chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Metabolic function test, Muscle rigidity, Somnolence, Tearfulness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642094) on 02-MAY-2017. This spontaneous report refers to a 14 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 05-JUL-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L024993, via unknown route in the left arm for prophylaxis. Immediately after vaccination, patient stated that she is going to pass out. Patient was made to lie down on bed and her mother was called for help. On the same day, the patient underwent urine analysis, metabolic function test, full blood count, fibrin D dimer, electroencephalogram normal, computerised tomogram head normal, carotid pulse abnormal (strong carotid pulse) and also experienced immediate post-injection reaction, urinary incontinence, muscle rigidity, loss of consciousness for approximately 1 minute, hypopnoea, dyspnea, labored and dizziness. After regaining consciousness, the patient was disoriented, tearful and sleepy. Patient was taken to the hospital via ambulance. Lab data included CT (computerize tomogram) scan of head and EEG (electroencephalogram) and both results were normal, "U/A (urine analysis)', CMP (comprehensive metabolic panel), CBC (complete blood count), D-dimer were also conducted the results of which were unknown. The outcome of the events was reported as recovered. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Urinary incontinence, Urine analysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642094) on 02-MAY-2017. This spontaneous report refers to a 14 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 05-JUL-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L024993, via unknown route in the left arm for prophylaxis. Immediately after vaccination, patient stated that she is going to pass out. Patient was made to lie down on bed and her mother was called for help. On the same day, the patient underwent urine analysis, metabolic function test, full blood count, fibrin D dimer, electroencephalogram normal, computerised tomogram head normal, carotid pulse abnormal (strong carotid pulse) and also experienced immediate post-injection reaction, urinary incontinence, muscle rigidity, loss of consciousness for approximately 1 minute, hypopnoea, dyspnea, labored and dizziness. After regaining consciousness, the patient was disoriented, tearful and sleepy. Patient was taken to the hospital via ambulance. Lab data included CT (computerize tomogram) scan of head and EEG (electroencephalogram) and both results were normal, "U/A (urine analysis)', CMP (comprehensive metabolic panel), CBC (complete blood count), D-dimer were also conducted the results of which were unknown. The outcome of the events was reported as recovered. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: CSF test normal, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Scan with contrast normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642460) on 02-MAY-2017. This spontaneous report refers to a 18 year old female patient. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications included estarylla (oral contraceptive). On 20-JUN-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # M004116, intramuscularly in the right arm for prophylaxis and VAQTA (dose, frequency and lot expiration date were not reported) (intramuscularly in the right arm, lot # 1023232) and other suspect therapies included MENACTRA (vaccinated date: 20-JUN-2016, intramuscularly in the left arm, lot# U5410AA; dose and expiration date unknown). On 01-JUL-2016, the patient underwent CSF (cerebrospinal fluid) test normal, scan with contrast normal, nuclear magnetic resonance imaging spinal normal, nuclear magnetic resonance imaging brain normal, had muscular weakness, lumbar puncture and presumptive Guillain-Barre syndrome. Patient also experienced lower extremity weakness. Lab data revealed MRI (Magnetic resonance imaging) of head, cervical, thoracic and lumbar spine with and without contrast were all normal. The outcome of the events was reported as unknown. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Anaemia, Differential white blood cell count, Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 647181) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Information on patient's medical history, other medications, concurrent illnesses and prior vaccinations were not reported. On 21-DEC-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L014415, dose 2, via unknown route in the left arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 21-DEC-2015,  via unknown route in the right arm, lot# U4986AA; dose and expiration date unknown). On 30-DEC-2015, the patient experienced immune thrombocytopenic purpura with subsequent anemia, full blood count, differential white blood cell count and underwent immunoglobulin therapy, which required emergency visit. Patient underwent IVIG infusions/therapy to prevent ITP (immune thrombocytopenic purpura). Patient's lab data includes CBC (complete blood count) with differential with hematologist. The outcome of anaemia, immunoglobulin therapy, immune thrombocytopenic purpura, full blood count and differential white blood cell count were reported as unknown. Causality assessment was not reported. The agency considered the case to be serious as these events led to disability and were life-threatening. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Varicella virus test negative, Viral test negative, Vomiting, pH urine normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 655540) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient's concurrent illness included fatigue and rash consistent with tinea versicolor. The patient's medical history included behavioral problems at school, possible ADHD (Attention deficit/hyperactivity disorder), possible anxiety and possible psychiatric issues. Information on prior vaccinations was not reported. On 11-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M007764 (dose, frequency and lot expiration date were not reported) for prophylaxis. The patient's other medications included selenium sulfide (SELSUN BLUE) 1% top shampoo for tinea versicolor on 23-AUG-2016 and it was reported that no other vaccines or medications were given at that time. On 30-AUG-2016, the patient experienced headache, fever, vomiting and severe ataxia. The patient was hospitalized for 28 days and given supportive care. The patient's (CSF) cerebrospinal fluid had elevated WBC's (white blood cells) but was negative for enterovirus and (HSV) herpes simplex virus. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel, the patient's ph urine normal, viral test negative, varicella virus test negative, had urine protein quantitative, urine amphetamine was negative, streptococcus test negative, specific gravity urine was decreased, respiratory syncytial virus test negative, underwent polymerase chain reaction, patient's platelet morphology normal, opiates was  negative, underwent monocyte percentage, patient's laboratory test was normal, influenza virus test was negative, underwent influenza b virus test, patient's influenza A virus was test negative, underwent human rhinovirus test, human metapneumovirus test, eosinophil percentage, drug screen was negative, creatinine urine was normal, csf white blood cell count increased, csf red blood cell count positive, csf protein was normal, csf monocyte count decreased, csf lymphocyte count was normal csf glucose normal, csf cell count increased, bordetella test was negative, blood immunoglobulin m normal, benzodiazepine drug level , bacterial test negative and adenovirus test. The patient's lab data included; component latest ref rng 31-AUG-2016 10:08 am: adenovirus DNA, PCR not detected coronavirus 229E RNA, not detected coronavirus HKU1 RNA, not detected coronavirus NL63 RNA. The patient had returned to baseline at time of discharge from hospital, but the doctors were unsure if the patient will have complete resolution from symptoms. The outcome of all the events was reported as unknown. Causality assessment was not reported. The agency considered the events to be serious due to hospitalization/prolonged hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Presyncope, Seizure like phenomena
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency #659207) and refers to a 15 year old male patient. No details about current illnesses, medical history and lab data, prior vaccination were provided. Patient was not on any other medications at this time. On 13-OCT-2016, the patient was vaccinated with VARIVAX, lot # L032394, dose 3, subcutaneously in the left arm and GARDASIL 9 lot # L043214, dose 3, intramuscularly in the right arm for prophylaxis. Other suspect therapy included vaccination with FLUZONE (INFLUENZA QUADRIVALENT). On 13-OCT-2016, the patient experienced vasovagal reaction with seizure like activity and was sent hospital by ambulance. The outcome of the events were unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Back pain, Blood test, Borrelia test negative, Chest X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 664907) which refers to a 12 year old female patient. The patient had no current illnesses and medical history included seasonal allergies. She had a prior vaccination with GARDASIL 9, dose 1 on an unspecified date at 12:00 and had experienced low grade fever. The patient's other medications included Zyrtec 10mg. On 12-SEP-2016, the patient was vaccinated with GARDASIL 9, lot # L036301, dose 2, intramuscularly, in the left arm for prophylaxis. On 16-SEP-2016, the patient experienced memory loss, was unresponsive to stimuli during sleep, tremor, syncope, episode with seizure like phenomena, low grade fever, pelvic pain, neck pain, sore muscles, swollen glands, irritability, headache, exhaustion, dizziness, dehydration, decreased appetite, constipation, chills, back pain and underwent urine analysis, ultrasound pelvis twice, computerised tomogram and nuclear magnetic resonance imaging of brain, electroencephalogram and 24 hour electroencephalogram, lumbar puncture, borrelia test which was negative, blood test and chest x-ray. The patient was hospitalized and was checked in the emergency room. The patient was misdiagnosed with both Lyme Disease and kidney infection. She was negative for Lyme Disease and her menstruation was misdiagnosed for kidney infection. The outcome of the events were reported as not recovered. Causality assessment was not provided. The Agency considered all the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Computerised tomogram head, Constipation, Decreased appetite, Dehydration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 664907) which refers to a 12 year old female patient. The patient had no current illnesses and medical history included seasonal allergies. She had a prior vaccination with GARDASIL 9, dose 1 on an unspecified date at 12:00 and had experienced low grade fever. The patient's other medications included Zyrtec 10mg. On 12-SEP-2016, the patient was vaccinated with GARDASIL 9, lot # L036301, dose 2, intramuscularly, in the left arm for prophylaxis. On 16-SEP-2016, the patient experienced memory loss, was unresponsive to stimuli during sleep, tremor, syncope, episode with seizure like phenomena, low grade fever, pelvic pain, neck pain, sore muscles, swollen glands, irritability, headache, exhaustion, dizziness, dehydration, decreased appetite, constipation, chills, back pain and underwent urine analysis, ultrasound pelvis twice, computerised tomogram and nuclear magnetic resonance imaging of brain, electroencephalogram and 24 hour electroencephalogram, lumbar puncture, borrelia test which was negative, blood test and chest x-ray. The patient was hospitalized and was checked in the emergency room. The patient was misdiagnosed with both Lyme Disease and kidney infection. She was negative for Lyme Disease and her menstruation was misdiagnosed for kidney infection. The outcome of the events were reported as not recovered. Causality assessment was not provided. The Agency considered all the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Electroencephalogram, Fatigue, Headache, Irritability
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 664907) which refers to a 12 year old female patient. The patient had no current illnesses and medical history included seasonal allergies. She had a prior vaccination with GARDASIL 9, dose 1 on an unspecified date at 12:00 and had experienced low grade fever. The patient's other medications included Zyrtec 10mg. On 12-SEP-2016, the patient was vaccinated with GARDASIL 9, lot # L036301, dose 2, intramuscularly, in the left arm for prophylaxis. On 16-SEP-2016, the patient experienced memory loss, was unresponsive to stimuli during sleep, tremor, syncope, episode with seizure like phenomena, low grade fever, pelvic pain, neck pain, sore muscles, swollen glands, irritability, headache, exhaustion, dizziness, dehydration, decreased appetite, constipation, chills, back pain and underwent urine analysis, ultrasound pelvis twice, computerised tomogram and nuclear magnetic resonance imaging of brain, electroencephalogram and 24 hour electroencephalogram, lumbar puncture, borrelia test which was negative, blood test and chest x-ray. The patient was hospitalized and was checked in the emergency room. The patient was misdiagnosed with both Lyme Disease and kidney infection. She was negative for Lyme Disease and her menstruation was misdiagnosed for kidney infection. The outcome of the events were reported as not recovered. Causality assessment was not provided. The Agency considered all the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Lumbar puncture, Lymphadenopathy, Myalgia, Neck pain, Nuclear magnetic resonance imaging brain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 664907) which refers to a 12 year old female patient. The patient had no current illnesses and medical history included seasonal allergies. She had a prior vaccination with GARDASIL 9, dose 1 on an unspecified date at 12:00 and had experienced low grade fever. The patient's other medications included Zyrtec 10mg. On 12-SEP-2016, the patient was vaccinated with GARDASIL 9, lot # L036301, dose 2, intramuscularly, in the left arm for prophylaxis. On 16-SEP-2016, the patient experienced memory loss, was unresponsive to stimuli during sleep, tremor, syncope, episode with seizure like phenomena, low grade fever, pelvic pain, neck pain, sore muscles, swollen glands, irritability, headache, exhaustion, dizziness, dehydration, decreased appetite, constipation, chills, back pain and underwent urine analysis, ultrasound pelvis twice, computerised tomogram and nuclear magnetic resonance imaging of brain, electroencephalogram and 24 hour electroencephalogram, lumbar puncture, borrelia test which was negative, blood test and chest x-ray. The patient was hospitalized and was checked in the emergency room. The patient was misdiagnosed with both Lyme Disease and kidney infection. She was negative for Lyme Disease and her menstruation was misdiagnosed for kidney infection. The outcome of the events were reported as not recovered. Causality assessment was not provided. The Agency considered all the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pelvic pain, Pyrexia, Seizure like phenomena, Syncope, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 664907) which refers to a 12 year old female patient. The patient had no current illnesses and medical history included seasonal allergies. She had a prior vaccination with GARDASIL 9, dose 1 on an unspecified date at 12:00 and had experienced low grade fever. The patient's other medications included Zyrtec 10mg. On 12-SEP-2016, the patient was vaccinated with GARDASIL 9, lot # L036301, dose 2, intramuscularly, in the left arm for prophylaxis. On 16-SEP-2016, the patient experienced memory loss, was unresponsive to stimuli during sleep, tremor, syncope, episode with seizure like phenomena, low grade fever, pelvic pain, neck pain, sore muscles, swollen glands, irritability, headache, exhaustion, dizziness, dehydration, decreased appetite, constipation, chills, back pain and underwent urine analysis, ultrasound pelvis twice, computerised tomogram and nuclear magnetic resonance imaging of brain, electroencephalogram and 24 hour electroencephalogram, lumbar puncture, borrelia test which was negative, blood test and chest x-ray. The patient was hospitalized and was checked in the emergency room. The patient was misdiagnosed with both Lyme Disease and kidney infection. She was negative for Lyme Disease and her menstruation was misdiagnosed for kidney infection. The outcome of the events were reported as not recovered. Causality assessment was not provided. The Agency considered all the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound pelvis, Unresponsive to stimuli, Urine analysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 664907) which refers to a 12 year old female patient. The patient had no current illnesses and medical history included seasonal allergies. She had a prior vaccination with GARDASIL 9, dose 1 on an unspecified date at 12:00 and had experienced low grade fever. The patient's other medications included Zyrtec 10mg. On 12-SEP-2016, the patient was vaccinated with GARDASIL 9, lot # L036301, dose 2, intramuscularly, in the left arm for prophylaxis. On 16-SEP-2016, the patient experienced memory loss, was unresponsive to stimuli during sleep, tremor, syncope, episode with seizure like phenomena, low grade fever, pelvic pain, neck pain, sore muscles, swollen glands, irritability, headache, exhaustion, dizziness, dehydration, decreased appetite, constipation, chills, back pain and underwent urine analysis, ultrasound pelvis twice, computerised tomogram and nuclear magnetic resonance imaging of brain, electroencephalogram and 24 hour electroencephalogram, lumbar puncture, borrelia test which was negative, blood test and chest x-ray. The patient was hospitalized and was checked in the emergency room. The patient was misdiagnosed with both Lyme Disease and kidney infection. She was negative for Lyme Disease and her menstruation was misdiagnosed for kidney infection. The outcome of the events were reported as not recovered. Causality assessment was not provided. The Agency considered all the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 63.0
Sex: F
Vaccine: RUB, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited case received from a non-healthcare professional on 02 May 2017. This case was linked to the case 2017SA080948 (same vaccine, same reporter). This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number: C5216AA, Expiry date: 06 Jun 2019, dose in series, and dose was not reported) intramuscularly in left deltoid on 19 Apr 2017. Patient's illness at the time of vaccination was not reported and pre-existing physician diagnosed allergies, birth defects, medical conditions included aspirin allergy. Patient's concomitant medications were not reported. On an unknown date, after the vaccination, the patient experienced arm pain, and redness for which the patient had been directed to go to hospital ER. On an unknown date, the patient was diagnosed with cellulitis. Relevant lab tests and corrective treatment were not reported. The outcome of all the events were reported as unknown. Upon internal review the company considered the case as serious, due to important medical event Cellulitis. List of documents held by sender: none. Sender's Comments: This case concerns 63 year female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and developed cellulitis. Time to onset is not reported. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 63.0
Sex: F
Vaccine: RUB, TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: Initial unsolicited case received from a non-healthcare professional on 02 May 2017. This case was linked to the case 2017SA080948 (same vaccine, same reporter). This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number: C5216AA, Expiry date: 06 Jun 2019, dose in series, and dose was not reported) intramuscularly in left deltoid on 19 Apr 2017. Patient's illness at the time of vaccination was not reported and pre-existing physician diagnosed allergies, birth defects, medical conditions included aspirin allergy. Patient's concomitant medications were not reported. On an unknown date, after the vaccination, the patient experienced arm pain, and redness for which the patient had been directed to go to hospital ER. On an unknown date, the patient was diagnosed with cellulitis. Relevant lab tests and corrective treatment were not reported. The outcome of all the events were reported as unknown. Upon internal review the company considered the case as serious, due to important medical event Cellulitis. List of documents held by sender: none. Sender's Comments: This case concerns 63 year female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and developed cellulitis. Time to onset is not reported. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 0.17
Sex: F
Vaccine: DTAPH
Symptoms: Crying, Encephalitis, Injection site erythema, Injection site swelling
Clinical narrative: Injection site (thigh) blew up, at least doubled in size and became beet red, high pitch inconsolable hysterical crying for hours (encephalitis). Brought her back to the dr., who admitted this was an unusual adverse reaction but didn't inform me about VAERS (as a first time mom I didn't know my rights). Instructed me to give infant TYLENOL.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, UNK
Symptoms: Rash, Urticaria
Clinical narrative: Welt hive on rear, hives and rash face, rash rear.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Angina pectoris, Asthenia, Blood test, Computerised tomogram, Dyspnoea
Clinical narrative: Weakness, trouble breathing, heart pain.  Went to doc and had CT scan and blood work.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Echocardiogram
Clinical narrative: Weakness, trouble breathing, heart pain.  Went to doc and had CT scan and blood work.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Dry mouth, Dry throat, Pain in extremity
Clinical narrative: Dry mouth/throat, drinking 2-3 gallons of water a day. If he doesn't drink water then his calves hurt.
Age: 9.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: MENVEO comes as 2 parts (CYW-135 liquid and Men-A lyophilized) which are to be mixed prior to administration, stated in package insert and on vial. The liquid portion only was sent to pharmacy from another pharmacy. 2 pharmacists checked the medication and sent it to the ICU. 2 RNs were involved with administering the vaccine. Only the liquid CYW-135 portion was given, not the men-A portion. On further review of package insert information one of the satellite pharmacists noted the error and it was confirmed with nursing. We contacted the company regarding the vaccine components and need to redoes the patient. Serotype A of N. meningitides is rare and therefore, unless travel is planned, the CDC does not recommend revaccinating patients that only receive the CYW-135 portion of the vaccine. There are no clinical trials looking at the CYW-135 portion alone.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Crying, Frequent bowel movements, Intussusception, Irritability, Ultrasound abdomen abnormal
Clinical narrative: 6 mo old w/fussiness. Crying assoc w/BM on and off for past few weeks. Increased in frequency over past 2 days - Episodes in sleep, not associated w/BM's. No fever, no sig. labs. (ED note 5/6/17).
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from nurse practitioner and refers to a 42 year old female patient. The patient had no pertinent medical history and concomitant medication. The patient had allergy to "sulfa". On an unknown date in childhood, the patient received a dose of M-M-R II (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date, for an unknown reason the patient had titers tested for M-M-R II with a result of negative. In May 2013, the patient received another dose of M-M-R II (dose, route of administration and expiration date were not provided) , lot number H013040 (also reported as lot number H013046), for prophylaxis. In June 2013, the patient received the next dose of M-M-R II (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On 10-AUG-2016, the patient had titers tested with a result of positive. On approximately 29-MAR-2017 (reported as 2 weeks ago), the patient had titers tested with a result of negative. There was an unspecified treatment given for an adverse events. There was no product quality complaint involved in this case. The outcome of the events was unknown. The relatedness between the events and vaccination with M-M-R II was not reported. Lot number H013046 was considered to be not valid for M-M-R II. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 19 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-AUG-2015, the patient was vaccinated with a first dose of GARDASIL 9 (dose, route of administration, anatomical location, lot# and expiration date were not reported). On 14-OCT-2015, the patient was vaccinated with a second dose of GARDASIL 9 (dose, route of administration, anatomical location, lot# and expiration date were not reported). On 12-APR-2017, the patient was vaccinated with a third dose of GARDASIL 9 lot # M044717, expiration date 19-JUL-2017 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 13-APR-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with Lot # M034780 and  expiration date of 15-APR-2019 (route, dose, dose number and frequency were unknown) for prophylaxis. This information was obtained with a digital data logger which reported that the vaccine was exposed to a temperature of 47 to 77 degrees Fahrenheit for 1 hour and 20 minutes. There was no adverse effect reported. No previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse. On an unknown date, the primary reporter stated that the cover of PROQUAD subcutaneously (lot number M043310 and expiration date 24-APR-2018) and the sterile diluent (lot number and expiration date were not reported) were very similar. The medical assistant inadvertently put the PROQUAD in the drawer and the sterile diluent in the freezer because the end cover was very similar to PROQUAD and the sterile diluent and it was easy to make the mistake. No doses of PROQUAD and the sterile diluent were administered to any patient, therefore, no adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored PROQUAD (albumin status rHA) (lot number L044056, expiration date: 02-MAY-2017 and lot number M038862, expiration date: 13-MAR-2018) (dose, route of administration and anatomical location were unknown) for prophylaxis. The vaccine experienced a temperature excursion of 6 Fahrenheit degrees (F) to 14 F for 10 minutes. Previous temperature excursion was of 6F to 14F for 10 minutes. The temperature excursions were detected by a digital data logger. The improperly stored vaccines were reconstituted with a properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (MARRS# 1704USA006527). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006527:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacy intern refers a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date in April 2017 (reported as last week), the patient was inadvertently vaccinated with a dose of VARIVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported), instead of ZOSTAVAX. No adverse effects were reported. No further information provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M035143 and expiration date of 30-JAN-2018 (route of administration, dose and anatomical location were unknown) for prophylaxis; reconstitued with sterile diluent (lot # and expiration date were not provided). The vaccine was exposed to a temperature excursion of  6°F to 14°F with a time frame of 45 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.  No adverse effects were reported. There was not product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA007143:
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 24-APR-2017, the patient was intramuscularly vaccinated with an expired dose of GARDASIL Injection (dose, frequency and route were not reported) lot # K010574 with expiration date of 08-APR-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: FLUX, MMR, TDAP
Symptoms: No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. No information was reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. The pharmacist stated that the patient received several concomitant vaccines on 27-APR-2017 at an unspecified physician's office. The vaccines included: M-M-R II, ADACEL, and "flu shot" (unspecified) (lot numbers, expiration dates, dosages, and routes of administration not provided). Product information indicated that M-M-R II is not recommended concurrently with ADACEL. No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-APR-2017, the patient was vaccinated with a dose of M-M-R II (strength, dose, lot# and expiration date were unknown), intramuscularly in the left thigh for prophylaxis. It was reported that the M-M-R II was administered with an sterile diluent. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and referred to a female patient of an unknown age. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date in April 2017 (reported as "one month ago"), the patient was administered a dose of PREVNAR 13 (dose, route of administration, lot number and expiration date were not reported) for prophylaxis and then on 01-MAY-2017 (reported as "today"), instead of waiting eight weeks between vaccine doses as it was recommended, the patient received a dose of PNEUMOVAX 23 (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. There were no adverse effects reported. Additional information is not expected as there was no contact consent provided.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Blood alcohol, Colonoscopy, Drug screen, HIV infection, Hypertension
Clinical narrative: This spontaneous report was received from a physician via Medical Record referring to a 57 year old male patient. No information regarding the patient's medical history or concomitant therapies was provided. The patient's concurrent conditions included Non-smoker, abstains from alcohol, abstains from recreational drugs and eye disorder in 2001. On 02-FEB-2002, the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in July 2008, a removal of sperm ducts procedure was performed (spermatic cord disorder). On 21-AUG-2007, the patient was vaccinated with the second dose of PNEUMOVAX 23 (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in August 2011, an unspecified procedure to repair ruptured musculotendinous cuff chronic was performed. On an unspecified date in October 2011, the patient experienced latent tuberculosis by blood test. On an unspecified date in November 2014, a colonoscopy was performed (no results provided). On 19-JUL-2014, the patient experienced hypertension and on 24-MAY-2016, the patient experienced HIV infection. Health Maintenance: Annual alcohol and drug screen, colon cancer screening occult blood test, diabetes screening, depression annual screening, lipid screening, third dose of PNEUMOVAX 23 scheduled for 21-DEC-2024, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid second dose scheduled for 05-JUN-2015 and third dose scheduled for 20-OCT-2025, PREVNAR completed. At the time of the report, the outcome of latent tuberculosis, hypertension, tendon rupture, spermatic cord disorder and HIV infection was not provided. The reporter did not assess the relatedness between the events and PNEUMOVAX 23. Upon internal review HIV infection and spermatic cord disorder were considered to be a medically significant. All available medical records will be provided upon request. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Investigation, Latent tuberculosis, Lipids, Mini mental status examination, Mycobacterium tuberculosis complex test positive
Clinical narrative: This spontaneous report was received from a physician via Medical Record referring to a 57 year old male patient. No information regarding the patient's medical history or concomitant therapies was provided. The patient's concurrent conditions included Non-smoker, abstains from alcohol, abstains from recreational drugs and eye disorder in 2001. On 02-FEB-2002, the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in July 2008, a removal of sperm ducts procedure was performed (spermatic cord disorder). On 21-AUG-2007, the patient was vaccinated with the second dose of PNEUMOVAX 23 (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in August 2011, an unspecified procedure to repair ruptured musculotendinous cuff chronic was performed. On an unspecified date in October 2011, the patient experienced latent tuberculosis by blood test. On an unspecified date in November 2014, a colonoscopy was performed (no results provided). On 19-JUL-2014, the patient experienced hypertension and on 24-MAY-2016, the patient experienced HIV infection. Health Maintenance: Annual alcohol and drug screen, colon cancer screening occult blood test, diabetes screening, depression annual screening, lipid screening, third dose of PNEUMOVAX 23 scheduled for 21-DEC-2024, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid second dose scheduled for 05-JUN-2015 and third dose scheduled for 20-OCT-2025, PREVNAR completed. At the time of the report, the outcome of latent tuberculosis, hypertension, tendon rupture, spermatic cord disorder and HIV infection was not provided. The reporter did not assess the relatedness between the events and PNEUMOVAX 23. Upon internal review HIV infection and spermatic cord disorder were considered to be a medically significant. All available medical records will be provided upon request. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Occult blood, Spermatic cord disorder, Tendon rupture, Tenoplasty
Clinical narrative: This spontaneous report was received from a physician via Medical Record referring to a 57 year old male patient. No information regarding the patient's medical history or concomitant therapies was provided. The patient's concurrent conditions included Non-smoker, abstains from alcohol, abstains from recreational drugs and eye disorder in 2001. On 02-FEB-2002, the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in July 2008, a removal of sperm ducts procedure was performed (spermatic cord disorder). On 21-AUG-2007, the patient was vaccinated with the second dose of PNEUMOVAX 23 (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in August 2011, an unspecified procedure to repair ruptured musculotendinous cuff chronic was performed. On an unspecified date in October 2011, the patient experienced latent tuberculosis by blood test. On an unspecified date in November 2014, a colonoscopy was performed (no results provided). On 19-JUL-2014, the patient experienced hypertension and on 24-MAY-2016, the patient experienced HIV infection. Health Maintenance: Annual alcohol and drug screen, colon cancer screening occult blood test, diabetes screening, depression annual screening, lipid screening, third dose of PNEUMOVAX 23 scheduled for 21-DEC-2024, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid second dose scheduled for 05-JUN-2015 and third dose scheduled for 20-OCT-2025, PREVNAR completed. At the time of the report, the outcome of latent tuberculosis, hypertension, tendon rupture, spermatic cord disorder and HIV infection was not provided. The reporter did not assess the relatedness between the events and PNEUMOVAX 23. Upon internal review HIV infection and spermatic cord disorder were considered to be a medically significant. All available medical records will be provided upon request. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Urticaria
Clinical narrative: This spontaneous report has been received from a physician via a company representative and referred to a 50-year-old female patient. The patient did not have any relevant medical history, concurrent conditions, or concomitant therapies. On 28-APR-2017, the patient was vaccinated with a single dose of ZOSTAVAX 19400 "PFU", 0.65 ml, subcutaneous injection (lot number and expiration date were not reported), for the prevention of shingles. On 29-APR-2017 (reported as "one day after receiving ZOSTAVAX"), the patient felt fatigue. On 30-APR-2017 (reported as "two days after the receiving the injection"), she took an unspecified dose of TYLENOL and on 01-MAY-2017 (reported as "on the third day") she broke out in hives that started on her neck. Subsequently, the patient sought medical attention and her physician prescribed an unspecified treatment of prednisone (manufacturer unknown) for the hives. There were no laboratory diagnostic tests performed. At the time of this report, the patient had not recovered from fatigue and hives. The causality assessment between fatigue and hives with ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Selective IgM immunodeficiency
Clinical narrative: Information has been received from the author of a literature article, referring to a 41 year-old female patient diagnosed with multiple sclerosis (MS) and optic neuritis at age 39. She presented with a history of Hashimoto's thyroiditis, recurrent non-menstrual toxic shock syndrome, recurrent sinusitis, and acute episodes of thrush, shingles, cellulitis, and gastroenteritis. CD19+CD27- transitional B cells were decreased but lymphocyte mitogen/antigen stimulation was normal. IgM was decreased (27 - 36 mg/dL) with a poor pneumococcal vaccine (manufacturer unknown) (dose, lot # and expiration date not reported) response. CH50, IgG, IgA, and protein-based vaccine response were normal. The outcome of the event was unknown. The causality between pneumococcal vaccine (manufacturer unknown) and the event was related. This is one of several reports received from the same literature (linked case# 1705USA000607). Additional information has been requested. Sender's Comments: US-009507513-1705USA000607.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Rotavirus infection
Clinical narrative: This spontaneous report was received from a medical assistant from a physician office via a company representative concerning a 4 year old male patient with asthma. On 05-JUN-2013, 15-AUG-2013 and 30-OCT-2013, the patient was vaccinated with the first, second and third doses respectively of ROTATEQ orally (dose, lot# and the expiration date were not reported) for prevention of rotavirus. There was no concomitant medication provided. On 23-APR-2017, the patient was admitted to a hospital due to rotavirus. Then on 28-APR-2017, the patient was discharged from the facility on 28-APR-2017. The outcome of gastroenteritis rotavirus was reported as did make a full recovery on an unspecified date. The relatedness between the therapy with ROTATEQ and the event was not reported. Upon internal review, gastroenteritis rotavirus was determined to be medically significant. Additional information has been requested.