chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Skin lesion
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 month old female patient. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On 15-APR-2015 the patient was vaccinated on unspecified dose of (Merck) PROQUAD 0.5 ml, subcutaneous, lot #K020753, expiration date 30-APR-2016, (anatomical location and dose number were unspecified). Concomitant therapies were not reported. On 29-APR-2015, patient developed pyrexia and rash, with "too many lesions to count". The patient's mother sought medical attention by calling the reporter's office. No treatment was given for the adverse events. The outcome of pyrexia and rash was reported as not recovered. The relatedness between the events and (Merck) PROQUAD was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. Pertinent medical history and drug reactions/allergies were unspecified. On an unknown date the patient was inadvertently administered with second dose of ZOSTAVAX subcutaneous. Concomitant medications were unspecified. On an unspecified date over three years ago, the patient was administered with dose on of the vaccine. No adverse effects were reported. Outcome of the event, in appropriate schedule of drug administration was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with LIQUID PEDVAXHIB, lot # K008873, expiration datte: 06-FEB-2017 or lot # K008877, expiration date: 24-FEB-2017, (dose, administration route and site were not reported) after it was exposed to a supported temperature excursion of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with (Oka/Merck) VARIVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with (Oka/Merk) VARIVAX was unknown. This is one of the many reports from the same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Symptoms first reported 4/21/2015 Headaches-onset 4/18. "Feverish"-4/19 onset. Redness at and around injection site-4/19. Large swelling at and around injection site-onset 4/19.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on patient's medical history, drug reactions or allergies were provided. On 27-APR-2015, the patient was subcutaneously vaccinated with 0.65 ml dose of improperly stored ZOSTAVAX lot # K020801, expiration date 31-JAN-2016, in the right arm. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (lot number and expiry date unknown0 (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. This is one of the many reports from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture, Blood gases, Full blood count, Pyrexia, Tremor
Clinical narrative: Fever to 105, shaking in afternoon that 5-12-15 after fast fever rise.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urine analysis
Clinical narrative: Fever to 105, shaking in afternoon that 5-12-15 after fast fever rise.
Age: 0.9
Sex: F
Vaccine: PNC13
Symptoms: Angiogram, Antimitochondrial antibody, Basal ganglia stroke, Blood test, Computerised tomogram
Clinical narrative: Stroke, right side basal ganglia, left side hemiparisis. Immediate transport to emergency room, 4 days hospitalization in Pediatric ICU.
Age: 0.9
Sex: F
Vaccine: PNC13
Symptoms: DNA antibody, Hemiparesis, Intensive care, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Stroke, right side basal ganglia, left side hemiparisis. Immediate transport to emergency room, 4 days hospitalization in Pediatric ICU.
Age: 0.9
Sex: F
Vaccine: PNC13
Symptoms: Urine analysis, X-ray
Clinical narrative: Stroke, right side basal ganglia, left side hemiparisis. Immediate transport to emergency room, 4 days hospitalization in Pediatric ICU.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Nightmare, Pyrexia
Clinical narrative: High Fever, chills, nightmares, severe pain in injection sight.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unspecified dates in 2015, the patients were vaccinated with doses of PNEUMOVAX 23 (administration routes, lot numbers and expiration dates were not provided), which were exposed to a temperature outside of the recommended range since an unspecified date in "early February 2015". There was no adverse events reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) refers to a patient of unknown demographics. Pertinent medical history and drug reactions/allergies were unspecified. On an unspecified date the patient received an improperly stored dose of (Oka/Merck) VARIVAX. Concomitant medications were unspecified. No adverse effect was reported. This is one of the two reports received from the same reporter (MARRS # 1501USA011420). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registere Nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date over the last 15 months 48 doses of improperly stored (Oka/Merck) VARIVAX from unspecified lots were given to an unspecified number of patients. These 48 doses were exposed to 7C for an unspecified length of time before administration to those unspecified patients. There was no known adverse effects. This is one of the two reports from the same source. Additional informattion has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. On an unknown date approximately in 2015 (during time frame of improper storage) the patient was vaccinated with 1 dose of (Merck) VARIVAX (lot# K010336 and expiration date 22-JUL-2016) which was improperly stored at 7C from 07-JAN-2015 to 11-MAY-2015 subcutaneous. There was no known adverse effects. This is one of the two reports from the same source. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old male patient. The patient's medical history and current conditions were not provided. The patient had no known drug reactions or allergies. On 23-APR-2015 at 8:00, the patient was vaccinated with a dose of ZOTAVAX lot # K014835, expiration date 14-DEC-2015, subcutaneous in the right deltoid. Secondary suspects and concomitant therapies were not reported. On 23-APR-2015 at 13:00, the patient experienced redness extending down the length of his arm. It was unknown if the patient developed a rash. There was no treatment given for adverse event. The outcome of redness was reported as not recovered. The patient did not seek medical attention. The relatedness between redness and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 61 year old female patient, who was also a registered nurse via company representative, reporting on herself. No information on patient's medical history and drug reactions or allergies was provided. On 12-DEC-2013, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were not reported). Concomitant therapies included SINGULAIR, aspirin, ZYRTEC, DULERA, trazodone hydrochloride (manufacturer unknown) and PRILOSEC. On 20-APR-2015, the patient developed shingles. The patient advised that it was her third case of developing the shingles (the other dates were not specified). The outcome of shingles was unknown. The relatedness between the events and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date the patients were inadvertently vaccinated with improperly stored (Oka-Merck) PROQUAD (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with (Oka-Merck) PROQUAD was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with (Oka-Merck) PROQUAD was unknown. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 07-MAY-2015 was vaccinated with an expired dose of ZOSTAVAX (dose and route were not provided), lot # K003599 and expiration date on 13-MAR-2015. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX, lot # reported as K026384, expiration date reported as 15-MAY-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to a 16 year old male patient. On 01-APR-2015 the patient was vaccinated with (Merck) PROQUAD (lot # K020755, expiration date 30-APR-2016, dose not reported) subcutaneously (Inappropriate schedule of drug administration). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On an unspecified dates from 16-APR-2015 to 30-APR-2015, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # reported as K02338, expiration date 23-JUN-2016 (dose and route were not reported). The reporting nurse stated she had not researched the medical records, so it was unknown how many patients were involved. The nurse stated no adverse effects were experienced by any patient. This is the one of several reports from the same reporter's source. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 26 year old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 20-MAR-2007, the patient started vaccination course with GARDASIL 0.5ml, intramuscular (lot numbers and expiration dates were not reported). The patient had completed GARDASIL vaccination schedule in 2008. On 27-APR-2015, the patient was vaccinated with the fourth dose of GARDASIL, 0.5 ml, intramuscular (lot # and expiration date were not provided). No information on patient's concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fatigue, Headache, Pyrexia
Clinical narrative: This spontaneous report was received from a health care worker refers to a female patient of unknown age. Patient medical history and current conditions was not reported. On 05-MAY-2015 the patient was vaccinated with GARDASIL third dose, (Lot # K023432 and expiry date reported as 18-JUN-2016) of dose 0.5 ml via intramuscular route. Patient started therapy with the GARDASIL on 21-AUG-2014. On 5-MAY-2015 (reported as with 24 hours after receiving the third dose of GARDASIL on 5-MAY-2015) the patient experienced low grade fever, headache, stomach ache and fatigue. No treatment was given to the patient. Product quality complaint was not reported. The outcome of the events was unknown. Causality assessment was not provided by the reporter. This is one of the two reports concerns siblings (1505USA005286). Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 21 month old patient of unknown gender. No medical history was reported. The patient received 3 doses of an unspecified Hib Vaccine on 04-DEC-2013, 04-MAR-2014 and 16-JUN-2014. On 30-APR-2015, the patient was then vaccinated with improperly stored PEDVAXHIB (lot # K019700, exp. 16-JUL-2017, intramuscular, dose not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the events was unknown. The events were considered to be not related to PEDVAXHIB. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Alopecia, Anxiety, Arthralgia, Myalgia
Clinical narrative: Information has been received from a Nurse Practitioner via a field employee concerning a 19 year old female patient with no pertinent medical history or drug reactions. The patient was vaccinated with three doses of GARDASIL (dose, lot number and expired date not reported, intramuscular) on 12-AUG-2011, 12-OCT-2011 and 15-MAR-2012 respectively. On unknown dates in 2011 the patient experienced muscle and joint pain, bloating, hair loss and anxiety. The patient sought medical attention by office visit. On an unknown date, unspecified lab diagnostic studies were performed. The patient had not recovered from the events. No treatment was given to the patient. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fatigue, Headache, Pyrexia
Clinical narrative: This spontaneous report was received from a health care worker refers to a male patient of unknown age. Patient medical history and current condition was not reported. On 05-MAY-2015 the patient was vaccinated with GARDASIL third dose, (Lot # K023432 and expiry date reported as 18-JUN-2016) of dose 0.5 ml via intramuscular route. Patient started therapy with the GARDASIL on 21-AUG-2014. On 5-MAY-2015 (reported as within 24 hours after receiving the third dose of GARDASIL on 5-MAY-2015) the patient experience low grade fever, headache, stomach ache and fatigue. No treatment was given to the patient. Product quality complaint was not reported. The outcome of the events was unknown. Causality assessment was not provided by the reporter. This is one of the two reports concerns siblings (1505USA005396). Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient developed chicken pox from varicella vaccine.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: High fevers Tmax 104, chills, headache, nausea.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to a 16 year old female patient. On 01-APR-2015 the patient was vaccinated with (Merck) PROQUAD (lot # K020755, expiration date 30-APR-2016, dose was not reported), subcutaneously (Inappropriate schedule of drug administration). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of unspecified patients. On an unspecified day in May 2015 (reported as 07-MAY-2015 or 08-MAY-2015), the patients were vaccinated with unspecified number of doses of improperly MMR II (lot# not reported, subcutaneously). No adverse event were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and referred to a male patient of unknown age. No pertinent medical history, drug reactions or allergies were reported. It was reported that the patient received 2 doses of ZOSTAVAX (lot #, expiration date, strength, dose, frequency and route of administration were not reported) vial 19400 (plaque-forming units (PFU). He received a first dose on 09-NOV-2012 and a second dose on 29-APR-2015. No adverse symptoms were reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Allergy test, Biopsy skin, Dehydration, Lethargy, Nausea
Clinical narrative: Information has been received from a physician assistant referring to a 63 year old female patient with hypertension, hypothyroidism, gastric esophageal reflux disease. The patient has multple allergies to morphine, contrast dye, textile dye and methyldibromo glutaronitrile. On 13-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (strength, lot#, dosage, frequency and route unspecified) for prevention of pneumococcal virus. Concomitant therapies included bisoprolol, colestipol hydrochloride, KLOR-CON, LASIX, amlodipine, SYNTHROID and ropinirole. In approximately September 2014, "a few days" after receiving the vaccination, the patient began to experienced dehydration, rash, swelling, lethargy, aching, vomiting and nausea. Physician assistant described the rash as an "urticarial scaling dermatitis-like rash" over an unspecified area of the patient's body. The patient was seen by physician assistant and skin patch testing, allergy testing, rash biopsy were performed two times. The patient received unspecified dose of intravenous fluids at an emergency room on an unspecified date due to dehydration. The patient had had "all kinds" of unspecified treatments, provided on unspecified dates and also the patient was given an dose of an unspecified topical steroid (manufacturer unspecified). The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash, Skin test, Swelling, Urticaria
Clinical narrative: Information has been received from a physician assistant referring to a 63 year old female patient with hypertension, hypothyroidism, gastric esophageal reflux disease. The patient has multple allergies to morphine, contrast dye, textile dye and methyldibromo glutaronitrile. On 13-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (strength, lot#, dosage, frequency and route unspecified) for prevention of pneumococcal virus. Concomitant therapies included bisoprolol, colestipol hydrochloride, KLOR-CON, LASIX, amlodipine, SYNTHROID and ropinirole. In approximately September 2014, "a few days" after receiving the vaccination, the patient began to experienced dehydration, rash, swelling, lethargy, aching, vomiting and nausea. Physician assistant described the rash as an "urticarial scaling dermatitis-like rash" over an unspecified area of the patient's body. The patient was seen by physician assistant and skin patch testing, allergy testing, rash biopsy were performed two times. The patient received unspecified dose of intravenous fluids at an emergency room on an unspecified date due to dehydration. The patient had had "all kinds" of unspecified treatments, provided on unspecified dates and also the patient was given an dose of an unspecified topical steroid (manufacturer unspecified). The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician assistant referring to a 63 year old female patient with hypertension, hypothyroidism, gastric esophageal reflux disease. The patient has multple allergies to morphine, contrast dye, textile dye and methyldibromo glutaronitrile. On 13-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (strength, lot#, dosage, frequency and route unspecified) for prevention of pneumococcal virus. Concomitant therapies included bisoprolol, colestipol hydrochloride, KLOR-CON, LASIX, amlodipine, SYNTHROID and ropinirole. In approximately September 2014, "a few days" after receiving the vaccination, the patient began to experienced dehydration, rash, swelling, lethargy, aching, vomiting and nausea. Physician assistant described the rash as an "urticarial scaling dermatitis-like rash" over an unspecified area of the patient's body. The patient was seen by physician assistant and skin patch testing, allergy testing, rash biopsy were performed two times. The patient received unspecified dose of intravenous fluids at an emergency room on an unspecified date due to dehydration. The patient had had "all kinds" of unspecified treatments, provided on unspecified dates and also the patient was given an dose of an unspecified topical steroid (manufacturer unspecified). The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. From 16-APR-2015 to 30-APR-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The reporting nurse stated she had no researched the medical records, so it was unknown how many patients were involved. The nurse stated no adverse effects were experienced by any patient. This is the one of the several reports from the same reporter's source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. The reporter stated that patient was vaccinated with first dose of GARDASIL (dose strength, route unspecified) approximately on an unknown date in 2012 (reported as 3 years ago). Approximately on 13-APR-2015 (reported as 3 weeks ago) the patient was vaccinated with GARDASIL (dose strength, route unspecified) dose 2. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV2
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. From 16-APR-2015 to 30-APR-2015, the patients were vaccinated with improperly stored GARDASIL (dose, route, lot # and expiration date were not provided). The reporting nurse stated she had not researched the medical records, so it was unknown how many patients were involved. The nurse stated no adverse effects were experienced by any patient. This is the one of several reports from the same reporter's source. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a 63 year old male patient concerning himself who was involved in a patient assistant program. The patient's medical history includes herpes. The patient was allergy to penicillin. On 27-APR-2015 the patient was vaccinated with ZOSTAVAX (dose, lot #, and route were not reported, strength: 19400 PFU). Concomitant therapies included FLOMAX. On 27-APR-2015, the patient was itchy after receiving ZOSTAVAX. No treatment was given for the event. No lab diagnostics studies were performed. The patient had not sought medical attention. The outcome of the event was reported as recovered on 28-APR-2015. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chest pain, Chills, Dyspnoea, Headache
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) refers to a 15 year old female patient. The concurrent condition of the patient included exercise induced asthma and penicillin allergy. On an unknown date sometime in October 2014, the patient was vaccinated with dose 1 of GARDASIL (injection dose unknown) by an unspecified physician, Concomitant medications were unspecified. On an unknown date the patient was vaccinated with its second dose. On 13-APR-2015, the patient was vaccinated with third dose of GARDASIL at unspecified facility and by unspecified physician. After receiving the third dose of vaccine, the patient experienced fever, tremors, chills, a very bad headache, chest pains and shortness of breath. On 13-APR-2015, the patient visited to emergency room of unspecified physician and received TYLENOL (unspecified dose/frequency and manufacturer) for the treatment of the adverse events. The patient visited to same emergency room again on 14-APR-2015 and received MOTRIN and prednisone as treatment. On an unknown date, blood tests were performed, the results of which were unknown. It was confirmed that the patient received all the three doses of GARDASIL. The outcome of the events were reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Tremor
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) refers to a 15 year old female patient. The concurrent condition of the patient included exercise induced asthma and penicillin allergy. On an unknown date sometime in October 2014, the patient was vaccinated with dose 1 of GARDASIL (injection dose unknown) by an unspecified physician, Concomitant medications were unspecified. On an unknown date the patient was vaccinated with its second dose. On 13-APR-2015, the patient was vaccinated with third dose of GARDASIL at unspecified facility and by unspecified physician. After receiving the third dose of vaccine, the patient experienced fever, tremors, chills, a very bad headache, chest pains and shortness of breath. On 13-APR-2015, the patient visited to emergency room of unspecified physician and received TYLENOL (unspecified dose/frequency and manufacturer) for the treatment of the adverse events. The patient visited to same emergency room again on 14-APR-2015 and received MOTRIN and prednisone as treatment. On an unknown date, blood tests were performed, the results of which were unknown. It was confirmed that the patient received all the three doses of GARDASIL. The outcome of the events were reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Back pain, Facial pain, Hypopnoea
Clinical narrative: Next day-neck/shoulder spasms-jaw pain-back pain ER visit-FLEXERIL/PERCOCET-2 days later-ER-still in spasms and pain-injection for pain-3 days later orthopedic exam and xrays-pain not caused by neck-fever/chilld face pain-weakness-shallow breathing.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: Next day-neck/shoulder spasms-jaw pain-back pain ER visit-FLEXERIL/PERCOCET-2 days later-ER-still in spasms and pain-injection for pain-3 days later orthopedic exam and xrays-pain not caused by neck-fever/chilld face pain-weakness-shallow breathing.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: Information has been received from the authors, in a literature published and reported that invasive pneumococcal disease (IPD) results in an estimated 5000 deaths annually. Reduction in morbidity and mortality associated with IPD in vaccinated patients, has led the ACIP to recommended routine vaccination in high-risk patients, Hospitalization provides an opportunity for immunization, thus agency had previously recommended screening every admitted patient for immunization. Most of locals hospitals have incorporated a pneumococcal immunization policy into the admission process. Although intended to be beneficial, it may result in immunization of patients not meeting stated ACIP criteria, or unwarranted repeat immunizations with studies suggesting that such practices may actually decrease immunity and thus be conterproductive. In an attempt to identify those patients not meeting ACIP immunization criteria but vaccinated anyway to meet hospital's vaccination protocol, the authors retrospectively reviewed tthe records of 661 patients admitted to the hospital and reported that on an unspecified date 53 elderly patients, were vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dosage, strength, lot # and expiration date were not reported) more than once. The authors also reported that they suspected the actual number of elderly patient revaccinated was higher as a lot of them could not recall previous vaccination and were thus vaccination again. This is one of several reports received from the same reporter. (MARRS # 1505USA000357). A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Pt got his PREVNAR 13 on 4/20/2015. He came in on 5/14/2015 and said he has rashes and itch all over his body.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Drug administration error, Injection site haemorrhage
Clinical narrative: When adminstering BOOSTRIX vaccine used 18 gauge needle instead of 25 gauge, pt bleed at injection site (right deltoid) and believe lost most of the vaccine.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: When adminstering BOOSTRIX vaccine used 18 gauge needle instead of 25 gauge, pt bleed at injection site (right deltoid) and believe lost most of the vaccine.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Rash erythematous, Rash generalised
Clinical narrative: After 6 days (5-10-15) the shot area turned red, itchy and my arms, hands, feet, legs and face became red and developed red rash. Took antihistamine, next day rash disappeared and only red skin remained another day. Puncture site is still red and itchy.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with PNEUMOVAX 23, lot # K007824, expiration date: 05-NOV-2015, (dose, adminsitration route and site were not reported) after it was exposed to a supported temperature excursion of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with VAQTA, lot # J016216, expiration date: 18-AUG-2016, (dose, administration route and site were not reported) after it was exposed to a supported temperature excursion of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, mulitple unspecified patients were vaccinated with COMVAX, lot # J013884, expiration date: 19-AUG-2016, (dose, administration route and site were not reported) after it was exposed to a supported temperature excursion of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from a health care professional refers to an unspecified number of patients. This is a market research program conducted by HRA. It was stated that in the last 3 months, in 2015, the reporter had seen or heard the PREVNAR 13 was the first vaccine that was to be given when a patient required a PNEUMOVAX 23 in 8 weeks and one additional dose of PNEUMOVAX 23 could be given after age 65. It was reproted that due to PREVNAR 13 formulation, a better immune response developed when given prior to the PNEUMOVAX 23. One dose was all that was ever needed of PREVNAR 13. At the time of the report, the patient's outcomes were unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Injection site reaction, Malaise, Pyrexia
Clinical narrative: Pt's wife wanted it reported on VAERS that pt experienced decrease appetite, malaise, chills, low-grade fever four days after receiving his vaccine. He also had a quarter-sized welt at the injection site. I informed her that those were not uncommon reaction, but she wanted it reported none the less.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Pt's wife wanted it reported on VAERS that pt experienced decrease appetite, malaise, chills, low-grade fever four days after receiving his vaccine. He also had a quarter-sized welt at the injection site. I informed her that those were not uncommon reaction, but she wanted it reported none the less.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Rash vesicular
Clinical narrative: 2 days after getting ZOSTAVAX pt presents to my office w/ herpetiform rash (L) chest (L) breast and malaise no fever. Still being treated w/ VALTREX.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Arthralgia, Cheilitis, Erythema, Peripheral swelling, Rash
Clinical narrative: "Rash" on face, chest and back. Hand joint pn w/ slight finger swelling and slight redness on both hands and upper lip and cheeks.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Developed rash on abdomen 1st day post vaccination. Not itchy. Then developed rash on trunk and legs. No injection site rash or reaction. Went to tanning bed day after vaccination.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Rash
Clinical narrative: Myalgia and skin rash. Diphenhydramine 25 mg TID.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a health care professional refers to an unspecified number of patients. This is a market research program conducted. It was stated in the last 3 months, the reporter had seen or heard about a new protocol to give PREVNAR 13 first then give PNEUMOVAX23 (dose, route, lot # and expiration date were not provided) and then 10 years later do PNEUMOVAX23 again which was considered an inappropriate schedule of drug administration. At the time of the report, the patient's outcome were unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Depression, Fatigue, Feeling cold, Urinary tract infection
Clinical narrative: Fatigue, lost of appetite, cold sensations, depress feeling.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Contusion, Erythema, Hypersensitivity
Clinical narrative: Allergic reaction to vaccines. Received three vaccines on 5/12/15. Bilateral arms pink yesterday 05/13/2015 with bruising on left arm. Increased redness today 05/14/2015.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal injury, Dizziness, Dysarthria, Fall, Head injury
Clinical narrative: Patient was checking out at reception desk, felt dizzy, started slurring words and fell. Patient hit her head on desk and floor. Also hit the side of her abdomen on floor. Patient was immediately brought back into office and evaluated by provider. Patient was given juice and crackers. Did state she did not eat before vaccination. Patient did start to feel better, and friend picked her up from office.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Skin rash, urticaria pruritus, swelling. Prednisone PO, hydrocortisone BID.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a "child" patient of unknown age with no pertinent medical history/drug allergies or drug reactions reported. On 06-MAY-2015, the patient was accidentally vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot# and expiration date were not reported) instead of (Merck) PROQUAD. There was not concomitant therapy reported. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age/gender. The patients' concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency, route, lot number and expiration date were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: A red, warm, hard 9 cm spot that  formed around the injection site.  Started on clindamycin for cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Left upper arm had 4" x 4" localized reaction to KINRIX vaccination. Red in color, warm to touch.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Eye movement disorder, Feeling abnormal, Loss of consciousness, Muscle twitching, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient stated she felt weird 1-2 minutes after injection. Patient then lost color in her face, eyes rolled back, had muscle twitching, urinated on herself, and lost consciousness for 15-20 seconds. This happened from 10:18 am -10:20 am - patient regained consciousness.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Urinary incontinence
Clinical narrative: Patient stated she felt weird 1-2 minutes after injection. Patient then lost color in her face, eyes rolled back, had muscle twitching, urinated on herself, and lost consciousness for 15-20 seconds. This happened from 10:18 am -10:20 am - patient regained consciousness.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema multiforme, Injection site reaction, Skin lesion
Clinical narrative: TDAP given 5/11/15. Developed 2 lesions right upper arm-day later. Developed one lesion right wrist 5/13/15. Dx. erythema multiforme. No tx.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Pain in extremity, Pyrexia
Clinical narrative: 2 hours after shot, fever 102 degrees F, ache/pain in limbs, tired, lump at site:(lasted 2 weeks) other symptoms lasted a day and a half.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth to administration area extending down R Bicep. Tx with 25mg Benadryl PO 1-2 tab Q6h.
Age: 23.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: 4/27/15 Reports that had more right arm discomfort than left through the day after vaccine given. The evening began to notice swelling with raised redness with also 3 circular red areas on right shoulder; describes as "welt like and itchy". Also noted on left arm "above the elbow and between the elbow and forearm, has two separate patchy red areas", but nothing at the injection site. The arm soreness improved by 4/26/15 and better on 4/27/15. Denied and shortness of breath or other sx. Was instructed to go to see a Dr. Reports on 5/14/15 that had f/u with a Dr. and received a steroid injection on 4/27/15. on 5/14/15 reports that later an area appeared on the left deltoid and that the areas are "slowly going away but still notices a different skin pigmentation where the lesions were. Denies other complaints.
Age: 23.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Limb discomfort, Pigmentation disorder, Urticaria
Clinical narrative: 4/27/15 Reports that had more right arm discomfort than left through the day after vaccine given. The evening began to notice swelling with raised redness with also 3 circular red areas on right shoulder; describes as "welt like and itchy". Also noted on left arm "above the elbow and between the elbow and forearm, has two separate patchy red areas", but nothing at the injection site. The arm soreness improved by 4/26/15 and better on 4/27/15. Denied and shortness of breath or other sx. Was instructed to go to see a Dr. Reports on 5/14/15 that had f/u with a Dr. and received a steroid injection on 4/27/15. on 5/14/15 reports that later an area appeared on the left deltoid and that the areas are "slowly going away but still notices a different skin pigmentation where the lesions were. Denies other complaints.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Odynophagia, Oropharyngeal pain
Clinical narrative: Reports on 3/9/15 that late in evening on 3/2/15 date of vaccine that began to have a "sore throat"; awoke at 2 am and had more discomfort and "Pain with swallowing". The pain continued through the next day, slightly relieved with Ibuprofen. Described the pain as being "only in the left side of the throat, pointing to below the chin and inner neck". On 3/10/15 Saw Dr. and was given an order to continue the series and take Benadryl prior to next dose.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash erythematous, Vomiting
Clinical narrative: Monday 5/11 onset erythematous confluent skin rash on trunk. Wed onset low grade fever and vomiting. Vomiting resolved this morning. Skin rash spread to face, but is now resolving on body.
Age: 48.0
Sex: M
Vaccine: RAB
Symptoms: Chest discomfort, Headache, Pain, Productive cough, Pyrexia
Clinical narrative: Received vaccine on 3/2/15 and did not have any problems until on 3/7/15 awoke with "headache, chest congestion/tightness, loose cough, and little fever and hurt all over. Spoke to client on 3/9/15 and still continued with headache and cough. Continued with illness until better to vaccinate with second vaccine on 3/23/15.
Age: 48.0
Sex: M
Vaccine: RAB
Symptoms: Respiratory tract congestion
Clinical narrative: Received vaccine on 3/2/15 and did not have any problems until on 3/7/15 awoke with "headache, chest congestion/tightness, loose cough, and little fever and hurt all over. Spoke to client on 3/9/15 and still continued with headache and cough. Continued with illness until better to vaccinate with second vaccine on 3/23/15.
Age: 57.0
Sex: M
Vaccine: RAB
Symptoms: Chest discomfort, Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Received vaccine on 3/2/15 and was well and without complaints until on 3/5/15 had a high fever, chest congestion and tightness and loose cough. Took Nyquil. Had up to a 102 degree fever until it "broke" at 10:30 pm on 3/8/15. Spoke with Novartis, and CDC and health department and will delay further dose until well.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Mass, Pain, Pruritus
Clinical narrative: Painful and itchy red lump, hot to the touch,  4" in diameter. As of 5/14/15 lump is still growing.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness where vaccine was administered, inconsolable crying. Spoke with pediatrician and applied warm compress to area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site mass
Clinical narrative: Lump about the size of quarter on thigh where shot was administered.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: The nurse made and error and administer the MMR dose that was supposed to go for my younger son to my older one, who had already completed his second MMR on 2008. As a consequence my older son got a third dose of MMR.