chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old female patient. Concomitant medication and pertinent medical history were not provided. On 10-JUN-2014 the patient was vaccinated with a dose of GARDASIL (lot number, dose, route and frequency were not provided) by the  healthcare worker, which was improperly stored and exposed to 51 F for 2 hours. No adverse effects were being reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The nurse reported on unknown date, multiple unspecified patients were administered VAQTA that were stored improperly. No adverse effects reported. This is one of several reports received from same source. 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 roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX, (strength, dose, frequency, rough of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot#J012211, expiration date: 28-SEP-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of plenty reports received from the same source. 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 roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of plenty reports received from the same source. 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 roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye infection
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 59 year old female patient with extreme dry eye. Drug reactions and allergies were not provided by the reporter. On 22-APR-2014, the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expiration date were not provided). The reporter stated that the patient developed a bilateral eye infection after receiving ZOSTAVAX (on 28-APR-2014). The reporter also stated that the patient reported this adverse event to the pharmacist and also visited two eye specialists, however their contact information was unspecified. The reporter also stated that the patient had been diagnosed with extreme dry eye before receiving ZOSTAVAX at an unspecified time and was placed on an unspecified steroid (manufacturer unknown) and an unspecified antibiotic (manufacturer unknown) and at some point later she was instructed to stop the antibiotic and continue with the steroid. It was unspecified whether the patient was taking the steroid at the time of receiving ZOSTAVAX. The outcome of bilateral eye infection was unknown. The reporter also stated that the pharmacist did not believe that the bilateral eye infection was related to ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Severe pain. Loss of mobility. Physical therapy.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Eye movement disorder, Feeling abnormal, Feeling hot, Hyperhidrosis
Clinical narrative: 22 mins/or at 2:22pm, stated "I feel funny". Eyes rolled back, non-responsive. Incontinent on self. Pulse at 92 faint/thready. B/P 80/?. Responded within 13-15 seconds. Sweaty/states "I'm hot". Felt weak, assisted in wheelchair to room. Placed in semi-Trendelenburg. Was able to sip on Pepsi, ate 1/2 peanut butter cracker. B/P decreased for 2:45 -> 3:30, increased 110/76, 68, 22. Vomited/color improved. Assist changing clothes. Wheelchair to car to go to ER.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Incontinence, Pulse abnormal, Pulse pressure decreased, Unresponsive to stimuli, Vomiting
Clinical narrative: 22 mins/or at 2:22pm, stated "I feel funny". Eyes rolled back, non-responsive. Incontinent on self. Pulse at 92 faint/thready. B/P 80/?. Responded within 13-15 seconds. Sweaty/states "I'm hot". Felt weak, assisted in wheelchair to room. Placed in semi-Trendelenburg. Was able to sip on Pepsi, ate 1/2 peanut butter cracker. B/P decreased for 2:45 -> 3:30, increased 110/76, 68, 22. Vomited/color improved. Assist changing clothes. Wheelchair to car to go to ER.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Wheelchair user
Clinical narrative: 22 mins/or at 2:22pm, stated "I feel funny". Eyes rolled back, non-responsive. Incontinent on self. Pulse at 92 faint/thready. B/P 80/?. Responded within 13-15 seconds. Sweaty/states "I'm hot". Felt weak, assisted in wheelchair to room. Placed in semi-Trendelenburg. Was able to sip on Pepsi, ate 1/2 peanut butter cracker. B/P decreased for 2:45 -> 3:30, increased 110/76, 68, 22. Vomited/color improved. Assist changing clothes. Wheelchair to car to go to ER.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 59 year old female patient with type 2 diabetes mellitus and rheumatoid arthritis, who on 11-NOV-2013, was vaccinated with a dose of ZOSTAVAX, subcutaneously, (lot # J003808, expiration date 03-JUL-2014). Concomitant therapies included HUMALOG and methotrexate. None drug reactions/allergies were reported. Pharmacist reported that the patient was diagnosed with shingles by her primary physician on an unspecified date after 11-NOV-2013 and before 19-NOV-2013. Pharmacist reported that the patient was treated with valacyclovir. Pharmacist stated that the patient's episode of the shingles resolved on an unspecified date, therefore no VZVIP packet faxed as per pharmacist request. None laboratories test were performed. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Erythema, Pain in extremity, Pyrexia, Rash, Skin warm
Clinical narrative: This spontaneous report as received from a physician refers to approximately 32 year old female patient. Patient current condition included diabetes. None of drug allergies / reactions was reported. On 30-MAY-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # K003074, expiry date: 13-MAR-2015), intramuscular. Other suspect therapies included RECOMBIVAX HB and ADACEL took on same day. Concomitant therapy included insulin. On 31-MAY-2014 (also reported as later that day), the patient developed pain in the left deltoid. The patient took TYLENOL (manufacturer unspecified). On 01-JUN-2014, the pain had partially resolved. However, she had developed a fever (temperature unspecified), and also a punctuate rash on the chest, the back, the shoulders, and on the stomach. On 02-JUN-2014, the fever and rash were gone. ON 03-JUN-2014, a "huge, red, hot patch developed from the left shoulder to 3/4ths down the length of the arm. The arm was very painful." The patient's present status was unspecified. None of the laboratory diagnostic studied was done. Patient sought medical attention and called physician. There was no product quality complaint. Outcome of the event pain in the left deltoid to be considered as recovering (partially recovered), fever and punctuate rash on the chest, the back, the shoulders, and on the stomach was recovered and huge, red, hot patch developed from the left shoulder to 3/4ths down the length of the arm was unknown. Causality of the reported events was unknown (not provided). 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 roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J003227, exp date: 15-MAR-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. 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 roughly 20 unspecified patients of unknown age and gender. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could support those conditions mentioned above that VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports from the same source. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Bursa removal, Debridement, Drug administered at inappropriate site, Mobility decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: 1. Loss of mobility, pain 2. Injection administered above deltoid muscle in shoulder joint 3. Saw primary care doctor who suggested seeing a orthopedic doctor and scheduling PT 4. Started PT and made appointment with Orthopedic doctor 5. Had x-rays which were negative and MRI which showed a partial rotator cuff tear 6. Continued PT 7. Saw Orthopedic doctor several times. Doctor prescription Prednisone and pain medication. Pain medication was not helpful. Prednisone was helpful. After 10 days treatment complete. All symptoms returned. 8. Symptoms of loss of mobility and pain not improving 9. Orthopedic suggested surgury 10. Continued PT, with little to no improvement 11. Rotator cuff surgery performed on 4-28-2014 12. Bursectomy and debridement of rotator cuff area performed
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rotator cuff repair, Rotator cuff syndrome, Surgery, X-ray normal
Clinical narrative: 1. Loss of mobility, pain 2. Injection administered above deltoid muscle in shoulder joint 3. Saw primary care doctor who suggested seeing a orthopedic doctor and scheduling PT 4. Started PT and made appointment with Orthopedic doctor 5. Had x-rays which were negative and MRI which showed a partial rotator cuff tear 6. Continued PT 7. Saw Orthopedic doctor several times. Doctor prescription Prednisone and pain medication. Pain medication was not helpful. Prednisone was helpful. After 10 days treatment complete. All symptoms returned. 8. Symptoms of loss of mobility and pain not improving 9. Orthopedic suggested surgury 10. Continued PT, with little to no improvement 11. Rotator cuff surgery performed on 4-28-2014 12. Bursectomy and debridement of rotator cuff area performed
Age: 24.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Local swelling, Pyrexia, White blood cell count increased
Clinical narrative: Fever, large red, swollen triceps area on left arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Small rash on L thigh. Pt reported to ED and discharged after short observation.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Severe pain and loss of range of motion resulting in ER visit 8 days later.
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, VARCEL, HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Fever during the nights of 06/13/2014 and 06/14/2014. A small rash appeared on stomach during PM of 06/15/2014 which had spread to face and chest by 06/16/2015. Rash is slightly itchy.
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, VARCEL, HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever during the nights of 06/13/2014 and 06/14/2014. A small rash appeared on stomach during PM of 06/15/2014 which had spread to face and chest by 06/16/2015. Rash is slightly itchy.
Age: 0.32
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on side of body 2 days after the zoster immunization was given.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Febrile convulsion, Pyrexia
Clinical narrative: Fever followed by complex febrile seizure.  Treated in ER.  Given Ativan to stop seizures.  Remained in hospital overnight for observation.  Released from hospital on 6/15/14.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Local swelling, Pain
Clinical narrative: Pt reported to me on 6/17/14 that at an unknown time after the vaccination her arm had significant bruising and experienced significant pain. The patient also reported significant swelling of the arm down to her hand. She is currently working with her doctor to get treatment. When I observed her on 6/17, I could see visible swelling of the left hand in comparison to the other.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Inflammation, redness, heat, minor itching, and firmness at injection site. Gradually spreading in a circular pattern from the injection site.
Age: 0.17
Sex: F
Vaccine: 6VAX-F
Symptoms: Blood test normal, Convulsion, Electroencephalogram normal, Epilepsy, Nuclear magnetic resonance imaging normal
Clinical narrative: She had a 4 minutes seizure. All her body trembing and shaking. She started having seizures every 8-10 days. She was diagnosed with epilepsy. The seizures became more frequent after second round of vaccines (sometimes almost every day). Doctors never found the right medications for her. We were never able to control her epilepsy.
Age: 0.17
Sex: F
Vaccine: 6VAX-F
Symptoms: Tremor
Clinical narrative: She had a 4 minutes seizure. All her body trembing and shaking. She started having seizures every 8-10 days. She was diagnosed with epilepsy. The seizures became more frequent after second round of vaccines (sometimes almost every day). Doctors never found the right medications for her. We were never able to control her epilepsy.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Cold urticaria, Urticaria thermal, Vaccine positive rechallenge
Clinical narrative: Temperature induced urticaria (angioedema?), involving the entire body (heat, as when sweating during a run, and cold, as when in ocean water for several minutes).  Symptoms last 1-2 hours, no response to benadryl.  Cannot be prevented with premedication with antihistamines.  Symptoms are recurrent and have increased in severity with each additional administration of HPV and Hep A vaccines.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On unspecified dates, improperly stored doses of GARDASIL lot # J009788, expiration date 17-MAR-2016 (strength, dose number, dose, frequency and indication were not reported) was administered. No concomitant medication reported. Outcome and causality was not reported. This is case has been linked to MARRS # 1406USA000382, 1406USA000549, 1406USA000551, 1406USA000552, 1406USA000550, 1406USA008391 and 1406USA008414. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On unspecified dates, improperly stored doses of MMR II lot # J006995 expiration date 14-JUN-2015 (strength, dose number, dose, frequency and indication were not reported) was administered. No concomitant medication reported. Outcome and causality was not reported. This is case has been linked to MARRS # 1406USA000382, 1406USA000549, 1406USA000551, 1406USA000552, 1406USA000550, 1406USA008414 and 1406USA008418. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 13 year old adolescent. Gender was not reported. Medical history and concurrent conditions were not reported. In 06-MAR-2007, the patient was vaccinated with first dose of VARIVAX (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Patient would like to received a second dose of VARIVAX. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a female patient of unknown age. Medical history was not reported. The reporter informed that on 21-DEC-2011 the patient received her first dose of GARDASIL injection, lot number, strength, dosage, route and anatomical location were not reported. On 07-JAN-2012 the patient received the second dose of GARDASIL injection, lot number, strength, dosage, route were not reported and she was at that time (09-JUN-20140 in the office to receive her third dose. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an unknown number of patients of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the nurse reported that vaccines of VAQTA (Lot # and expiry date were not provided); vaccines of "Tetanus" (therapy unspecified) and "Diphtheria", were exposed to temperature excursion and were administered to unknown number of patients. The vaccines were exposed to 50F for 1 hour and 5 minutes, and were administered to unspecified number of patients since the temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an unknown number of patients of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the nurse reported that vaccines of ROTATEQ (Lot # and expiry date were not provided); vaccines of Tetanus (therapy unspecified) and Diphtheria, were exposed to temperature excursion and were administered to unknown number of patients. The vaccines were exposed to 50F for 1 hour and 5 minutes, and were administered to unspecified number of patients since the temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an unknown number of patients of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the nurse reported that the vaccines of PNEUMOVAX 23 (Lot # and expiry date were not provided); vaccines of "Tetanus" (therapy unspecified) and "Diphtheria", were exposed to temperature excursion and were administered to unknown number of patients. The vaccines were exposed to 50F for 1 hour and 5 minutes, and were administered to unspecified number of patients since the temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an unknown number of patients of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the nurse reported that the vaccines of MMR II (Lot # and expiry date were not provided); vaccines of "Tetanus" (therapy unspecified) and "Diphtheria", were exposed to temperature excursion and were administered to unknown number of patients. The vaccines were exposed to 50F for 1 hour and 5 minutes, and were administered to unspecified number of patients since the temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age. Nurse reported that unspecified number of improperly stored RECOMBIVAX HB, (lot # not reported). Doses had been administered to unspecified number of patients. Vaccines were exposed to 50F for 48 hours. No adverse effects reported. This is one of several reports from the same reporter source. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Diplopia, Dizziness, Erythema, Feeling cold, Feeling hot
Clinical narrative: Afternoon next day had headache, dizziness, tingling and numbness on extremities, 101 fever, muscle aches, totally lethargic (felt like if walked into a door), rapid heart beat, double vision like when cross eyed. Given ibuprofen for fever. In the morning took another ibuprofen got dizzy in school and just wanted to sleep. It is very out of the norm since she usually rune 3-4 miles a day. Had fever of 100.7. Symptoms continued, felt like if heart beat was even faster. On Saturday had 103.7 fever so taken to the ER. Blood work revealed low WBC and platelets. Felt extremely hot and sweaty and then really cold. Face was beet red, even the whites of her eyes were red. Sent home from ER. Sunday was feeling better. Today, low grade fever but dropping from prior readings. She went to school but picked up by 10am and taken to the doctor for fever, reading around 102.7. Strep throat test done and negative. No other flu like symptoms. Continue to take fever reducing medicine (TYLENOL and ibuprofen). Temp is dropping but she still looks out of it, has a glazed look.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Lethargy
Clinical narrative: Afternoon next day had headache, dizziness, tingling and numbness on extremities, 101 fever, muscle aches, totally lethargic (felt like if walked into a door), rapid heart beat, double vision like when cross eyed. Given ibuprofen for fever. In the morning took another ibuprofen got dizzy in school and just wanted to sleep. It is very out of the norm since she usually rune 3-4 miles a day. Had fever of 100.7. Symptoms continued, felt like if heart beat was even faster. On Saturday had 103.7 fever so taken to the ER. Blood work revealed low WBC and platelets. Felt extremely hot and sweaty and then really cold. Face was beet red, even the whites of her eyes were red. Sent home from ER. Sunday was feeling better. Today, low grade fever but dropping from prior readings. She went to school but picked up by 10am and taken to the doctor for fever, reading around 102.7. Strep throat test done and negative. No other flu like symptoms. Continue to take fever reducing medicine (TYLENOL and ibuprofen). Temp is dropping but she still looks out of it, has a glazed look.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Myalgia, Ocular hyperaemia, Paraesthesia, Platelet count decreased, Pyrexia
Clinical narrative: Afternoon next day had headache, dizziness, tingling and numbness on extremities, 101 fever, muscle aches, totally lethargic (felt like if walked into a door), rapid heart beat, double vision like when cross eyed. Given ibuprofen for fever. In the morning took another ibuprofen got dizzy in school and just wanted to sleep. It is very out of the norm since she usually rune 3-4 miles a day. Had fever of 100.7. Symptoms continued, felt like if heart beat was even faster. On Saturday had 103.7 fever so taken to the ER. Blood work revealed low WBC and platelets. Felt extremely hot and sweaty and then really cold. Face was beet red, even the whites of her eyes were red. Sent home from ER. Sunday was feeling better. Today, low grade fever but dropping from prior readings. She went to school but picked up by 10am and taken to the doctor for fever, reading around 102.7. Strep throat test done and negative. No other flu like symptoms. Continue to take fever reducing medicine (TYLENOL and ibuprofen). Temp is dropping but she still looks out of it, has a glazed look.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Somnolence, Streptococcus test negative, White blood cell count decreased
Clinical narrative: Afternoon next day had headache, dizziness, tingling and numbness on extremities, 101 fever, muscle aches, totally lethargic (felt like if walked into a door), rapid heart beat, double vision like when cross eyed. Given ibuprofen for fever. In the morning took another ibuprofen got dizzy in school and just wanted to sleep. It is very out of the norm since she usually rune 3-4 miles a day. Had fever of 100.7. Symptoms continued, felt like if heart beat was even faster. On Saturday had 103.7 fever so taken to the ER. Blood work revealed low WBC and platelets. Felt extremely hot and sweaty and then really cold. Face was beet red, even the whites of her eyes were red. Sent home from ER. Sunday was feeling better. Today, low grade fever but dropping from prior readings. She went to school but picked up by 10am and taken to the doctor for fever, reading around 102.7. Strep throat test done and negative. No other flu like symptoms. Continue to take fever reducing medicine (TYLENOL and ibuprofen). Temp is dropping but she still looks out of it, has a glazed look.
Age: 1.3
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 16 month old male patient. Medical history was not reported. The reporter informed that on 05-MAY-2014 the patient was vaccinated with PROQUAD lot number, strength, dosage and route were not reported, and on 09-JUN-2014 the patient received a dose of VARIVAX lot number, strength, dosage and route were not reported. Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. It was reported that the patient received a first dose of both VARIVAX (route, lot number and expiration date not reported) and PROQUAD (route, lot number and expiration date not reported) on 09-JUN-2014. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient pertinent medical history was not provided. The nurse reported that the patient received her first dose of GARDASIL (dose, route of administration, lot# and expiration date were unspecified) "two years and a couple months ago" and her second dose of GARDASIL (dose, route of administration, lot# and expiration date were unspecified) in approximately April 2014 (reported as "two months ago"). No adverse effect reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Patient received shot b/t 10:30 and 11:00 AM. Went to eye doctor at 1PM for eye exam. B/t 1-3PM  pt developed a rash. Returned to our practice on Thursday and we sent her to dermatologist.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age. Nurse reported that unspecified number of improperly stored ROTATEQ. Doses had been administered to unspecified number of patients. Vaccines were exposed to 50F for 48 hours. ROTATEQ was exposed to the following excursions: On 27-MAR-2014: 47F for 12 hours. On 02-APR-2014: 47F for 12 hours. On 17-APR-2014: 47F for 12 hours. On 18-APR-2014 for 12 hours. Dates of administration of lot # J013625, exp 31-MAR-2015: 02-JUN-2014, 03-JUN-2014, 04-JUN-2014 (3 doses), and 06-JUN-2014. Dates of administration of lot # J012519, exp 30-APR-2015: 22-MAY-2014, 28-MAY-2014 (2 doses), 29-MAY-2014, 05-JUN-2014, 06-JUN-2014, 09-JUN-2014, and 10-JUN-2014. No adverse effect had been observed or reported. This is one of several reports from the same reporter source. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site reaction
Clinical narrative: Localized reaction to left deltoid.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Myoclonus, Syncope
Clinical narrative: Apparently fainted 10-12 minutes after receiving vaccines. Had 2 to 3 myoclonic jerks of trunk and arms - nothing sustained. Laid down for 20 mins. - then sat for 10 more - initially received oxygen. Had juice box - stable after 30 mins.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash, Rash papular
Clinical narrative: Dull pain at site of injection, started same day, very severe day 3-5, then slowly subsided. Rash, papular, vertically along the arm, from site of injection, resolved over 4-5d.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse referring to an unspecified number of patients of unknown age. Nurse reported that unspecified number of improperly stored VAQTA, (lot # not reported). Doses had been administered to unspecified number of patients. Vaccines were exposed to 50F for 48 hours. No adverse effects reported. This is one of several reports from the same reporter source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age. Nurse reported that unspecified number of improperly stored PNEUMOVAX 23, (lot # not reported). Doses had been administered to unspecified number of patients. Vaccines were exposed to 50F for 48 hours. No adverse effects reported. This is one of several reports from the same reporter source. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperhidrosis, Hypotension, Presyncope, Syncope
Clinical narrative: This spontaneous report was received from a physician via field employee refers to a 16 year old male patient. Medical history was not reported. On 04-APR-2014 the patient was vaccinated with the first dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016) injection, strength, dosage and route was not reported. On 06-JUN-2014 the patient was vaccinated with the second dose of GARDASIL (lot number J009788 expiration date 17-MAR-2016) injection, strength, dosage and route was not reported. There were not others vaccines administered. Concomitant therapy was not reported. The physician informed that on 04-APR-2014 after the first dose of GARDASIL the patient experienced syncope, while still in physician's office. Treatment was laying the patient down, giving him water, placing a fan on the patient and taking his blood pressure, the blood pressure was unspecified. The patient recovered fully after treatment in the physician's office. On 06-JUN-2014 after the second dose of GARDASIL the patient experienced being diaphoretic further described as he was so drenched and sweating that he drenched the table, hypotensive and vasovagal in the physician's office, treatment was laying the patient down, giving water and taking his blood pressure, the result of the patient's blood pressure was unspecified, the patient recovered fully after treatment was given. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Patient went to our waiting room feeling fine. He slumped down and eyes rolled back and he became very stiff. He did not respond when his father was talking to him. After a minute he started to feel and act normal.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Pt arrived at clinic on 6/12/14 and was diagnosed with shingles in one dermatome from the back of her neck down her right arm. She reports intense pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced swelling and soreness around injection site. It started 2 days after injection was given. Recommended ice, naproxen, and BENADRYL as treatment. I examined the area 1 week after injection. It was slightly improved but still red and swollen.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Less than 30 second episode of syncope s/p GARDASIL vaccination. Patient regained consciousness and was laid supine 2 legs elevated, ice pack to back of neck. Patient remained in office for 15 additional minutes, with boyfriend at bedside. No adverse effects noted. Patient pink, denied dizziness and was released to home with boyfriend.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Pruritus, Swelling
Clinical narrative: Local reaction, area of swelling and itching.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Nasal congestion, Pain in extremity
Clinical narrative: 6/15 - Pt experienced headache same day as receiving the vaccine. 6/16 - Pain in right arm starting in the late afternoon, along with chills and fever. 6/17 - Nasal congestion, flu-like symptoms, pt going to primary care doctor.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 6/15 - Pt experienced headache same day as receiving the vaccine. 6/16 - Pain in right arm starting in the late afternoon, along with chills and fever. 6/17 - Nasal congestion, flu-like symptoms, pt going to primary care doctor.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with PEDVAXHIB (dose, lot number and route not provided). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered PEDVAXHIB that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USA008435, 1406USA008521, 1406USA008523, 1406USA008524 and 1406USA008525 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with VAQTA (dose, lot number and route not provided). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered VAQTA that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USSA008435, 1406USA008522, 1406USA008523, 1406USA008524 and 1406USA008525 (same reporter link). 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 medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with VARIVAX (dose, lot number and route not provided). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered VARIVAX (merck) that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USA008521, 1406USA008522, 1406USA008523, 1406USA008524 and 1406USA008525 (same reporter link). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Moderate to severe reaction at site, (R) FA. 2x2.5 cm knot at site, with induration, redness extending 7x6 cm around inj. site. Cool compresses TID, BENADRYL PRN.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Blood creatine phosphokinase, Dysuria, Full blood count, Metabolic function test
Clinical narrative: Fever 101.2. Aching in all muscles and joints, vomiting, nausea. Dysuria. Lower legs and feet and hands tingling. Sore throat.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Paraesthesia, Pyrexia
Clinical narrative: Fever 101.2. Aching in all muscles and joints, vomiting, nausea. Dysuria. Lower legs and feet and hands tingling. Sore throat.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Red blood cell sedimentation rate, Streptococcus test, Streptococcus test negative, Vomiting
Clinical narrative: Fever 101.2. Aching in all muscles and joints, vomiting, nausea. Dysuria. Lower legs and feet and hands tingling. Sore throat.
Age: 0.6
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old patient. On 16-JUN-2014, the patient was vaccinated with an expired 0.5 ml dose of RECOMBIVAX HB (Lot # 1625AA, expiration date 06-JUN-2014) (route not reported). No adverse events were reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, lot number and route not provided). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered RECOMBIVAX HB that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USA008435, 1406USA008521, 1406USA008522, 1406USA008524 and 1406USA008525 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with ROTATEQ, orally (dose and lot number). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered ROTATEQ that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USA008435, 1406USA008521, 1406USA008522, 1406USA008523 and 1406USA008525 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with PNEUMOVAX23 (dose, lot number and route not provided). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered PNEUMOVAX23 that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USA008435, 1406USA008521, 1406USA008522, 1406USA008523 and 1406USA0085524 (same reporter link).
Age: 1.55
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Irritability, Pruritus, Rash
Clinical narrative: Rash on torso started 6/16/14. Irritable and complains of itch. No documented fever, respiratory symptoms or GI sx.
Age: 34.0
Sex: F
Vaccine: HEP, TD
Symptoms: Angioedema, Rash
Clinical narrative: Patient experienced facial rash/angioedema to lips. No airway compromise. No wheezing. No hypotension.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient came in with rash on chest and shoulders. She said it started the evening of vaccine and was improving by next day. Advised her to take BENADRYL and go to ER if symptoms worsen.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt seen 6/14/14 presents with left upper arm and left forearm upper 1/3 with diffuse swelling and erythema (+). No pain, no tenderness. Neuro exam (NL). Difference in arm size Lt > Rt. Improving with time. Phone call 6/16/14. 7/17/14 5pm p. call swelling much better.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Patient was given pediatric Hepatitis A, as opposed to scheduled Human Papilloma Virus vaccine.
Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Complex partial seizures, Cytogenetic analysis, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Partial Complex seizure.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian failure
Clinical narrative: This spontaneous report was received from a physician assistant via a social media (unspecified new source) concerning two female patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (dose and route were not reported). The physician assistant reported that a patient brought a news article that on unknown date, two sisters developed ovarian failure after receiving GARDASIL. The physician assistant is not the healthcare provider for the sisters and did not have any patients who are experiencing ovarian failure after receiving GARDASIL. The outcome of patients developed ovarian failure after receiving GARDASIL was unknown. This is an unconfirmed case and one of two reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, VARCEL, HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Pt developed fever on the evening of 6/13, broke the next day, then returned the evening of 6/14.  The following day, 6/15, her fever broke and she developed a rash.  Rash started on abdomen then spread to chest, face, back, and arms.  Rash is still present.
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, VARCEL, HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Pt developed fever on the evening of 6/13, broke the next day, then returned the evening of 6/14.  The following day, 6/15, her fever broke and she developed a rash.  Rash started on abdomen then spread to chest, face, back, and arms.  Rash is still present.