chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza virus test positive, Intensive care, Vaccination failure
Clinical narrative: Case number PHHY2014US021411 is an initial literature report received on 15 Feb 2014. The author discussed about the high intensive care unit admission rate for 2013-2014 Influenza associated with a low rate of vaccination. Thirteen of 55 (23.6%) patients were vaccinated against influenza at least 2 weeks prior to the onset of their acute illness. This report refers to a patient of an unknown age and gender, among the thirteen patients who received influenza vaccination. His current condition included chronic lymphocytic leukemia for which the patient received rituximab. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination the patient got admitted in the intensive care unit. The patient tested positive for influenza virus. It was reported that there might be likely an impeding adequate immune response to vaccination. The outcome of the event was not reported. The author concluded that there observations support encouraging influenza vaccination for all individuals without a contraindication, as this might prevent severe lower respiratory tract complications requiring ICU level care. Following an internal review, a significant correction was done for the information received on 15 Feb 2014. Added events (influenza and vaccination failure). The case upgraded to serious from non serious due to vaccination failure.
Age: 48.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error, Respiratory tract congestion
Clinical narrative: A report has been received from a Health Professional concerning a 48 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 15-Oct-2013. The patient received FLUMIST QUADRIVALENT last night nothing went into first nostril and in other nostril ran out of nose into mouth and onto shirt which started on 15-Oct-2013 and experienced mild congestion which started on 15-Oct-2013. The outcome of the event of patient received FLUMIST QUADRIVALENT nothing went into first nostril and in other nostril ran out of nose into mouth and onto shirt and mild congestion is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, unspecified number of patients were vaccinated with MMR II (lot# unspecified) (dose, frequency and route were not reported) which were exposed to temperature range:-0.7C Time frame: 15 minutes Temperature Range:-0.5C Time frame: 15 minutes. No adverse effects were reported. No concomitant medications were reported. No adverse events or Product quality issue (PQC) were reported. This case is linked to case # 1401USA000286, 1401USA000288, 1312USA011848, 1402USA010745, 1402USA010746 and 1402USA010747 (same reporter link). Additional information in not expected.
Sex: U
Vaccine: FLUX
Symptoms: Alcohol withdrawal syndrome, Influenza, Influenza virus test positive, Intensive care
Clinical narrative: Case number PHHY2014US021476 is an initial literature report received on 15 Feb 2014. The author discussed about the high intensive care unit admission rate for 2013-2014 influenza associated with a low rate of vaccination. Thirteen of 55 (23.6%) patients were vaccinated against influenza at least 2 weeks prior to the onset of their acute illness. This report refers to a patient of an unknown age and gender, among the thirteen patients who received influenza vaccination. The patient's current condition included hepatitis C and alcohol abuse. The patient was vaccinated with Influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination the patient got admitted in the intensive care unit overnight due to alcohol withdrawal. The patient was tested positive for influenza virus. The outcome of the events was not reported. The author concluded that there observations support encouraging influenza vaccination for all individuals without a contraindication, as this might prevent severe lower respiratory tract complications requiring ICU level care.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Abortion spontaneous, Exposure during pregnancy, Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This spontaneous retrospective pregnancy report as received from a consumer (patient's sister) refers to a 38 year old female patient with allergy to sulfur products. The patient did not have a pertinent medical history. Approximately in February 2011 (reported as "about 3 years ago") the patient was vaccinated with a dose of ZOSTAVAX (one time vaccine) erroneously. Dose, route and lot number were not provided. There were no concomitant medications. It was reported that the patient was under age for ZOSTAVAX. The reporter further stated that her sister was to get the Malaria vaccine, but was accidentally given ZOSTAVAX instead. It was reported that the patient had experienced 3 miscarriages since taking the ZOSTAVAX vaccine. The adverse event onset date was reported as "late 2011". This report concerns one of the three miscarriages. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) is not known. The pregnancy outcome was spontaneous abortion. Reporter causality was not provided. The event "3 miscarriages since taking the ZOSTAVAX vaccine" was considered medically significant upon internal review. This case is linked to 1402USA011619 and 1402USA011620 (same patient). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from an 18 year old female patient, for GARDASIL, a Pregnancy Registry product, with no pertinent medical history or drug allergy who in December 2011, was vaccinated with the first dose of GARDASIL (dose, frequency, route, lot # unknown). On an unspecified day the patient was vaccinated with the second dose of GARDASIL (dose, frequency, route, lot # unknown). There was no concomitant medication. The patient reported receiving her second dose of the GARDASIL series and learning afterwards that she was pregnant (reported in February 2012). She was discontinued therapy and would not receive the third dose. No AE reported. The patient sought medical attention and pregnancy test was performed. Follow up information has been unsuccessful. The pregnancy outcome lost to follow up. Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from an unknown type reporter refers to a female patient of unknown age. The patient was vaccinated with M-M-R II (lot number, dose, route, and indication were not reported) on an unspecified date was 8 weeks pregnant at the time of report. The LMP and EDD were not known. The pregnancy outcome was pending. The outcome and action taken were not provided. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old female patient. The patient pertinent medical history included pulmonary hypertension and COPD. On 07-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J007208 (Expiry: 20-SEP-2014), 0.65 ml, subcutaneous. Concomitant therapies included acetaminophen, oxygen, and hydrocodone and unspecified nebulizer treatments. On 07-JUL-2013, 1 day after onset of therapy the patient experienced headaches and that the injectio site was red, hard, swollen and warm after receiving ZOSTAVAX. The patient sought medical attention and called the pharmacist. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Breast mass, Menstruation irregular, Nausea, Ovarian cyst
Clinical narrative: This spontaneous report as received from other health professional refers to 15 years old female patient. Patient has no pertinent medical history and drug allergic reactions. Patient was normal before the vaccination. On an unknown date of 2012, the patient was vaccinated with first dose of GARDASIL injection (strength, dose, unit, route, lot# and expiry date unknown). On unkonwn date of August 2013, patient received second dose of GARDASIL (strength, dose, unit and rout unknown) with lot number # J007354 and expiry date 20-FEB-2016. Patient has no concomitant medications. Since 2012, after vaccination with first dose of GARDASIL, patient has been experiencing abdominal pain, irregular menstrual cycle, painless lumps in left breast, and intermittent nausea. Patient has been twice to the emergency room with ovaries issue, delayed menstrual cycle, lumps in breast, nausea and extreme pain. On an unknown date of October 2013, patient visited unspecified emergency room and was diagnosed with left ovarian cyst. She was prescribed with TYLENOL for pain. The outcome of left ovarian cyst and painless lumps in left breast was unknown. No further information provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian disorder, Pain
Clinical narrative: This spontaneous report as received from other health professional refers to 15 years old female patient. Patient has no pertinent medical history and drug allergic reactions. Patient was normal before the vaccination. On an unknown date of 2012, the patient was vaccinated with first dose of GARDASIL injection (strength, dose, unit, route, lot# and expiry date unknown). On unkonwn date of August 2013, patient received second dose of GARDASIL (strength, dose, unit and rout unknown) with lot number # J007354 and expiry date 20-FEB-2016. Patient has no concomitant medications. Since 2012, after vaccination with first dose of GARDASIL, patient has been experiencing abdominal pain, irregular menstrual cycle, painless lumps in left breast, and intermittent nausea. Patient has been twice to the emergency room with ovaries issue, delayed menstrual cycle, lumps in breast, nausea and extreme pain. On an unknown date of October 2013, patient visited unspecified emergency room and was diagnosed with left ovarian cyst. She was prescribed with TYLENOL for pain. The outcome of left ovarian cyst and painless lumps in left breast was unknown. No further information provided. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant via company representative refers to approximately 60 year old patient of unknown gender. On an unknown date of September 2013 (5 months ago), the patient was vaccinated with ZOSTAVAX (strength, dose unit, lot# and expiry date unknown) subcutaneously. On an unknown date of February 2014 (within this past week), patient received second injection of ZOSTAVAX. No adverse event reported. The outcome of patient received a ZOSTAVAX injection 5 months ago and then received a second injection within this past week and no ae reported was unknown. No further information was provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of currently 22 years old. The patient has a history of 4 previous pregnancies and 2 live births on 39 and 40 weeks from last menstrual period (LMP). No birth defects or no infant complications in previous pregnancies were present. On 16-JAN-2014 the patient was vaccinated with the third dose GARDASIL (lot # H020901, expiration date 05-JUL-2015). The patient became pregnant with LMP of 06-DEC-2013 and estimated date of delivery (EDD) of 12-SEP-2014. Initial exposure to GARDASIL was at 6 week(s). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Papule
Clinical narrative: Pain, redness and swelling at injection site. Temp of > 102. Papules on eyes and face with itching.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: Pain, redness and swelling at injection site. Temp of > 102. Papules on eyes and face with itching.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Acute lymphocytic leukaemia, Blood immunoglobulin G abnormal, Death, Exposure to communicable disease
Clinical narrative: This literature marketed report as received from a physician refers to a 4 year old girl who had received her first dose of VARIVAX (Merck) in March 2009. She was diagnosed with acute lymphoblastic leukemia (ALL) in March 2011. At that time, she was varicella-zoster virus (VZV) immunoglobulin G (IgG)-positive. On 10-APR-2012, the girl was exposed to a mildly ill cousin who developed a varicella rash 2 days later (12-APR-2012). The episode was reported to the child's oncologist after 13 days. The girl was prescribed 7 days of oral acyclovir (manufacturer unknown) and concurrently began her scheduled chemotherapy, which included a 5-day course of dexamethasone (manufacturer unknown) (prednisone equivalent dose of 23 mg/day). Twenty-two days after her varicella exposure (01-MAY-2012) the girl was taken to an emergency department for fever and abdominal pain. She was treated symptomatically; her caretakers were instructed to discontinue chemotherapy and to follow up with her oncologist. Two days later on 03-MAY-2012 the girl returned to the emergency department with a generalized rash. She was hospitalized and treated with intravenous acyclovir (manufacturer unknown) and antibiotics. However, she developed multi-organ failure and died on 07-MAY-2012. Varicella was confirmed by polymerase chain reaction testing, and no alternative diagnoses were found for her acute illness. This patient's fatal varicella likely was the result of profound immunosuppression, resulting in part from the chemotherapy and corticosteroid treatment. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Immunodeficiency, Multi-organ failure, Polymerase chain reaction, Pyrexia, Rash generalised
Clinical narrative: This literature marketed report as received from a physician refers to a 4 year old girl who had received her first dose of VARIVAX (Merck) in March 2009. She was diagnosed with acute lymphoblastic leukemia (ALL) in March 2011. At that time, she was varicella-zoster virus (VZV) immunoglobulin G (IgG)-positive. On 10-APR-2012, the girl was exposed to a mildly ill cousin who developed a varicella rash 2 days later (12-APR-2012). The episode was reported to the child's oncologist after 13 days. The girl was prescribed 7 days of oral acyclovir (manufacturer unknown) and concurrently began her scheduled chemotherapy, which included a 5-day course of dexamethasone (manufacturer unknown) (prednisone equivalent dose of 23 mg/day). Twenty-two days after her varicella exposure (01-MAY-2012) the girl was taken to an emergency department for fever and abdominal pain. She was treated symptomatically; her caretakers were instructed to discontinue chemotherapy and to follow up with her oncologist. Two days later on 03-MAY-2012 the girl returned to the emergency department with a generalized rash. She was hospitalized and treated with intravenous acyclovir (manufacturer unknown) and antibiotics. However, she developed multi-organ failure and died on 07-MAY-2012. Varicella was confirmed by polymerase chain reaction testing, and no alternative diagnoses were found for her acute illness. This patient's fatal varicella likely was the result of profound immunosuppression, resulting in part from the chemotherapy and corticosteroid treatment. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: This literature marketed report as received from a physician refers to a 4 year old girl who had received her first dose of VARIVAX (Merck) in March 2009. She was diagnosed with acute lymphoblastic leukemia (ALL) in March 2011. At that time, she was varicella-zoster virus (VZV) immunoglobulin G (IgG)-positive. On 10-APR-2012, the girl was exposed to a mildly ill cousin who developed a varicella rash 2 days later (12-APR-2012). The episode was reported to the child's oncologist after 13 days. The girl was prescribed 7 days of oral acyclovir (manufacturer unknown) and concurrently began her scheduled chemotherapy, which included a 5-day course of dexamethasone (manufacturer unknown) (prednisone equivalent dose of 23 mg/day). Twenty-two days after her varicella exposure (01-MAY-2012) the girl was taken to an emergency department for fever and abdominal pain. She was treated symptomatically; her caretakers were instructed to discontinue chemotherapy and to follow up with her oncologist. Two days later on 03-MAY-2012 the girl returned to the emergency department with a generalized rash. She was hospitalized and treated with intravenous acyclovir (manufacturer unknown) and antibiotics. However, she developed multi-organ failure and died on 07-MAY-2012. Varicella was confirmed by polymerase chain reaction testing, and no alternative diagnoses were found for her acute illness. This patient's fatal varicella likely was the result of profound immunosuppression, resulting in part from the chemotherapy and corticosteroid treatment. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Injection site extravasation, Underdose
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL injection (dose, strength, frequency not reported). On an unknown date the patient received incomplete dose of GARDASIL due to leakage from the injection site (no further specified). No adverse effect reported. The outcome of events was unknown. The relatedness between the events and GARDASIL was not assessed by the reporter. Product Quality Complaint (PQC) was not involved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (lot#, expiry date, route, dose and strength not reported). The nurse reported that after an unspecified patient was vaccinated with GARDASIL "they started losing their hair". The outcome of the event was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 15 year old female patient with no pertinent medical history and no drug reactions/allergies. On 18-FEB-2014 the pregnant patient was administered with a dose of 0.5 ml GARDASIL, (lot # J012212, expiration date 18-FEB-2014), intramuscular and a dose of influenza virus vaccine (manufacturer unknown) (lot #, expiration date and dose unspecified). Concomitant therapies included CLARITIN. The patient became pregnant with LMP of 17-DEC-2013 and EDD of 23-SEP-2014. Initial exposure to GARDASIL was at 9 week(s). The pregnancy outcome was outcome pending. No adverse effects reported. The patient underwent unspecified pregnancy test and unspecified "flu and strep screening test". Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a other health professional refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II (dose, route and frequency were not reported). On an unknown date, titer done on an unspecified date after this dose of M-M-R II came back low with an unspecified result. On an unknown date in June 2013, another dose of M-M-R II was administered and on an unknown date an unspecified titer result obtained on an unspecified date six months after this dose of M-M-R II was still low for measles. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Nasopharyngitis
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 18-Sep-2013. The patient experienced cold symptoms which started on 19-Sep-2013. At the time of reporting, the event of cold symptoms was improving. The report was considered to be non-serious.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse concerning a patient of unknown age and gender who on 18-FEB-2014 was vaccinated with 0.5 ml dose of PROQUAD (route and lot # not provided) and a dose of VARIVAX (Merck) (dose, route and lot # not provided). No adverse effect was reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Hyperhidrosis
Clinical narrative: 11 AM 2/19/14 clt had 1st Hep B and TB test done. 11:25 AM clt c/o dizziness no diaphoresis was noted. HR 100 BP 120/70. Clt was taken to lab area and was laid down. Clt continued to c/o headache, head pressure occipital region and increased dizziness BP and pulse unchanged. Transport via ambulance to MC for evaluation.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pt. reports half-dollar sized area was pink when she woke morning after vaccine. Area was itchy. Over weekend redness, swelling and itching increased. On 2-24-14 saw doctor. Noted 3 1/2 x 3 cm mild raised erythema with surrounding 7 cm faint erythema.
Sex: U
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: This spontaneous report was received from a pharmacist refers to an adult patient of unknown age. On 23-FEB-2013, the adult patient was vaccinated with second pediatric dose of RECOMBIVAX HB 5 microgram. It was reported that the date and manufacturer of first dose of Hepatitis B vaccine was unknown. No adverse event reported, No product confusion discovered, just medication error. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: 02/25/2014 Moderate Anaphylactic Reaction Dr assessed pt et advised mom to give BENADRYL when home, can take asthma rescue meds if respiratory issues develop, or take to E.R. immediately.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood chloride normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Pt. had flu shot and within a few days developed (R) lat. lower leg pain and weakness. Ascending and involving (R) ant. thigh and hip flexors, compromising gait. Next, (L) lower extrem. developed weakness. Pt. lost appetite and began losing wt. 11-16-13, pt came to ER b/c (R) sided facial weakness -> Bell's palsy. 11-17-13, pt. admitted to hospital b/c progressive weakness, (R) sided facial droop, difficulty eating and drinking. As an outpt., pt saw orthopedic spine doctor, int. med. primary doc. Inpatient, he saw neurology. (+) P.T./O.T. He was hospitalized x9 days. He has ongoing PT/OT to develop gait. Uses wheelchair now.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Blood thyroid stimulating hormone decreased, Blood urea normal, C-reactive protein increased, CSF test normal, Carbon dioxide decreased
Clinical narrative: Pt. had flu shot and within a few days developed (R) lat. lower leg pain and weakness. Ascending and involving (R) ant. thigh and hip flexors, compromising gait. Next, (L) lower extrem. developed weakness. Pt. lost appetite and began losing wt. 11-16-13, pt came to ER b/c (R) sided facial weakness -> Bell's palsy. 11-17-13, pt. admitted to hospital b/c progressive weakness, (R) sided facial droop, difficulty eating and drinking. As an outpt., pt saw orthopedic spine doctor, int. med. primary doc. Inpatient, he saw neurology. (+) P.T./O.T. He was hospitalized x9 days. He has ongoing PT/OT to develop gait. Uses wheelchair now.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Culture negative, Decreased appetite, Eating disorder
Clinical narrative: Pt. had flu shot and within a few days developed (R) lat. lower leg pain and weakness. Ascending and involving (R) ant. thigh and hip flexors, compromising gait. Next, (L) lower extrem. developed weakness. Pt. lost appetite and began losing wt. 11-16-13, pt came to ER b/c (R) sided facial weakness -> Bell's palsy. 11-17-13, pt. admitted to hospital b/c progressive weakness, (R) sided facial droop, difficulty eating and drinking. As an outpt., pt saw orthopedic spine doctor, int. med. primary doc. Inpatient, he saw neurology. (+) P.T./O.T. He was hospitalized x9 days. He has ongoing PT/OT to develop gait. Uses wheelchair now.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paresis, Fluid intake reduced, Gait disturbance, Haematocrit normal, Haemoglobin normal
Clinical narrative: Pt. had flu shot and within a few days developed (R) lat. lower leg pain and weakness. Ascending and involving (R) ant. thigh and hip flexors, compromising gait. Next, (L) lower extrem. developed weakness. Pt. lost appetite and began losing wt. 11-16-13, pt came to ER b/c (R) sided facial weakness -> Bell's palsy. 11-17-13, pt. admitted to hospital b/c progressive weakness, (R) sided facial droop, difficulty eating and drinking. As an outpt., pt saw orthopedic spine doctor, int. med. primary doc. Inpatient, he saw neurology. (+) P.T./O.T. He was hospitalized x9 days. He has ongoing PT/OT to develop gait. Uses wheelchair now.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Intervertebral disc disorder, Intervertebral disc space narrowing, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Pt. had flu shot and within a few days developed (R) lat. lower leg pain and weakness. Ascending and involving (R) ant. thigh and hip flexors, compromising gait. Next, (L) lower extrem. developed weakness. Pt. lost appetite and began losing wt. 11-16-13, pt came to ER b/c (R) sided facial weakness -> Bell's palsy. 11-17-13, pt. admitted to hospital b/c progressive weakness, (R) sided facial droop, difficulty eating and drinking. As an outpt., pt saw orthopedic spine doctor, int. med. primary doc. Inpatient, he saw neurology. (+) P.T./O.T. He was hospitalized x9 days. He has ongoing PT/OT to develop gait. Uses wheelchair now.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: PCO2 decreased, Pain in extremity, Platelet count normal, Red blood cell sedimentation rate increased, Spinal X-ray abnormal
Clinical narrative: Pt. had flu shot and within a few days developed (R) lat. lower leg pain and weakness. Ascending and involving (R) ant. thigh and hip flexors, compromising gait. Next, (L) lower extrem. developed weakness. Pt. lost appetite and began losing wt. 11-16-13, pt came to ER b/c (R) sided facial weakness -> Bell's palsy. 11-17-13, pt. admitted to hospital b/c progressive weakness, (R) sided facial droop, difficulty eating and drinking. As an outpt., pt saw orthopedic spine doctor, int. med. primary doc. Inpatient, he saw neurology. (+) P.T./O.T. He was hospitalized x9 days. He has ongoing PT/OT to develop gait. Uses wheelchair now.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Ultrasound Doppler, Ultrasound Doppler abnormal, Urine analysis normal, VIIth nerve paralysis, Weight decreased
Clinical narrative: Pt. had flu shot and within a few days developed (R) lat. lower leg pain and weakness. Ascending and involving (R) ant. thigh and hip flexors, compromising gait. Next, (L) lower extrem. developed weakness. Pt. lost appetite and began losing wt. 11-16-13, pt came to ER b/c (R) sided facial weakness -> Bell's palsy. 11-17-13, pt. admitted to hospital b/c progressive weakness, (R) sided facial droop, difficulty eating and drinking. As an outpt., pt saw orthopedic spine doctor, int. med. primary doc. Inpatient, he saw neurology. (+) P.T./O.T. He was hospitalized x9 days. He has ongoing PT/OT to develop gait. Uses wheelchair now.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Wheelchair user, White blood cell count increased
Clinical narrative: Pt. had flu shot and within a few days developed (R) lat. lower leg pain and weakness. Ascending and involving (R) ant. thigh and hip flexors, compromising gait. Next, (L) lower extrem. developed weakness. Pt. lost appetite and began losing wt. 11-16-13, pt came to ER b/c (R) sided facial weakness -> Bell's palsy. 11-17-13, pt. admitted to hospital b/c progressive weakness, (R) sided facial droop, difficulty eating and drinking. As an outpt., pt saw orthopedic spine doctor, int. med. primary doc. Inpatient, he saw neurology. (+) P.T./O.T. He was hospitalized x9 days. He has ongoing PT/OT to develop gait. Uses wheelchair now.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site swelling, Mobility decreased, Pain, Weight bearing difficulty
Clinical narrative: Soreness and limited range of motion in (L) arm. Swelling at injection site. Difficulty in supporting weight on (L) arm in yoga; Unable to remove clothes over head. Treat with acupuncture and PT.
Age: 54.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Throat tightness, Tuberculin test negative, Tunnel vision, Urticaria
Clinical narrative: Ct received injections 100pm around 5:30 pm c/o "throat tightening with progression of hives to chest, tunnel vision. Ct used personal epi-pen in route to med facility , then to ER. Given IV fluids and BENADRYL. No further treatment.
Age: 88.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Thermal burn
Clinical narrative: This spontaneous report as received from an 88 year old female consumer reporting on herself. The patient's current conditions or medical history were not reported. On an unknown date at an unspecified time in the past, the patient may have been vaccinated with a dose of tetanus and diphtheria toxoids, adsorbed (Manufacturer unknown) (dose, route, indication, lot and expiration date were not reported). Co suspect therapy included ZOSTAVAX (dose, route, indication, lot and expiration date were not reported) at an unspecified time in the past. On an unknown date, in the recent past, the patient spilled a cup of tea on herself that resulted in burns. On an unknown date the patient was hospitalized for burn care. At the time of the report outcome for burned was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: CM localized allergic rxn to (L) anterior thigh. (+) Redness, (+) swelling. TX: BENADRYL; ORAPRED; TYLENOL/MOTRIN PRN; Cool compress.
Age: 65.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 year old male patient. In approximately 2009 (reported as 'approximately 5 years ago') the patient was vaccinated with his first dose of GARDASIL (dose and route of administration were not reported, unknown lot number and expiration date). Concomitant medications were not reported. The nurse called for recommendations for 2nd dosing of GARDASIL to a gentleman who received his first dose approximately 5 years ago, but then reported that the gentleman was currently 65 years old. It was reported that she quickly added that he was not their patient 5 years ago and she was not sure he was actually administered suspected medication and that he might be confused. No adverse effects were noted to patient. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Intradermal lesion persists at site of injection. It is not painful, growing or deteriorating. It appears to be a dermatofibroma. The lesion is under surveillance.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray abnormal, Cough
Clinical narrative: I was coughing for 10 months after TDAP shot. An X-ray showed patches on my lungs. They gave me antibiotics and I am not coughing as much now. (X-ray was 10 months later after vaccination).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Corrective lens user, Glycosylated haemoglobin increased, Headache, IVth nerve paralysis
Clinical narrative: Onset blurred vision, unresolving headache. Saw eye MD 11-8-13, ER 11-9-13, had MRI and labs, saw primary care MD 11-12-13 - BP was increased, gave me Lisinopril I was really stressed because of my blurred vision and constant headache, 11-27-13 eye MD, prism added to glasses to help vision 11-27-13 diagnosed 4th cranial nerve paralysis believed to be caused by post viral or flu vaccine. 12-9-13 saw PCP, dc lisinopril, add NORVASC, had labs HgbA1C 6.5, repeat MRI 12-11-13 - normal, 12-16-13 eye MD and 1-31-14 still recovering. See eye MD every month.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Stress, Vision blurred
Clinical narrative: Onset blurred vision, unresolving headache. Saw eye MD 11-8-13, ER 11-9-13, had MRI and labs, saw primary care MD 11-12-13 - BP was increased, gave me Lisinopril I was really stressed because of my blurred vision and constant headache, 11-27-13 eye MD, prism added to glasses to help vision 11-27-13 diagnosed 4th cranial nerve paralysis believed to be caused by post viral or flu vaccine. 12-9-13 saw PCP, dc lisinopril, add NORVASC, had labs HgbA1C 6.5, repeat MRI 12-11-13 - normal, 12-16-13 eye MD and 1-31-14 still recovering. See eye MD every month.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain, Myalgia, Pain
Clinical narrative: Left arm where shot was administered was painful for 2 days. I could not lift arm. Seemed to get better then a week later my arm was very sore. Pain when I lifted above (elbow) shoulder. I feel discomfort and am aware of pain throughout the day. Seems to get worse at night. Pharmacist said to apply heat and take ibuprofen. Arm still hurts after 28 days. I have no previous injuries and have not exercised my arm. The pain is in the muscle 4 in. below top of shoulder inside of arm.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Left arm where shot was administered was painful for 2 days. I could not lift arm. Seemed to get better then a week later my arm was very sore. Pain when I lifted above (elbow) shoulder. I feel discomfort and am aware of pain throughout the day. Seems to get worse at night. Pharmacist said to apply heat and take ibuprofen. Arm still hurts after 28 days. I have no previous injuries and have not exercised my arm. The pain is in the muscle 4 in. below top of shoulder inside of arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Cough, Pyrexia, Rash, Vomiting
Clinical narrative: Approx 2 days after vaccination - cough, fever and vomiting began. Rash to dorsum of both hands/wrists and lower forearms. Same appearance rash to lower 1/2 of both buttocks. "Pinpoint dots" behind both ears. (x) All pics not present at exam re: all about symptoms.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Tdap given between 4 and 5pm -2-18-14. Patient states site sore that evening. The next day site hurt bad then he ran a low fever -just over 100 degrees F for a few days. Fever gone today. Site is a little sore. patient denied noticing any swelling or warmness at the site.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Atelectasis, Bronchitis, Computerised tomogram abnormal, Death, Mechanical ventilation
Clinical narrative: 2-6-14 pt presents to Hosp. with resp s/s dx with bronchitis and allergic rhinitis tx with amoxicillin, ZYRTEC and Guaifenesin. On 2-9-14 back to Hosp dx per CT scan with early pneumonia aspiration or atelectasis pulse ox 88-92. Pt given tetracycline, FLAGYL and IMODIUM in addition to other meds given early pt d/c to home. On 2-11-14 pt presents to another Hosp. Dx with double pneumonia, admitted 2-18-14 placed on vent, 2-22-14 pt died.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Pneumonia aspiration, Rhinitis allergic
Clinical narrative: 2-6-14 pt presents to Hosp. with resp s/s dx with bronchitis and allergic rhinitis tx with amoxicillin, ZYRTEC and Guaifenesin. On 2-9-14 back to Hosp dx per CT scan with early pneumonia aspiration or atelectasis pulse ox 88-92. Pt given tetracycline, FLAGYL and IMODIUM in addition to other meds given early pt d/c to home. On 2-11-14 pt presents to another Hosp. Dx with double pneumonia, admitted 2-18-14 placed on vent, 2-22-14 pt died.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Chest X-ray abnormal, Convulsion, Pneumonia viral
Clinical narrative: This case was reported by a physician and described the occurrence of seizure in a 19-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 28 January 2014 between 08:00 and 17:00, the subject received 1st dose of HAVRIX (unknown details). The physician could not name the hepatitis vaccine given; however, the lot number was found in the sales data for HAVRIX. On 31 January 2014, 3 days after vaccination with HAVRIX, the subject experienced seizure. In January 2014, within days after vaccination with HAVRIX, the subject experienced viral pneumonia. The date of onset of pneumonia was not reported. Per the physician, the subject was "ruled in for pneumonia. It was presumed to be viral." On 31 January 2014, at approximately 11:00, the subject experienced the first seizure that was not witnessed. At 12:30 on the same date, the subject experienced the second seizure that was witnessed at the emergency room. The subject was "started on medication and was given medication to abort the seizure." No details regarding the treatment medications were provided. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). Relevant test results included: Per the physician, there was "evidence from a chest x-ray that [the subject] had pneumonia." The date of the chest x-ray was not reported. On 31 January 2014, the event of seizure was resolved. The outcome of the viral pneumonia was not reported. The vaccination course with HAVRIX was discontinued. The physician considered the event of seizure was possibly related to vaccination with HAVRIX. The physician did not report whether he considered the viral pneumonia related to HAVRIX.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Culture positive, Meningitis meningococcal, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Meningococcal meningitis, confirmed.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Culture positive, Meningitis, Neisseria test positive, Polymerase chain reaction, Sepsis
Clinical narrative: Meningitis & sepsis.
Age: 23.0
Sex: F
Vaccine: ANTH, MMR, SMALL
Symptoms: Fatigue, Headache, Oral herpes
Clinical narrative: Headache, fatigue, cold sores.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Vaccine positive rechallenge, X-ray normal
Clinical narrative: Shortness of breath, can't breathe deep. Saw my doctor 3 weeks later and had 2 x-rays found nothing. Had same problem prior 2 flu shots that only last 5hrs each time. This time it won't go away.
Age: 47.0
Sex: F
Vaccine: TTOX
Symptoms: Activities of daily living impaired, Arthralgia, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Arm swollen, unable to lift arm above shoulder, pain in injection sight, 2 days later...muscle and joint aches and pains, intense fatigue, 3 days later....intense fatigue, muscle and joint aches and pains, nauseous, diarrhea, dizziness, fever. I was unable to get out of bed or eat or drink anything for 36 hours, except to get up for severe diarrhea.  Was unable to work.
Age: 47.0
Sex: F
Vaccine: TTOX
Symptoms: Impaired work ability, Injection site pain, Local swelling, Mobility decreased, Myalgia
Clinical narrative: Arm swollen, unable to lift arm above shoulder, pain in injection sight, 2 days later...muscle and joint aches and pains, intense fatigue, 3 days later....intense fatigue, muscle and joint aches and pains, nauseous, diarrhea, dizziness, fever. I was unable to get out of bed or eat or drink anything for 36 hours, except to get up for severe diarrhea.  Was unable to work.
Age: 47.0
Sex: F
Vaccine: TTOX
Symptoms: Nausea, Pyrexia
Clinical narrative: Arm swollen, unable to lift arm above shoulder, pain in injection sight, 2 days later...muscle and joint aches and pains, intense fatigue, 3 days later....intense fatigue, muscle and joint aches and pains, nauseous, diarrhea, dizziness, fever. I was unable to get out of bed or eat or drink anything for 36 hours, except to get up for severe diarrhea.  Was unable to work.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Left upper arm redness and swelling at site of vaccine, no rash, no tongue/throat swelling.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abscess, Cellulitis
Clinical narrative: Cellulitis and abscess of upper arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes simplex
Clinical narrative: Had not had herpes simplex, oral, break out in years. After the shingles vaccine had herpes blister for 4+ months! I know it isn't exactly the same, but viral load?
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Condition aggravated, Convulsion, Postictal state
Clinical narrative: At 7 pm on evening after vaccination, had seizure, brief, with 1-hour post-ictal period. Child has known seizure disorder and takes an anticonvulsant medication - KEPPRA.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Pallor
Clinical narrative: At 1230 heard yell for help. APRN assessed. Mother indicated "eyes rolled back, slumped over and pale. Dr arrived at patint side. PAC brought cold cloth for forehead. Within about 8 minutes patient pink and alert. No complaints.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Dizziness, Headache
Clinical narrative: Increased BP, dizzy, frontal headache 1 1/2 hr. after Boostrix 0.5 ml IM
Age: 37.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Activities of daily living impaired, Blood copper increased, Malaise, Myalgia, Nausea
Clinical narrative: Pt claims after receiving FLUCELVAX she became ill and missed work. S/S: Muscle ache, N and V.
Age: 37.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Vomiting
Clinical narrative: Pt claims after receiving FLUCELVAX she became ill and missed work. S/S: Muscle ache, N and V.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dry eye, Nuclear magnetic resonance imaging brain normal, VIIth nerve paralysis
Clinical narrative: (L) facial droop 2/2/2014. Dry (L) eye. Resolved within 7 days. No treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left upper-outer thigh 6x5 cm area red much improved was much bigger 9x8 per mom Sat. Right outer thigh - 3x3 cm area - per mom quarter size hot red. Both sites today mildly pink.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Rec'd shot 2/07/14 - Pain started 2/08/14 and has persisted until the present - feels like she can't lift her arm up - It is a deep pain that sometimes radiates to elbow and down to her wrist - taking Ibu around the clock.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Haematochezia, Intussusception, Mental status changes, Urinary system X-ray
Clinical narrative: 10 m/o presented to ED with c/o altered mental status on 2/21. KUB 2/22 showed intussusception. Bloody stools x 2, refusal of PO.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: X-ray abnormal
Clinical narrative: 10 m/o presented to ED with c/o altered mental status on 2/21. KUB 2/22 showed intussusception. Bloody stools x 2, refusal of PO.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Arthralgia, Bone disorder, Cardiovascular disorder, Discomfort, Dyspnoea
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (strength, dose unit, route, lot# and expiry date unknown). On an unknown date after administering with ZOSTAVAX the patient experienced the following adverse reactions, that have last for more than three months including crawling feeling underneath her skin, bad blood circulation, joint pain, heart palpitations, it was hard for her to breath, pressure in head and ears, tightness in her bones, she felt discomfort, spicy feeling in her fingers and nerve throbbing in her legs. On unspecified dates, she has seen many doctors and was currently wearing a heart monitor because of these symptoms. Physician asked for the following information: Have there been any reports of patients experiencing neuropathic or neuralgia symptoms after receiving ZOSTAVAX and was there any treatment. Physician also asked if a patient could develop post-herpetic neuralgia from the ZOSTAVAX vaccine. The outcome of hard for her to breathe, nerve throbbing in her legs, spicy feeling in her fingers, feels discomfort, tightness in her bones, pressure in her head and ears, heart palpitations, joint pain, bad blood circulation and crawling feeling underneath her skin was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Ear discomfort, Formication, Headache, Neuralgia, Palpitations
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (strength, dose unit, route, lot# and expiry date unknown). On an unknown date after administering with ZOSTAVAX the patient experienced the following adverse reactions, that have last for more than three months including crawling feeling underneath her skin, bad blood circulation, joint pain, heart palpitations, it was hard for her to breath, pressure in head and ears, tightness in her bones, she felt discomfort, spicy feeling in her fingers and nerve throbbing in her legs. On unspecified dates, she has seen many doctors and was currently wearing a heart monitor because of these symptoms. Physician asked for the following information: Have there been any reports of patients experiencing neuropathic or neuralgia symptoms after receiving ZOSTAVAX and was there any treatment. Physician also asked if a patient could develop post-herpetic neuralgia from the ZOSTAVAX vaccine. The outcome of hard for her to breathe, nerve throbbing in her legs, spicy feeling in her fingers, feels discomfort, tightness in her bones, pressure in her head and ears, heart palpitations, joint pain, bad blood circulation and crawling feeling underneath her skin was unknown. Additional information has been requested.