chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a female pregnant patient of unknown age. Medical history of the patient includes anemia. On 07-JUL-2014 the pregnant patient was inadvertently administered GARDASIL INJ 120 Y, 0.5 ml, intramuscular instead of TDap. No adverse effects noted. Concomitant therapies reported include prenatal vitamins. Lab diagnostic tests were unspecified. The patient was 32 weeks pregnant. The LMP was estimated as 24-NOV-2013 and EDD as 31-AUG-2014. The patient sought medical attention. The pregnancy outcome was outcome pending. The causality was unspecified. No PQC and IRRE reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blindness unilateral, Echocardiogram abnormal, Ophthalmological examination abnormal, Pupil dilation procedure, Pupillary reflex impaired
Clinical narrative: Patient presented to the Emergency Room with acute onset of unilateral vision loss. Exam notable for absent pupillary reflex. Was transferred to an eye specialist. Dilated eye exam was suspicious for thrombosis of retinal artery.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Retinal artery thrombosis
Clinical narrative: Patient presented to the Emergency Room with acute onset of unilateral vision loss. Exam notable for absent pupillary reflex. Was transferred to an eye specialist. Dilated eye exam was suspicious for thrombosis of retinal artery.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# were not reported) which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may had been administered to the patient. No adverse effects reported. Follow-up information has been received from the registered nurse and refers to a 59 years old male patient. On 15-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # K003074, expiration date 13-MAR-2015) that was stored improperly. The diluent was exposed to lower than 2C for more than 15 days, the lowest temperature was -1C for 5 days. No symptoms were reported. No PQC (product quality complaint) involved. The reporter asked if the patient had to be revaccinated. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# were not reported) which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may had been administered to the patient. No adverse effects reported. Follow-up information has been received from the registered nurse and refers to a 64 years old male patient. On 16-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot #K003074, expiration date 13-MAR-2015) that was stored improperly. The diluent was exposed to lower than 2C for more than 15 days, the lowest temperature was -1C for 5 days. No symptoms were reported. No PQC (product quality complained) involved. The reporter asked if the patient had to be revaccinated. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: My injection site became very red, hot and itchy. It was 4 cm across. The full edematous area was 7 cm across. I was very tired the night before. Used Benadryl cream and one 50 mg capsule.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: Pain and limited range of motion in arm that was debilitating for 6 weeks following vaccination. Minor fever and chills on day after receipt of vaccine.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # were not reported) which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may had been administered to the patient. No adverse effects reported. Follow-up information has been received from the registered nurse and refers to a 49 year old female patient. On 20-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # K003074, expiration date 13-MAR-2015) that was stored improperly. The diluent was exposed to lower than 2C for more than 15 days, the lowest temperature was -1C for 5 days. No symptoms were reported. No PQC (product quality complained) involved. The reporter asked if the patient had to be revaccinated. This is one of several reports from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# were not reported) for prophylaxis which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may had been administered to the patient. No adverse effects reported. Follow-up information has been received from the registered nurse and refers to a 56 year old female patient. On 20-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # K003074, expiration date 13-MAR-2015) that was stored improperly. The diluent was exposed to lower than 2C for more than 15 days, the lowest temperature was -1C for 5 days. No symptoms were reported. No PQC (product quality complaint) involved. The reporter asked if the patient had to be revaccinated. This is one of several reports from the same source. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# were not reported) which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may have been administered to the patient. No adverse effects reported. This is one of several reports from the source. Follow-up information has been received from the registered nurse and refers to a 55 year old male patient. On 14-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # K003074, expiration date 13-MAR-2015) that was stored improperly. The diluent was exposed to lower than 2C for more than 15 days, the lowest temperature was -1C for 5 days. No symptoms were reported. No PQC (product quality complained) involved. The reporter asked if the patient had to be revaccinated. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product label confusion
Clinical narrative: This spontaneous report as received from a nurse who at the physician's office via a company representative, stated that they would no longer order RECOMBIVAX HB pediatric doses, (Lot# unspecified) dose, frequency and route unspecified, because this vaccine's caps were the same color as SANOFIs flu vaccines, and the physician's office stated they were afraid of mixing the products up. No adverse effects occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant worker refers to unspecified number of patients of unknown age and gender. The reporter stated that M-M-R II was improperly stored and administered (dose, units, anatomical location, route of administration, lot number were not reported) to unspecified number of patients on unspecified dates. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The reporter stated that GARDASIL was improperly stored and administered (dose, units, anatomical location, route of administration, lot number were not reported) to unspecified number of patients on unspecified dates. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant worker refers to unspecified number of patients of unknown age and gender. The reporter stated that PNEUMOVAX23 was improperly stored and administered (dose, units, anatomical location, route of administration, lot number were not reported) to unspecified number of patients on unspecified dates. This is one of several reports from the same reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 10-JUN-2014 the patient was vaccinated with MMR II (one dose, 0.5ml, lot# and expiry date were not reported) that was administered intramuscularly. No adverse effect was reported. Follow up information as received from the registered nurse refers to the 45 year old female patient. The patient had no pre-existing allergies, birth defects or medical conditions. On an unknown date, the patient was vaccinated with the second dose of MMR II (lot number, dose, route, strength and indication were not reported). On 10-JUN-2014 the patient was vaccinated with the second dose of MMR II (lot # H017027, expired date 14-SEP-2014) (0.5 ml, in the left arm) intramuscularly instead of subcutaneously (S.Q.). The patient had no illness at time of vaccination. There was no relevant diagnostic tests or lab data reported. The outcome was reported as recovered by the reporter. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-JUL-2014 the patient was administered with a dose of MMR II (lot# H012133, expiration date 29-JUN-2014, dose, route, indication not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter (other MARRS# 1407USA004631). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 03-JUL-2014 the patient was administered with a dose of expired M-M-R II (HSA) (lot # H012133, expiration date 29-JUN-2014, dose, route, indication not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter (other MARRS# 1407USA004545). Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a 55 year old female patient refers to herself. On 24-MAY-2014 the patient was vaccinated with ZOSTAVAX (dose, units, route of administration, anatomical location, lot number, expiration date were not reported). On 03-JUN-2014 the patient experienced (6) red bumps in total that become hardened, 2 bumps along her neck and 1 at each elbow and each of her shoulders. The outcome of reported adverse events was reported as not recovered/resolved. The relatedness between adverse events and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: 6VAX-F, PNC13, RV1
Symptoms: Cyanosis, Dyspnoea, Floppy infant, Lethargy
Clinical narrative: This female subject was enrolled in a study. On 01 July 2014, she received a 1st dose of INFANRIX HEXA, Pfizer's PREVENAR 13 and ROTARIX. On 01 July 2014, approximately 6 hours after the 1st dose of INFANRIX HEXA, approximately 6 hours after the 1st dose of PREVNAR 13, and approximately 6 hours after the 1st dose of ROTARIX, this two-month-old subject developed lethargy event. The subject was hospitalised. The event resolved on 01 July 2014. The investigator considered that there was a reasonable possibility that the lethargy event may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. Investigator text: Baby was given vaccines at 10:20 this morning. At approximately 16:00. Baby was noted by mother to be blue around the lips baby was aroused, and then had 2 more episodes and at that time mother noted baby appeared to have some floppiness. Mother also noted some short breathing patterns and it appeared that the baby was having a hard time expelling air. Brought into the Clinic to be examined by the MD. Per exam it was normal at that time. Baby was admitted to the hospital for observation at this time. No treatment being done at this time. Per the Principal Investigator this event is possibly related as there is noted to be a possibility of an lethargic event after episodes that can be traumatic to infants under 3 months of age.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Local swelling, Pyrexia, Rash, Rash generalised
Clinical narrative: 05/04/14 - 05/11/14 - Fever of 102-103 05/07/14(AM) - 05/13/14 - Rash (started with legs around injection site, spread over entire body, including face) 05/07/14(PM) - 05/13/14 - Swelling of Hands & Feet
Age: 0.9
Sex: M
Vaccine: DTAPIPV, PNC
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: RN administered Kinrix as third dose of DTaP and IPV to 10 month old child. Intervals between vaccines in this series was correct. However, Kinrix is not licensed for this age group.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 23-JUN-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot # J008443, expiration date 09-JUL-2015, 0.5 ml subcutaneously. No co-suspect and concomitant therapies were reported. Nurse reported that patient was administered an improperly stored dose of (Oka/Merck) VARIVAX. No adverse events were reported. This is one of two reports from the same source (other case # 1407USA005531). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Off label use, Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a patient of unknown age (adult) reporting on himself. The patient's medical history included recurrent herpes like inflammation in his mouth. The patient's historical drug included L-lysine taken for recurrent herpes like inflammation in mouth. Approximately on an unknown date in 2013, reported as last year, the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, site of administration and lot number were not reported). There were no concomitant medications reported. The patient reported that for most of his adult life, he had had problem with recurrent herpes like inflammation in his mouth which began with him biting his cheek or some similar injury. Within days, the patient would have an extremely painful inflammation that would last 6-10 days. Taking L-lysine helped ameliorate the symptoms, but did not prevent them. On an unknown date, since his ZOSTAVAX vaccination the patient did not have a flare up and reported that this might be a potential off label use of the vaccine. The patient also felt that thought the patient never had a cold sore, the vaccine might be helpful with them as well. The patient stated that it's just an observation of his, but it might be something worth looking into. There was no product quality complaint involved. It was unspecified whether the patient had sought any medical attention. The outcome and causality were unknown. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Arthralgia, Blood pressure increased, Chest discomfort, Computerised tomogram head normal
Clinical narrative: I received the shot at 2:30 pm while at work about 5 minutes later I became nauseated, felt a warm sensation down the center of my chest, then difficulty breathing, by 2:45 pm I was placed on a gurney at which time I started having facial twitching on the left and right side of my face, then I was unable to speak. At 3:00 pm I was given an IV injection of ATIVAN 0.5mg and I was also given an IM injection of BENADRYL 50mg, they did a EKG and CT to rule out stroke both were negative, my blood pressure was elevated 161/93 respirations 25 and temperature 99.1. When I was able to speak again I was stuttering and facial twitching continued, I had uncontrollable jerky movement of my left arm, in which the intradermal shot was administered (paresthesia) I was treated in the ER Dept were I worked as an Admission Nurse from approximately 2:45 pm to 6:15 pm when I was discharged home and told to follow up with my PCP the next day. In the days and weeks following the flu shot my symptoms have increased headaches, muscle and joint pain, swelling in my fingers, numbness and tingling in my feet and calves, difficulty with memory, unable to do much without becoming very tired, ringing in my ears that makes me have the feeling of electrical jolts from my head to my feet, and I continue to stutter. I saw a neurologist on December 10, 2013 and he diagnosed me with dysarthria and hemifacial spasms and in his notes observed me having dysnomia.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Dyskinesia, Dysphemia, Electrocardiogram normal, Facial spasm
Clinical narrative: I received the shot at 2:30 pm while at work about 5 minutes later I became nauseated, felt a warm sensation down the center of my chest, then difficulty breathing, by 2:45 pm I was placed on a gurney at which time I started having facial twitching on the left and right side of my face, then I was unable to speak. At 3:00 pm I was given an IV injection of ATIVAN 0.5mg and I was also given an IM injection of BENADRYL 50mg, they did a EKG and CT to rule out stroke both were negative, my blood pressure was elevated 161/93 respirations 25 and temperature 99.1. When I was able to speak again I was stuttering and facial twitching continued, I had uncontrollable jerky movement of my left arm, in which the intradermal shot was administered (paresthesia) I was treated in the ER Dept were I worked as an Admission Nurse from approximately 2:45 pm to 6:15 pm when I was discharged home and told to follow up with my PCP the next day. In the days and weeks following the flu shot my symptoms have increased headaches, muscle and joint pain, swelling in my fingers, numbness and tingling in my feet and calves, difficulty with memory, unable to do much without becoming very tired, ringing in my ears that makes me have the feeling of electrical jolts from my head to my feet, and I continue to stutter. I saw a neurologist on December 10, 2013 and he diagnosed me with dysarthria and hemifacial spasms and in his notes observed me having dysnomia.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling hot, Headache, Hypoaesthesia, Local swelling
Clinical narrative: I received the shot at 2:30 pm while at work about 5 minutes later I became nauseated, felt a warm sensation down the center of my chest, then difficulty breathing, by 2:45 pm I was placed on a gurney at which time I started having facial twitching on the left and right side of my face, then I was unable to speak. At 3:00 pm I was given an IV injection of ATIVAN 0.5mg and I was also given an IM injection of BENADRYL 50mg, they did a EKG and CT to rule out stroke both were negative, my blood pressure was elevated 161/93 respirations 25 and temperature 99.1. When I was able to speak again I was stuttering and facial twitching continued, I had uncontrollable jerky movement of my left arm, in which the intradermal shot was administered (paresthesia) I was treated in the ER Dept were I worked as an Admission Nurse from approximately 2:45 pm to 6:15 pm when I was discharged home and told to follow up with my PCP the next day. In the days and weeks following the flu shot my symptoms have increased headaches, muscle and joint pain, swelling in my fingers, numbness and tingling in my feet and calves, difficulty with memory, unable to do much without becoming very tired, ringing in my ears that makes me have the feeling of electrical jolts from my head to my feet, and I continue to stutter. I saw a neurologist on December 10, 2013 and he diagnosed me with dysarthria and hemifacial spasms and in his notes observed me having dysnomia.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Memory impairment, Muscle twitching, Myalgia, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: I received the shot at 2:30 pm while at work about 5 minutes later I became nauseated, felt a warm sensation down the center of my chest, then difficulty breathing, by 2:45 pm I was placed on a gurney at which time I started having facial twitching on the left and right side of my face, then I was unable to speak. At 3:00 pm I was given an IV injection of ATIVAN 0.5mg and I was also given an IM injection of BENADRYL 50mg, they did a EKG and CT to rule out stroke both were negative, my blood pressure was elevated 161/93 respirations 25 and temperature 99.1. When I was able to speak again I was stuttering and facial twitching continued, I had uncontrollable jerky movement of my left arm, in which the intradermal shot was administered (paresthesia) I was treated in the ER Dept were I worked as an Admission Nurse from approximately 2:45 pm to 6:15 pm when I was discharged home and told to follow up with my PCP the next day. In the days and weeks following the flu shot my symptoms have increased headaches, muscle and joint pain, swelling in my fingers, numbness and tingling in my feet and calves, difficulty with memory, unable to do much without becoming very tired, ringing in my ears that makes me have the feeling of electrical jolts from my head to my feet, and I continue to stutter. I saw a neurologist on December 10, 2013 and he diagnosed me with dysarthria and hemifacial spasms and in his notes observed me having dysnomia.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: I received the shot at 2:30 pm while at work about 5 minutes later I became nauseated, felt a warm sensation down the center of my chest, then difficulty breathing, by 2:45 pm I was placed on a gurney at which time I started having facial twitching on the left and right side of my face, then I was unable to speak. At 3:00 pm I was given an IV injection of ATIVAN 0.5mg and I was also given an IM injection of BENADRYL 50mg, they did a EKG and CT to rule out stroke both were negative, my blood pressure was elevated 161/93 respirations 25 and temperature 99.1. When I was able to speak again I was stuttering and facial twitching continued, I had uncontrollable jerky movement of my left arm, in which the intradermal shot was administered (paresthesia) I was treated in the ER Dept were I worked as an Admission Nurse from approximately 2:45 pm to 6:15 pm when I was discharged home and told to follow up with my PCP the next day. In the days and weeks following the flu shot my symptoms have increased headaches, muscle and joint pain, swelling in my fingers, numbness and tingling in my feet and calves, difficulty with memory, unable to do much without becoming very tired, ringing in my ears that makes me have the feeling of electrical jolts from my head to my feet, and I continue to stutter. I saw a neurologist on December 10, 2013 and he diagnosed me with dysarthria and hemifacial spasms and in his notes observed me having dysnomia.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient. On 30-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (1 standard pack vial of 1) 0.65 ml dose, once, subcutaneously (lot number reported as K00327, exp. date reported as March 2015 (indication and anatomical location not reported). On 01-JUL-2014, the patient presented to pharmacy with a possible injection site reaction which was really big, red and itchy and warm. The patient additionally reported that she experienced headache, fever and felt weak. The outcome of events was reported as not recovered/not resolved and the events remained ongoing. There was no treatment given for the event. There was no intervention to prevent serious criteria. The relatedness between the events and ZOSTAVAX was not reported. Lot number K00327 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 32 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 09-JUL-2014, the patient was vaccinated (Oka-Merck) PROQUAD, 0.5 ml, subcutaneous. Lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that a 32 year old patient received a dose of (Oka-Merck) PROQUAD (on 09-JUL-2014). No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unkown date the patients were vaccinated with RECOMBIVAX HB. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that multiple unspecified patients received RECOMBIVAX HB that was stored improperly. No adverse effects reported. Additional information is not expected.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a pharmacist refers to patients of under 50 years old. On an unknown date the patients were vaccinated with ZOSTAVAX (dose unknown and route) "off-label". Amount of patients that received ZOSTAVAX "off-label" was unknown. No adverse effect reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pain, Rash
Clinical narrative: Reaction occurred at injection site. Rash and soreness, redness.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and referred to a patient of unknown age and gender. The patient received first injection dose of GARDASIL (lot #, expiration date, strength, dose and frequency were not reported) on 08-MAY-2007 and on 19-JUL-2007 received second dose of GARDASIL (lot #, expiration date, strength, dose and frequency were not reported). It was reported that the patient waned to received a third dose now. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with ROTATEQ oral (lot number, expiration date and dosage were not reported). Concomitant therapy was not reported. The reporter informed that on an unknown date the ROTATEQ, reached temperatures outside of the prescribing information. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with GARDASIL injection, (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The reporter informed that on an unknown date the GARDASIL reached temperatures outside of the prescribing information. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with (Oka-Merck) PROQUAD injection, (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The reporter informed that on an unknown date the (Oka-Merck) PROQUAD reached temperatures outside of the prescribing information. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) injection, (lot number, expiration date, dosage, dosage and route were not reported). Concomitant therapy was not reported. The reporter informed that on an unknown date the VARIVAX (Merck) reached temperatures outside of the prescribing information. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to three patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) 0.5 ml subcutaneously. Lot number and expiration dates were not reported. No co-suspect and concomitant therapies were reported. Nurse reported that three patients were administered improperly stored doses of VARIVAX (Merck) (on an unknown date). No adverse event were reported. This is one of two reports from the same source (other case # 1407USA003655). Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: TDAP Vaccine (administered at 32 weeks of pregnancy): Injection site enlarged to three inch diameter/swelling/pain/redness (10 days); Nausea (1 day); Sore throat (3 days); Severe cold symptoms (aches, cough, congestion) (8 days).
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Nasopharyngitis, Nausea, Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: TDAP Vaccine (administered at 32 weeks of pregnancy): Injection site enlarged to three inch diameter/swelling/pain/redness (10 days); Nausea (1 day); Sore throat (3 days); Severe cold symptoms (aches, cough, congestion) (8 days).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash erythematous, Rash generalised, Swelling
Clinical narrative: Family noticed multiple red spots all over child's body with swelling and itching. Mom gave oral OTC Benadryl and topical Allerest cream when she got home from work that day.  Child's rash is lessening next day (7/11/14).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient received the Zostavax vaccine on 7/8/14 and returned to pharmacy on 7/11/14 presenting with a localized, rectangular-shaped rash on the inside of his left arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Redness, warmth, and induration noted in right deltoid measuring 60X45 mm, extending to the axillary zone with a welted area. Patient denied pain or tenderness. Mom first noted above signs this morning. RN called PCP which was unreachable, then counseled mom to take patient to ER.
Age: 30.0
Sex: M
Vaccine: MMRV
Symptoms: Depressed level of consciousness, Ear pain, Hypoacusis
Clinical narrative: I have a constant pain in my ears that doesn't go away since my vaccines, I don't hear good. My conscious is very low.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Reddened, tender, slightly itchy area approximately the size of fifty cent peice; area expanded for the next 48 hours with bullseye effect to area the size of saucer.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site induration, Pyrexia
Clinical narrative: Fever up to 102.6 and 26x28mm induration on right thigh.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Abasia, Aphagia, Atrophy, Blood test, Computerised tomogram
Clinical narrative: STIFF JOINTS, HANDS, JAW.. BY 4/12/2014 COULD NOT WALK, EAT. BECAME PARALYZED FROM THE WAIST DOWN. DIAGNOSED WITH GUILLAIN BARRE SYNDROME AND BRACHIAL NEURITIS. IMMUNE SYSTEM ATTACKED NERVOUS SYSTEM AND ENTIRE BODY, JOINTS, HEART, ETC. SHOULDER (LEFT) DOWN TO ELBOW IS ATROPHIED AND PARALYZED. SPENT 30 DAYS IN HOSPITAL AND 15 DAYS AT AN OT AND PT FACILITY.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Diplegia, Guillain-Barre syndrome, Immune system disorder, Joint stiffness, Lumbar puncture
Clinical narrative: STIFF JOINTS, HANDS, JAW.. BY 4/12/2014 COULD NOT WALK, EAT. BECAME PARALYZED FROM THE WAIST DOWN. DIAGNOSED WITH GUILLAIN BARRE SYNDROME AND BRACHIAL NEURITIS. IMMUNE SYSTEM ATTACKED NERVOUS SYSTEM AND ENTIRE BODY, JOINTS, HEART, ETC. SHOULDER (LEFT) DOWN TO ELBOW IS ATROPHIED AND PARALYZED. SPENT 30 DAYS IN HOSPITAL AND 15 DAYS AT AN OT AND PT FACILITY.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Monoplegia, Nuclear magnetic resonance imaging, Radiculitis brachial
Clinical narrative: STIFF JOINTS, HANDS, JAW.. BY 4/12/2014 COULD NOT WALK, EAT. BECAME PARALYZED FROM THE WAIST DOWN. DIAGNOSED WITH GUILLAIN BARRE SYNDROME AND BRACHIAL NEURITIS. IMMUNE SYSTEM ATTACKED NERVOUS SYSTEM AND ENTIRE BODY, JOINTS, HEART, ETC. SHOULDER (LEFT) DOWN TO ELBOW IS ATROPHIED AND PARALYZED. SPENT 30 DAYS IN HOSPITAL AND 15 DAYS AT AN OT AND PT FACILITY.
Age: 18.0
Sex: F
Vaccine: HEP, HIBV, IPV, PPV, TDAP
Symptoms: Neutrophil percentage increased, Pyrexia, Red blood cell sedimentation rate increased, Sepsis, White blood cell count increased
Clinical narrative: Fever, Tmax 104.2 F, Sepsis.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: Immediate headache. Nausea. Diarrhea.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles like rash on opposite armpit/shoulder area of administration, reaction started approximately 1 week after admin.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles like rash on opposite armpit/shoulder area of administration, reaction started approximately 1 week after admin.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Local pain and swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Gianotti-Crosti syndrome, Injection site reaction, Rash generalised, Rash pruritic, Streptococcus test negative
Clinical narrative: Patient began developing itchy bumps on upper arms and thighs on 07/06/14. The bumps continued to spread throughout the limbs and onto the torso, neck, and face by late in the day on 07/07/14. Parent took patient to the pediatrician to be examined on 07/08/2014. Patient was diagnosed with Gianotti-Crosti Syndrome and tested negative for strep. Patient experienced no other illness in the period between vaccination on 06/09/14 and the adverse event on 07/06/14. No fever or other symptoms or signs of illness were present during that period or since the onset of the adverse event.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Rash erythematous
Clinical narrative: Pin point red spots, as rash areas with raised bumps that are blistering and popping with fluid inside.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red and warm area L arm at injection site (red area)(size 4 inch as by 3 inches circle. 7/11/14 - area increased to 8 inches by 3 inches.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Mother came to patient's 4 month checkup and stated to the physician that patient had prolonged crying for two days after last vaccines (5-2-2014). No ER visit. No MD visit.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Pt given PROQUAD instead of MMR vaccine: MMR ordered at time of visit.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting, diarrhea, subjective fever 3d after vaccines/well child visit.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness et swelling at injection site, began day after injection. TX: Acetaminophen PRN, pain; cook most cloth to area.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Within 24 developed high fever and slight erythema, edema at site a immunication. Rx'd with BENADRYL/Ibuprofen.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Eye movement disorder, Hypotonia, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: After I gave her Tdap vaccine at 1235, and as I was conversing with her, she became limp, rolled her eyes back, her arms contracted and moved rhythmically, she became unconscious for less than 2 minutes, then she woke up, skin pale, became alert and oriented x3, she was clammy and complaining of hands tingling. We had call 911 and ambulance took her to emergency dept for evaluation. Denies history of seizures.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Paraesthesia
Clinical narrative: After I gave her Tdap vaccine at 1235, and as I was conversing with her, she became limp, rolled her eyes back, her arms contracted and moved rhythmically, she became unconscious for less than 2 minutes, then she woke up, skin pale, became alert and oriented x3, she was clammy and complaining of hands tingling. We had call 911 and ambulance took her to emergency dept for evaluation. Denies history of seizures.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Expired drug administered
Clinical narrative: An MMR vaccine was given after the expiration date of 7/3/14. Patient's parents will be called and an additional MMR will be given when appropriate.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Dizziness, Headache, Injection site discomfort, Vision blurred
Clinical narrative: 06/05/14 - Described a "bug bite" feeling at site, 5 minutes after injection. 3 hours after injection, pt reports dizziness, blurred vision, joint pain. Reports a headache the next morning, went to an urgent care center and received BENADRYL. Patient reports no symptoms on 06/06/14. No changes in vitals on 06/05/2014. 06/12/14 - Reports dizziness within hour after injection. Reports lightheaded, lasted two days. 06/26/14 - Reports dizziness within hour after injection. Denies other symptoms.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity, Rash
Clinical narrative: Rash and pain to right arm. MENACTRA.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Skin irritation, Swelling, Vaccination complication
Clinical narrative: Pt experienced adverse reaction to varicella vaccine given on right arm, swelling and irritation appears with no other symptoms.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Headache, Pain, Pruritus
Clinical narrative: Pt reports h/a and body aches 4 days post Zoster vaccine. Pt states 7 days post Zoster vaccine red, itchy, weeping, crater-like sores started appearing.  Shooting pain in left wrist x10 min's.  Spots/areas still appearing.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Secretion discharge, Skin ulcer
Clinical narrative: Pt reports h/a and body aches 4 days post Zoster vaccine. Pt states 7 days post Zoster vaccine red, itchy, weeping, crater-like sores started appearing.  Shooting pain in left wrist x10 min's.  Spots/areas still appearing.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Redness, mild swelling on (L) arm, warm to touch. Area measures 4 inch circum. No breathing problems noted. Gave 25mg BENADRYL at office exam and to take 25mg BENADRYL tonight and apply ice.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: 2 days post vaccines - firm, indurated welt on left upper arm measuring 4.5" x 4"; warm, red. - present x 1 day - pruritic
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 2 days post vaccines - firm, indurated welt on left upper arm measuring 4.5" x 4"; warm, red. - present x 1 day - pruritic
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypersensitivity, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Allergic reaction, macular/patchy erythematous rash whole body 2 days after 4 month imms (PEDIARIX, PREVNAR, Rota and Hib) in absence of other viral symptoms.
Sex: M
Vaccine: HPV4
Symptoms: Asthma, Bronchitis, Gynaecomastia
Clinical narrative: On 02-JUL-2014 information has been received from the mother of the patient. The reporter was calling for her son who was vaccinated with GARDASIL on 28-JUL-2011. The dose number was not reported. The reporter stated that since receiving the GARDASIL her son has had numerous effects that she believes are related to the vaccine including: asthma, bronchitis and the physical appearance of "man boobs". The reporter felt that these effects are directly related to the "yeast" contained within the vaccine. The reporter indicated she will get an attorney involved in her request to medically help remove the GARDASIL, specifically the "yeast" from her son's body. The outcome of asthma, "yeast", physical appearance of "man boobs" and bronchitis was reported as not recovered/not resolved. No further information was provided. Additional information has been requested.
Age: 1.61
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Febrile convulsion, Full blood count normal, Pyrexia
Clinical narrative: High fever, febrile seizure. EMS responded per parent call - transferred to ER 1pm on 7/10/14 (mother stated fever started 7am) 104 degrees.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Purulent discharge, Swelling
Clinical narrative: Patient rec'd AFLURIA vac 10/2/13 said was swollen and oozed pus at site in April 2014, as of July still visible (2014) wound.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous reported as received from a consumer refers to his male son, of unknown age. Medical history and concurrent conditions were not reported. In approximately 2002 (reported as about 12 years ago), the patient was vaccinated with M-M-R II (dose, strength, route, lot number and expiration date). Secondary and concomitant therapies were not reported. Consumer reported that his son had a violet reaction to M-M-R II in approximately 2002 (reported as about 12 years ago), with high fever. Outcome of the adverse events were not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Medication error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's medical history included chemotherapy. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The nurse reported that the patient received ZOSTAVAX one month after she completed chemotherapy. The nurse also reported that the patient developed shingles six weeks after receipt of the vaccine. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. Medical history was not reported. In approximately July 2012 (also reported as two years ago) the patient was vaccinated with ZOSTAVAX (lot number, expiration date, routed, and dosage were not reported) for prophylaxis. Concomitant therapy was not reported. The reporter informed that approximately in 2012 (also reported as two weeks later) the patient developed pericarditis. The physician was not sure if the patient developed pericarditis attack as a result of the vaccinated with ZOSTAVAX vaccine, he stated that there were other factors and other vaccines (unspecified). The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unspecified date in 2012, the patient received complete series of RECOMBIVAX HB (dose, Lot # and route were not reported). This series "did not take". This was clarified that the patient was a no responder to series of vaccine. No adverse effects were noted. On an unknown date, the patient sought medical attention. No treatment was given. The outcome of the series of vaccine "did not take" and the patient was a non responder to series of vaccine was unknown. This is one of two reports from the same source. Additional information has been requested.