chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Abdominal pain, Alopecia, Arthralgia, Asthenia, Autoimmune disorder
Clinical narrative: This solicited report was received from a social media researcher regarding an article about HPV vaccine as a part of market research. The patient demographics and numbers were unknown. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates the patients received GARDASIL (dosing details not specified). On an unknown date, a lot of reactions were reported in number of patients such as epilepsy, dizziness, fatigue, weakness, headache, abdominal pain, muscle pain, and muscle weakness, joint pain, autoimmune problems, chest pain, hair loss, loss of appetite, personality changes, insomnia, trembling hands/feet, shortness of breath, heart disease, paralysis, itching, hives, swelling, muscle aches, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea, temporary vision loss and temporary hearing loss. Action taken with the vaccine was not applicable. The outcome of the events was not reported. Causality of the events with the study therapy was not reported. Upon internal review the events of epilepsy, stroke, autoimmune problems, paralysis, temporary hearing loss and temporary vision loss were considered as medically significant. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for contact.
Sex: U
Vaccine: HPV4
Symptoms: Blindness transient, Cardiac disorder, Chest pain, Decreased appetite, Dizziness
Clinical narrative: This solicited report was received from a social media researcher regarding an article about HPV vaccine as a part of market research. The patient demographics and numbers were unknown. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates the patients received GARDASIL (dosing details not specified). On an unknown date, a lot of reactions were reported in number of patients such as epilepsy, dizziness, fatigue, weakness, headache, abdominal pain, muscle pain, and muscle weakness, joint pain, autoimmune problems, chest pain, hair loss, loss of appetite, personality changes, insomnia, trembling hands/feet, shortness of breath, heart disease, paralysis, itching, hives, swelling, muscle aches, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea, temporary vision loss and temporary hearing loss. Action taken with the vaccine was not applicable. The outcome of the events was not reported. Causality of the events with the study therapy was not reported. Upon internal review the events of epilepsy, stroke, autoimmune problems, paralysis, temporary hearing loss and temporary vision loss were considered as medically significant. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for contact.
Sex: U
Vaccine: HPV4
Symptoms: Dyspnoea, Epilepsy, Fatigue, Headache, Insomnia
Clinical narrative: This solicited report was received from a social media researcher regarding an article about HPV vaccine as a part of market research. The patient demographics and numbers were unknown. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates the patients received GARDASIL (dosing details not specified). On an unknown date, a lot of reactions were reported in number of patients such as epilepsy, dizziness, fatigue, weakness, headache, abdominal pain, muscle pain, and muscle weakness, joint pain, autoimmune problems, chest pain, hair loss, loss of appetite, personality changes, insomnia, trembling hands/feet, shortness of breath, heart disease, paralysis, itching, hives, swelling, muscle aches, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea, temporary vision loss and temporary hearing loss. Action taken with the vaccine was not applicable. The outcome of the events was not reported. Causality of the events with the study therapy was not reported. Upon internal review the events of epilepsy, stroke, autoimmune problems, paralysis, temporary hearing loss and temporary vision loss were considered as medically significant. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for contact.
Sex: U
Vaccine: HPV4
Symptoms: Lymphadenopathy, Menstrual disorder, Muscular weakness, Myalgia, Nausea
Clinical narrative: This solicited report was received from a social media researcher regarding an article about HPV vaccine as a part of market research. The patient demographics and numbers were unknown. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates the patients received GARDASIL (dosing details not specified). On an unknown date, a lot of reactions were reported in number of patients such as epilepsy, dizziness, fatigue, weakness, headache, abdominal pain, muscle pain, and muscle weakness, joint pain, autoimmune problems, chest pain, hair loss, loss of appetite, personality changes, insomnia, trembling hands/feet, shortness of breath, heart disease, paralysis, itching, hives, swelling, muscle aches, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea, temporary vision loss and temporary hearing loss. Action taken with the vaccine was not applicable. The outcome of the events was not reported. Causality of the events with the study therapy was not reported. Upon internal review the events of epilepsy, stroke, autoimmune problems, paralysis, temporary hearing loss and temporary vision loss were considered as medically significant. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for contact.
Sex: U
Vaccine: HPV4
Symptoms: Night sweats, Paralysis, Personality change, Pruritus, Swelling
Clinical narrative: This solicited report was received from a social media researcher regarding an article about HPV vaccine as a part of market research. The patient demographics and numbers were unknown. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates the patients received GARDASIL (dosing details not specified). On an unknown date, a lot of reactions were reported in number of patients such as epilepsy, dizziness, fatigue, weakness, headache, abdominal pain, muscle pain, and muscle weakness, joint pain, autoimmune problems, chest pain, hair loss, loss of appetite, personality changes, insomnia, trembling hands/feet, shortness of breath, heart disease, paralysis, itching, hives, swelling, muscle aches, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea, temporary vision loss and temporary hearing loss. Action taken with the vaccine was not applicable. The outcome of the events was not reported. Causality of the events with the study therapy was not reported. Upon internal review the events of epilepsy, stroke, autoimmune problems, paralysis, temporary hearing loss and temporary vision loss were considered as medically significant. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for contact.
Sex: U
Vaccine: HPV4
Symptoms: Syncope, Tremor, Urticaria
Clinical narrative: This solicited report was received from a social media researcher regarding an article about HPV vaccine as a part of market research. The patient demographics and numbers were unknown. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates the patients received GARDASIL (dosing details not specified). On an unknown date, a lot of reactions were reported in number of patients such as epilepsy, dizziness, fatigue, weakness, headache, abdominal pain, muscle pain, and muscle weakness, joint pain, autoimmune problems, chest pain, hair loss, loss of appetite, personality changes, insomnia, trembling hands/feet, shortness of breath, heart disease, paralysis, itching, hives, swelling, muscle aches, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea, temporary vision loss and temporary hearing loss. Action taken with the vaccine was not applicable. The outcome of the events was not reported. Causality of the events with the study therapy was not reported. Upon internal review the events of epilepsy, stroke, autoimmune problems, paralysis, temporary hearing loss and temporary vision loss were considered as medically significant. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates the patients received improperly stored doses of RECOMBIVAX HB (lot # reported as M018625 with expiry date: 11-AUG-2018). The temperature and timeframe that the RECOMBIVAX HB was exposed to were as follows: Temperature: 50.4F. Timeframe: 19.5 hours total cumulative. The medical assistant reported that the patients received doses of improperly stored RECOMBIVAX HB but lot numbers and expiry dates of those specific vaccines that were administered was unknown. No adverse effects reported. Medical assistant also reported that the vaccines were not yet back in range. Data logger was involved. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unspecified date in December 2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose, frequency and route were not provided. Then on 21-AUG-2016, he was vaccinated with the second dose of RECOMBIVAX HB (lot # M01864, expiration date: 31-MAY-2018), (dose, frequency and route were not provided). No adverse effects were reported. No product quality complaint was involved. Lot number M01864 has been verified to a be a valid lot number for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown demographics. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Lot # M019641 with expiry date 20-APR-2018, Lot # L013063 with expiry date 14-APR-2017, Lot # L035124 with expiry date 14-SEP-2017, Lot # L032395 with expiry date 26-AUG-2017 and Lot # L034267 with expiry date 08-AUG-2017). The temperature and timeframe that the VARIVAX was exposed to were as follows, Temperature: 14.9F, Time frame: 1 hour. There were no previous temperature excursions. Data Logger was involved. The medical assistant confirmed that the improperly stored vaccines were administered. No adverse effect was reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patient of unknown demographics. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Lot # M006102, expiry date 01-AUG-2017, Lot # M011664, expiry date 18-SEP-2017, Lot # L051098, expiry date 17-JUL-2017 and Lot # M006102, expiry date 01-AUG-2017). The temperature and timeframe that the PROQUAD was exposed to were as follows, Temperature: 14.9F, Time frame: 1 hour. There were no previous temperature excursions. Data Logger was involved. The medical assistant confirmed that the improperly stored vaccines were administered. No adverse effect was reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant referring to a 29 year old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 29-JUL-2016, the patient was inadvertently vaccinated with a dose of (Oka-Merck) PROQUAD (strength, dose and frequency unknown, lot # M015700, expiration date: 26-SEP-2017) subcutaneously instead of a dose of (Wistar RA 27-3) M-M-R II. The nurse was not aware that there was a difference between (Oka-Merck) PROQUAD and (wistar RA 27-3) M-M-R II (Product label confusion). No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local redness, swelling and pain at site of injection, Treated with diphenhydramine and ibuprofen by mouth once.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Agitation, Injection site erythema, Injection site rash, Rash erythematous, Rash generalised
Clinical narrative: Rash on body w/itchiness. Blotchy red rash on various parts of the body x 1 week after having 3 vaccines on 9/2/16. After vaccines, area became agitated and red spots around injection site ZYRTEC given for rash.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash macular
Clinical narrative: Rash on body w/itchiness. Blotchy red rash on various parts of the body x 1 week after having 3 vaccines on 9/2/16. After vaccines, area became agitated and red spots around injection site ZYRTEC given for rash.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site swelling, Oedema peripheral
Clinical narrative: Edema of injection (R) arm away from site of injection. Swelling near bicep area-mild edema, pt asked to take BENADRYL and ice.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adolescent male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXERO. Additional details were provided as follows: the age at vaccination was not reported. the patient experienced a little pain at the injection site after his 1st dose of BEXSERO. the reporter did not want to provide her complete demographics or answer any questions for this report.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site significantly swollen, with associated pain, erythema, induration limiting movement of arm/shoulder. Ice pack applied, plus diphenhydramine, with improvement in swelling and range of motion (and pain).
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) deltoid red, warm to touch, bump, "size of a quarter."
Age: 3.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Body temperature increased, Injection site induration, Injection site pain, Injection site swelling, Tearfulness
Clinical narrative: Adverse effect of other bacterial vaccines, init encntr on 2016-03-30.
Age: 3.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Vaccination site warmth, Weight bearing difficulty
Clinical narrative: Adverse effect of other bacterial vaccines, init encntr on 2016-03-30.
Age: 3.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Adverse event
Clinical narrative: Adverse effect of other bacterial vaccines, init encntr on 2016-03-30.
Sex: M
Vaccine: ANTH, JEV, SMALL, ANTH, JEV, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest pain, Electrocardiogram ST segment elevation, Myocarditis
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 635171. This case involves a 20-years old male patient who received the following vaccinations on 28 April 2016: A dose of ACAM2000 (lot number-VV03019C, site of administration was reported as unknown, and route of administration was not reported), first dose of JE-VAX (lot number- JEV14J74E, route and site of administration was reported as unknown), single dose of BIOTHRAX (lot number- FAV449A, manufacturer-EMERGENT) route and site of administration was reported as unknown. The patient had not received other medications. Patient's current illness, history was reported as none and prior vaccination was not reported. On 08 May 2016, 10 days post vaccination, patient started to develop positional, dull, left chest pain that worsened over the next 2 days, blood creatine phosphokinase and blood creatine phosphokinase MB increased, electrocardiogram showed ST segment elevation, N-terminal prohormone brain natriuretic peptide increased (pro-BNP), troponin increased (elevated). On 10 May 2016, Patient was diagnosed as pericarditis (myocarditis). On 10 May 2016, patient was transferred to a hospital on the evening and admitted for further evaluation. On an unspecified date patient was diagnosed with myopericarditis while on the Cardiology service. Patient required emergency visit. Laboratory investigations reported as diffuse ST elevation on EKG. On an unspecified date, patient was recovered from events. It was reported that myopericarditis was felt to be possibly related to recent vaccination for smallpox and Japanese encephalitis. List of documents held by sender: none. Sender's Comments: A 20 years old experienced Myopericarditis and Pericarditis after vaccination with SMALLPOX (VACCINIA) LIVE VACCINE simultaneously with JAPANESE ENCEPHALITIS INACTIVATED BIKEN VACCINE and ANTHRAX VACCINE from other manufacturer. Myopericarditis and Pericarditis are listed with SMALLPOX (VACCINIA) LIVE VACCINE. Time to onset is compatible with role of vaccine. Details regarding relevant medical history, any history of infection pre or post vaccination and alternative etiology are needed for complete assessment of the case.
Sex: M
Vaccine: ANTH, JEV, SMALL, ANTH, JEV, SMALL
Symptoms: N-terminal prohormone brain natriuretic peptide increased, Pericarditis, Troponin increased
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 635171. This case involves a 20-years old male patient who received the following vaccinations on 28 April 2016: A dose of ACAM2000 (lot number-VV03019C, site of administration was reported as unknown, and route of administration was not reported), first dose of JE-VAX (lot number- JEV14J74E, route and site of administration was reported as unknown), single dose of BIOTHRAX (lot number- FAV449A, manufacturer-EMERGENT) route and site of administration was reported as unknown. The patient had not received other medications. Patient's current illness, history was reported as none and prior vaccination was not reported. On 08 May 2016, 10 days post vaccination, patient started to develop positional, dull, left chest pain that worsened over the next 2 days, blood creatine phosphokinase and blood creatine phosphokinase MB increased, electrocardiogram showed ST segment elevation, N-terminal prohormone brain natriuretic peptide increased (pro-BNP), troponin increased (elevated). On 10 May 2016, Patient was diagnosed as pericarditis (myocarditis). On 10 May 2016, patient was transferred to a hospital on the evening and admitted for further evaluation. On an unspecified date patient was diagnosed with myopericarditis while on the Cardiology service. Patient required emergency visit. Laboratory investigations reported as diffuse ST elevation on EKG. On an unspecified date, patient was recovered from events. It was reported that myopericarditis was felt to be possibly related to recent vaccination for smallpox and Japanese encephalitis. List of documents held by sender: none. Sender's Comments: A 20 years old experienced Myopericarditis and Pericarditis after vaccination with SMALLPOX (VACCINIA) LIVE VACCINE simultaneously with JAPANESE ENCEPHALITIS INACTIVATED BIKEN VACCINE and ANTHRAX VACCINE from other manufacturer. Myopericarditis and Pericarditis are listed with SMALLPOX (VACCINIA) LIVE VACCINE. Time to onset is compatible with role of vaccine. Details regarding relevant medical history, any history of infection pre or post vaccination and alternative etiology are needed for complete assessment of the case.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Electroencephalogram, Loss of consciousness, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: This spontaneous report as received from a pharmacist who was also patient's mother, refers to a 13 year old male patient. The patient did not have any medical history or drug allergies or reactions. In January 2016, the patient was intramuscularly vaccinated with the first dose of GARDASIL 9 (dose and lot number were not reported). The second dose was administered in March 2016 and the third dose was not administered at the time of the report. In May 2016, also reported as after receiving GARDASIL 9, the patient passed out and then had a seizure. He was taken to the hospital and was hospitalized during 28-MAY-2016 and 29-MAY-2016. During that time, he had an electroencephalography (EEG) and an magnetic resonance imaging (MRI) done (both results were not provided). The patient had another episode later on an unspecified date in 2016, he blacked out and had a vacant scare. When the emergency personnel arrived, they stated that his heart rate was twice what it should have been. The patient was given oxygen and went to an unspecified emergency room. On 28-AUG-2016, the patient was playing with his laptop, when he collapsed on top of the laptop and started to have a seizure. That was the last episode. The patient was given clonazepam and was taken to an urgent care. At the time of the report, he was taking KEPPRA (500 mg twice a day). The outcome of passed out and seizure (onset dates: May 2016) was reported as recovered/resolved in 2016. The outcome of the events of seizure (onset date: 28-AUG-2016), collapsed, heart rate was twice what it should have been, vacant scare and blacked out was reported as recovering/resolving. The relatedness between the event and the vaccination with GARDASIL 9 was not provided. Upon internal review, the events of seizure and black out were considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Electroencephalogram, Fear, Heart rate abnormal, Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a pharmacist who was also patient's mother, refers to a 13 year old male patient. The patient did not have any medical history or drug allergies or reactions. In January 2016, the patient was intramuscularly vaccinated with the first dose of GARDASIL 9 (dose and lot number were not reported). The second dose was administered in March 2016 and the third dose was not administered at the time of the report. In May 2016, also reported as after receiving GARDASIL 9, the patient passed out and then had a seizure. He was taken to the hospital and was hospitalized during 28-MAY-2016 and 29-MAY-2016. During that time, he had an electroencephalography (EEG) and an magnetic resonance imaging (MRI) done (both results were not provided). The patient had another episode later on an unspecified date in 2016, he blacked out and had a vacant scare. When the emergency personnel arrived, they stated that his heart rate was twice what it should have been. The patient was given oxygen and went to an unspecified emergency room. On 28-AUG-2016, the patient was playing with his laptop, when he collapsed on top of the laptop and started to have a seizure. That was the last episode. The patient was given clonazepam and was taken to an urgent care. At the time of the report, he was taking KEPPRA (500 mg twice a day). The outcome of passed out and seizure (onset dates: May 2016) was reported as recovered/resolved in 2016. The outcome of the events of seizure (onset date: 28-AUG-2016), collapsed, heart rate was twice what it should have been, vacant scare and blacked out was reported as recovering/resolving. The relatedness between the event and the vaccination with GARDASIL 9 was not provided. Upon internal review, the events of seizure and black out were considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Seizure, Staring, Syncope
Clinical narrative: This spontaneous report as received from a pharmacist who was also patient's mother, refers to a 13 year old male patient. The patient did not have any medical history or drug allergies or reactions. In January 2016, the patient was intramuscularly vaccinated with the first dose of GARDASIL 9 (dose and lot number were not reported). The second dose was administered in March 2016 and the third dose was not administered at the time of the report. In May 2016, also reported as after receiving GARDASIL 9, the patient passed out and then had a seizure. He was taken to the hospital and was hospitalized during 28-MAY-2016 and 29-MAY-2016. During that time, he had an electroencephalography (EEG) and an magnetic resonance imaging (MRI) done (both results were not provided). The patient had another episode later on an unspecified date in 2016, he blacked out and had a vacant scare. When the emergency personnel arrived, they stated that his heart rate was twice what it should have been. The patient was given oxygen and went to an unspecified emergency room. On 28-AUG-2016, the patient was playing with his laptop, when he collapsed on top of the laptop and started to have a seizure. That was the last episode. The patient was given clonazepam and was taken to an urgent care. At the time of the report, he was taking KEPPRA (500 mg twice a day). The outcome of passed out and seizure (onset dates: May 2016) was reported as recovered/resolved in 2016. The outcome of the events of seizure (onset date: 28-AUG-2016), collapsed, heart rate was twice what it should have been, vacant scare and blacked out was reported as recovering/resolving. The relatedness between the event and the vaccination with GARDASIL 9 was not provided. Upon internal review, the events of seizure and black out were considered to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with the second dose in GARDASIL 9 (intramuscularly: dose, lot # and expiration date were not reported) (also reported as vaccine). On 12-SEP-2016, the patient hives. The patient sought medical attention and on 13-SEP-2016 started the treatment of the adverse event with ALLEGRA (dose and frequency were not provided). The outcome of hives was unknown. The relatedness between the adverse event and GARDASIL 9 was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with the second dose in GARDASIL 9 (intramuscularly: dose, lot # and expiration date were not reported) (also reported as vaccine). On 12-SEP-2016, the patient hives. The patient sought medical attention and on 13-SEP-2016 started the treatment of the adverse event with ALLEGRA (dose and frequency were not provided). The outcome of hives was unknown. The relatedness between the adverse event and GARDASIL 9 was not provided. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Musculoskeletal chest pain
Clinical narrative: Deep pain in ribs and back near spine. (Vaccine was given in right arm). Shingles rash developed 09/12/2016. Diagnosed with shingles 09/15/2016.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainted. Presumed Vasovagal response to injection. Had her lay down for 10 minutes, monitored vitals, gave her fluids when able to sit up.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Autism, Cytogenetic analysis normal
Clinical narrative: Autism.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Chest X-ray normal, Feeling cold, Injection site pain, Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, low grade fever (100.0), chills, pain at vaccine site.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, low grade fever (100.0), chills, pain at vaccine site.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a consumer on 06-Sep-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (manufacturer unknown batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. The patient's medical history, ongoing illness and risk factors were not reported. On unspecified date, following the vaccination patient had a reaction to a flu vaccine. Lab data and corrective treatment was not reported. The outcome of the event was not reported. Documents held by sender: none.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a currently 66 year old female patient referring to herself. Information about medical history and concurrent condition was unspecified. On an unknown date the patient was vaccinated with one dose of PNEUMOVAX 23 (one shot one time, lot number, expiration date and dose were unknown) intramuscularly. Concomitant therapies included PREVNAR 13. On an unknown date, long after the vaccination, the patient developed pneumonia. The patient sought medical attention via contacting physician. The outcome of the event was reported as not recovered. The causality between the event and PNEUMOVAX 23 was unspecified. No product quality complaint (PQC) was involved. Upon internal review, the event pneumonia was considered to be medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Nausea
Clinical narrative: Patient notice nausea and weakness but also told me he told a Venlafaxine 75mg tablet which can also present those reactions.
Age: 0.3
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 4 month old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the 4 months old patient was vaccinated with M-M-R II (rHA, 0.5 ml, lot # L026553, expiration date 16-JUL-2017) subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M003434 with expiry date on 19-JUL-2017, therapy type, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L045953; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.92
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 23-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-MAR-2016, the patient was vaccinated with an incorrectly stored dose of PROQUAD (therapy type: rHA, lot # L031601, an expiration date 18-FEB-2017, dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 09-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L045953; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L045953; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP
Symptoms: Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a female patient who received DTaP (Reduced antigen). In September 2016, the patient received the 1st dose of DTaP vaccine. On an unknown date, less than a month after receiving DTaP vaccine, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to DTaP vaccine. Additional details were provided as follows: The case was received as a public comment on Facebook. The patient received DTaP vaccine and experienced huge knot on her arm that also sore. The reporter stated that, after reading some of the complaints she guessed that could not really complain.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chronic inflammatory demyelinating polyradiculoneuropathy, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Numbness, weakness, difficulty walking, aprox 5 days after flu shot. Plasmapheresis IVIG (several treatments of both) diagnosed w/GBS followed by CIDP.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Plasmapheresis
Clinical narrative: Numbness, weakness, difficulty walking, aprox 5 days after flu shot. Plasmapheresis IVIG (several treatments of both) diagnosed w/GBS followed by CIDP.
Sex: F
Vaccine: HPV9
Symptoms: Contusion, Urticaria
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of unknown age with no drug reactions or allergies. The patient had no pertinent medical history. On 18-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 in the right arm for immunization (lot # M003659, expiration date: 20-SEP-2017; dose and route were not provided). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and an unspecified seasonal birth control pill. On an unknown date in 2016, the patient experienced hives and big bruise on her right arm. Hives occurred a few days after receiving GARDASIL 9 dose and extended from near injection site all the way down to her hand. The patient took BENADRYL for hives and the event subsided within a few days. No lab diagnostics studies were performed. The outcome of the events was reported as recovered on an unknown date in 2016. The patient did not seek medical attention. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: Started with nausea at 1AM Fri. morn woke up with diarrhea vomiting stomach pains went to hosp. at 3:30 AM.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Vaccine administrator accidentally only gave the diluent portion of the vaccine, resulting in no active ingredient being administered.
Age: 1.25
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-05-12.
Age: 67.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-05-13.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pulmonary granuloma, Pyrexia
Clinical narrative: Information has been received from a physician via a company representative referring to an approximately 67 years old female patient. The patient was allergic to iodine, dyes and sulfonamides. The patient had no medical history. Concomitant therapies included NEXIUM, VASOTEC, albuterol sulfate (manufacturer unknown) and ATIVAN. On 29-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # reported as 1035882, expiration date 19-APR-2017, dose not reported) intramuscularly. In 2016 (reported as "subsequently"), the patient developed pulmonary granuloma and fever. On 13-AUG-2016, the patient went to a walk in clinic and was given doxycycline. The outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 was not provided. The physician asked a lot check for 1035882. Lot number 1035882 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent). Additional information has been requested.
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 06-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (lot # M011840 with expiry date: 01-FEB-2018; strength, dose, route and site of administration were unspecified) or ROTATEQ injection (lot # M025565 with expiry date: 06-NOV-2017; strength, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 51.3 degrees Fahrenheit for 86.5 hours. There was no previous temperature excursion. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, Needle issue, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-SEP-2016, during administration of a dose of RECOMBIVAX HB 5/0.5 mcrg/ml, lot # M010671, expiration date 02-JUN-2018, the needle and syringe came apart (due to user error), resulting some vaccine going on the patient's leg and only a partial dose of RECOMBIVAX HB being administered. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-JAN-2016, the patient was vaccinated with an incorrectly stored dose of PROQUAD (therapy type: rHA, # L031601, an expiration date 18-FEB-2017, dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Asthma, Hypersensitivity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 4 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown dates (at appropriate times of near 12 months of age), the patient was vaccinated with M-M-R II and VARIVAX, (lot/expiration, dose and frequency not reported). Pharmacist (parents) stated last year (2015), patient developed allergies/asthma that required medication and patient took QVAR, (1 puff twice daily, 40 mcg dose). Pharmacist stated "the allergies/asthma have nothing to do with the vaccines." The outcome of the event was unknown. The reporter considered event to be not related to M-M-R II and VARIVAX (nothing to do with the vaccines). Patient did not seek medical attention. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 9 year old male patient. No information regarding the patient's medical history and concurrent conditions was provided. In approximately August 2016 (reported as "about one month ago"), the patient was vaccinated with the first dose of GARDASIL 9 injection, (dose, route of administration, injection site, lot number and expiration date were not provided). There were no concomitant medications reported. On an unspecified date in 2016, the patient started feeling pain in his left arm. It was not specified how long after receiving the first dose of GARDASIL 9 the pain occurred. The nurse practitioner also stated that the patient was "not able to sleep because of the pain" since an unknown date in 2016. The patient sought medical attention via contacting the nurse practitioner. An unspecified treatment was given for the events. The outcome of feeling pain in the left arm and not being able to sleep because of the pain was unknown since the patient had not returned to the office until the day of this report. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-APR-2016, the patient was vaccinated with an incorrectly stored dose of PROQUAD (therapy type: rHA, lot # L031601, an expiration date 18-FEB-2017, dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-APR-2016, the patient was vaccinated with an incorrectly stored dose of PROQUAD (therapy type: rHA, lot # L031601, an expiration date 18-FEB-2017, dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, these patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M003659 with expiry date: 20-SEP-2017; strength, dose, route and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 30 degrees Fahrenheit for 30 days. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-06-20.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-06-10.