chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urinary tract infection, Vasculitis
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an 86 year old female patient with diabetes, hypertension, lumbar spondylosis, hyperlipidemia and chronic allergies. Patient's medical history included elevated c-reactive protein and elevated eosinophil levels. On 11-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included PRAVACHOL (20 milligrams), KLOR-CON 10 milligrams(mg), hydrochlorothiazide (dose unspecified), SOMA (350 mg), atenolol (50 mg) and amitriptyline hydrochloride (50 mg). On 31-MAR-2013, the patient experienced palpable purpura and vasculitis covering her body two weeks after receiving ZOSTAVAX. Her physician advised her to immediately go to the hospital. The patient was admitted to the hospital (name unspecified) on 31-MAR-2013 and was given medication to treat her condition (prednisone-dosage unspecified). The patient was discharged on 02-APR-2013. Approximately on an unknown date in April 2013, upon returning home the patient developed a urinary tract infection, and experienced profound weakness and anemia. The patient was readmitted to the unspecified hospital for these symptoms on 18-APR-2013. Upon discharge (exact date unspecified in 2013) the patient was sent to a rehabilitation center (unspecified) where she remained until two days before her death. The events were not resolved at the time of reporting. On 11-MAY-2013, the patient died due to sepsis. It was unknown if the autopsy was done. The physician noted that blood work that was taken from the patient directly preceding vaccination indicated that she had elevated C-reactive protein levels directly before she received the vaccine which may have been an indicator of the declining conditions of the patient. The relatedness for the events was unknown for ZOSTAVAX. The reporter considered the events to be life threatening. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neoplasm malignant
Clinical narrative: This spontaneous report as received from a 70 year old female patient with no medical history and with no drug reactions/allergies. In May 2010, "3 years ago", the patient was vaccinated with ZOSTAVAX (one injection, strength, lot#, dose/frequency, route and duration were unspecified). No concomitant drug was taken. Patient stated that 2 years after she took the vaccine (October 2012) she came down with cancer and after her radiation therapy she came down with a case of shingles. Patient did not seek medical attention. No lab diagnostics studies was performed and no treatment was given for the events. The outcome was unknown. Upon internal review, cancer was considered as other medical significant event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a newborn female whose mother was pregnant at 19 years old and was with low iron, nausea, penicillin allergy, UTI (Urinary tract infection), vomiting. On 17-JUL-2012, the mother was vaccinated intramuscular with 0.5 dose of GARDASIL (lot # 672233/1561AA, exp. date 26-AUG-2014). The mother became pregnant with LMP (Last Menstrual Period) of 25-MAY-2012 and EDD (estimated date of delivery) was 01-MAR-2013 (also reported as 17-FEB-2013). On 20-FEB-2013 at 40 weeks 3 days gestation, the mother spontaneous delivered the infant via vaginal. The infant was weighing 7 lbs 7 oz, with Length of 20 inches, Head circumference of 13 inches. The infant experienced no complications during the delivery. The infant had congenital anomalies (unspecified). It also reported that the infant was normal. Apgar score was 7 at one minute and 9 at 5 minute. At the time of report, the outcome of event was unknown. The mother's experience was captured in MARRS#11207USA006880. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old female patient. On 15-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (lot # 1860AA; exp. date 30-SEP-2014; dose and route was unknown). There was no concomitant medication, no medical history and no known drug allergies. Since she received her first dose of GARDASIL, she had a migraine on 15-MAY-2013. She reported that she was in a lot of pain - an 8-9 on a pain scale. The patient treated with TYLENOL, ibuprofen and aspirin. No lab diagnostics was performed. The outcome of migraine was reported as not recovered/not resolved. The event was considered to be an significant disability by the reporter. Patient reported that her physician cannot see her in the office until 12-JUN-2013, so patient might go to the emergency room to seek medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MNQ
Symptoms: Petechiae
Clinical narrative: Patient experienced "pin-point, red dots" on stomach and legs. They appeared within days of immunization (5/21/13) and are still present but are improving (5/27/13). No other symptoms. Condition is improving.
Age: 40.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Measles antibody negative, Mumps antibody test, Rubella antibody positive
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 42 year old female, non pregnant patient, with no drug reactions or allergies and no pertinent medical history. On 18-MAY-2010 the patient was vaccinated with the first dose of M-M-R II, 0.5 ml, subcutaneous. There was no concomitant medication. In November 2012 the patient found to be not immune to measles at 0.9 which is equivocal, immune to rubella and had unknown status for mumps since it was not tested. In May 2013 the patient process and IgG (Immunoglobulin G) was done for measles and mumps, but not for rubella. The patient was found to have 1 which is equivocal for measles and immune for mumps. The patient sought medical attention. The outcome of adverse event is unknown. The relatedness between adverse event and M-M-R II is unknown. Additional information has been assistant.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: This spontaneous report was received from a licensed practiced nurse refers to a 18 year old male patient. The patient has asthma. The patient had no drug reactions or allergies. On 22-MAY-2013, the patient was vaccinated with dose 1 of 0.5 ml (milliliter) GARDASIL, (lot # reported as H017698, expiry date 02-JUL-2015, route was intramuscular). Other suspect therapies included MENACTRA which was administered on 22-MAY-2013 in the opposite arm. Concomitant therapies included FLOVENT as needed. On 22-MAY-2013, the patient experienced dizziness and nausea. The patients blood pressure also dropped. These symptoms occurred immediately after administration of both vaccine while the patient was still in office. The vaccinations were administered later in the afternoon and the patient mentioned he had a very little to eat during the day before coming to office. The patient observed for 30 to 40minutes after the GARDASIL and MENACTRA were administered and was given a cup of water. Blood pressure readings were taken. On 22-MAY-2013. The outcome of all the evenrs were repored as recovered. The patient sought medical attention(was in the office). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old female patient with no drug reactions/allergies or pertinent medical history. On 11-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # and route not reported). There was no concomitant medication. On 16-MAY-2013, the patient experienced a mild case of shingles on one side of the face after receiving the ZOSTAVAX. The patient went to physician's office for medical attention. No treatment was given. No lab diagnostics studies were performed. The outcome of case of shingles on one side of the face was reported as recovering/resolving. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 16 year old patient. On 10-MAY-2013 the patient was vaccinated with an expired dose of M-M-R II (lot # 670618/0567AA, exp date 15-APR-2013) (dose and route was not reported), as the second dose of M-M-R II (date of first dose of M-M-R II was unspecified). No adverse event reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Musculoskeletal pain, Pain
Clinical narrative: This spontaneous report as received from a 9 year old female patient refers to herself. On 20-MAY-2011 the patient was vaccinated with ZOSTAVAX. Lot# and administration route was unspecified. Concomitant therapies included hydrocodone and aspirin. On 02-MAY-2013, the now 11 years old patient felt a pain on her back right shoulder, which went a week with out noticing the rash. One the patient looked at her back she noticed a red irritated skin. The rash went from her breast bone to her spine on the right hand side. The rash pain was accompanied by blisters, no itching just burning sensation. Unspecified treatment was given. Outcome of event was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin irritation
Clinical narrative: This spontaneous report as received from a 9 year old female patient refers to herself. On 20-MAY-2011 the patient was vaccinated with ZOSTAVAX. Lot# and administration route was unspecified. Concomitant therapies included hydrocodone and aspirin. On 02-MAY-2013, the now 11 years old patient felt a pain on her back right shoulder, which went a week with out noticing the rash. One the patient looked at her back she noticed a red irritated skin. The rash went from her breast bone to her spine on the right hand side. The rash pain was accompanied by blisters, no itching just burning sensation. Unspecified treatment was given. Outcome of event was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient of an unknown gender. No concurrent conditions details and medical history provided. On 17-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number not reported) (0.5 ml, subcutaneously) instead of VARIVAX (Merck). The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a medical assistant for the office via company representative refers to a male patient of unknown age. On 16-MAY-2013 the patient was vaccinated intramuscular with the third dose of GARDASIL (dosage unknown, lot# not provided). Reporter explained that standard third dose of GARDASIL was given after one month from receiving second dose of GARDASIL given on approximately 16-APR-2013. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction. (Redness, swelling, itchy, painful). The following day after the vaccine was administered.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 18 year old patient. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose 1, route, concentration and lot number unknown). On an unknown date the patient experienced vesicular rash in clusters. The reporter stated the nurse practitioner mentioned the patient does not recall their vaccination history and is not sure if they ever received a second dose of VARIVAX (Merck). The patient sought medical attention by office visit. The outcome of vesicular rash in clusters was reported as recovered (date unspecified). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patient. Physician reported that VARIVAX (Merck) was exposed to 19F for an unknown amount of time and did not know if any improperly stored VARIVAX may have been administered to unspecified patients. Physician could not provide lot numbers, expiration dates of VARIVAX or names of healthcare providers that may have administered improperly stored vaccines. No adverse events were reported. Additional information is not expected.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 27 year old patient of an unknown gender who on 19-MAR-2013, was vaccinated with a dose of MMR II (lot# 0259AE) 0.5 ml, subcutaneous in the left arm, which was improperly stored. MMR II was stored at 48 degrees F for total hours of 25.5. Per National Service Center - potency projection indicated administered doses of MMR II was expected to maintain a potency within label usage. This is one of several reports from the same reporter source. Additional information is not expected.
Age: 30.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 30 year old patient of an unknown gender who on 10-APR-2013, was vaccinated with a dose of MMR II (lot# H011889, expiration date, 25-JUN-2014) 0.5 ml, subcutaneous in the right arm, which was improperly stored. MMR II was stored at 48 degrees F for total hours of 25.5. Per National Service Center - potency projection indicated administered doses of MMR II was expected to maintain a potency within label usage. This is one of several reports from the same reporter source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Headache, Mass, Pallor, Wheezing
Clinical narrative: This spontaneous report as received from a 70 year old female patient with asthma, chronic obstructive pulmonary disease (COPD), allergic to PLAVIX, LIPITOR and penicillin. On 29-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously. Concomitant therapies included CARDIZEM, digoxin, MICARDIS, aspirin, LASIX, RANEXA, VENTOLIN and SPIRIVA. The patient reported the following adverse experiences while using ZOSTAVAX on 29-APR-2013: "a large lump on her arm, headaches, atrial fibrillations for the duration of ten days straight, wheezing, and a pale complexion." The patient stated she has thirty-six percent lung function and that she was "extremely drug sensitive." The patient stated her blood pressure went severely low while using CARDIZEM and MICARDIS concomitantly, and that LIPITOR "affected her badly." Patient sought medical attention by office visit on an unspecified day. Increasing CARDIZEM was as treatment. There were no labs performed. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Blood test, Cardioversion, Echocardiogram normal, Induration
Clinical narrative: This spontaneous report as received from a 70 year old female patient with asthma, chronic obstructive pulmonary disease (COPD), allergic to PLAVIX, LIPITOR and penicillin. On 29-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously. Concomitant therapies included CARDIZEM, digoxin, MICARDIS, aspirin, LASIX, RANEXA, VENTOLIN and SPIRIVA. The patient reported the following adverse experiences while using ZOSTAVAX on 29-APR-2013: "a large lump on her arm, headaches, atrial fibrillations for the duration of ten days straight, wheezing, and a pale complexion." The patient stated she has thirty-six percent lung function and that she was "extremely drug sensitive." The patient stated her blood pressure went severely low while using CARDIZEM and MICARDIS concomitantly, and that LIPITOR "affected her badly." Patient sought medical attention by office visit on an unspecified day. Increasing CARDIZEM was as treatment. There were no labs performed. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local reaction, Mass
Clinical narrative: This spontaneous report as received from a 70 year old female patient with asthma, chronic obstructive pulmonary disease (COPD), allergic to PLAVIX, LIPITOR and penicillin. On 29-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously. Concomitant therapies included CARDIZEM, digoxin, MICARDIS, aspirin, LASIX, RANEXA, VENTOLIN and SPIRIVA. The patient reported the following adverse experiences while using ZOSTAVAX on 29-APR-2013: "a large lump on her arm, headaches, atrial fibrillations for the duration of ten days straight, wheezing, and a pale complexion." The patient stated she has thirty-six percent lung function and that she was "extremely drug sensitive." The patient stated her blood pressure went severely low while using CARDIZEM and MICARDIS concomitantly, and that LIPITOR "affected her badly." Patient sought medical attention by office visit on an unspecified day. Increasing CARDIZEM was as treatment. There were no labs performed. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 2 year old patient. On an unknown date, the patient was vaccinated with an adult dose of VAQTA, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Exposure to vaccinated person, Lip swelling, Paraesthesia oral
Clinical narrative: This spontaneous report as received from a male consumer refers to his wife of unknown age. In the morning of 17-MAY-2013 the patient's daughter was vaccinated with a dose of ROTATEQ (dose, route, lot# not reported). A few hours later, the patient thought she came in contact with her daughters from a shared cookie and that there may have been transmission of the ROTATEQ. The patient's lip was swollen and it tingled at the suspected site of the ROTATEQ transmission. At the time of reporting, the patient's outcome was not recovered.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. the patients medical history and drug reactions was unspecified. On 10-MAY-2013, the patient was vaccinated with ZOSTAVAX lot # H020845, expiry date 20-FEB-2014, subcutaneous. On 12-MAY-2013, 3 days after onset of therapy the patient experienced redness 'about a half dollar size', itching, swelling and a lump. The outcome of a lump, itching, swelling and redness 'about a half dollar size' was reported as recovering/resolving. The reporter did not assess the relationship between the events and ZOSTAVAX. Additional information has been requested.
Age: 1.31
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: This spontaneous report as received from a patient's grandmother refers to a 4 year old male patient with no allergies, drug reactions or pertinent medical history. On 11-MAR-2010 (reported as two years ago) the patient was vaccinated with VARIVAX (Merck) (dose 1, 0.5 ml, subcutaneous, lot number not reported). No concomitant medications. On 07-MAY-2013, the patient was diagnosed with shingles. The patient sought medical attention by an office visit and was treated immediately with unspecified medications and lesions were resolving. Additional information is not expected.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Joint range of motion decreased, Pain
Clinical narrative: This spontaneous report as received from a physician refers to a 53 year old male patient with asthma and recurrent pneumonia with no drug reactions or allergies. The patient's medical history included pneumonia in April 2013 that was treated outpatient and recovered. Patient received a standard pneumonia vaccine in 2007 and did not experience any symptoms. On 20-MAY-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # and expiration date unspecified) 0.5 ml, intramuscular for recurrent pneumonia. Concomitant therapies included FORTESTA, BYSTOLIC, CIALIS, losartan potassium (manufacturer unknown), ZEGERID and ADVAIR. On 21-MAY-2013 "over the next 24 hours from receiving the vaccine" the patient developed induration at injection site, "20*22 cm"  erythema beginning at the deltoid all the way down to the triceps and significant pain including difficulty with range of motion after receiving PNEUMOVAX 23. The patient called the physician's office on 21-MAY-2013 and spoke with a nurse about the symptoms he developed and was instructed to use compresses and take unspecified anti-inflammatories. Physician reported that symptoms did not subside so the patient called and spoke with the physician on 22-MAY-2013 and was being seen at the time of the report. Laboratory tests were not performed. At the time of the report the outcome of induration at injection site, erythema, difficulty with range of motion and significant pain was reported as not recovered. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dizziness, Epistaxis, Haemoptysis, Paraesthesia
Clinical narrative: Case number PHHY2013US044401 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483835) website on 06 May 2013 with a follow-up received from Quality Assurance department (reference number: 227421) on 22 May 2013: This report refers to a 10-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number:  A12002) intramuscularly into left arm on 29 Jan 2012. On the same day, she experienced tingling of extremities, fever within two hours after vaccination. Fever increased to 103.5 and continued the next day with epistaxis once and blood tinged phlegm. She also experienced weakness and felt some dizzy. The outcome of the events was reported as not recovered as of 30 Jan 2012. The seriousness and causality of the events were not reported. Batch review was performed and based on the document review, it was stated that the concerned MENVEO (batch number: A12002) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance department on 22 May 2013: Updated batch review report.
Age: 10.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US044401 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483835) website on 06 May 2013 with a follow-up received from Quality Assurance department (reference number: 227421) on 22 May 2013: This report refers to a 10-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number:  A12002) intramuscularly into left arm on 29 Jan 2012. On the same day, she experienced tingling of extremities, fever within two hours after vaccination. Fever increased to 103.5 and continued the next day with epistaxis once and blood tinged phlegm. She also experienced weakness and felt some dizzy. The outcome of the events was reported as not recovered as of 30 Jan 2012. The seriousness and causality of the events were not reported. Batch review was performed and based on the document review, it was stated that the concerned MENVEO (batch number: A12002) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance department on 22 May 2013: Updated batch review report.
Age: 10.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dizziness, Epistaxis, Increased upper airway secretion, Paraesthesia
Clinical narrative: Case number PHHY2013US044401 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483835) website on 06 May 2013 with a follow-up received from Quality Assurance department (reference number: 227421) on 22 May 2013: This report refers to a 10-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number:  A12002) intramuscularly into left arm on 29 Jan 2012. On the same day, she experienced tingling of extremities, fever within two hours after vaccination. Fever increased to 103.5 and continued the next day with epistaxis once and blood tinged phlegm. She also experienced weakness and felt some dizzy. The outcome of the events was reported as not recovered as of 30 Jan 2012. The seriousness and causality of the events were not reported. Batch review was performed and based on the document review, it was stated that the concerned MENVEO (batch number: A12002) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance department on 22 May 2013: Updated batch review report.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a 87 year old female patient concerning herself. The patient had no pertinent medical history, drug reactions or allergies. On 25-APR-2012 the patient was vaccinated with ZOSTAVAX (Lot # and dose not provided), subcutaneous. The patient had no concomitant medications. On 01-MAY-2012, 7 days after onset of therapy the patient had gotten numbness in her hands, and later in her legs. The patient was given vitamin B12 as treatment for the adverse event. There were no lab diagnostics studies performed. The patient's outcome was unknown. The patient sought unspecified medical attention. The relationship between therapy with ZOSTAVAX and the event was unknown. Follow up information has been received from the physician concerning a patient with not known drug allergies and medical history of herpes zoster in 2009. On 25-APR-2012 at 9:10 am the patient was vaccinated with the first dose of ZOSTAVAX (Lot # 671451/1193AA), subcutaneous in the right upper arm. There were no illness at time of vaccination. On 02-MAY-2012 the patient experienced numbness of hands and tingling of legs and arm numbness. It was reported that the patient required medical / surgical intervention to prevent on of the outcomes listed. The outcome of numbness of hands and tingling of legs was reported as not recovered. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report was received from a 87 year old female patient concerning herself. The patient had no pertinent medical history, drug reactions or allergies. On 25-APR-2012 the patient was vaccinated with ZOSTAVAX (Lot # and dose not provided), subcutaneous. The patient had no concomitant medications. On 01-MAY-2012, 7 days after onset of therapy the patient had gotten numbness in her hands, and later in her legs. The patient was given vitamin B12 as treatment for the adverse event. There were no lab diagnostics studies performed. The patient's outcome was unknown. The patient sought unspecified medical attention. The relationship between therapy with ZOSTAVAX and the event was unknown. Follow up information has been received from the physician concerning a patient with not known drug allergies and medical history of herpes zoster in 2009. On 25-APR-2012 at 9:10 am the patient was vaccinated with the first dose of ZOSTAVAX (Lot # 671451/1193AA), subcutaneous in the right upper arm. There were no illness at time of vaccination. On 02-MAY-2012 the patient experienced numbness of hands and tingling of legs and arm numbness. It was reported that the patient required medical / surgical intervention to prevent on of the outcomes listed. The outcome of numbness of hands and tingling of legs was reported as not recovered. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Blood test normal, Dizziness, Dyskinesia, Muscle twitching, Thirst
Clinical narrative: Initial report received on 06 May 2013 from a health care professional. A 19 year-old male had received a subcutaneous injection of YF VAX vaccine (lot number UH598AA) and an intramuscular injection of TYPHIM VI (lot number G1542-1 on 30 April 2013 and 5 days later on 05 May 2013 was taken to the emergency department around 10:30 PM with symptoms of dizziness, increased thirst, twitching of both upper and lower extremities. The patient received corrective treatment of ATIVAN and was discharged from the emergency department around 3:00 AM. The reporter spoke with the patients mother on 06 May 2013 who reported the patient's symptoms had resolved upon hospital discharge, and had not re-occurred. According to the mother, laboratory work (not identified) that was completed in the emergency department was normal. Patient had no illnesses at time of vaccination, or any pre-existing medical conditions. He takes only a multivitamin daily. The emergency department report with physician diagnosis was not available to the reporter at time of this report. Follow-up information received on 14 May 2013 from a health care professional who reported that the patient had jolts, like a seizure. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious (Temporary VAERS number 70406). The patient had received YF VAX subcutaneously in the left triceps and TYPHIM VI in the right deltoid on 30 April 2013 and on 05 May 2013 (also reported as 06 May 2013) experienced "arm twitching, leg twitching, jolts, like a seizure, though alert, no change in mental status". The patient follow-up with primary care physician and had a normal neurological exam. On 12 May 2013, the patient experienced a second "twitching episode". The patient was evaluated by a neurologist and had a "negative exam". Blood and urinalysis labs were normal. According to the reporter, the Centers for Disease Control and Prevention (CDC) advised him that the patient would need a spinal tap to confirm that it is vaccine related. No further tests were planned unless episode recurred. The patient's outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Urine analysis
Clinical narrative: Initial report received on 06 May 2013 from a health care professional. A 19 year-old male had received a subcutaneous injection of YF VAX vaccine (lot number UH598AA) and an intramuscular injection of TYPHIM VI (lot number G1542-1 on 30 April 2013 and 5 days later on 05 May 2013 was taken to the emergency department around 10:30 PM with symptoms of dizziness, increased thirst, twitching of both upper and lower extremities. The patient received corrective treatment of ATIVAN and was discharged from the emergency department around 3:00 AM. The reporter spoke with the patients mother on 06 May 2013 who reported the patient's symptoms had resolved upon hospital discharge, and had not re-occurred. According to the mother, laboratory work (not identified) that was completed in the emergency department was normal. Patient had no illnesses at time of vaccination, or any pre-existing medical conditions. He takes only a multivitamin daily. The emergency department report with physician diagnosis was not available to the reporter at time of this report. Follow-up information received on 14 May 2013 from a health care professional who reported that the patient had jolts, like a seizure. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious (Temporary VAERS number 70406). The patient had received YF VAX subcutaneously in the left triceps and TYPHIM VI in the right deltoid on 30 April 2013 and on 05 May 2013 (also reported as 06 May 2013) experienced "arm twitching, leg twitching, jolts, like a seizure, though alert, no change in mental status". The patient follow-up with primary care physician and had a normal neurological exam. On 12 May 2013, the patient experienced a second "twitching episode". The patient was evaluated by a neurologist and had a "negative exam". Blood and urinalysis labs were normal. According to the reporter, the Centers for Disease Control and Prevention (CDC) advised him that the patient would need a spinal tap to confirm that it is vaccine related. No further tests were planned unless episode recurred. The patient's outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Blood test normal, Dizziness, Muscle twitching, Neurological examination normal, Seizure like phenomena
Clinical narrative: Initial report received on 06 May 2013 from a health care professional. A 19 year-old male had received a subcutaneous injection of YF VAX vaccine (lot number UH598AA) and an intramuscular injection of TYPHIM VI (lot number G1542-1 on 30 April 2013 and 5 days later on 05 May 2013 was taken to the emergency department around 10:30 PM with symptoms of dizziness, increased thirst, twitching of both upper and lower extremities. The patient received corrective treatment of ATIVAN and was discharged from the emergency department around 3:00 AM. The reporter spoke with the patients mother on 06 May 2013 who reported the patient's symptoms had resolved upon hospital discharge, and had not re-occurred. According to the mother, laboratory work (not identified) that was completed in the emergency department was normal. Patient had no illnesses at time of vaccination, or any pre-existing medical conditions. He takes only a multivitamin daily. The emergency department report with physician diagnosis was not available to the reporter at time of this report. Follow-up information received on 14 May 2013 from a health care professional who reported that the patient had jolts, like a seizure. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious (Temporary VAERS number 70406). The patient had received YF VAX subcutaneously in the left triceps and TYPHIM VI in the right deltoid on 30 April 2013 and on 05 May 2013 (also reported as 06 May 2013) experienced "arm twitching, leg twitching, jolts, like a seizure, though alert, no change in mental status". The patient follow-up with primary care physician and had a normal neurological exam. On 12 May 2013, the patient experienced a second "twitching episode". The patient was evaluated by a neurologist and had a "negative exam". Blood and urinalysis labs were normal. According to the reporter, the Centers for Disease Control and Prevention (CDC) advised him that the patient would need a spinal tap to confirm that it is vaccine related. No further tests were planned unless episode recurred. The patient's outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Thirst, Urine analysis normal
Clinical narrative: Initial report received on 06 May 2013 from a health care professional. A 19 year-old male had received a subcutaneous injection of YF VAX vaccine (lot number UH598AA) and an intramuscular injection of TYPHIM VI (lot number G1542-1 on 30 April 2013 and 5 days later on 05 May 2013 was taken to the emergency department around 10:30 PM with symptoms of dizziness, increased thirst, twitching of both upper and lower extremities. The patient received corrective treatment of ATIVAN and was discharged from the emergency department around 3:00 AM. The reporter spoke with the patients mother on 06 May 2013 who reported the patient's symptoms had resolved upon hospital discharge, and had not re-occurred. According to the mother, laboratory work (not identified) that was completed in the emergency department was normal. Patient had no illnesses at time of vaccination, or any pre-existing medical conditions. He takes only a multivitamin daily. The emergency department report with physician diagnosis was not available to the reporter at time of this report. Follow-up information received on 14 May 2013 from a health care professional who reported that the patient had jolts, like a seizure. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious (Temporary VAERS number 70406). The patient had received YF VAX subcutaneously in the left triceps and TYPHIM VI in the right deltoid on 30 April 2013 and on 05 May 2013 (also reported as 06 May 2013) experienced "arm twitching, leg twitching, jolts, like a seizure, though alert, no change in mental status". The patient follow-up with primary care physician and had a normal neurological exam. On 12 May 2013, the patient experienced a second "twitching episode". The patient was evaluated by a neurologist and had a "negative exam". Blood and urinalysis labs were normal. According to the reporter, the Centers for Disease Control and Prevention (CDC) advised him that the patient would need a spinal tap to confirm that it is vaccine related. No further tests were planned unless episode recurred. The patient's outcome was recovered (date not reported). Documents held by sender: None.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaemia, Asthenia, Death, Palpable purpura, Sepsis
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 86 year old female patient with diabetes, hypertension, lumbar spondylosis, hyperlipidemia and chronic allergies. Patient's medical history included elevated eosinophil levels and elevated C-reactive protein. On 11-MAR-2013 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported) (also reported as shingles vaccination). Concomitant therapies included PRAVACHOL, KLOR-CON, hydrochlorothiazide, SOMA, atenolol and amitriptyline. On approximately 25-MAR-2013, two weeks after vaccination with ZOSTAVAX the patient experienced palpable purpura and vasculitis covering her body. The patient was admitted to the hospital on 31-MAR-2013 and was given medication (reported as prednisone) to treat her condition. The patient was discharged on 02-APR-2013. Upon returning home, approximately in April 2013 the patient developed a urinary tract infection and experienced profound weakness and anemia. She was readmitted to the hospital for these symptoms on 18-APR-2013. Upon discharge she was sent to a rehabilitation center where she remained two days before her death. On an unspecified date, approximately in April 2013 the patient developed sepsis. It was also reported that the onset date of all events was on 31-MAR-2013. She died on 11-MAY-2013. The sepsis was reported as a cause of patient's death. Lab diagnostics studies included blood work that was taken from the patient directly preceding vaccination on 11-MAR-2013 and it indicated that the patient had had elevated C-reactive protein levels directly before she received the vaccine which may have been an indicator of the patient's declining condition. The relatedness between palpable purpura, vasculitis, urinary tract infection, profound weakness, anemia, sepsis and ZOSTAVAX was not reported. Outcome of all events was provided - not recovered (excluding sepsis). All events was considered to be life threatening by the reporter. Upon internal review sepsis was considered to be medically significant. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urinary tract infection, Vasculitis
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 86 year old female patient with diabetes, hypertension, lumbar spondylosis, hyperlipidemia and chronic allergies. Patient's medical history included elevated eosinophil levels and elevated C-reactive protein. On 11-MAR-2013 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported) (also reported as shingles vaccination). Concomitant therapies included PRAVACHOL, KLOR-CON, hydrochlorothiazide, SOMA, atenolol and amitriptyline. On approximately 25-MAR-2013, two weeks after vaccination with ZOSTAVAX the patient experienced palpable purpura and vasculitis covering her body. The patient was admitted to the hospital on 31-MAR-2013 and was given medication (reported as prednisone) to treat her condition. The patient was discharged on 02-APR-2013. Upon returning home, approximately in April 2013 the patient developed a urinary tract infection and experienced profound weakness and anemia. She was readmitted to the hospital for these symptoms on 18-APR-2013. Upon discharge she was sent to a rehabilitation center where she remained two days before her death. On an unspecified date, approximately in April 2013 the patient developed sepsis. It was also reported that the onset date of all events was on 31-MAR-2013. She died on 11-MAY-2013. The sepsis was reported as a cause of patient's death. Lab diagnostics studies included blood work that was taken from the patient directly preceding vaccination on 11-MAR-2013 and it indicated that the patient had had elevated C-reactive protein levels directly before she received the vaccine which may have been an indicator of the patient's declining condition. The relatedness between palpable purpura, vasculitis, urinary tract infection, profound weakness, anemia, sepsis and ZOSTAVAX was not reported. Outcome of all events was provided - not recovered (excluding sepsis). All events was considered to be life threatening by the reporter. Upon internal review sepsis was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: TYP
Symptoms: Throat tightness, Urticaria
Clinical narrative: Initial report was received 20 May 2013 from a health care professional. A female patient had received an injection of TYPHIM VI in 2010 (Sanofi Pasteur, lot number unknown; route, site of administration, and exact date of administration not provided). Following vaccination, the patient experienced hives and throat tightening. The patient was hospitalized for the symptoms. The reporter did not have any other information since the patient had received the vaccine at another facility and wasn't their patient at that time. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: 8" x 1" erythematous area (L) upper arm. No tx needed.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Thursday evening I was fine; woke to soreness in (R) shoulder on Friday a.m. Began feeling nauseated with extreme fatigue throughout day. Significant redness puffiness(2in. in diameter around injection sight). Ice & ibuprofen helped but these symptoms lasted for 3 days. Tenderness persists today-day # 4.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Tenderness
Clinical narrative: Thursday evening I was fine; woke to soreness in (R) shoulder on Friday a.m. Began feeling nauseated with extreme fatigue throughout day. Significant redness puffiness(2in. in diameter around injection sight). Ice & ibuprofen helped but these symptoms lasted for 3 days. Tenderness persists today-day # 4.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child was seen 2 days after immunization. He had an area 12 cm x 19 cm of erythema, swelling, increased temperature on left thigh. He had received BENADRYL at home. He was alert, playful and in NAD. No further treatment ws necessary.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a physician concerning a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number not provided) while she was pregnant. The LMP and EDD was not known. The patient was under the care of the reporting physician for seeking medical attention. The outcome of the pregnancy was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm, red area 5 cm diameter at injection site.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching and redness on injection site (SQ left arm) measuring 3 x 4 1/2 cm. Vaccine was administered 05/13/13; reaction occurred 05/14/13.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site pain
Clinical narrative: Patient started feeling extreme pain on quadriceps, after vaccines. No swelling or respiratory difficulty.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) upper arm red, swollen, hard, warm to touch, painful.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Injection site swelling
Clinical narrative: Minor swelling at injection site.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Nausea
Clinical narrative: Triamcinolone crm 0.1% rub into affected area bid prn. ZOFRAN 4mg tab q8 hrs for nausea #15 f/u prn.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Injection site erythema, Myalgia, Nausea, Pyrexia
Clinical narrative: Injection site red pepper 4 cm nausea-fever, myalgias, headache. Tx: Ice, TYLENOL, ondansetron
Age: 1.73
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Gait disturbance, Injection site bruising, Injection site erythema, Injection site rash, Pain
Clinical narrative: Red circular rash around left thigh injection site that appeared two or three days after receiving immunizations on 5/16/13. Has not grown in size, but has not gone away. Injection site on right thigh shows minor bruising and no redness. Patient had difficulty walking normally secondary to pain for only one day after the injections. The pain has since resolved and she is walking normally.
Age: 8.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given DTaP vaccine. Patient should have received the Tdap vaccine because he is 8 years old. No adverse side effects reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt states that she had full outbreak shingles on the 13th of May and still has shingles presently.