chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: PPV, TD
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Pyrexia, Wheezing
Clinical narrative: Wheezing around 9am on 5/18 (took 25mg Benadryl then later wheezing stop). Pt stated that she also has fever, severe pain on the upper arm, neck, shoulder.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: WRONG VACCINE TYPE ADMINISTERED TO PATIENT. HE WAS SUPPOSED TO RECEIVE MENINGITIS B (TRUMEMBA) INSTEAD HE RECEIVED MCV4 (MENACTRA).
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Blood culture, Blood test, Cough, Crying, Flatulence
Clinical narrative: Fever, irritability, sleeplessness, painful crying, gas, drop in white blood cell count to 200 which is extremely low, cough. Currently treating with Amoxicillin.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Influenza virus test, Insomnia, Irritability, Pain, Pyrexia
Clinical narrative: Fever, irritability, sleeplessness, painful crying, gas, drop in white blood cell count to 200 which is extremely low, cough. Currently treating with Amoxicillin.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Urine analysis, White blood cell count decreased
Clinical narrative: Fever, irritability, sleeplessness, painful crying, gas, drop in white blood cell count to 200 which is extremely low, cough. Currently treating with Amoxicillin.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt was vaccinated and the following day complained of pain and decreased mobility.
Age: 38.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 52 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JAN-2017, 1 ml, intramuscularly, in deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 27 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, MMR
Symptoms: Incorrect product storage, No adverse event, Product packaging confusion
Clinical narrative: This spontaneous report was received from a nurse. The nurse stated that a box of PEDVAXHIB lot # L012835, exp. 11-MAR-2018 was inadvertently stored in the freezer because the box of PEDVAXHIB "looks just like M-M-R II". This happened due to human error. No patient received any doses of PEDVAXHIB. No adverse effects to report. No additional information was provided. No Product Quality Complaint (PQC). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in 2016 (reported as last week), the patient was vaccinated with PNEUMOVAX 23, 1 shot subcutaneously. Approximately in 2016, the patient experienced injection site reaction, swelling, redness, and a lot of pain around the area in her arm. The reporter did not mention any treatment for the events. The patient sought medical attention which included a visit to doctor's office. The outcome of injection site reaction, swelling, redness, and a lot of pain around the area in her arm was reported as recovering/resolving. The reporter did not provided the causality between the events and PNEUMOVAX 23. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified number of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L030872, expiry date: 11-JUN-2018). Healthcare worker reported that the vaccine underwent temperature excursion at 34 degree Fahrenheit for 72 hours. There were no previous excursions. No adverse effects were reported. This is one of the three 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 refers to unspecified number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L019297, expiry date: 18-AUG-2017 and lot # L043213, expiry date: 28-AUG-2017). Healthcare worker reported that the vaccine underwent temperature excursion at 34 degree Fahrenheit for 72 hours. There were no previous excursions. No adverse effects were reported. This is one of the three 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 was received from a healthcare worker refers to unspecified number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L013827, expiry date: 21-APR-2017). Healthcare worker reported that the vaccine underwent temperature excursion at 6 degree Fahrenheit for 196 hours. There were no previous excursions. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse refers to a female patient of unknown age. Information regarding her medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 29-APR-2016, the patient was vaccinated with M-M-R II (lot # L029266, expiry date: 04-AUG-2017). Other suspect therapies included VARIVAX. Nurse reported that the patient was unaware that she was pregnant at the time of vaccination, and discovered her pregnancy on 03-MAY-2016. Her LMP and EDD were reported as 01-APR-2016 and 06-JAN-2017, respectively. Nurse reported that due to this time frame, she thought that the patient was already pregnant at the time of vaccination. Outcome of patient's pregnancy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an adult patient of unknown gender. Information on the concurrent conditions and medical history of the patient were not reported. On 03-MAY-2016 the patient was vaccinated subcutaneously with a dose of PROQUAD batch/lot # L017146, expiry date 13-MAY-2017 (dose number, dose units and anatomical location were not specified) and M-M-R II lot/batch #L023113, expiry date 24-DEC-2016 (dose number, dose units and anatomical location were not specified) (overdose). Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 06-MAY-2016, the patient was inadvertently vaccinated with an expired dose of VAQTA with lot # L018498 Expiration date: 28-APR-2016 (dose and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MEN, MMR, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 15 year old female patient. Information about the patient's medical history and concurrent conditions was not provided. On 10-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L018351 dose 2 in the right arm. Concomitant therapies included: poliovirus vaccine (unspecified), hepatitis a virus vaccine (unspecified), meningococcal vaccine (unspecified), MMR I, hepatitis b virus vaccine (unspecified) and Tdap vaccine (unspecified), tetanus toxoid. No adverse events were reported. This is one of two reports from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red and swollen lt arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Inject site area is red, raised, and warm to touch. Pt has taken Ibuprofen, BENEDRYL tabs and BENADRYL gel for treatment. Injection site area is 2.3 inches in diameter and is no longer painful.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: C-reactive protein normal, Cervical radiculopathy, Full blood count normal, Glomerular filtration rate normal, Hypoaesthesia
Clinical narrative: 4-14-16 - Pain LUE (specifics not known to me). 4-19-16 Trip to ED for pain (I have no access to details). 4-26-16 To ED with increasing and severe pain L. neck going down L. shoulder and arm. Dx: muscle and spasm neck and Cervical Radiculopathy. Work Comp case opened- at that time pt. thought pain due to non-ergonomic chair. 4-27 to 5-13-16 - Tx'd by MD or P.A. and physical therapy. 5-13-16 to ED - Increased weakness, numbness LUE and LUE weakness. Dx: Weakness LUE abnormal MRI of head.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Metabolic function test normal, Muscle spasms, Muscular weakness, Neck pain
Clinical narrative: 4-14-16 - Pain LUE (specifics not known to me). 4-19-16 Trip to ED for pain (I have no access to details). 4-26-16 To ED with increasing and severe pain L. neck going down L. shoulder and arm. Dx: muscle and spasm neck and Cervical Radiculopathy. Work Comp case opened- at that time pt. thought pain due to non-ergonomic chair. 4-27 to 5-13-16 - Tx'd by MD or P.A. and physical therapy. 5-13-16 to ED - Increased weakness, numbness LUE and LUE weakness. Dx: Weakness LUE abnormal MRI of head.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Neutrophil percentage decreased, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity
Clinical narrative: 4-14-16 - Pain LUE (specifics not known to me). 4-19-16 Trip to ED for pain (I have no access to details). 4-26-16 To ED with increasing and severe pain L. neck going down L. shoulder and arm. Dx: muscle and spasm neck and Cervical Radiculopathy. Work Comp case opened- at that time pt. thought pain due to non-ergonomic chair. 4-27 to 5-13-16 - Tx'd by MD or P.A. and physical therapy. 5-13-16 to ED - Increased weakness, numbness LUE and LUE weakness. Dx: Weakness LUE abnormal MRI of head.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Information has been received from a registered nurse via a field representative concerning a 15 year old female patient. The patient's pertinent medical history, drug reactions and concomitant medications were not provided. On 26-APR-2016 the patient received her third dose of GARDASIL 9 injection (route reported as injection, lot# and dosage not provided). The patient's mother contacted the physician's office and reported the patient was experiencing an injection site rash and a lump on 26-APR-2016 (onset date also reported as unspecified date) for an unspecified reason. The mother scheduled a physician's visit for the patient but she did not provide the date. The outcome of the events, and the causality of the events with GARDASIL 9 was not reported. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Chest pain, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Initial unsolicited report received from a nurse on 17 September 2015. This case involves a 43-year-old male patient who was vaccinated with a dose of TENIVAC (batch number U4669AA, expiry date 10 January 2016, dose details, route and site of administration were not reported) on 30 April 2015. Illness at time of vaccination was not provided. The patient did not have any known allergy. Pre-existing physician diagnosed birth defects and medical conditions was not reported. Concomitant medications were not provided. On 30 April 2015, 30 minutes following the vaccination patient experienced dizziness. He also complained of chest pain (CP), headache (HA), nausea and fatigue. It was reported patient required emergency room (ER)/doctor visit. Patient laboratory investigation and corrective treatment was not reported. The patient had not recovered from the above mentioned events. List of documents held by sender: none. Follow-up information received from nurse on 18 February 2016. No additional information received.
Age: 28.0
Sex: M
Vaccine: IPV
Symptoms: Wrong drug administered
Clinical narrative: On 17MAY16 at roughly 1530 a PT received the wrong vaccination. The PT was administered an IPV vaccination subcutaneously in lieu of  his scheduled IPPD.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Throat tightness, Weight increased
Clinical narrative: Initial unsolicited report received from consumer on 19 May 2015. A 40-year-old female patient, whose medical history was allergies of latex, egg whites, milk, shrimp and concomitant medication was not reported, had received a dose of TENIVAC (batch number, expiration date, dose, dose number and site of administration were not reported) intramuscularly in morning on 18 May 2015. On 18 May 2015 in evening, after vaccination patient experienced tightness in throat and gained five pounds weight in overnight. Illness at the time of vaccination was reported as none. Laboratory investigation was none and corrective treatment was not reported. At the time of this report, outcome of the event was not resolved. List of documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Chest pain, Dizziness, Nausea, Pain in extremity
Clinical narrative: Initial unsolicited report received from a healthcare professional (nurse practitioner) on 13 August 2015. A 43-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of TENIVAC (batch number was unknown, route and site of administration were not reported) on 30 April 2015. Illness at time of vaccination and pre-existing allergies, birth defects, medical conditions were not reported. On 30 April 2015, same day within 30 minutes after vaccination, the patient experienced pain in arm and dizziness. He also stated that events continued till 13 August 2015. The patient also experienced chest pain, lightheadedness, and nausea on unspecified date. Laboratory investigations and corrective treatments were not reported. Patient required ER doctor visit. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Chills, Headache, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 05 May 2016. This case involves 19-year-old female patient who was vaccinated with a first dose of YELLOW FEVER VACCINE (YF) (batch number- UF285AA, site of administration was reported as unknown) subcutaneously on 14 April 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination was reported as unknown. Concomitant medications was reported as unknown. On 14 April 2016, same day following the vaccination, the patient had experienced flu like illness: chills, fever and headache for one week. On an unspecified date, one week later, the patient had experienced sore throat and lymph swelling. The patient required ER/doctor visit. Laboratory data and corrective treatment were not reported. The patient was recovered from events flu like illness: chills, fever and headache and was not recovered from events sore throat and lymph swelling. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial unsolicited report received from a non healthcare professional (office manager)on 09-May-2016. This case involves a three patients (age and gender not reported) who were vaccinated with a dose of DAPTACEL (batch number C4756AA, expiry date: 11-Jun-2017, route of administration: not reported) in the deltoid on an unspecified date (reported as vaccinated on different days from 26-Apr to 30 Apr). Patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patients had redness at the injection site warmed and hardness. The patients were previously vaccinated with DAPTACEL vaccine (details not provided). It was reported that the patients required doctor visit (unspecified date, reported as next day). Laboratory investigations was reported as none. The patients received corrective treatment warm compresses and TYLENOL. On an unspecified date, within three days, the patient recovered from the events. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse via pharmacist via office manager refers to a 04 year old male patient. The patient's relevant medical history and concurrent condition were not reported. On an unknown date, patient was vaccinated with first dose of VARIVAX injection (lot number and dosage not reported). On L035127 (expiry date: 14-SEP-2017) (dosage not reported), which had previously undergone a supported temperature excursion. Concomitant therapies included M-M-R II, it was administered but according to the prescribing information it never left proper storage conditions (negative 58 to positive 46 degrees Fahrenheit). It was unknown if there was any relevant laboratory data. As of 04-MAY-2016, it was unknown if the patient continued to take VARIVAX and the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: 5/18/16 It was identified that Tdap was administered not Dtap.  no symptoms of issues.
Age: 52.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Impaired quality of life, Muscle disorder
Clinical narrative: This study report as received from a consumer, as part of a marketing research study refers to a currently 52 year old female patient enrolled in a study. The patient's concurrent conditions, relevant medical history and concomitant medications were not reported. The reporter stated that a friend of a friend's daughter (the patient) was vaccinated on an unknown date with GARDASIL (dose, frequency, route and lot number unspecified). Within few months of vaccination, the patient began to have muscular problems and she was no longer able to be the athlete she once was (impaired quality of life). Action taken with GARDASIL was not applicable. The outcome of the events was not reported. The causality of the events muscle disorder and impaired quality of life with GARDASIL was not reported. Additional information is not expected since the reporter was not willing to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAY-2016, the patient was vaccinated with for prophylaxis with a dose of ZOSTAVAV (lot #, dose, route and site of administration were not reported) that expired on an unspecified date in 2014. No adverse effect was reported. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Croup infectious, Medication error
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 6 month old male patient. The patient had no pertinent medical history and no drug reactions or allergies. On 08-DEC-2015 and on 02-MAR-2016, the patient was vaccinated with the first and the second dose of PEDVAXHIB, respectively (dose, route of administration, lot # and expiry date were not reported). On 08-APR-2016, the patient inadvertently received both the third dose of PEDVAXHIB (lot # L042835 and expiry date 19-AUG-2018; dose and route of administration were not reported) and PENTACEL (dose, route of administration, lot # and expiry date were not reported). No concomitant medications were administered. On 25-APR-2016, the patient's mother took him to emergency room (ER) and he was diagnosed with croup. The symptoms of croup were unknown. In the ER, the patient received the treatment with epinephrine nebulizer and dexamethasone (manufacturer unknown). The patient was not admitted to hospital. On 26-APR-2016, the patient was brought in to the physician's office for follow up visit. No lab diagnostic studies were performed. The outcome of croup was reported as recovered on an unknown date in 2016. The relatedness between the event of croup and PEDVAXHIB and PENTACEL was not reported. Upon internal review, the event of croup was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a male patient of unknown age. The medical history, concurrent conditions and concomitant medications were unknown. On APR-2016 (reported as beginning of April), the patient was vaccinated with GARDASIL 9 dose 2, intramuscular. On an unknown date, the patient developed an unspecified red rash before he left the examination room. The rash got larger as time went on. The rash was also reported to be lacy. The nurse explained that the rash was unlike anything they had seen before. The patient had no issues after the fist injection. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Between 07-APR-2016 and early May 2016, the unspecified number of patients were administered unspecified dose of oral ROTATEQ (lot # L035508, expired on 12-MAY-2017 immunization series, which were improperly stored. The temperature was 65F and the time frame was 11 hours as reported. There was no previous temperature excursion. No data logger involved. No adverse effect was reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since unspecified dates starting on or after 05-MAY-2016, the patients were vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported, lot #K011325 with expiration date 05-APR-2017 or lot# reported as K010125 with expiration date 05-MAY-2017). The temperature was 11 Fahrenheit degrees during 11 days (digital data logger). There was no previous temperature excursion. There was no adverse events reported. This is one of several reports received from the same source. 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 licensed practical nurse regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since unspecified dates starting on or after 05-MAY-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose and route were not reported, lot #L038018 with expiration date 13-SEP-2017). The temperature was 11 Fahrenheit degrees during 11 days (digital data logger). There was no previous temperature excursion. There was no adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Blood sodium decreased, Contusion, White blood cell count decreased
Clinical narrative: Per Patient; bruising to arms, legs, inner thighs and shoulders.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Patient states that she has had muscle spasms ever since the day after the vaccine was given. She reported this to us here at the pharmacy today.
Sex: U
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a nurse on 24 September 2015. This case involves two patients (age and gender not reported) those were vaccinated with a dose of TENIVAC (batch number, dose, route and site of administration were unknown) on an unspecified date in September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. Concomitant medications were not reported. On September 2015, following the vaccination, both patients had pain at the injection site and unable to move arms. Lab data and corrective treatments were not reported. Both patients were not recovered from the events. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Pt got redness at injection site increasing in size every 2 days. So far about 50 cent piece size.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dyskinesia, Dysphemia
Clinical narrative: One week after vaccines administered, patient began occasionally stuttering and turning head and eyes to the right when stuttering. Patient is no longer turning head and eyes to the right but continues to occasionally stutter.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has erythema, pain and swelling ~ 2" circumference surrounding injection site.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Erythema, Feeling of body temperature change, Localised infection
Clinical narrative: Severly red, swollen, a lot of pain, very bad itching, went to my doctor on 05/18/2016, diagnosis, left arm cellulitis, bad infection, hot to touch, hot and cold chills, arm is throbbing, red, itching, and hurts, was put on strong antibiotics, Tylenol, and Benadryl for itching.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Severly red, swollen, a lot of pain, very bad itching, went to my doctor on 05/18/2016, diagnosis, left arm cellulitis, bad infection, hot to touch, hot and cold chills, arm is throbbing, red, itching, and hurts, was put on strong antibiotics, Tylenol, and Benadryl for itching.
Age: 1.05
Sex: F
Vaccine: MMR
Symptoms: Irritability, Pallor, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Diffuse erythematous papular blanchable rash, fever, fussy.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L035510, expiry date: 13-MAY-2017, dose and site of administration not reported. Concomitant medications were not mentioned by the reporter. The ROTATEQ was stored at 33F for a time frame of 1 week. This temperature excursion was latter back in range. There was no previous temperature excursion reported. The call was a result of a data logger. No adverse effects reported. No additional information was provided. Product quality complaint was not filed. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program refers to 11-17 year old male patient. The patient had no concurrent condition. On an unknown date the patient was vaccinated with his first dose of GARDASIL 9 (dose and route were not reported). There was no concomitant therapy. The reporter stated that patients faint in response to GARDASIL 9, boys faint more frequently than girls. On an unknown date 1 out of 60 girls fainted. After fainting the kids sit still until their "color comes back" and then they leave the Pediatrician office. The outcome of faint was reported as recovering. The event did not prevent administration of second and third dose of GARDASIL 9. The reporter considered faint to be related to GARDASIL 9. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: BELL'S PALSY.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: 05/11/16.
Age: 1.03
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and continued to get worse as days went on with fever starting the day after rash started.
Age: 16.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Heart rate increased, Hypertension
Clinical narrative: My son was brought to the hospital by EMTs from school for possible stoke.  Nauseousness, blood pressure and heart rate were dangerously high and he lost control of CNS in arms and legs, violently shaking.  Very scary!!!
Age: 16.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Nausea, Nervous system disorder, Tremor
Clinical narrative: My son was brought to the hospital by EMTs from school for possible stoke.  Nauseousness, blood pressure and heart rate were dangerously high and he lost control of CNS in arms and legs, violently shaking.  Very scary!!!
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (doses, route and site of administration, lot# and expiration date were not reported). It was reported that an unspecified number of patients developed redness at the injection site following the administration of ZOSTAVAX. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Faint erythema medially leading down to elbow where there is brighter erythema and swelling, warm to touch. Diagnosed cellulitis.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nervous system disorder
Clinical narrative: Information has been received from the physician via Market research Agency concerning a 15 year old female patient (race unknown), who were enrolled in the program. The patient had no relevant medical history or concurrent conditions. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route and lot # not reported). Another physician told reporter two days ago that following receiving GARDASIL 9, patient suffered "neurological problems that affected her lower extremities. Events were being treated by a chiropractor. No tests were carried out for diagnosis. Action taken with respect to the GARDASIL 9 was reported as none. The outcome of the events was recovered. The reporter considered events to be related to GARDASIL 9. Additional information is not expected because the physician was not willing to be contacted.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received ZOSTAVAX SQ on 5/9/16 - continued redness swelling and pain around injection site.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician (also reported as healthcare worker) refers to an unspecified number of patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K024552, Expiry: 22-OCT-2016). No adverse effects were reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Immediate post-injection reaction, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: After Tdap admin, pt developed immediate significant shoulder arm pain/swelling redness seen today for follow up imaging shows tendon tear NSAIDS rest.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Tendon rupture, X-ray limb
Clinical narrative: After Tdap admin, pt developed immediate significant shoulder arm pain/swelling redness seen today for follow up imaging shows tendon tear NSAIDS rest.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness/swelling/itching at site of injection/lasted approx. 24 hrs/applied BENADRYL cream.
Age: 59.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker referring to a 59 years old patient of unknown gender. On 16-MAY-2016 the patient was accidentally received a dose of VARIVAX (dose, frequency and route were not reported) instead of ZOSTAVAX (wrong vaccine administered). No adverse effect was reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Back pain, Injection site pain, Muscle spasms, Musculoskeletal pain
Clinical narrative: Within days of receiving flu shot, experienced pain in back, shoulder and upper left arm. Muscle spasms of rhomboid muscle. Saw chiropractor 2 times w/no relief, received muscle relaxer from GP, didn't help. Got 2 massages, no relief, saw GP again and got steroids-Didn't last, GO gave more muscle relaxers and prescribed P.T.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine given 5-10-16, pt returned 5-13-16 with redness and slight swelling at and around the injection site. Advised BENADRYL by mouth and to apply ice.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since unspecified dates starting on or after 05-MAY-2016, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (dose and route were not reported, lot# L044475 with expiration date 12-MAY-2017 or lot# L019297 with expiration date 18-AUG-2017). The temperature was 11 Fahrenheit degrees during 11 days (digital data logger). There was no previous temperature excursion. There was no adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Within 12 hrs of PENTACEL and PCV-13 administration fever, vomiting and erythema/induration surrounding injection site. From where PENTACEL was given developed fatigue, decreased appetite.
Age: 1.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Vomiting
Clinical narrative: Within 12 hrs of PENTACEL and PCV-13 administration fever, vomiting and erythema/induration surrounding injection site. From where PENTACEL was given developed fatigue, decreased appetite.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Vaccine provided 5/11/16. Symptoms of redness, warmth, swelling (central wheal) at site began on 5/17/16.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Dyspnoea, Rash, Swollen tongue, Urticaria
Clinical narrative: Rash/hives, tongue swollen, burning, trouble breathing.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that on an unknown date multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (dosing details were not reported) (therapy type: Digital Data Logger) (lot # L044917 with an expiry date of 05-OCT-2018), at a temperature of 51 F for a time frame of 5 years (Incorrect product storage). There was a previous temperature excursion reported for RECOMBIVAX HB at a temperature of 59 F for 29 hours. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. 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 nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that on an unknown date multiple unspecified patients were vaccinated with improperly stored VAQTA (dosing details were not reported) (therapy type: Digital Data Logger) (lot # L048222 with an expiry date of 19-DEC-2016), at a temperature of 51 F for a time frame of 5 years. There was a previous temperature excursion reported for VAQTA at a temperature of 59 F for 29 hours. No adverse effects were reported. There was no product quality complaint involved. 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 nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that on an unknown date multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (therapy type: Digital Data Logger) (lot # L016428 with an expiry date of 30-JUL-2017, lot # L044475 with an expiry date of 21-MAY-2017 and lot # L001312 with an expiry date of 24-FEB-2017), at a temperature of 51 F for a time frame of 5 years (incorrect product storage). There was a previous temperature excursion reported for GARDASIL 9 at a temperature of 59 F for 29 hours. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 16-MAY-2016 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L002424 with expiration date 23-APR-2016, subcutaneous, dose unknown). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Influenza like illness, Peripheral swelling
Clinical narrative: This spontaneous report as received from the patient's wife refers to an elderly male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The patient's wife stated that her husband received the PNEUMOVAX 23 injection (dosing details, lot#, expiry, strength were not reported) two times on unspecified dates by unspecified physicians (inappropriate schedule of drug administration). One dose was before the age of 65 and another dose was after 65 years of age. The doses were six years apart. On an unknown date, the patient experienced swollen arm and influenza-like illness. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information is not expected as no contact details provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that on an unknown date multiple unspecified patients were vaccinated with improperly stored PEDVAXHIB (dosing details were not reported) (therapy type: Digital Data Logger) (lot # K008679 with an expiry date of 05-MAR-2017), at a temperature of 51 F for a time frame of 5 years (Incorrect product storage). There was a previous temperature excursion reported for PEDVAXHIB at a temperature of 59 F for 29 hours. No adverse effects were reported. There was no product quality complaint involved. 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 healthcare worker refers to an unspecified number of patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored doses ROTATEQ orally (lot # L025598, Expiry: 13-JAN-2017). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program refers to 11-17 year old female patient. The patient had no concurrent condition. On an unknown date the patient was vaccinated with her first dose of GARDASIL 9 (dose and route were not reported). There was no concomitant therapy. The reporter stated that patients faint in response to GARDASIL 9, boys faint more frequently than girls. On an unknown date 1 out of 60 girls fainted. After fainting the kids sit still until their "color comes back" and then they leave the Pediatrician office. The outcome of faint was reported as recovering. The event did not prevent administration of second and third dose of GARDASIL 9. The reporter considered faint to be related to GARDASIL 9. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 57.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Dyspnoea, Erythema
Clinical narrative: Patient called and complained of arm redness and difficulty breathing. RPh on duty told patient to go to ER immediately. Patient was given Benadryl and sent home.
Age: 26.0
Sex: F
Vaccine: DTP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: 4 inch diameter circle of swelling and redness; Pain in the affected area.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since unspecified dates starting on or after 05-MAY-2016, the patients were vaccinated with an improperly stored doses of VAQTA (dose and route were not reported, lot# L045713 with expiration date 14-JAN-2017). The temperature was 11 Fahrenheit degrees during 11 days (digital data logger). There was no previous temperature excursion. There was no adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a female pharmacist of unknown age referring to herself. The patient was vaccinated with her first dose, second dose and third dose of RECOMBIVAX HB (first dose: lot# K018796, expire date: October 2016; second and third dose: lot # L000717, expire date: 15-APR-2017, dose and route were unknown) on 07-MAY-2015, 16-JUN-2015 and 17-JUL-2015 (inappropriate schedule of drug administration), respectively. This was outside the recommendations per the RECOMBIVAX HB prescribing information. No adverse effects were reported. Additional information has been requested.