chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urine analysis
Clinical narrative: Low-grade fever onset on 08/13/2015 (100-101 F). Fever increased to 103 F by early afternoon of 08/15/2015, spiked to 105-106 F that evening, and stayed in range of 103-105 into evening of 08/17/2015.  Fever meds (oral ibuprofen and acetominophen suppositories) were used to bring fever down during this time.  Child was taken to pediatrician on 08/17/2015.  Doctor did urine analysis and ordered stat bloodwork (comprehensive metabolic panel, LD, CBC panel with differential, and Sed Rate).  Bloodwork revealed high BUN/Creatinine (36.8), high CRP (15.4), slightly elevated monocytes (1080) and high Westergren Sed Rate (39).  All other results were normal.  Patient fever was 104 that night, ibuprofen was used to reduce to about normal.  As of PM on 08/18/2015, no signs of fever.  Child saw doctor on 08/18/2015 and doctor said to monitor for fever return or other unusual signs.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever, left shoulder swelling.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Urticaria
Clinical narrative: Soreness with rash and welt around injection site (L upper arm).
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia, Paralysis
Clinical narrative: Increasing tingling and numbness in fingers, toes, arms, and legs followed by increasing weakness in arms and legs and eventually paralysis.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: RIGHT UPPER ARM NEAR INJECTION SITE WAS RED, RAISED, AND ITCHY. BENADRYL, IBUPROFEN AND ICE TO SITE WERE ADMINISTRERED BY MOTHER. REACTION RESOLVED BY THAT EVENING.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site joint movement impairment, Injection site pain
Clinical narrative: Left shoulder pain with restricted range of motion starting right after vaccination.
Age: 10.0
Sex: M
Vaccine: YF
Symptoms: Dyspnoea, Malaise, Rash macular, Salivary hypersecretion, Throat irritation
Clinical narrative: ~ 45 minutes after receiving the injection in left upper arm, the patient c/o a scratchy throat, dyspnea, increased oral secretions and 'no feeling well'. A blotchy rash was noted on his right anterior abd. His lungs were clear and his speech was clear.  50 mg diphenhydramine was injected in his right deltoid and a prescription for a tapering dose prednisone was walked to our in facility pharmacy. He was given his initial 30mg dose of prednisone.  The patient began to improve quickly, with the blotchiness disappearing and the oral secretions returning to normal.  He was then discharged with instructions to notify us immediately (off-hours phone number provided) if any problems should arise.  The patient and his family will be traveling out of country and a prescription for an epi pen was sent to their pharmacy.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Dizziness, Feeling hot, Headache
Clinical narrative: Patient received employee vaccine of Hep B Vaccination at roughly about 2:30pm. He complained of symptoms at around 2:45pm that his headache got worse. Prior to receiving vaccine donor had minor headache. He complained of dizziness/feeling warm. That resolved. Temperature was 97.0 prior. Tempterature after was 97.2 at 3:00pm. He was given an icepack for his head.
Age: 0.23
Sex: M
Vaccine: HIBV
Symptoms: Irritability, Pyrexia
Clinical narrative: Mild fever - 100.0 lasting over 24 hours so far, fussiness.
Age: 75.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: Not sure about the time this occured - pt stated he experienced extreme weakness/fatigue after a fairly short bike ride on Monday 8/17/15.
Age: 63.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt c/o numbness/ tingling in L index finger.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness
Clinical narrative: Patient felt faint and clamminess after vaccination.  Instructed patient to sit down and rest for awhile.  After about 15 minutes patient felt much better.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Mobility decreased, Pain in extremity
Clinical narrative: Patient called 08/18/2015 stating her arm hurts to the point where she is unable to really move it and starting to look red at injection site.  Instructed patient to be seen by doctor.
Age: 0.83
Sex: M
Vaccine: PNC13
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: Extremely high fever over 103, vomiting, excessive crying for more than 2 hours. These lasted 2 1/2 days. Treatment was lukewarm baths, alternating Tylenol and ibuprofen, and plenty of liquids (breastmilk and water). After the initial he was not completely himself until a full week after vaccine.  a
Age: 0.53
Sex: M
Vaccine: PNC13, RV1
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: High fever 103.4, vomiting, excessive crying. Treatment included alternating Tylenol and ibuprofen, lukewarm baths, plenty of fluids (breastmilk). Lasted 2 days. Full recovery to old self was a week.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Headache, Myalgia, Nausea
Clinical narrative: Headache, hives, back ache, muscle aches, spine pain, nausea, weakness.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Spinal pain, Urticaria
Clinical narrative: Headache, hives, back ache, muscle aches, spine pain, nausea, weakness.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Blood culture, Blood glucose decreased, C-reactive protein, CSF test, Chest X-ray
Clinical narrative: On 8-8-15 (approximately 60 hrs after vaccines), he suddenly became hypothermic (94.9 F in ER), lethargic/altered mental status, and hypoglycemic. Full sepsis/encephalitis work-up completed (CBC with diff, CMP, blood culture, CRP, U/A, Lumbar puncture with CSF studies, head CT, CXR and drug screen completed. (Glucose=40). Life-flighted to hospital-admitted to PICU.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Computerised tomogram head, Differential white blood cell count, Drug screen, Full blood count, Hypoglycaemia
Clinical narrative: On 8-8-15 (approximately 60 hrs after vaccines), he suddenly became hypothermic (94.9 F in ER), lethargic/altered mental status, and hypoglycemic. Full sepsis/encephalitis work-up completed (CBC with diff, CMP, blood culture, CRP, U/A, Lumbar puncture with CSF studies, head CT, CXR and drug screen completed. (Glucose=40). Life-flighted to hospital-admitted to PICU.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Hypothermia, Intensive care, Lethargy, Lumbar puncture, Mental status changes
Clinical narrative: On 8-8-15 (approximately 60 hrs after vaccines), he suddenly became hypothermic (94.9 F in ER), lethargic/altered mental status, and hypoglycemic. Full sepsis/encephalitis work-up completed (CBC with diff, CMP, blood culture, CRP, U/A, Lumbar puncture with CSF studies, head CT, CXR and drug screen completed. (Glucose=40). Life-flighted to hospital-admitted to PICU.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Metabolic function test, Urine analysis
Clinical narrative: On 8-8-15 (approximately 60 hrs after vaccines), he suddenly became hypothermic (94.9 F in ER), lethargic/altered mental status, and hypoglycemic. Full sepsis/encephalitis work-up completed (CBC with diff, CMP, blood culture, CRP, U/A, Lumbar puncture with CSF studies, head CT, CXR and drug screen completed. (Glucose=40). Life-flighted to hospital-admitted to PICU.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Blood lactic acid increased, Dyspnoea, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse via a field representative referring to a 17 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date and in the end of July 2015 the patient respectively was vaccinated with her first and second doses of GARDASIL (dose, strength, route and lot# were not reported). In the end of July 2015 the patient experienced shortness of breath, fever, body aches, back pain, increased white count, and increased lactate and was hospitalized at an unspecified hospital on an unspecified date in 2015 after receiving her second dose of GARDASIL. The patient had recovered on an unspecified date in 2015. The causality was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a registered nurse via a field representative referring to a 17 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date and in the end of July 2015 the patient respectively was vaccinated with her first and second doses of GARDASIL (dose, strength, route and lot# were not reported). In the end of July 2015 the patient experienced shortness of breath, fever, body aches, back pain, increased white count, and increased lactate and was hospitalized at an unspecified hospital on an unspecified date in 2015 after receiving her second dose of GARDASIL. The patient had recovered on an unspecified date in 2015. The causality was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Brain injury, Coma, Immune system disorder, Seizure
Clinical narrative: This spontaneous report was received from a consumer (reported as 'consumer's daughter') and refers to a 14 year old female patient (currently 21 years old). Patient's concurrent condition included 'pollyosis' (Poliosis). The patient had allergies to unspecified seizure medication. In 2008 the patient was vaccinated with GARDASIL (3 injections). The reporter stated that she had a perfectly healthy 'young girl' before the patient had taken the GARDASIL vaccine. After the vaccine was taken, the patient began experiencing seizures. The patient also suffered brain damage. The patient sought medical attention-she had been in and out of hospitals, was in 2 comas and she suffered through seizures that were over 20 minutes long. The patient also developed an immune disease called 'estinbarr' (immune system disorder). The patient was treated with VIMPAT, 'Popnaf (also reported as Topnax)', 'Nortthintron' and NEURONTIN (these drugs were also reported as concomitant medications). The patient had not recovered from the events. Causality assessment was not provided. The reporter considered all the events to be serious due to hospitalization. Upon internal review, seizure and coma was considered to be medically significant. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Nausea, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a 74 year old female patient reporting on herself. The patient's concurrent conditions included arthritis, osteoporosis and drug reactions/allergy to aspirin, KEFLEX, DILANTIN, sulfa and TERRAMYCIN. Historical drug included aspirin, KEFLEX, DILANTIN, sulfa and TERRAMYCIN. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX in the left arm (dose, route, lot number and expiration date were not provided). Concomitant therapy included unspecified thyroid and cholesterol medications. On an unknown date, the patient experienced loss of appetite, nausea, and intermittent fever. The patient also reported that she experienced erythema and pain in her extremities reported as "redness underneath top layer of her skin and red shiny, painful sores on her arms and legs". The patient reported that the pharmacist provided Nortriptyline as a treatment for the adverse events, however she ceased the treatment since nortriptyline made her "sick". At the time of the report, the outcome of loss of appetite, nausea, pyrexia, intermittent fever, pain in extremities and erythema was reported as not recovered/not resolved. The primary reported considered loss of appetite, nausea, pyrexia, intermittent fever, pain in extremities and erythema as other important medical events as these events required intervention to prevent serious criteria. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: This spontaneous report as received from a 74 year old female patient reporting on herself. The patient's concurrent conditions included arthritis, osteoporosis and drug reactions/allergy to aspirin, KEFLEX, DILANTIN, sulfa and TERRAMYCIN. Historical drug included aspirin, KEFLEX, DILANTIN, sulfa and TERRAMYCIN. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX in the left arm (dose, route, lot number and expiration date were not provided). Concomitant therapy included unspecified thyroid and cholesterol medications. On an unknown date, the patient experienced loss of appetite, nausea, and intermittent fever. The patient also reported that she experienced erythema and pain in her extremities reported as "redness underneath top layer of her skin and red shiny, painful sores on her arms and legs". The patient reported that the pharmacist provided Nortriptyline as a treatment for the adverse events, however she ceased the treatment since nortriptyline made her "sick". At the time of the report, the outcome of loss of appetite, nausea, pyrexia, intermittent fever, pain in extremities and erythema was reported as not recovered/not resolved. The primary reported considered loss of appetite, nausea, pyrexia, intermittent fever, pain in extremities and erythema as other important medical events as these events required intervention to prevent serious criteria. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 21 year old female patient. The patient was a chronic, every day cigarette smoker and had no known drug allergies. On 05-AUG-2015, the patient had an uncomplicated cesarean section. On 06-AUG-2015 (also reported as her first day postpartum), the patient was vaccinated with PNEUMOVAX 23 (dose number, route and lot # were not reported) by an unspecified healthcare provider. Concomitant medications were none. On 06-AUG-2015, the patient experienced a fever of 101.1 F with redness, warmth and swelling at the unspecified injection site within 12 hours of receiving the vaccine. The patient sought medical attention and was treated with antibiotic gentamycin and clindamycin. The patient's fever and redness, warmth, and swelling at the unspecified injection site improved with antibiotic treatment and the patient was discharged at the normal length of stay for an uncomplicated cesarean section (length of stay and discharge date was unspecified). The outcome of the events was reported as recovered/resolved. The reporter did not provide the causality between the events and the suspect therapy. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history was reported. Approximately in 2015 (between 24-JUL-2015 to 10-AUG-2015), the patients were vaccinated with 5 doses of improperly stored (Oka/Merck) VARIVAX (unknown route, strength and dose) (L010144 with expiry date of 24-MAR-2017, Lot # L001335 with expiry date of 13-JAN-2017, lot # L008272 with expiry date of 11-MAR-2017). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-MAR-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a nurse refers to an approximately 11 year old female patient. No concurrent condition or medical history was reported. The nurse reported that the mother of the patient called physician to report that on 10-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L004014, dose 2, intramuscular, dose not provided). No concomitant therapy was reported. On 11-AUG-2015, the patient had an unspecified fever. The therapy was not discontinued. The outcome of the event was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of oral, ROTATEQ lot # K022990, expiration date 26-JUN-2016, route defaulted to oral (dose and dose number were not reported). There were no adverse effects. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot # K011562, expiration date 08-APR-2017 (dose, dose number and route of administration were not reported). There were no adverse effects. This is one of two reports received from the same source. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from an unspecified reporter via TeleRx referring to a 40 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 01-MAY-2015 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, dose #, lot #, route and application site were not reported) (inappropriate schedule of drug administration). This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a patient of unkonwn age and gender. The patent's concurrent conditions and medical history were not reported. On 07-APR-2015, the patient was vaccinated with expired PNEUMOVAX23 lot # K001504 which was expired on 28-MAR-2015 (unknown strength, route and dose). Concomitant medications were not reported. No adverse experience was reported. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a male patient (also a physician) regarding himself. No current condition or medical history was reported. On 14-AUG-2015, the physician administered himself, improperly stored ZOSTAVAX (lot # L006392, Exp. 25-MAY-2016, 1 shot, 0.65 ml, subcutaneous). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical histories and drug reactions/allergies were not reported. On unkonwn dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, strength and router were not reported). These unspecified doses of PEDVAXHIB might have been administered using the following lot#: J016188 with expiration date 02-OCT-2016; J015435 with expiration date 13-OCT-016; K002747 with expiration date 09-DEC-2016; K008879 with expiration date 30-MAR-2017; K016964 with expiration date 16-JUL-2017; K025006 with expiration date 22-JUL-2017; L002867 with expiration date 11-NOV-2017; L009649 with expiration date 19-NOV-2017. No adverse effects were reported. This is one of several cases from the same reproter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-FEB-2015, the patient was vaccinated with improperly stored M-M-R II lot # J014872 and 21-NOV-2015 (unknown strength and route). Concomitant medications were not reported. 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: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unkonwn age and gender. Concurrent conditions, medical history, concomitant therapies and known allergies were not reported. On unspecified dates since 30-JUN-2015, the patients were vaccinated with unknown number of doses of RECOMBIVAX HB (lot # reported as K020218, an expiration date 24-OCT-2016; dose, route of administration and anatomical location were not reported), which were improperly stored. No adverse effects were reported. This is one of the several reports received from the same reporter. Lot number K020218 has been verified to be a valid lot number for the RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-FEB-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. 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, HPV9, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (L006547 exp. 04-MAR-2017) (route, dose and frequency unspecified). Other suspect therapies included the patients were vaccinated with improperly stored ROTATEQ (K009181 exp. 24-APR-2016, K017573 exp. 11-JUN-2015) and RECOMBIVAX HB (K008986 exp. 01-APR-2016, K021444 exp. 17-SEP-2016) (route, dose and frequency unspecified). No concomitant therapy were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-APR-2015, the patient was vaccinated with improperly stored M-M-R II lot # J014872 and 21-NOV-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-FEB-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-JUL-2015, the patient was vaccinated with improperly stored M-M-R II lot # K000998 and 22-JAN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receive from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 08-APR-2015, the patient was vaccinated with improperly stored M-M-R II lot # J014872 and 21-NOV-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. Concurrent conditions, medical history, concomitant therapies and known allergies were not reported. On unspecified dates since 30-JUN-2015, the patients were vaccinated with unknown number of doses of GARDASIL 9 (lot # K026247, an expiration date 29-JAN-2017; dose, route of administration and anatomical location were not reported), which were improperly stored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with fourth dose of GARDASIL or GARDASIL 9, both, unknown strength, route and dose. Concomitant medications were not reported. Consumer could not confirm if vaccine was GARDASIL or GARDASIL 9. It could not be confirmed if any adverse events occurred. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and age. The healthcare worker reported, that unspecified patients received improperly stored PROQUAD (Merck) (lot # L005293, an expiration date: 17-SEP-2016) and PROQUAD (Merck) (lot # L008354, an expiration date: 11-SEP-2016) (dose, frequency, route of administration and indication were not reported). No adverse effects were reported for the additional unspecified patients. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical histories and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (dose, strength and route were not reported). These unspecified doses of GARDASIL might have been administered using the following lot#: K006124 with expiration date 02-FEB-2017; K006960 with expiration date 19-FEB-2017; K007828 with expiration date 02-MAR-2017. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On 29-JUL-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) injection, lot # L009210, expiration date 17-SEP-2016 (route of administration and dose were not reported). No information on patient's concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-FEB-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, medical assistant who reported that 6 doses of improperly stored GARDASIL were administered to 6 patients on unspecified dates (lot# K007264 expiration date 02-MAR-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, 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 concurrent conditions and medical history were not reported. The patient was vaccinated with GARDASIL (unknown strength and lot #) intramuscular in 2008 and later on 03-NOV-2014 and 06-AUG-2015 (Inappropriate schedule of drug administration). Concomitant medications were not reported. There were no known adverse effects. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an additional unspecified patients of unknown age and gender. The healthcare worker reported, that an additional unspecified patients received improperly stored VARIVAX (lot # K003420, expiration date: 06-MAR-2015) (dose, frequency route of administration and indication were not reported). No adverse effects were reported for the additional unspecified patients. This is one of the several reports received from the same source. Additional information has been requested.
Age: 49.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from an unspecified reporter referring to a 49 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 08-MAY-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose #, lot #, route and application site were not reported). This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 26-MAR-2015, the patient was vaccinated with improperly stored M-M-R II lot # J014872 and 21-NOV-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 26-MAR-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-JUL-2015, the patient was vaccinated with improperly stored MMR II lot # J016232 and 19-DEC-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-JUN-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Wheezing.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-JUL-2015, the patient was vaccinated with improperly stored M-M-R II,lot # J016232 and 19-DEC-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUL-2015, the patient was vaccinated with improperly stored M-M-R II lot # K000998 and 22-JAN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-JUN-2015, the patient was vaccinated with improperly stored MMR II lot # J014872 and 21-NOV-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAY-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 26-MAR-2015, the patient was vaccinated with improperly stored MMR II lot # J016234 and 19-DEC-2015, lot # K005110, expiration date 04-APR-2016 (therapy type, dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as re received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with the doses of improperly stored PNEUMOVAX23., lot # reported as J013394, expiration date reported as 25-AUG-2016 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported.  This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with the doses of improperly stored GARDASIL lot # J011272, expiration date 21-APR-2016, lot # K006124, expiration date 02-FEB-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports 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, medical assistant who reported that 10 doses of improperly stored ROTATEQ suspension were administered to 10 patients on unspecified dates (2 doses from lot # K006457 expiration date 08-MAR-2015 and 8 doses from lot K023537 expiration date 22-JUN-2016, dose and route not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. The reporting medical assistant reported that unspecified patients were vaccinated with GARDASIL (lot # K007828, expiration date 02-MAR-2017; lot# K011562, 08-APR-2017; dose and route not reported) which were exposed to temperatures outside of the recommended range. Among them, the GARDASIL (lot# K007828, expiration date 02-MAR-2017) were vaccinated to unspecified patients on 10-AUG-2015 and 12-AUG-2015. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Exposure via direct contact, Eye irritation
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient (other nurse) of unknown age. The registered nurse stated that during administration of a dose of PNEUMOVAX 23 to an unspecified patient on 10-AUG-2015, some of the PNEUMOVAX 23 lot#L003227, expiration date 13-OCT-2016, inadvertently splashed in the eye of the nurse who was administering the dose and caused a burning sensation in the nurse's eye. The primary reporter confirmed that despite this occurrence, the unspecified patient was not topically exposed to the vaccine and received the full dose of PNEUMOVAX 23. No adverse effect was reported for the unspecified patient. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unkonwn gender. Since 02-APR-2015, the unspecified patients were vaccinated with GARDASIL (lot # K005881 and expiry date: 14-JAN-2017) which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB lot # J011112, expiration date 12-JUN-2016 (dose, route and site of administration were not reported). Concomitant medications were not reported. 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: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with the doses of improperly RECOMBIVAX HB (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. Since 02-APR-2015, the unspecified patients were vaccinated with VARIVAX (lot # K007982 and expiry date: 03-JUN-2016) which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with the doses of improperly stored ROTATEQ lot # K016278, expiration date 21-APRI-2016 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. On approximately 29-JUN-2015 (reported as "6 weeks ago"), the patient was vaccinated with first dose of GARDASIL 9 (intramuscularly, dose was not reported). The patient would receive the second dose on 08-AUG-2015. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with the doses of improperly stored VAQTA lot # K009506, expiration date 22-SEP-2016, lot # K005958, expiration date 09-FEB-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified doses of improperly stored VAQTA 25/0.5 (lot # K019560 with expiration date of 02-JUN-2015, dose and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. Since 02-APR=2015, the unspecified patients were vaccinated  with ZOSTAVAX (lot # K024031 and expiry date: 20-FEB-2016) which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. Since 02-APR-2015, the unspecified patients were vaccinated with PNEUMOVAX 23 (lot # K02130 and expiry date: 22-JUN-2016) single dose vials which were exposed to temperature outside of the recommended range. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. Since 02-APR-2015, the unspecified patients were vaccinated with LIQUID PEDVAXHIB (lot # K025002 and expiry date: 20-JUL-2017) which was exposed to temperatures outside of the recommended ranged. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with the doses of improperly stored GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Patient with chills, fever, body aches, and fatigue x 3 days.