9/8/16 with her physician.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient received a FLUZONE HD vaccination at 10:30 am 9/7/16-She returned to the pharmacy at 4:00 pm and complained of arm shoulder/pain that started at 2pm and was not relieved by Ibuprofen/Ice pack treatment-She was referred to her physician for advice/treatment- She had an apt 9/8/16 with her physician.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Only noticed a warm, raised, red area tonight, only slightly tender when touched. About 5 cm long by 3cm wide (elliptical shaped).
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Full blood count, Headache, Lumbar puncture, Metabolic function test
Clinical narrative: Headache, fatigue, low grade fever, lower extremity weakness.
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Muscular weakness, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Headache, fatigue, low grade fever, lower extremity weakness.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Puffiness, erythema, mild ache in deltoid muscle on left side lasting for about 24 hours; since resolved.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 10 cm oval area of warmth, erythema and edema right deltoid and similar 8 centimeter area left deltoid.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Differential white blood cell count, Disturbance in attention, Epstein-Barr virus antibody negative, Feeling abnormal, Haematocrit normal
Clinical narrative: Pt received Flu vaccine lot UI625AA on 8/29/16. Within 24 hrs developed severe headache within 48 hr developed mental "fogginess", poor Focus/concentration, ear difficulty. Required 2 office visits. CBC WNL, EBV titers Negative. Parent requested reporting due to persistence of sx to present.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Haemoglobin normal, Headache, Platelet count normal, White blood cell count normal
Clinical narrative: Pt received Flu vaccine lot UI625AA on 8/29/16. Within 24 hrs developed severe headache within 48 hr developed mental "fogginess", poor Focus/concentration, ear difficulty. Required 2 office visits. CBC WNL, EBV titers Negative. Parent requested reporting due to persistence of sx to present.
Age: 21.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: Lg, circular warm to touch red raised rash, itching.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Hypophagia, Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: One episode of bloody stool and decreased formula intake (drank two ounces during day).  Was sent to ED at Hospital.  In ED they did an ultrasound and patient was found to have an intussusception and required surgery.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Extreme pain radiating from injection site on upper arm up to neck my neck and down to my fingures.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Induration, Pain, Skin warm, Urticaria
Clinical narrative: Red from shoulder to elbow, hard, hives and hot plus pain. Went to urgent care on 12 Sep 2016. Was given an antibiotic shot, steroid injection and 10 day treatment of oral antibiotic.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Blood test, Feeling cold, Muscular weakness, Pain
Clinical narrative: This spontaneous report was received from a nurse (licensed vocational nurse) refers to a 52 year old female patient. The patient's pertinent medical history included hypothyroidism and dyslipidaemia. Patient was allergic to codeine (manufacturer unknown). On 07-SEP-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L029306 and expiration date as 26-MAR-2017) 0.5 ml, intramuscular injection. Concomitant therapies included ZETIA and levothyroxine sodium (manufacturer unknown). On 07-SEP-2016 (reported as in the evening) the patient experienced severe body ache and severe right arm pain, the patient also vomited once and had muscle weakness needing assistance to get up and walk (abasia) (medically significant). It was also reported that the patient took Ibuprofen (manufacturer unknown) and it helped with the body ache but did not help with the right arm pain. On 07-SEP-2016 the patient also felt cold but her relatives stated that her skin felt very hot. On an unknown date in September 2016 the patient underwent unspecified blood work results were not specified. The patient sought medical attention and contacted her doctor. There was no product quality complaint reported. The outcome of the adverse events  was reported as recovering. The causality assessment was not provided by the reporter. Upon internal review the event abasia was considered to be medically significant. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm, Vomiting
Clinical narrative: This spontaneous report was received from a nurse (licensed vocational nurse) refers to a 52 year old female patient. The patient's pertinent medical history included hypothyroidism and dyslipidaemia. Patient was allergic to codeine (manufacturer unknown). On 07-SEP-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L029306 and expiration date as 26-MAR-2017) 0.5 ml, intramuscular injection. Concomitant therapies included ZETIA and levothyroxine sodium (manufacturer unknown). On 07-SEP-2016 (reported as in the evening) the patient experienced severe body ache and severe right arm pain, the patient also vomited once and had muscle weakness needing assistance to get up and walk (abasia) (medically significant). It was also reported that the patient took Ibuprofen (manufacturer unknown) and it helped with the body ache but did not help with the right arm pain. On 07-SEP-2016 the patient also felt cold but her relatives stated that her skin felt very hot. On an unknown date in September 2016 the patient underwent unspecified blood work results were not specified. The patient sought medical attention and contacted her doctor. There was no product quality complaint reported. The outcome of the adverse events  was reported as recovering. The causality assessment was not provided by the reporter. Upon internal review the event abasia was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient in her late 50's. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the dose of ZOSTAVAX (subcutaneously, lot # M001746, expiration date 07-APR-2017; dose was not provided). In September 2016 (reported as at the beginning of the week), the patient developed what her doctor later diagnosed as cellulitis. The patient sought medical attention and received an unspecified treatment of the adverse event. The pharmacist requested a lot check. The outcome of cellulitis was reported as not recovered at the time of this report. The relatedness between the adverse event and ZOSTAVAX was not provided. Upon internal review, the adverse event of cellulitis was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster, Laboratory test, Rash
Clinical narrative: Information has been received from a 73 year old male patient referring to himself. The patient's drug reactions/allergies included ROCEPHIN. The patient's concurrent conditions and pertinent medical history were not provided. In approximately 2009 (reported as 6-7 years ago), the patient was vaccinated with ZOSTAVAX (subcutaneous; dose, lot # and expiration date were unknown). The patient stated that right after receipt of the vaccine he developed a mild rash in his ears. The rash was not immediately identified as shingles. The rash in the patient's ears eventually spread to other areas of his face on both sides, and was accompanied by Bell's Palsy. The rash was later confirmed to be shingles. The patient explained that he had developed intermittent breakouts of shingles on his face since receipt of the vaccine, which had been occurring for the last 6 years and occur approximately every 6 months, and take approximately 4 months to recover from it. The patient was being treated with unspecified antiviral medications. The patient was not recovered at this time, as the breakouts continually occur. The patient visited physician for medical attention. Unspecified lab tests were performed (result not provided). The causality was not provided. Upon internal review, Bell's Palsy was considered to be medically significant. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Headache, Seizure
Clinical narrative: This spontaneous report as received from a consumer refers to her 19 year old son. The patient's pertinent medical history and drug allergies were none. On 05-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9 (dosing details were not reported). Concomitant medications included CLARINEX and unspecified vitamins. On 05-AUG-2016 (same day), while the patient was sitting in the office waiting to check his second appointment, the patient experienced seizures. While "seizing" the patient hit the back of his head against the wall and developed a headache that took days to clear up. The patient sought medical attention and treatment was given for the adverse events. On 07-AUG-2016, the patient completely recovered from headache. The outcome of the events was reported as recovered/resolved. The causal relationship between the events and the GARDASIL 9 was not reported. Upon internal review, the event seizures were considered to be serious, medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via field representative refers to his/her 12 year old daughter. The patient's pertinent medical history and concurrent conditions were not reported. Approximately in 2013 (reported as almost 3 years ago), the patient was vaccinated with GARDASIL (dosing details were not reported). Concomitant medications were unknown. On an unknown date (reported as unspecified amount for time after the dose was administered), the patient experienced rash on her face and torso. The outcome of rash on her face and torso was unknown. The relatedness of the events with GARDASIL was not reported. This is one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUN-2016, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD lot # M00152 (exact dose, expiration date, therapy type and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 58 year old female patient. The patient's concurrent conditions included rheumatoid arthritis. The patient was vaccinated with PREVENAR 13 on an unknown date in July 2016. The patient had no drug reactions and no allergies. On 06-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 subcutaneously (dose, lot# and expiration date were not reported). The patient's concomitant therapies included methotrexate and sulfasalazine. On 06-SEP-2016 (reported also as following PNEUMOVAX 23 administration), the patient developed redness, warmth at the injection site and her arm was very painful. The patient received an unspecified treatment for the events. None lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information is not expected as there was no consent for further contact.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 65-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date: 01-FEB-2017 )dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Red, swelling, 2 spots larger than a quarter, painful to lay on or touch.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Joint range of motion decreased, Joint swelling, Musculoskeletal pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: On 05/23/16, 32 yo F presented to clinic for comprehensive physical exam. During this visit, pt received MMR vaccination 0.5 mL SC in right arm (NDC: 0006-4681-00, Lot #M001200; exp: 08/28/2016). On 07/31/16, pt sent an e-mail stating "When I came in May to get my vaccines, the nurse told me that I may experience discomfort near the injection site for up to two months. It has now been just a little over two months and my arm still hurts, in fact it seems to be getting worse rather than better. I think I may need to see another doctor to determine if there was any injury from the injection. Do you have any advice on what I should do?" On 08/01, RN replied and asked pt to call and schedule an appointment for evaluation. On 08/15, pt was evaluated by MD and charted "The quality of the pain is described as aching. The pain is at a severity of 7/10 (up to 10 while sleeping). Associated symptoms include an inability to bear weight (struggle to use hair brush), joint swelling and a limited range of motion. Pertinent negatives include no numbness, stiffness or tingling. She has tried acetaminophen for the symptoms. Patient is concerned that it is all related to her MMR vaccination almost 3 months ago for her college and it was on her right arm and since then she is having this shoulder pain which is getting more worse." MD unable to rule out rotator cuff syndrome. Pt prescribed tramadol 100 mg PO Q6H PRN and referred to Orthopedics.  On 08/15, pt seen by ortho PA. Per note ...talked about potential neuritis or Parsonage Turner secondary to vaccination. Hopefully this is not the case. We have also talked about more common problems in the shoulder such as rotator cuff impingement and bursitis. Given the timing of the events, it does seem that the vaccination may be directly related to the onset of shoulder pain." Therapies discussed and pt given injection of 6 ccs of Marcaine 0.25%, 4 mgs Dexamethasone, and 40 mgs Kenalog into the right subacromial space. Pt also advised to start an exercise program. On 09/06, pt's emailed "I am still experiencing the pain in my arm, despite seeing and having to pay for a shoulder specialist for consultation." PA replied with options of physical therapy or MRI. No subsequent encounters charted. Current plan unknown. Reportedly, pt refused MRI.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site swelling, Pain, Tenderness
Clinical narrative: Swelling (L) tricep, redness, tenderness, painful, headache.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction (red, hot, swollen).
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 69-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date: 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and drug reaction/allergies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M011840, expiration date 01-FEB-2018; dose and route were unknown). The vaccines were stored at 48.7 Fahrenheit degree for 65 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.