chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPA, TYP
Symptoms: Blood test normal, Peripheral swelling, Swelling face
Clinical narrative: Initial report received from a health care professional on 22 May 2014. A male patient (age and date of birth not reported), had received intramuscular dose of TYPHIM VI vaccine (lot number: not reported, dose number and site of administration not reported) on an unspecified date and also received a dose of HEPATITIS A VACCINE (Manufacturer- unknown, lot number: not reported, dose number, route and site of administration not reported) on an unspecified date. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was not provided. It was reported that Patient received vaccines prior to traveling to another country and upon return began experienced facial and hand swelling. Swelling appears and subsides, not lasting very long. Corrective treatments details were not reported. Laboratory details included - Blood work-normal result. At the time of this report, outcome of the event was not recovered. Documents held by sender: None. Follow-up received from healthcare professional on 26 June 2014. It was reported that the patient was not medicated by the reporter. It was reported that the patient was came for allergy test and reporter was only gathering patient history. No new information was reported. Documents held by sender: None.
Sex: U
Vaccine: TYP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 April 2014. A patient (age and gender not reported) had received an unstable dose (exposed to -8 degree Celsius) of TYPHIM VIA on an unspecified date. No adverse event was reported. Documents held by sender: None.
Age: 0.5
Sex: U
Vaccine: TYP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 OCT 2013. The case was received on 21 March 2014. This is an invalid case as individual patient identifiers are not reported. The 06 month old patient inadvertently received a dose of TYPHIM VI on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: A few hours after receiving 2 vaccinations pt noted tenderness in area - left upper arm. Red raised and pain emanating from injection site down arm, to axilla, radiating to shoulder/neck.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in deltoid muscle left arm. Cannot raise above head or reach back wiithout severe pain. Left arm is injection site.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29 July 2014. A patient had received a dose of TD (manufacturer other) on an unspecified date. It was reported that the patient was administered an expired dose of TD, thus expired vaccine was used. No adverse event was reported. List of documents held by sender: none.
Age: 26.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Pt with known seizure disorder and cerebral palsy got vaccines 10/31/14. 11/3/14 had T-C seizure was admitted to hospital.
Age: 11.0
Sex: M
Vaccine: DTAP, FLU3, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Adminisitered Dtap in place of Tdap.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Symptoms for 6 hours after the vaccine. Fever and chills, fever, sweats
Sex: M
Vaccine: FLU3
Symptoms: Hot flush, Nausea, Rash, Visual impairment
Clinical narrative: Case number PHHY2014US000955, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509124) web site on 06 JAN 2014. This report refers to a 51-year-old male patient. His medical history included diabetes and hypertension and concomitant medication was not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307601) intramuscularly in the left arm on 06 SEP 2013. On the same day, approximately 10 minutes after vaccination, he had white spots in vision and hot flash. He also experienced a little nausea that lasted approximately 15-20 minutes, rash thought without shortness of breath. The outcome of the event  was reported as completely recovered. The seriousness and causality of the event were not reported. No additional information was available.
Age: 1.3
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Pinpoint rash on torso, belly, back, neck, chin, and cheeks.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Laboratory test normal, Pain
Clinical narrative: Around 3:30 PM 12/22/14 shaking chills, aches, and 99.8 temperature. Took TYLENOL, finished, work, and went to bed at 6:15 PM. Chills, fever, aches, headaches have continued only to be relieved by TYLENOL. Tested negative for flu at pharmacy. No respiratory issues. Have taken 2 - 3 naps per day. Low energy level - only do what is necessary. This morning temp was 99.8 and 6 hours later after taking TYLENOL around 6 AM, 100 degrees. Trying to limit TYLENOL ES to 3 per day since I have been taking TYLENOL since 12/22/14. Dr. says to continue with TYLENOL. It is very unusual to have fever for greater than 7 days.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Tremor
Clinical narrative: Around 3:30 PM 12/22/14 shaking chills, aches, and 99.8 temperature. Took TYLENOL, finished, work, and went to bed at 6:15 PM. Chills, fever, aches, headaches have continued only to be relieved by TYLENOL. Tested negative for flu at pharmacy. No respiratory issues. Have taken 2 - 3 naps per day. Low energy level - only do what is necessary. This morning temp was 99.8 and 6 hours later after taking TYLENOL around 6 AM, 100 degrees. Trying to limit TYLENOL ES to 3 per day since I have been taking TYLENOL since 12/22/14. Dr. says to continue with TYLENOL. It is very unusual to have fever for greater than 7 days.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder pain arm pain still do not have full range had severe pain. Almost 3 yrs later still have shoulder pain severe and arm pain started immediately after flu shot.  No previous history of arm or shoulder problem.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Headache, Mobility decreased
Clinical narrative: The worse headache I have ever had.  I could not even move, couldn't eat or drink anything.  This has never happened before and I always get a flu shot.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: My arm swelled up like there was an egg under my skin, it itches really bad, the area was very red and warm.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Death, Febrile convulsion
Clinical narrative: This spontaneous report was received from a physician concerning a 3 year old patient (gender unknown), who on an unknown date was vaccinated with a varicella containing vaccine which could be possible VARIVAX (Merck) or PROQUAD (Merck) (vaccines, routes, doses, lot numbers and expiration dates were not provided). Other suspect therapies or concomitant medication were not provided. The physician reported, that she was told that a patient's younger relative developed febrile seizure and on an unknown date died after getting the varicella containing vaccine. The physician stated that she was not sure the brand name of the vaccine (possibly VARIVAX (Merck) or PROQUAD (Merck)). The patient cause of death was febrile seizure. It was unknown if an autopsy was performed. Upon internal review, the event of febrile seizure was considered to be another important medical event. This is one of several reports received from the same source. Additional information is not expected because the physician did not have much information about the patient and refused to continue with the AE reporting.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Generalised tonic-clonic seizure, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer reporting on a 13 year old daughter. The patient had no pertinent medical history and no drug reactions or allergies. On 19-DEC-2014 the patient was vaccinated with GARDASIL one dose, (dose, route, lot # not reported). There was no concomitant medications. On 24-DEC-2014 the patient experienced grand mal seizure. On 24-DEC-2014 she was with her father when collapsed with her "legs and arms twisted and contorted". The patient's father call an ambulance and daughter was examined at the hospital and released. On 28-DEC-2014 the patient collapsed again, demonstrating the same shaking and seizure-like movements of her arms and legs. The reporter's daughter was transported again by ambulance to the emergency department. Computerized tomogram (CT scan) and unspecified "blood work" (on unknown date in approximately December 2014) were within normal ranges. The patient described her experience as "things started to go blue, her one arm started shaking, and then she did not remember anything until she woke up, and upon awaking, her extremities hurt and tingle". The reporter informed that both episodes of seizure activity last around 3-4 minutes. The patient was not hospitalized and no medications were administered as a treatment. The reporter informed her daughter's pediatricians of grand mal seizures activity and the patient was referred to a neurologist at hospital where she was scheduled for an electroencephalogram (EEG). At the time of report the patient did not recover from the event. Relatedness between the event and GARDASIL was not specified. Upon internal review the event of grand mal seizures was considered to be medically significant.  This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Posture abnormal, Seizure like phenomena, Syncope, Tremor
Clinical narrative: This spontaneous report as received from a consumer reporting on a 13 year old daughter. The patient had no pertinent medical history and no drug reactions or allergies. On 19-DEC-2014 the patient was vaccinated with GARDASIL one dose, (dose, route, lot # not reported). There was no concomitant medications. On 24-DEC-2014 the patient experienced grand mal seizure. On 24-DEC-2014 she was with her father when collapsed with her "legs and arms twisted and contorted". The patient's father call an ambulance and daughter was examined at the hospital and released. On 28-DEC-2014 the patient collapsed again, demonstrating the same shaking and seizure-like movements of her arms and legs. The reporter's daughter was transported again by ambulance to the emergency department. Computerized tomogram (CT scan) and unspecified "blood work" (on unknown date in approximately December 2014) were within normal ranges. The patient described her experience as "things started to go blue, her one arm started shaking, and then she did not remember anything until she woke up, and upon awaking, her extremities hurt and tingle". The reporter informed that both episodes of seizure activity last around 3-4 minutes. The patient was not hospitalized and no medications were administered as a treatment. The reporter informed her daughter's pediatricians of grand mal seizures activity and the patient was referred to a neurologist at hospital where she was scheduled for an electroencephalogram (EEG). At the time of report the patient did not recover from the event. Relatedness between the event and GARDASIL was not specified. Upon internal review the event of grand mal seizures was considered to be medically significant.  This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Blood test normal, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a consumer reporting on a 13 year old daughter. The patient had no pertinent medical history and no drug reactions or allergies. On 19-DEC-2014 the patient was vaccinated with GARDASIL one dose, (dose, route, lot # not reported). There was no concomitant medications. On 24-DEC-2014 the patient experienced grand mal seizure. On 24-DEC-2014 she was with her father when collapsed with her "legs and arms twisted and contorted". The patient's father call an ambulance and daughter was examined at the hospital and released. On 28-DEC-2014 the patient collapsed again, demonstrating the same shaking and seizure-like movements of her arms and legs. The reporter's daughter was transported again by ambulance to the emergency department. Computerized tomogram (CT scan) and unspecified "blood work" (on unknown date in approximately December 2014) were within normal ranges. The patient described her experience as "things started to go blue, her one arm started shaking, and then she did not remember anything until she woke up, and upon awaking, her extremities hurt and tingle". The reporter informed that both episodes of seizure activity last around 3-4 minutes. The patient was not hospitalized and no medications were administered as a treatment. The reporter informed her daughter's pediatricians of grand mal seizures activity and the patient was referred to a neurologist at hospital where she was scheduled for an electroencephalogram (EEG). At the time of report the patient did not recover from the event. Relatedness between the event and GARDASIL was not specified. Upon internal review the event of grand mal seizures was considered to be medically significant.  This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 12 month old patient of unknown gender. No pertinent medical history was reported. On 23-DEC-2014, the patient was inadvertently administered improperly stored PROQUAD (Merck) injection (strength, dose, route, lot# were not reported) when patient was supposed to receive MMR II instead. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history and current condition was not reported. On 17-NOV-2014 the patient was vaccinated with expired ZOSTAVAX, of dose 0.65 ml via subcutaneous route (frequency reported as once). Expiration date for the ZOSTAVAX was reported as JULY-2014. No adverse events were reported. The outcome of the events was unknown. This is one of the several reports received 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 receive from medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date unspecified number of patients were inadvertently vaccinated with PEDVAXHIB (dose, lot#, route of administration and anatomical location was unknown) that had been improperly stored. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history and current condition was not reported. On 20-NOV-2014 the patient was vaccinated with expired ZOSTAVAX, of dose 0.65 ml via subcutaneous route (frequency reported as once). Expiration date for the ZOSTAVAX was repotted as JULY-2014. No adverse events were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rosacea, Skin warm, Swelling face
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient had drug allergy to Morphine and no pertinent medical history. On 10-DEC-2014 the patient was vaccinated with one dose of ZOSTAVAX (lot # K012785, expiration date: 28-NOV-2015, 0.65 ml) subcutaneously. Concomitant therapies included potassium chloride (manufacturer unknown) and DAYPRO. On 11-DEC-2014, the patient presented with red, warm, swollen, painful rash on her bilateral cheeks that the pharmacist described the presentation as "resembling Rosacea in appearance". There was no treatment given for the adverse event. No lab diagnostics studies performed. The patient saw the pharmacist for medical attention. The outcome of the adverse event was reported as not recovered. The causal relationship between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: None reported. Vaccine was slightly out of date. (12/6/14 exp.)
Age: 69.0
Sex: F
Vaccine: FLUC3
Symptoms: Activities of daily living impaired, Headache, Muscular weakness, Pain in extremity
Clinical narrative: Sore arm - no inflammation, loss of muscle use - weakness, headaches. Constant arm pain, difficulty lifting even a cup of coffee.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pustule, Injection site swelling
Clinical narrative: Patient informed pharmacy of a swollen reddened injection site that was oozing pus.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date in April 2014, patient received his or her second dose of GARDASIL (dose, frequency, product lot #, expiration date not specified). On an unknown date in December 2014, the patient was present in the office to receive the third dose. Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Causality was reported as not related to GARDASIL. This is one of several reports received from the same source (MARRS # 1412USA013447). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of 4 years old patients of unknown gender. Since 15-NOV-2014 the unspecified patients were vaccinated with doses of VARIVAX (Merck), that were exposed to a supported temperature excursion, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effect has been observed. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. On 25-SEP-2014, the patient was vaccinated with the first dose of GARDASIL (route, dose and lot # not reported), on 21-NOV-2014, the patient received the second dose of GARDASIL (route, dose and lot # not reported) and on 29-DEC-2014, the patient received the third dose of GARDASIL (route, dose and lot # not reported) in error. Any adverse effects were 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 medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date unspecified number of patients were inadvertently vaccinated with VAQTA (dose, lot#, route of administration and anatomical location was unknown) that had been improperly stored. No adverse effects reported. The outcome of the events was unknown. 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 registered nurse refers to a patient of unknown age and gender. On 04-DEC-2014 the patient was subcutaneously vaccinated with an improperly stored dose of M-M-R II (dose was 0.5 ml, lot#, therapy type and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information is not expected, because there was no consent for further contact.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from an adult female patient of unknown age. The patient's medical history and concomitant medications were not reported. On an unknown date in December 2014 (reported as "yesterday") the patient was vaccinated with a "shot" of GARDASIL (dose, route of administration were not reported). On the same day, in the afternoon, the doctor called back the patient to inform her that she was pregnant. The LMP (Last Menstrual Period), date of conception, and EDD (Estimated Date of Delivery) were unknown. There was no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date unspecified number of patients were inadvertently vaccinated with PNEUMOVAX 23 (dose, lot#, route of administration and anatomical location was unknown) that had been improperly stored. No adverse effects reported. The outcome of the events was unknown. 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: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as "between 19-SEP-2014 and 17-NOV-2014"), unspecified number of patients were vaccinated with a dose of GARDASIL (lot number, expiry date, dose, route were not reported), that was improperly stored. GARDASIL was unsupported with in-house stability data. No adverse symptoms 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 received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as "between 19-SEP-2014 and 17-NOV-2014"), unspecified number of patients were vaccinated with a dose of PNEUMOVAX 23 (lot number, Expiry Date, dose, route were not reported), that was improperly stored. PNEUMOVAX 23 was unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. On an unknown date approximately in 2013 (about a year ago), the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular. The healthcare worker reported that the patient was currently in the office to receive her third dose of GARDASIL. No adverse effect reported. No Product Quality Complaint (PQC) was involved. 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 nurse refers to a patient of unknown age. The patient was vaccinated with doses of 0.5 ml GARDASIL, intramuscular on the following dates: first dose on 24-JUN-2014, second dose on 26-AUG-2014 and third dose on 15-OCT-2014. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history was not reported. On 02-DEC-2014 date the patient was vaccinated with expired ZOSTAVAX, of dose 0.65 ml via subcutaneous route (frequency reported as once). Expiration date for the ZOSTAVAX was reported as JULY-2014. No adverse events were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 years old female patient. Medical history and current conditions were not reported. On 12-AUG-2014, the patient was vaccinated with VARIVAX (Merck) lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old female patient. Medical history and current conditions were not reported. On 01-MAY-2014, the patient was vaccinated with a dose of VARIVAX (Merck), lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history and current condition was not reported. On 06-NOV-2014 date the patient was vaccinated with expired ZOSTAVAX, of dose 0.65 ml via subcutaneous route (frequency reported as once). Expiration date for the ZOSTAVAX was reported as JULY-2014. No adverse events were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history and current condition was not reported. On 2-DEC-2014 date the patient was vaccinated with expired ZOSTAVAX, of dose 0.65 ml via subcutaneous route (frequency reported as once). Expiration date for the ZOSTAVAX was reported as JULY-2014. No adverse events were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Bronchospasm, Cough
Clinical narrative: This spontaneous report as received on 03-DEC-2014 from a consumer refers to a 40 year old female patient with multiple sclerosis, fibromyalgia, reactive arthritis and no known drug allergies. On 11-NOV-2014 the patient was vaccinated with PNEUMOVAX 23. Concomitant therapies included COPAXONE, ibuprofen and HYDROCORTONE. On 17-NOV-2014, 7 days after onset of therapy the patient experienced coughing and bronchial spasms. On an unspecified date the patient sought medical attention at an urgent care facility and received unspecified lab tests. The patient was treated with azithromycin. The outcome of coughing and bronchial spasms is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure to product, No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report was received from a other health professional (female patient) of unknown age, regarding herself. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL. Concomitant medications were not reported. She reported that medication from a leaking GARDASIL syringe dripped onto her hands when it leaked from the base of a defective syringe. On an unknown date product quality complaint (PQC) was filled. Outcome of the event was not reported. No adverse effects were reported. Causality was reported as not related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date unspecified number of patients were inadvertently vaccinated with GARDASIL (dose, lot#, route of administration and anatomical location was unknown) that had been improperly stored. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date in April 2014, patient received his or her second dose of GARDASIL (dose, frequency, product lot #, expiration date not specified). On an unknown date in December 2014, the patient was present in the office to receive the third dose. Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Causality was reported as not related to GARDASIL. This is one of several reports from the same source (MARRS # 1412USA013535. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date unspecified number of patients were inadvertently vaccinated with ROTATEQ (oral, dose, lot# and anatomical location was unknown) that had been improperly stored. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Seizure, Staring
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial information received from a consumer who is the patient's parent on 05 March 2014. A male infant, date of birth reported as 2009 experienced body jerks and blank stares up to 4 days after receiving "DtaP" 5 years ago. The patient was immunized at 2 months of age intramuscularly with a first dose of DAPTACEL on 21 May 2009 (batch # C3082AA) site not reported, and a second dose of DAPTACEL intramuscularly at 4 months of age on 23 July 2009 (batch # C3142AA), site not reported. The parent stated what she was calling a seizure, one occurred two days post vaccination and one again four days post vaccination. The patient did not remember if it was after the 1st dose, 2nd dose or both that the patient experienced a seizure. The child has not received any DT/DTAP vaccine. Concomitant medications and laboratory tests were not reported. Her son also received "other vaccine as required by the government when he received the dtap", manufacturer and dates not reported. The reporter stated that she filed her own VAERS report because the "pediatrician declined that her son had a fever at the time and has not experienced any further seizures since then. The patient outcome was recovered on an unreported date. Documents held by sender: None.
Age: 7.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2013US121211, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 490597) website on 15 Oct 2013. This report refers to a 07.5 year-old male patient. His medical history and concomitant medications was not reported. On an unspecified date a couple of weeks ago he was inadvertently vaccinated with 0.5 ml of GARDASIL (batch number: not reported) intramuscularly instead of influenza vaccine, which had a similar cap color as GARDASIL. No adverse event was reported following this administration error. No additional information was available.
Age: 24.0
Sex: M
Vaccine: SMALL, YF
Symptoms: Activities of daily living impaired, Lymphadenopathy
Clinical narrative: This case was received on 03 September 2013 via a third party query tool search on the VAERS database, under reference number 490893. A 24 year-old male patient had received on 13 February 2013 a dose 0, left arm injection of ACAM2000 (lot number VV04003A) and a dose of 0 intramuscular right arm injection of YF VAX, lot number UH354AA and 18 days later on 03 March 2013, experienced activities of daily living impaired and lymphadenopathy. The patient reported a strong lymph node reaction with swelling. He went to the ER on 23 February 2013 and was treated with antibiotics and BENADRYL. On 25 February 2013, the patient followed up in  the clinic and returned to work. History, lab data, other medications and current illnesses were reported as none. Prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, YF
Symptoms: Chest pain, Dyspnoea, Feeling abnormal, X-ray
Clinical narrative: This case was received on 12 November 2013 via a third party query tool search on the VAERS database, under reference number 495887. A 21-year-old male patient had received an injection of ACAM2000 (SP Biologics Co. lot number VV04003A) in the left arm and an injection of YF-VAX (Sanofi Pasteur Inc., lot number UH596AA) in the right arm on 26 June 2013. The patient stated he went to take a PT test this morning and when it came time to running the mile and a half, about 10 seconds after starting it felt like his whole body was telling him to stop. He had trouble keeping his breathing under control and had pain in his chest. He pushed himself to finish. but the entire time he could not keep control of his breathing and the pain continued. The patient had an x-ray and was sent to the emergency room. Other medications, current illnesses and history were reported as none. Outcome was recovered. Documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: SMALL, YF
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference 499303. A 24 year-old male patient had received the following vaccines on 31 July 2013 a left arm injection of ACAM2000, (lot number VV04003A) and a subcutaneous right arm injection of YFVAX, (lot number UH666AA and on 11 August 2013, woke up with hives of all different sizes on body, mostly on elbows, knees, arms and wrists. The hives were itchy and in clusters. The hives went away as the day went on. The patient also woke up with swollen hands and fingers but it goes away after a few hours after waking. The patient had an emergency visit. History, Lab data, other medications and current illnesses were reported as none. Prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Activities of daily living impaired, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This case was received on 05 December 2013 via a third party query tool search on the VAERS database, under reference number 502706. A 25-year-old male patient had received the following vaccinations on 04 September 2013: ACAM2000, SP Biologics Co. lot number VV04003A) in the left arm and YF VAX (Sanofi Pasteur Inc., lot number UH670AA) in the right arm. On 07 September 2013, the patient experienced fever, body aches, extreme fatigue and headaches. The patient missed one day of work and caused him to go home early on the second day. The patient had symptoms for three days. The events required an emergency visit. Lab data, other medication, current illnesses and history were reported as none. Outcome was recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Case number PHHY2013US139461, is an initial spontaneous report received via vaccine adverse event reporting system (the source of the case in VAERS is a literature publication, reference number 504860) on 25 Nov 2013. The author described a prospective cohort study which was conducted to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. In this study, vaccine exposed and unexposed women residing in two countries were recruited during pregnancy, compared and followed to outcome between Oct 2009 and Aug 2012. Out of 1032 subjects available for analysis, 841 women were exposed to a pH1N1-containing vaccine in pregnancy and 191 women were unexposed to any influenza vaccine in pregnancy. This report refers to a pregnant female patient whose age was not reported. She was vaccinated with H1N1 vaccine (manufacturer and batch number: not reported) on an unknown date. Her last menstrual period and estimated date of delivery was not reported. It was reported that she received vaccine at the first trimester of her pregnancy. On an unknown date, she delivered a neonate by unknown delivery method and the baby had congenital anomaly and was born with hypertrophic pyloric stenosis (see related case number: PHHY2013US135770). Birth weight and APGAR scores were not provided. The article was concluded stating that the potential serious consequences of maternal influenza infection in pregnancy was long been recognized; pregnant women were at increased risk for influenza-associated morbidity and mortality. Even though there were limited data on the safety of influenza vaccine in pregnancy; however, to date, there was no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus and this led to the current recommendation that all pregnant women should be vaccinated with the seasonal influenza vaccine regardless of trimester. Surveys demonstrated that mothers' concerns about safety contributed to poor compliance with vaccine recommendations. The author stated that no meaningful evidence of increased relative risk or hazard ratio (HR) for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Case number PHHY2013US139472, is an initial spontaneous report received via vaccine adverse event reporting system (the source of the case in VAERS is a literature publication, reference number 504861) on 25 Nov 2013. The author described a prospective cohort study which was conducted to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. In this study, vaccine exposed and unexposed women residing in two countries were recruited during pregnancy, compared and followed to outcome between Oct 2009 and Aug 2012. Out of 1032 subjects available for analysis, 841 women were exposed to a pH1N1-containing vaccine in pregnancy and 191 women were unexposed to any influenza vaccine in pregnancy. This report refers to a pregnant female patient whose age was not reported. She was vaccinated with H1N1 vaccine (manufacturer and batch number: not reported) on an unknown date. Her last menstrual period and estimated date of delivery was not reported. It was reported that she received vaccine at the first trimester of her pregnancy. On an unknown date, she delivered a neonate by unknown delivery method and the baby had congenital anomaly and was born with hypertrophic pyloric stenosis (see related case number: PHHY2013US135777). Birth weight and APGAR scores were not provided. The article was concluded stating that the potential serious consequences of maternal influenza infection in pregnancy was long been recognized; pregnant women were at increased risk for influenza-associated morbidity and mortality. Even though there were limited data on the safety of influenza vaccine in pregnancy; however, to date, there was no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus and this led to the current recommendation that all pregnant women should be vaccinated with the seasonal influenza vaccine regardless of trimester. Surveys demonstrated that mothers' concerns about safety contributed to poor compliance with vaccine recommendations. The author stated that no meaningful evidence of increased relative risk or hazard ratio (HR) for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Case number PHHY2013US139479, is an initial spontaneous report received via vaccine adverse event reporting system (the source of the case in VAERS is a literature publication, reference number 504863) on 25 Nov 2013. The author described a prospective cohort study which was conducted to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. In this study, vaccine exposed and unexposed women residing in two countries were recruited during pregnancy, compared and followed to outcome between Oct 2009 and Aug 2012. Out of 1032 subjects available for analysis, 841 women were exposed to a pH1N1-containing vaccine in pregnancy and 191 women were unexposed to any influenza vaccine in pregnancy. This report refers to a pregnant female patient whose age was not reported. She was vaccinated with H1N1 vaccine (manufacturer and batch number: not reported) on an unknown date. Her last menstrual period and estimated date of delivery was not reported. It was reported that she received vaccine at the first trimester of her pregnancy. On an unknown date, she delivered a neonate by unknown delivery method and the baby had congenital anomaly and was born with ventricular septal defect and a peripheral pulmonary artery stenosis(see related case number: PHHY2013US135786). Birth weight and APGAR scores were not provided. The article was concluded stating that the potential serious consequences of maternal influenza infection in pregnancy was long been recognized; pregnant women were at increased risk for influenza-associated morbidity and mortality. Even though there were limited data on the safety of influenza vaccine in pregnancy; however, to date, there was no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus and this led to the current recommendation that all pregnant women should be vaccinated with the seasonal influenza vaccine regardless of trimester. Surveys demonstrated that mothers' concerns about safety contributed to poor compliance with vaccine recommendations. The author stated that no meaningful evidence of increased relative risk or hazard ratio (HR) for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: Case number PHHY2013US139486 is an initial spontaneous report received via vaccine adverse event reporting system (the source of the case in VAERS is a literature publication, reference number 504865) on 25 Nov 2013. The author described a prospective cohort study which was conducted to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. In this study, vaccine exposed and unexposed women residing in two countries were recruited during pregnancy, compared and followed to outcome between Oct 2009 and Aug 2012. Out of 1032 subjects available for analysis, 841 women were exposed to a pH1N1-containing vaccine in pregnancy and 191 women were unexposed to any influenza vaccine in pregnancy. This report refers to a pregnant female patient whose age was not reported. She was vaccinated with H1N1 vaccine (manufacturer and batch number: not reported) on an unknown date. Her last menstrual period and estimated date of delivery was not reported. It was reported that she received vaccine at the first trimester of her pregnancy. On an unknown date, she delivered a male neonate by unknown delivery method and the baby had congenital anomaly and was born with undescended testis (see related case number: PHHY2013US135792). Birth weight and APGAR scores were not provided. The article was concluded stating that the potential serious consequences of maternal influenza infection in pregnancy was long been recognized; pregnant women were at increased risk for influenza-associated morbidity and mortality. Even though there were limited data on the safety of influenza vaccine in pregnancy; however, to date, there was no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus and this led to the current recommendation that all pregnant women should be vaccinated with the seasonal influenza vaccine regardless of trimester. Surveys demonstrated that mothers' concerns about safety contributed to poor compliance with vaccine recommendations. The author stated that no meaningful evidence of increased relative risk or hazard ratio (HR) for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.