chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Fatigue, Hypersomnia, Irritability, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration not provided). No concomitant therapy was reported. On an unknown date the patient experienced malaise/fatigue and the patient was sleeping for 22 hours per day for 3 weeks. The patient went to unspecified physician on 09-DEC-2015 and it was noted that patient seemed irritated. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, a health care worker refers to patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. The reporter stated that on an unspecified date, the patients were vaccinated with improperly stored VARIVAX Lot # L002871 EXP: 27-JAN-2017, Lot # L015047 EXP: 29-APR-2017 and Lot # L008272 EXP: 11-MAR-2017 (unknown how many). No adverse effects reported. No product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker referring to a 6 month old male patient. The patient had no pertinent medical history or drug reactions/allergies. On 30-NOV-2015 the patient was vaccinated with the first dose of PEDVAXHIB (lot# reported as L030868 with expiration date of 09-JUN-2018, 0.5 ml, intramuscular) in the left thigh. There was no concomitant medication. On 03-DEC-2015, the patient's mother called the physician's office to report a lump at the injection site that was red and swollen. Warm compresses were given for the treatment. No lab diagnostics study was performed. On 14-DEC-2015, the patient was seen in the physician's office again to follow up. The lump was going down but still present. The outcome of the event was recovering. Causality was not provided. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician assistant referring to a male patient of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. The patient received the first dose of unidentified Merck HPV vaccine (name and lot number not provided) on 14-JUN-2014 and the second dose on an unspecified date in Jun 2015 (dose and route unknown for both doses) (inappropriate schedule of drug administration). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practiced nurse refers to 5 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 05-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practiced nurse refers to 3 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 06-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practiced nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-NOV-2015, the patient was vaccinated with improperly stored doses of GARDASIL 9 was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practiced nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-DEC-2015, the patient was vaccinated with improperly stored doses of GARDASIL 9 was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practiced nurse refers to 2 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 12-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Polymenorrhoea
Clinical narrative: Information has been received from a certified medical assistant via a field representative referring to a female patient of unknown age. The patient was not pregnant. Information about medical history, concurrent condition and concomitant medication was not reported. On an unknown date the patient was vaccinated with GARDASIL or GARDASIL 9 (strength, dosage, frequency, series and route unspecified). The patient's mother reported that prior to the GARDASIL or GARDASIL 9, the patient's menstrual cycle was every four weeks. After vaccination the patient's menstrual cycle was every 2 weeks on an unspecified date in 2015 (reported as "now"). The patient sought medical attention via calling the reporter. The outcome of the event was unknown. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Cytogenetic analysis, Exposure during pregnancy, No adverse event, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report has been received from a medical assistant referring to a 38 year old female patient. The patient had nausea and vomiting with SULFA. The patient also had angioedema with penicillin. On 19-OCT-2015, the pregnancy patient (pregnancy onset date unspecified) was inadvertently administered VARIVAX (dose, strength, lot # and route were not reported). Concomitant therapy included extended released metformin hydrochloride. There was no treatment for drug exposure during pregnancy. The reporter stated that the patient was currently 15 weeks pregnancy as of 03-DEC-2015 (reported as today). So the last menstruation period (LMP) was estimated on approximately 20-AUG-2015. The estimated delivery date (EDD) would be on approximately 26-MAY-2016. The reporter also reported that the patient had routine unspecified blood work, an ultrasound and panorama genetic testing performed on 03-DEC-2015. The result of ultrasound was normal and the results of unspecified blood work and panorama genetic testing were pending as of 03-DEC-2015. No adverse effects were reported. The patient had sought medical attention by seeing the physician in office. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The unspecified patients were administered ROTATEQ (lot# K024700, expiration date 30-JUL-2016) (oral, dose and frequency not reported), which were exposed to temperatures outside of the recommended range since 05-NOV-2015. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed redness, swelling and itching to right upper outer arm and painful to touch on 12/20/15. The redness, swelling and itching improved, however, was still present on 12/21/15. Patient seen in office visit on 12/21/15. Patient had been applying ice and cortisone cream at onset. This treatment and BENADRYL was recommended at MD visit.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Laboratory test, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 84 year old female patient. The patient's concurrent conditions included diabetes mellitus. The patient's concomitant medications included unspecified diabetes medications. She did not have any known drug reactions or allergies. In approximately 2012 (reported as "about 3 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not reported). In approximately 2015 (reported as "recently"), the patient experienced shingles on her face. The nurse reported that shingles resolved on an unknown date in approximately 2015, but the patient was left with only a little redness at the site of where rash was, which was going away slowly. The patient did not receive any treatment. There were unknown laboratory tests performed, but the results were not provided. The patient sought unspecified medical attention. The outcome of the little redness was reported as recovering/resolving by the time of the report. The causal relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUN3, HPV9, FLUN4, HPV4, FLUN3, HPV9
Symptoms: Activities of daily living impaired, Adverse event, Death
Clinical narrative: A report has been received from a physician (medical doctor), reported by a medical representative via Merck, concerning a female patient. Relevant medical history, concurrent diseases and concomitant medications were not reported. On unspecified date, the patient received FLUMIST (intranasal). Another vaccine was given on the same day, GARDASIL 9. It was unknown if the quadrivalent HPV virus vaccine injection was the first, second, or third in a series of three injections. The patient went back to the doctor's office the same day, she received the injection for an unspecified reason. The next day, the patient did not participate in gym class at school for an unspecified reason and died at an unknown time. Cause of death was unspecified. It was unknown whether autopsy was performed. The reporter assessed the case as serious with death criterion.
Sex: F
Vaccine: FLUN3, HPV9, FLUN4, HPV4, FLUN3, HPV9
Symptoms: Activities of daily living impaired, Death
Clinical narrative: A report has been received from a physician (medical doctor), reported by a medical representative via Merck, concerning a female patient. Relevant medical history, concurrent diseases and concomitant medications were not reported. On unspecified date, the patient received FLUMIST (intranasal). Another vaccine was given on the same day, GARDASIL 9. It was unknown if the quadrivalent HPV virus vaccine injection was the first, second, or third in a series of three injections. The patient went back to the doctor's office the same day, she received the injection for an unspecified reason. The next day, the patient did not participate in gym class at school for an unspecified reason and died at an unknown time. Cause of death was unspecified. It was unknown whether autopsy was performed. The reporter assessed the case as serious with death criterion.
Sex: F
Vaccine: FLUN3, HPV9, FLUN4, HPV4, FLUN3, HPV9
Symptoms: Death
Clinical narrative: A report has been received from a physician (medical doctor), reported by a medical representative via Merck, concerning a female patient. Relevant medical history, concurrent diseases and concomitant medications were not reported. On unspecified date, the patient received FLUMIST (intranasal). Another vaccine was given on the same day, GARDASIL 9. It was unknown if the quadrivalent HPV virus vaccine injection was the first, second, or third in a series of three injections. The patient went back to the doctor's office the same day, she received the injection for an unspecified reason. The next day, the patient did not participate in gym class at school for an unspecified reason and died at an unknown time. Cause of death was unspecified. It was unknown whether autopsy was performed. The reporter assessed the case as serious with death criterion.
Age: 1.7
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Lethargy, Polymerase chain reaction, Rash generalised, Scab, Skin lesion
Clinical narrative: This medically confirmed spontaneous report (initial receipt 14-Dec-2015) concerns a 19-month-old female patient who had no drug reactions/allergies. On 13-Nov-2015, the patient received unspecified inactivated flu vaccine (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Varivax injection (varicella virus vaccine, batch number K002919) for the prevention of varicella. On 26-Nov-2015, the patient started to exhibit severe lethargy.  On 27-Nov-2015, the patient had a fever and crusting lesions on her thigh and abdomen. She was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the body and she was admitted to the hospital on 28-Nov-2015.  Treatment included intravenous acyclovir and unspecified antibiotic. She was still experiencing chickenpox like vesicles. The outcome was not recovered (unknown for inappropriate age at vaccine administration). Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, all events are unlisted except for pyrexia. Causality: Unrelated. The causative agent for the diagnosis is varicella virus, which is not transmitted via influenza vaccines; and is therefore biologically implausible. It is more reasonable to assume that the diagnosis was related to the varicella vaccine concomitantly received. All other symptoms are assessed in context of the diagnosis.
Age: 1.7
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test
Clinical narrative: This medically confirmed spontaneous report (initial receipt 14-Dec-2015) concerns a 19-month-old female patient who had no drug reactions/allergies. On 13-Nov-2015, the patient received unspecified inactivated flu vaccine (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Varivax injection (varicella virus vaccine, batch number K002919) for the prevention of varicella. On 26-Nov-2015, the patient started to exhibit severe lethargy.  On 27-Nov-2015, the patient had a fever and crusting lesions on her thigh and abdomen. She was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the body and she was admitted to the hospital on 28-Nov-2015.  Treatment included intravenous acyclovir and unspecified antibiotic. She was still experiencing chickenpox like vesicles. The outcome was not recovered (unknown for inappropriate age at vaccine administration). Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, all events are unlisted except for pyrexia. Causality: Unrelated. The causative agent for the diagnosis is varicella virus, which is not transmitted via influenza vaccines; and is therefore biologically implausible. It is more reasonable to assume that the diagnosis was related to the varicella vaccine concomitantly received. All other symptoms are assessed in context of the diagnosis.
Age: 1.7
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Eczema, Herpes virus infection, Polymerase chain reaction, Pyrexia, Rash pruritic
Clinical narrative: This medically confirmed spontaneous report (initial receipt 14-Dec-2015) concerns a 19-month-old female patient who had no drug reactions/allergies. On 13-Nov-2015, the patient received unspecified inactivated flu vaccine (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Varivax injection (varicella virus vaccine, batch number K002919) for the prevention of varicella. On 26-Nov-2015, the patient started to exhibit severe lethargy.  On 27-Nov-2015, the patient had a fever and crusting lesions on her thigh and abdomen. She was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the body and she was admitted to the hospital on 28-Nov-2015.  Treatment included intravenous acyclovir and unspecified antibiotic. She was still experiencing chickenpox like vesicles. The outcome was not recovered (unknown for inappropriate age at vaccine administration). Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, all events are unlisted except for pyrexia. Causality: Unrelated. The causative agent for the diagnosis is varicella virus, which is not transmitted via influenza vaccines; and is therefore biologically implausible. It is more reasonable to assume that the diagnosis was related to the varicella vaccine concomitantly received. All other symptoms are assessed in context of the diagnosis.
Age: 1.7
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Simplex virus test positive, Skin lesion
Clinical narrative: This medically confirmed spontaneous report (initial receipt 14-Dec-2015) concerns a 19-month-old female patient who had no drug reactions/allergies. On 13-Nov-2015, the patient received unspecified inactivated flu vaccine (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Varivax injection (varicella virus vaccine, batch number K002919) for the prevention of varicella. On 26-Nov-2015, the patient started to exhibit severe lethargy.  On 27-Nov-2015, the patient had a fever and crusting lesions on her thigh and abdomen. She was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the body and she was admitted to the hospital on 28-Nov-2015.  Treatment included intravenous acyclovir and unspecified antibiotic. She was still experiencing chickenpox like vesicles. The outcome was not recovered (unknown for inappropriate age at vaccine administration). Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, all events are unlisted except for pyrexia. Causality: Unrelated. The causative agent for the diagnosis is varicella virus, which is not transmitted via influenza vaccines; and is therefore biologically implausible. It is more reasonable to assume that the diagnosis was related to the varicella vaccine concomitantly received. All other symptoms are assessed in context of the diagnosis.
Age: 1.7
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Blister, Injection site reaction, Lethargy, Pyrexia, Scab
Clinical narrative: This medically confirmed spontaneous report (initial receipt 14-Dec-2015) concerns a 19-month-old female patient who had no drug reactions/allergies. On 13-Nov-2015, the patient received unspecified inactivated flu vaccine (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Varivax injection (varicella virus vaccine, batch number K002919) for the prevention of varicella. On 26-Nov-2015, the patient started to exhibit severe lethargy.  On 27-Nov-2015, the patient had a fever and crusting lesions on her thigh and abdomen. She was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the body and she was admitted to the hospital on 28-Nov-2015.  Treatment included intravenous acyclovir and unspecified antibiotic. She was still experiencing chickenpox like vesicles. The outcome was not recovered (unknown for inappropriate age at vaccine administration). Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, all events are unlisted except for pyrexia. Causality: Unrelated. The causative agent for the diagnosis is varicella virus, which is not transmitted via influenza vaccines; and is therefore biologically implausible. It is more reasonable to assume that the diagnosis was related to the varicella vaccine concomitantly received. All other symptoms are assessed in context of the diagnosis.
Age: 1.7
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: This medically confirmed spontaneous report (initial receipt 14-Dec-2015) concerns a 19-month-old female patient who had no drug reactions/allergies. On 13-Nov-2015, the patient received unspecified inactivated flu vaccine (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Varivax injection (varicella virus vaccine, batch number K002919) for the prevention of varicella. On 26-Nov-2015, the patient started to exhibit severe lethargy.  On 27-Nov-2015, the patient had a fever and crusting lesions on her thigh and abdomen. She was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the body and she was admitted to the hospital on 28-Nov-2015.  Treatment included intravenous acyclovir and unspecified antibiotic. She was still experiencing chickenpox like vesicles. The outcome was not recovered (unknown for inappropriate age at vaccine administration). Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, all events are unlisted except for pyrexia. Causality: Unrelated. The causative agent for the diagnosis is varicella virus, which is not transmitted via influenza vaccines; and is therefore biologically implausible. It is more reasonable to assume that the diagnosis was related to the varicella vaccine concomitantly received. All other symptoms are assessed in context of the diagnosis.
Age: 1.7
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL, FLUX, VARCEL, FLUX, VARCEL
Symptoms: Injection site reaction, Lethargy, Pyrexia, Rash vesicular, Scab
Clinical narrative: This medically confirmed spontaneous report (initial receipt 14-Dec-2015) concerns a 19-month-old female patient who had no drug reactions/allergies. On 13-Nov-2015, the patient received unspecified inactivated flu vaccine (Influenza virus vaccine, manufacturer and batch number not provided). On the same day, the patient also received Varivax injection (varicella virus vaccine, batch number K002919) for the prevention of varicella. On 26-Nov-2015, the patient started to exhibit severe lethargy.  On 27-Nov-2015, the patient had a fever and crusting lesions on her thigh and abdomen. She was taken to the family physician and was diagnosed with post vaccine varicella. The lesions spread all over the body and she was admitted to the hospital on 28-Nov-2015.  Treatment included intravenous acyclovir and unspecified antibiotic. She was still experiencing chickenpox like vesicles. The outcome was not recovered (unknown for inappropriate age at vaccine administration). Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, all events are unlisted except for pyrexia. Causality: Unrelated. The causative agent for the diagnosis is varicella virus, which is not transmitted via influenza vaccines; and is therefore biologically implausible. It is more reasonable to assume that the diagnosis was related to the varicella vaccine concomitantly received. All other symptoms are assessed in context of the diagnosis.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Electroencephalogram normal, Fracture treatment
Clinical narrative: Patient's husband called on 11-20-2015 at 2:15pm. The call was addressed by pharmacist. Patient's husband reported that his wife, had seizures at 3am 11/20 and she broke both arms, her doctor was dumbfounded and couldn't find a reason for her seizure or any reason that she broke both arms while sleeping in bed. Had surgery 11/23/2015 for fractured and dislocation of humerus of each arm.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Generalised tonic-clonic seizure, Humerus fracture, Joint dislocation, Muscle contractions involuntary, Neurological examination normal
Clinical narrative: Patient's husband called on 11-20-2015 at 2:15pm. The call was addressed by pharmacist. Patient's husband reported that his wife, had seizures at 3am 11/20 and she broke both arms, her doctor was dumbfounded and couldn't find a reason for her seizure or any reason that she broke both arms while sleeping in bed. Had surgery 11/23/2015 for fractured and dislocation of humerus of each arm.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Shoulder operation
Clinical narrative: Patient's husband called on 11-20-2015 at 2:15pm. The call was addressed by pharmacist. Patient's husband reported that his wife, had seizures at 3am 11/20 and she broke both arms, her doctor was dumbfounded and couldn't find a reason for her seizure or any reason that she broke both arms while sleeping in bed. Had surgery 11/23/2015 for fractured and dislocation of humerus of each arm.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Humerus fracture, Joint dislocation, Seizure, Surgery, Upper limb fracture
Clinical narrative: Patient's husband called on 11-20-2015 at 2:15pm. The call was addressed by pharmacist. Patient's husband reported that his wife, had seizures at 3am 11/20 and she broke both arms, her doctor was dumbfounded and couldn't find a reason for her seizure or any reason that she broke both arms while sleeping in bed. Had surgery 11/23/2015 for fractured and dislocation of humerus of each arm.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a pharmacist referring to a 61 year old male patient with oxycodone allergy and none pertinent medical history. On 14-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L026415, expiration date: 15-OCT-2016, 1 vial/once, subcutaneous). In December 2015 the patient experienced cellulitis in his right arm after receiving ZOSTAVAX. The pharmacist saw the patient on 18-DEC-2015 but not sure of the exact date of the adverse event. The patient saw a physician for medical attention and KEFLEX was given to treat the event. The outcome of cellulitis was reported as recovering/resolving. The causality was not reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist referring to a 61 year old male patient with oxycodone allergy and none pertinent medical history. On 14-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L026415, expiration date: 15-OCT-2016, 1 vial/once, subcutaneous). In December 2015 the patient experienced cellulitis in his right arm after receiving ZOSTAVAX. The pharmacist saw the patient on 18-DEC-2015 but not sure of the exact date of the adverse event. The patient saw a physician for medical attention and KEFLEX was given to treat the event. The outcome of cellulitis was reported as recovering/resolving. The causality was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Light fever and irritability, Rash over back, palms and dorsal of hands, moving to lips and face, then to inside the mouth in cheeks and on tongue, persisting on lips for 10 days.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apparent life threatening event, Chest X-ray, Crying, Decreased eye contact, Dyspnoea
Clinical narrative: Infant had lethargy and possible ALTE. 6 mo shots, 12/7/15; mom went into patient's room and found pt crying, she picked patient up and noted his head was floppy, she placed patient back on crib and patient's eyes rolled back. Patient is a 6 month old otherwise healthy male who presented for evaluation of an ALTE. On the evening of admission patient awoke from sleep about an hour after eating screaming as if in pain. Parents went to him and when mom picked him up he was limp and not focusing on them. They noticed his eyes appeared to be open and rolling up into his head (straight, no deviation). No jerking or rhythmic movements. No cyanosis. No apnea but some snorting, grunting, and gasps as the event was resolving. Muscle tone slowly returned to normal with the entire event lasting about 3 minutes. No sick contacts. Parent deny patient having any fever, cough, congestion, vomiting or diarrhea prior to this episode.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Electrocardiogram, Eye movement disorder, Grunting, Hypotonia, Lethargy
Clinical narrative: Infant had lethargy and possible ALTE. 6 mo shots, 12/7/15; mom went into patient's room and found pt crying, she picked patient up and noted his head was floppy, she placed patient back on crib and patient's eyes rolled back. Patient is a 6 month old otherwise healthy male who presented for evaluation of an ALTE. On the evening of admission patient awoke from sleep about an hour after eating screaming as if in pain. Parents went to him and when mom picked him up he was limp and not focusing on them. They noticed his eyes appeared to be open and rolling up into his head (straight, no deviation). No jerking or rhythmic movements. No cyanosis. No apnea but some snorting, grunting, and gasps as the event was resolving. Muscle tone slowly returned to normal with the entire event lasting about 3 minutes. No sick contacts. Parent deny patient having any fever, cough, congestion, vomiting or diarrhea prior to this episode.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pain, Screaming
Clinical narrative: Infant had lethargy and possible ALTE. 6 mo shots, 12/7/15; mom went into patient's room and found pt crying, she picked patient up and noted his head was floppy, she placed patient back on crib and patient's eyes rolled back. Patient is a 6 month old otherwise healthy male who presented for evaluation of an ALTE. On the evening of admission patient awoke from sleep about an hour after eating screaming as if in pain. Parents went to him and when mom picked him up he was limp and not focusing on them. They noticed his eyes appeared to be open and rolling up into his head (straight, no deviation). No jerking or rhythmic movements. No cyanosis. No apnea but some snorting, grunting, and gasps as the event was resolving. Muscle tone slowly returned to normal with the entire event lasting about 3 minutes. No sick contacts. Parent deny patient having any fever, cough, congestion, vomiting or diarrhea prior to this episode.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Receives Flu shot 05Nov15 - Arm is still sore and cannot raise arm above head.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Paraesthesia, Peripheral swelling
Clinical narrative: Swelling, Red arm, Tingling down arm.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site swelling, Pain, Peripheral swelling
Clinical narrative: Swelling from injection site to hand, pain, numbness, decreased grip strength.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Reported erythema, mild to moderate swelling, warmth, and tenderness at the injection site.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Pain, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: Patient's arm swelled up and red blotches appeared around the area. Patient states she is experiencing flu like sx. Area is hot to touch and very painful.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient stated a worsening raised red rash developed over 3 days after receiving the shot. When I saw it on 12/12, it looked like a fried egg with a dark red round spot surrounded by a lighter pink spot with a white border. I advised her to take loratadine 10mg every day, I drew an ink line around the rash's current borders, and advised her to call her MD if it worsens. I spoke with her today and she said her MD said she didn't need to be seen and the rash is slowly going away.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Disorientation, Feeling cold, Mental impairment, Tremor
Clinical narrative: Patient indicated 2-3 hours after she received a flu vaccine she started to get very cold, felt like she was freezing then patient was shaking like chills. She said she felt disoriented like she was in shock and could not think clearly enough to push her medical alert button. It subsided in 3-4 hours.
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Eyelid oedema
Clinical narrative: Swelling around right eye.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome - work-up/treatment details at hospital.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Symptoms started 9/17/15 - I started experiencing pain and aching in my left shoulder. I was unable to sleep on that shoulder due to the pain. Since that time, I have experienced pain and decreased mobility/range of motion in left shoulder arm.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Inflammation, Neuralgic amyotrophy, X-ray limb
Clinical narrative: Few hours after administration, pt felt arm in inflamed, burning spreaded from arm to neck and shoulder blades and arms. Seek medical attention from her physician. Doctor diagnosed her with Brachial Plexus Neuritis. Taking anti-inflammatory.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac flutter, Tachycardia, Tinnitus
Clinical narrative: Initial unsolicited report received from a pharmacist on 08-Dec-2015. This case involves a 61-year-old female patient who was vaccinated with an intramuscular second dose of FLUZONE QIV (batch number- UI464AA, expiry date- 30-Jun-2016 and site of administration was not reported) on 16-Oct-2015. It was unknown whether patient had an illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions included penicillin allergy. Other medical conditions and concomitant medications were not reported. On 16-Oct-2015, within two hours after vaccination, patient had experienced fluttering of the heart, tachycardia, fluttering and ringing in her ears. Lab tests and corrective treatments were not reported. On unspecified date, patient recovered from the events. Upon internal review, case was considered as serious due to important medical events: heart fluttering and tachycardia. Documents held by sender: none.
Age: 1.21
Sex: M
Vaccine: FLU4, HEPA, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events/reactions reported at this time.
Sex: U
Vaccine: FLUX
Symptoms: Dermatitis bullous
Clinical narrative: Initial unsolicited report received from physician on 15-Dec-2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of influenza vaccine (manufacturer: unknown, batch number, expiry date, route and site of administration was not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient had experienced bullous reaction to the Influenza vaccine. Lab tests and corrective treatments were not reported. Outcome of the event was not reported. Upon internal review, case was considered as serious due to important medical event: Bullous reaction. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Fatigue, followed by chills. Next morning 12/20 temp 101.0 with headache, muscle aches, entire upper arm very sore with red splotches. Symptoms lasted all day. Next morning 12/21 same symptoms, temp 101.8. Stayed in bed both days. Left message w/Doctor's office; call not returned. Next morning woke covered with sweat but temp 98.0 (my normal) and felt fine. Arm still very sore and nasty looking.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity, Rash macular
Clinical narrative: Fatigue, followed by chills. Next morning 12/20 temp 101.0 with headache, muscle aches, entire upper arm very sore with red splotches. Symptoms lasted all day. Next morning 12/21 same symptoms, temp 101.8. Stayed in bed both days. Left message w/Doctor's office; call not returned. Next morning woke covered with sweat but temp 98.0 (my normal) and felt fine. Arm still very sore and nasty looking.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthma, Condition aggravated, Cough, Croup infectious, Dyspnoea
Clinical narrative: Croupy cough, trouble breathing, asthma flare-up.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Joint range of motion decreased, Myalgia
Clinical narrative: Severe lasting pain in upper arm muscle, drastically reduced range of motion, inability to sleep due to pain.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: My son began complaining of his chest hurting meaning difficulty breathing (from chest up into neck area) and also rapid heart beat (intermittent).  He had the first shot 11/16/2015 and complained saying his chest hurt for the first two days, but didn't explain what he meant.  Second shot symptoms were worse and have lasted a week. We are going to his primary care today for course of treatment. I'm checking life threatening illness only because the vaccine info sheet shows these conditions as being serious allergic reactions.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Hypersensitivity, Swelling face
Clinical narrative: Rec'd FLUMIST 12-17-15 about 330PM -12-18-15 at 9:30PM. Nostrils and left cheek swollen - got worse. Went to ER and was admitted for allergic reaction -possible to FLUMIST - given BENADRYL and ZANTAC. Discharged the next day. We will refer to allergist.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-DEC-2015, the patient was inadvertently vaccinated with third dose of RECOMBIVAX HB (strength and route were unknown) lot # L029631 with expiry date of 14-AUG-2015, which was less than 1 month from the 2nd dose. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Crying
Clinical narrative: Information has been received from a physician referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with MMRII (dose, route, lot# and expiration date were not reported) and VARIVAX (dose, route, lot# and expiration date were not reported). The physician stated that, in her experience, these patients cried much more when she administered red doses of MMRII and VARIVAX, than when she administered other vaccines (manufacturer unknown). Outcome of the event was not reported. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The nurse reported that the patients were administered improperly stored doses of GARDASIL 9 (lot # L019287, expiration date 14-SEP-2017) (dosage, strength and route unknown) on multiple unspecified dates. There was no concomitant medication reported. No adverse effects was reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: GARDASIL was inadvertently given as a 4th dose. No adverse reaction.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site warmth, Pain, Paraesthesia
Clinical narrative: Shortly after shot my left shoulder began to hurt and tingle. It was warm and sore to the touch. By bedtime it was starting to hurt to lift or move my left arm. I am only able to sleep on my left side but due to the pain I wasn't able to do so. This pain lasted for about 4-5 days. After that although it is not as painful I still have a constant ache in my shoulder and it is still difficult to raise or use my left arm without pain.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: Shortly after shot my left shoulder began to hurt and tingle. It was warm and sore to the touch. By bedtime it was starting to hurt to lift or move my left arm. I am only able to sleep on my left side but due to the pain I wasn't able to do so. This pain lasted for about 4-5 days. After that although it is not as painful I still have a constant ache in my shoulder and it is still difficult to raise or use my left arm without pain.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states that she continues to have pain in her left arm after she received Tdap vaccine.  Patient also states that it is difficult for her to lift her arm past a certain point.  Received Tdap vaccine on 07/20/2015.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient told me the arm that vaccine was administered was in pain and radiated down arm.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient told me the arm that vaccine was administered was in pain and radiated down arm.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: Red, swollen, itchy and painful. Size of hive 10 x 11 cm.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site on left arm became red and fevered the day after the shot. Then the redness spread to the size of 4x4 inches.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Left upper deltoid slightly warm to touch & mildly erythematous. Approx. 4cm X 3cm area. hard knot at injection site. No swelling, streaks numbness or tingling. No hives, trouble breathing or rest distress.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Feeling hot, Influenza like illness, Malaise
Clinical narrative: PATIENT COMPLAINED OF BIG RED SORE SPOT THAT FELT VERY HOT. SHE ALSO HAD FLU-LIKE SYMPTOMS (FEVER, WEAKNESS, MALAISE).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: PATIENT COMPLAINED OF BIG RED SORE SPOT THAT FELT VERY HOT. SHE ALSO HAD FLU-LIKE SYMPTOMS (FEVER, WEAKNESS, MALAISE).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Arm swelled after leaving pharmacy.  Visited physician on 12/14/15.  Instructed to go to hospital and patient was admitted.  Discharged on 12/18/15.  Diagnosed with cellulitis of left arm.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Bone pain, Chills, Ear pain, Headache, Tremor
Clinical narrative: 1. 6:30 PM: Started getting chills. 2. 8:30 PM: Evolved into shaking, chills, could not get warm, bones ached, ears hurt, severe headache.  Note:  The patient did not take his temperature. 3.  Between 12 AM and 2 AM symptoms did not improve.  Patient took 2 tablets of Tylenol 650mg ea. 4.  Around 3 AM all symptoms resolved except for Headache.  Patient fell asleep. 5. When patient woke up at about 8 AM on 12/23/15, all symptoms were resolved.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Skin discolouration
Clinical narrative: RECEIVED HPV VACCINE, THEN MOB ELECTED FLU AS WELL.  SHE WATCHED AS NURSE PREPARED VACCINE.  NURSE ADMINISTERED FLU VACCINE, AND SHE LOST CONSCIOUSNESS WITHIN A MINUTE OF THE SECOND VACCINE.  HER LEGS WERE ELEVATED, ICE PUT ON HER NECK AND FOREHEAD.  BLOOD PRESSURE CHECK AT 2:25 WAS 112/62 AFTER SHE REGAINED CONSCIOUSNESS.  LOC WAS 1-2 SECONDS.  MOTHER REPORTED SHE HAS DONE THIS IN THE PAST.  BP AT 2:30 WHEN SHE WAS SITTING WAS 108/52.  SHE DRANK JUICE, HER COLOR BECAME PINK AGAIN, AND SHE REPORTED FEELING NORMAL.  SHE WAS LAUGHING AND JOKING WITH MEDICAL PERSONNEL FOR 20 MINUTES BEFORE SHE LEFT THE OFFICE.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Frozen right arm. Pain at injection site. Pain in shoulder and upper arm. Motrin and ice packs.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Fatigue, Full blood count, Headache, Herpes zoster
Clinical narrative: Patient developed decreased appetite, increased fatigue, complaints of right lower leg pain, headache.  The following day patient developed a small cluster of pustules on right ankle with continued headache, fatigue, and loss of appetite.  The patient was seen by Dr. who ordered a CBC and CMP to rule out leukemia.  At the end of the week the patient developed several pustules along her L4 and L5 dermatome, which was diagnosed as shingles.  The patient was prescribed acyclovir.  The patient had no known chicken pox exposure other than the vaccine.