chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Tremor, Urinary incontinence
Clinical narrative: Client received Tdap (Boostrix), Menactra and HPV 9 injections. About 5 minutes after vaccines were administered, the client had a change in facial color to pallor and became diaphoretic. The client lost consciousness and her body began to shake. The client also was incontinent of urine. The client responded after about 45 seconds to her name and was oriented to time and place. Cold compresses were applied. Parent informed that the client would be ok with plenty of fluids and adequate nutrition.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Patient states fever and diarrhea. He did not take his temperature.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, knotted, warm to touch, painful in area where shot was given.  Pain in underarm, swollen lymph node. Pain in shoulder to side of neck. Lymph node in side of neck tender.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site warmth, Lymph node pain, Lymphadenopathy, Musculoskeletal pain, Neck pain
Clinical narrative: Swelling, redness, knotted, warm to touch, painful in area where shot was given.  Pain in underarm, swollen lymph node. Pain in shoulder to side of neck. Lymph node in side of neck tender.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, redness, knotted, warm to touch, painful in area where shot was given.  Pain in underarm, swollen lymph node. Pain in shoulder to side of neck. Lymph node in side of neck tender.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypersensitivity, Injection site rash, Injection site warmth, Rash
Clinical narrative: PT HAD RASH RADIATING DOWN LEFT DELTOID TO FOREARM. SITE WAS SENSITIVE AND WARM TO TOUCH. NO EXUDUS. NO PREVIOUS HISTORY OF CHIEF COMPLAINT.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Electroencephalogram normal, Feeling abnormal, Generalised tonic-clonic seizure, Migraine
Clinical narrative: Information has been received from the patient's mother referring to an approximately 26 year old female patient who was not pregnant. The patient had no pertinent medical history and no drug reactions/allergies. On 20-OCT-2010 the patient was vaccinated with the first dose of GARDASIL (lot # 666598/0786Z, expiry date 18-OCT-2012), on 22-DEC-2010, the patient received the second dose of GARDASIL (lot# 666929/0331Z, expiry date 20-NOV-2012) and on 27-APR-2011, the patient was administered the third dose of GARDASIL (lot# not provided, expiry date 25-FEB-2013) (dose and route unspecified).The events began after the third dose of GARDASIL. In approximately 2011, the patient "started with stomach pain, and violent headaches". It was also reported that the patient had an "out of body feeling like she wasn't there" which was identified by her physician as a petite-mal seizure. The following summer (2012) it progressed to grand-mal seizures. She had a total of 9 grand-mal seizures between 2012 and the present day. She had a "few petit-mal ones." She was "not the same person that she was", she suffers from body ailments which they try to help with diet but never seems to be fully resolved. She had at least Magnetic Resonance Imaging (MRIs) but they couldn't find anything wrong with her brain and they couldn't do an electroencephalograph (EEG) until after the seizure." On an unspecified date, the patient spent time at a seizure disorder clinic where she was "wired for a full week 24-7." They were unable to duplicate the seizure during that week. The patient was placed on therapy with KEPPRA with maximum dosage on an unspecified date. The patient had only had one seizure this past year. The patient had been in the Emergency Room due to the seizures however she was not admitted to the hospital. The patient had no lab diagnostics studies performed. Upon internal review, generalized tonic-clonic seizure was considered as medically significant event. The outcome of generalized tonic-clonic seizure and petit mal epilepsy was reported as not recovered/not resolved. The outcome of abdominal pain upper and migraine was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Petit mal epilepsy
Clinical narrative: Information has been received from the patient's mother referring to an approximately 26 year old female patient who was not pregnant. The patient had no pertinent medical history and no drug reactions/allergies. On 20-OCT-2010 the patient was vaccinated with the first dose of GARDASIL (lot # 666598/0786Z, expiry date 18-OCT-2012), on 22-DEC-2010, the patient received the second dose of GARDASIL (lot# 666929/0331Z, expiry date 20-NOV-2012) and on 27-APR-2011, the patient was administered the third dose of GARDASIL (lot# not provided, expiry date 25-FEB-2013) (dose and route unspecified).The events began after the third dose of GARDASIL. In approximately 2011, the patient "started with stomach pain, and violent headaches". It was also reported that the patient had an "out of body feeling like she wasn't there" which was identified by her physician as a petite-mal seizure. The following summer (2012) it progressed to grand-mal seizures. She had a total of 9 grand-mal seizures between 2012 and the present day. She had a "few petit-mal ones." She was "not the same person that she was", she suffers from body ailments which they try to help with diet but never seems to be fully resolved. She had at least Magnetic Resonance Imaging (MRIs) but they couldn't find anything wrong with her brain and they couldn't do an electroencephalograph (EEG) until after the seizure." On an unspecified date, the patient spent time at a seizure disorder clinic where she was "wired for a full week 24-7." They were unable to duplicate the seizure during that week. The patient was placed on therapy with KEPPRA with maximum dosage on an unspecified date. The patient had only had one seizure this past year. The patient had been in the Emergency Room due to the seizures however she was not admitted to the hospital. The patient had no lab diagnostics studies performed. Upon internal review, generalized tonic-clonic seizure was considered as medically significant event. The outcome of generalized tonic-clonic seizure and petit mal epilepsy was reported as not recovered/not resolved. The outcome of abdominal pain upper and migraine was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Electroencephalogram, Gastrointestinal disorder, Generalised tonic-clonic seizure, Laboratory test normal
Clinical narrative: Information has been received from the patient's mother referring to an approximately 26 year old female patient who was not pregnant. The patient had no pertinent medical history and no drug reactions/allergies. On 20-OCT-2010 the patient was vaccinated with the first dose of GARDASIL (lot # 666598/0786Z, expiry date 18-OCT-2012), on 22-DEC-2010, the patient received the second dose of GARDASIL (lot# 666929/0331Z, expiry date 20-NOV-2012) and on 27-APR-2011, the patient was administered the third dose of GARDASIL (lot# not provided, expiry date 25-FEB-2013) (dose and route unspecified).The events began after the third dose of GARDASIL. In approximately 2011, the patient "started with stomach pain, and violent headaches". It was also reported that the patient had an "out of body feeling like she wasn't there" which was identified by her physician as a petite-mal seizure. The following summer (2012) it progressed to grand-mal seizures. She had a total of 9 grand-mal seizures between 2012 and the present day. She had a "few petit-mal ones." She was "not the same person that she was", she suffers from body ailments which they try to help with diet but never seems to be fully resolved. She had at least Magnetic Resonance Imaging (MRIs) but they couldn't find anything wrong with her brain and they couldn't do an electroencephalograph (EEG) until after the seizure." On an unspecified date, the patient spent time at a seizure disorder clinic where she was "wired for a full week 24-7." They were unable to duplicate the seizure during that week. The patient was placed on therapy with KEPPRA with maximum dosage on an unspecified date. The patient had only had one seizure this past year. The patient had been in the Emergency Room due to the seizures however she was not admitted to the hospital. The patient had no lab diagnostics studies performed. Upon internal review, generalized tonic-clonic seizure was considered as medically significant event. The outcome of generalized tonic-clonic seizure and petit mal epilepsy was reported as not recovered/not resolved. The outcome of abdominal pain upper and migraine was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Ultrasound abdomen
Clinical narrative: Information has been received from the patient's mother referring to an approximately 26 year old female patient who was not pregnant. The patient had no pertinent medical history and no drug reactions/allergies. On 20-OCT-2010 the patient was vaccinated with the first dose of GARDASIL (lot # 666598/0786Z, expiry date 18-OCT-2012), on 22-DEC-2010, the patient received the second dose of GARDASIL (lot# 666929/0331Z, expiry date 20-NOV-2012) and on 27-APR-2011, the patient was administered the third dose of GARDASIL (lot# not provided, expiry date 25-FEB-2013) (dose and route unspecified).The events began after the third dose of GARDASIL. In approximately 2011, the patient "started with stomach pain, and violent headaches". It was also reported that the patient had an "out of body feeling like she wasn't there" which was identified by her physician as a petite-mal seizure. The following summer (2012) it progressed to grand-mal seizures. She had a total of 9 grand-mal seizures between 2012 and the present day. She had a "few petit-mal ones." She was "not the same person that she was", she suffers from body ailments which they try to help with diet but never seems to be fully resolved. She had at least Magnetic Resonance Imaging (MRIs) but they couldn't find anything wrong with her brain and they couldn't do an electroencephalograph (EEG) until after the seizure." On an unspecified date, the patient spent time at a seizure disorder clinic where she was "wired for a full week 24-7." They were unable to duplicate the seizure during that week. The patient was placed on therapy with KEPPRA with maximum dosage on an unspecified date. The patient had only had one seizure this past year. The patient had been in the Emergency Room due to the seizures however she was not admitted to the hospital. The patient had no lab diagnostics studies performed. Upon internal review, generalized tonic-clonic seizure was considered as medically significant event. The outcome of generalized tonic-clonic seizure and petit mal epilepsy was reported as not recovered/not resolved. The outcome of abdominal pain upper and migraine was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Headache, Pruritus, Pyrexia
Clinical narrative: Redness and itching away from the site of injection - gave shot in muscle of shoulder - elbow turned red and itched. Moderate headache and 100 degree fever next day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HPV9, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine was administered at the time of patient visit during her well child check-up.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. having redness and mild swelling on where vaccine given.
Age: 18.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse events reported. Patient received adult dose of Hep B (20 mcg/mL) and should have received 10 mcg/0.5 mL dose based on age.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Had injection 4-18. 4-19 noticed redness and tenderness with warmth in BP cuff distribution. (L) upper arm (+) itching and swelling.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: (L) arm red and swollen, sore and painful, stomach upset.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 27.0
Sex: F
Vaccine: HEP, MNQ, TD, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4-20-16 Left arm, back of arm, VZV site, red, swollen, using cold compresses.
Age: 0.63
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for shock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 5 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 30-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 8 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 10 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 09-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 10 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.59
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 30-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.21
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 11 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.39
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). Then, on 04-APR-2016, the patient was revaccinated with another improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. On 12-APR-2016, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 which had lot # of K020215, that had expired on 23-MAR-2016 dose, (dosage number, route of administration were not provided); although no adverse events were reported. Additional information has been requested.
Sex: M
Vaccine: HEPAB
Symptoms: Ocular hyperaemia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye red in a adult male patient who received TWINRIX adult. On an unknown date, the patient received the 2nd dose of TWINRIX adult. On an unknown date, 1 hr after receiving TWINRIX adult, the patient experienced eye red. On an unknown date, the outcome of the eye red was unknown. It was unknown if the reporter considered the eye red to be related to TWINRIX adult. Additional details provided as follows: A later after vaccination, the patient's eye became red. The patient declined to proceed with Safety report. No further details were known. Age at vaccination was not provided.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Contusion, Injection site bruising, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 17-year-old male patient who received BEXSERO (batch number 153701, expiry date unknown). On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain and injection site bruising. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the injection site pain and injection site bruising to be related to BEXSERO. Additional details provided were as follows: The patient experienced painful or sore arm after vaccination with BEXSERO in the deltoid region of his arm. The patient also had bruising on the inside of the arm in which the vaccine was administered. The reporter stated that she preferred to not answer further questions regarding the event due to time constraints. Further product details and patient identifying information was not available at the time of reporting. No further information was reported regarding the event.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.63
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 25-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.46
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 5 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 05-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.44
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 5 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 28-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-MAR-2016, the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX 23 injection, lot # K010522, expiration date 25-FEB-2016 (strength, dose, route and site of administration were not reported). No adverse effect was reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-MAR-2016, the patient was inadvertently vaccinated with a dose of expired PNEUMOVAX 23 injection, lot # K010522, expiration date 25-FEB-2016 (strength, dose, route and site of administration were not reported). No adverse effect was reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 17-MAR-2016 the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck) (with lot # and expiration date K002920 and 26-FEB-2016, respectively) (dose and route of administration were not provided). Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Information regarding medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with their first dose of unspecified GARDASIL or GARDASIL 9; then, on an unknown date, reported as "6 months later" received their second dose, also reported as unspecified if was GARDASIL or GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported for any vaccine). No adverse effects reported. Concomitant therapies were not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The nurse reported that multiple unspecified patients were administered improperly stored VARIVAX (Merck) (lot # L001331, expired date 13-JAN-2017, dose and route not reported) on multiple unspecified dates following an excursion on 22-DEC-2015. The temperature and time frame was reported as -12.3 Centigrade for 1 hour and 6 minutes; -13.6 Centigrade for 48 minutes. There was no previous temperature excursion. At the time of report, the status of patients was unknown. Additional information is not expected as reporter refused additional contact.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse (L.V.N.) referring to a male patient of unknown age. On 22-MAR-2016, the patient received his first dose of GARDASIL 9 (route, lot# and dose were unknown). On 20-APR-2016, the patient receive his second dose of GARDASIL 9 (route, lot# and dose were unknown) in the reporter's office, which was outside of the recommendations in the GARDASIL 9 prescribing information (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored VAQTA (lot # L007559 with expire date 01-JUN-2017, dosage was not provided) orally. The conditions storage was 32 F for 240 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored RECOMBIVAX HB (lot # L004754 with expire date 10-NOV-2016, dosage and route not provided). The conditions storage was 32 F for 240 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored ROTATEQ (lot # L013192 with expire date 19-JAN-2017, dosage was not provided) orally. The conditions storage was 32 F for 240 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Pt presents with redness, swelling, hardening and pat at site of injection. reports feeling 'run down' since injection. Pt evaluated by provider and treated with NSAIDs.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site warmth, Lymph node pain, Lymphadenopathy, Musculoskeletal pain, Neck pain
Clinical narrative: Pt presents with redness, swelling, hardening and pat at site of injection. reports feeling 'run down' since injection. Pt evaluated by provider and treated with NSAIDs.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt presents with redness, swelling, hardening and pat at site of injection. reports feeling 'run down' since injection. Pt evaluated by provider and treated with NSAIDs.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Troponin I increased
Clinical narrative: Initial solicited report received on 22 October 2013 an investigator participating in the below mentioned trial. A 30-year-old male subject with no reported past medical history had received smallpox (vaccinia) vaccine, live (ACAM2000, lot number, route and site not reported) on 31 March 2011 and 16 days later was found to have on 16 April 2011 an elevated Troponin. The subject had a Troponin I level on 14 April 2011that was 0.64 ng/mL. Troponin was unable to be rechecked due to broken tube. The subject was asymptomatic. An ECG on 18 April 2011 was normal. The subject was seen by cardiology who performed and ECG and echocardiogram, they ruled out myopericarditis and the subject returned to fully duty. Troponin was redrawn on 18 April 2011 and rapid was within normal limits (WNL). Outcome was not recovered. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Relationship to investigational product according to company: associated. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Follow-up information was received from the investigator on 07 November 2013. Lot number and site of ACAM2000 was unknown, route was percutaneous. Final diagnosis and results of pending EKG was no cardiac pathology found. Date of outcome was unknown. Documents held by sender: None. Follow up information received on 07 April 2016: The subject's race was updated. The event elevated troponin was resolved on 18 April 2011. A questionnaire of smoking and drinking habits was received. Sender's Comments: Follow-up information received on 07 April 2016, does not change the previous medical assessment. A central lab troponin elevation in a male subject 16 days post-vaccination with ACAM2000. The patient had no symptoms. ECG was normal. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Myopericarditis is a known event following vaccination with live vaccinia virus and is listed in the reference safety information. Follow-up information on 07 November 2013 did not alter prior assessment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash erythematous, Skin warm
Clinical narrative: Cellulitis (warm, red rash) requiring treatment with Keflex. Patient was seen at her doctors office 4/21/16.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Depression, Irritability, Rash, Somnolence
Clinical narrative: Difficulty waking-up, irritability and depression persistent until about 1 pm. Following day woke-up with rash on torso, arms, neck.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Zostavax given instead of Varicella vaccination - No adverse reactions.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis, Rotavirus test positive, Vomiting
Clinical narrative: This literature marketed report as received from a physician, the author of a literature article. Using a multicenter, active surveillance network from 2 rotavirus seasons (2012 and 2013), the reporters assessed the vaccine effectiveness for RV5 (ROTATEQ) and RV1 (ROTARIX) rotavirus vaccines in preventing rotavirus gastroenteritis hospitalizations and emergency department (ED) visits for numerous demographic and secular strata. The reporters enrolled children hospitalized or visiting the ED with acute gastroenteritis (AGE) for the 2012 and 2013 seasons at 7 medical institutions. Stool specimen were tested for rotavirus by enzyme immunoassay and genotyped, and rotavirus vaccination histories were compared for rotavirus-positive cases and rotavirus-negative AGE controls. The reporters calculated the vaccine effectiveness (VE) for preventing rotavirus associated hospitalizations and ED visits for each vaccine, stratified by vaccine dose, season, clinical setting, age, predominant genotype, and ethnicity, RV5-specific VE analyses included 2961 subjects, 402 rotavirus cases (14%) and 2559 rotavirus-negative AGE controls. Description of 402 rotavirus cases was as below: median age, (35 months); Gender (male: 233 and female: 199); Race; Ethnicity; Insurance (private: 128 and public/none: 274); Clinical Setting (inpatient: 66 and ED: 336); Season (2012: 77 and 2013: 325). This report was concerning the 147 patients (unknown age and gender) of the 402 patients in the RV5-specific VE analyses. On unknown dates the patients were vaccinated with ROTATEQ (lot#, expiration date, dose and duration were unspecified) orally. All the patients received a full course of RV5 (per the recommended schedule of three oral doses administered at ages 2, 4, and 6 months). On unknown dates, the patients experienced acute gastroenteritis (AGE) and they were either hospitalized or seen in the ED from 01-DEC-2011 through 30-NOV-2012 (hereafter "2012") and 01-DEC-2012 through 30-NOV-2013 (hereafter "2013") with diarrhea (>=3 episodes within 24 hours) and/or vomiting (>= 1 episode within 24 hours). All of them had a rotavirus test-positive stool specimen. The outcome of events was unknown. The reporter considered the events to be related to ROTATEQ. Additional information has been requested.