chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site movement impairment, Injection site swelling, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 34 year old female patient with dermatomyositis, rheumatoid arthritis and none drug reaction or allergies. On 18-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, intramuscular, in the arm, lot# K007262 with expiry date: 25-NOV-2015). Concomitant therapies included biotin, prednisone (manufacturer unknown), omeprazole (manufacturer unknown) and calcium. On 18-NOV-2014, the patient experienced severe muscle weakness, pain in the arm, redness and swelling from injection site, across the anterior arm to the axilla and difficulty moving the injection site arm after receiving PNEUMOVAX 23. There was none lab diagnostic studies performed. The patient was treated with ice to site, tramadol and KEFLEX. The patient sought medical attention via visiting an urgent care and a physician. The outcome of events was not reported. The relatedness between events and PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 22-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reports as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2014 from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 9, units not reported) of unknown gender. On 10-NOV-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored VAQTA (dose, route of administration and lot # were not reported). It was reported that the vaccine was exposed to 1 degree C for 48 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient. On 27-OCT-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous (lot # not reported). On unknown date in 2014 the patient developed an injection site reaction of redness and severe pain. Moreover the injection site area felt like there was a "nodule". The patient sought medical attention and the physician prescribed unspecified antibiotics as a treatment. The outcome of injection site area felt like there was a "nodule" and an injection site reaction of redness and severe pain was unknown. Relatedness between the events and ZOSTAVAX was not specified. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified amount of patients (demographics unknown). Pertinent medical history, drug allergies or reactions were not reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (dose, lot numbers and route were not reported) that underwent temperature excursions. Concomitant medication was not reported. No adverse effect reported. This is one of several 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 healthcare worker refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 21-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J003808, expiry date 03-JUL-2014, 0.65 ml/once) subcutaneously. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 21-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a patient of 7 years old child patient and unknown gender. On 12-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 09-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 02-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender. On 06-NOV-2014, the patient was vaccinated with improperly stored GARDASIL (dose: 0.5 ml, intramuscular, lot # K004205, expiration date 12-JAN-2017, anatomical location not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Blood immunoglobulin M increased, Measles antibody positive, Rash, Rash pruritic, Streptococcus test positive
Clinical narrative: This spontaneous report as received from a nurse refers to her 14 months old (currently 15 month old) daughter. In September 2014, when the patient was 13 months old, the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, lot number, expiration date were not reported). In October 2014, on an unspecified date, the patient experienced a rash, which started on her legs and spread to her head. The rash was itchy but there was no fever. The nurse took her daughter to consult an unspecified dermatologist on an unspecified date in 2014. Approximately in 2014, blood titers tests for strep, rubella and varicella were performed. The dermatologist found that the child had increased levels of IGM for rubella. The outcome od the events was not reported. Relatedness between the events and vaccination with M-M-R II was not reported. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Varicella virus test positive
Clinical narrative: This spontaneous report as received from a nurse refers to her 14 months old (currently 15 month old) daughter. In September 2014, when the patient was 13 months old, the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, lot number, expiration date were not reported). In October 2014, on an unspecified date, the patient experienced a rash, which started on her legs and spread to her head. The rash was itchy but there was no fever. The nurse took her daughter to consult an unspecified dermatologist on an unspecified date in 2014. Approximately in 2014, blood titers tests for strep, rubella and varicella were performed. The dermatologist found that the child had increased levels of IGM for rubella. The outcome od the events was not reported. Relatedness between the events and vaccination with M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 17-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 06-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified amount of patients of unknown age and gender. Nurse stated that on an unknown date in 2014 within the past 2 weeks an unspecified amount of patients were vaccinated with a dose of RECOMBIVAX HB which was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 16-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 29-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 29-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J003453, expiry date: 25-MAR-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a  other health professional (registered nurse) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Since 05-NOV-2014, patients were administered with GARDASIL (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, GARDASIL was exposed to temperatures (9 degree for 6 hours) out of the recommended range and administered to unspecified patients. It was reported that the nurse was not aware of any adverse effects. At the time of this report, the excursion has not ended. It was reported to nurse that as per stability assessment data, GARDASIL would not be adversely affected by this specific temperature excursion. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014, who stated that it would take some time to get the VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age was reported as 10, units not reported) of unknown gender. On 29-OCT-2014, the patient was vaccinated with a dose of VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014, who stated that it would take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age reported as 5, units not reported) of unknown gender. On 29-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified amount of patients of unknown age and gender. Nurse stated that on an unknown date in 2014 within the past 2 weeks an unspecified amount of patients were vaccinated with a dose of GARDASIL which was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receive from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 26-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored RECOMBIVAX HB (dose, route of administration and lot # were not reported). It was reported that the vaccine was exposed to 1 degree C for 48 hours. 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: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On approxiamtely 17-OCT-2014 (reported as about 3 weeks ago), the patient was inadvertently administered a 2nd dose of VAQTA (Lot #, dose and route not reported), which was only 1 month after the 1st dose (applied on approximately 17-SEP-2014). Concomitant therapy was not reported. No adverse effects reported. 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 medical assistant refers to a patient of unknown age and gender. On 18-NOV-2014, the patient was vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneous (lot number and expiration date were not reported) that underwent a supported temperature excursion. No adverse experience 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 medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 25-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J003528, expiry date: 25-MAR-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse via field representative on 19-NOV-2014 refers to a 16 year old female patient. On an unknown date the patient was vaccinated with her first dose of GARDASIL. Concomitant therapies included MENACTRA and hepatitis a virus vaccine (unspecified). On an unknown date the patient fainted for thirty minutes after receiving her first dose of GARDASIL. The event outcome was recovered. The patient sought medical attention via office visit on an unknown date. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a practice administrator refers to a patient of unknown age and gender. The administrator reported that on 10-NOV-2014, a nurse gave the patient an expired dose of ZOSTAVAX (expiry 30-SEP-3014). No adverse effect noted. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 26-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored GARDASIL (dose, route of administration and lot # were not reported). It was reported that the vaccine was exposed to 1C for 48 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to an approximately 12 year old female patient. Patient was not pregnant. Current conditions and medical history was reported as none. On 05-NOV-2014, the patient was vaccinated with GARDASIL injection 120 Y (dose, route and frequency was not reported). Lot number was reported as 6512156 and expiry date was February 2016. Concomitant therapies included ALLEGRA. On 06-NOV-2014, the patient experienced a reaction to GARDASIL and had redness and a rash around the injection site which was swollen and patient's arm hurt. No treatment was given for the events. No lab diagnostics studies performed. The outcome of the events was reported as recovering. Causality assessment was not reported. Product quality complaint was not reported.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 03-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from registered nurse (who worked in a health clinic) refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II (dosing details and lot number unknown). On an unknown date, a routine titer testing was done and an unspecified number of patients had negative titers for MMR. Some patients decided not to receive a booster M-M-R II dose. The outcome of the negative MMR titers was unknown. No product quality complaint was involved. Causality assessment was not provided. This is one of the two reports 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 other health professional (registered nurse) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Since 05-NOV-2014, patient were administered with VAQTA injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, VAQTA vaccine was exposed to temperature (9 degree for 6 hours) out of the recommended range and administered to unspecified patients. It was reported that the nurse was not aware of any adverse effects. At the time of this report, the excursion has not ended. It was reported to nurse that as per stability assessment data, VAQTA would not be adversely affected by this specific temperature excursion. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014, who stated that it would take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age reported as 5, units not reported) of unknown gener. On 28-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Case number PHEH2014US023147 is an initial spontaneous report received from a nurse on 14 Nov 2014. This report refers to a 47 years old male patient. His medical history included sickness over the weekend prior to vaccination. His current condition included allergy to BACTRIM. His concomitant medications were not reported. His vaccination history included prior administration of FLUVIRIN, (batch number: not reported) and FLUZONE, (other manufacturer, batch number: not reported) which were well tolerated. He was vaccinated with FLUVIRIN, (batch number: 146505) intramuscularly on 10 Nov 2014. It was reported that approximately 1 hour after vaccination; he experienced diaphoresis, vertigo, shortness of breath, chest pressure, severe nausea and vomiting. The nurse reported that he did not receive any other vaccination on that day. The events outcome was unknown. The seriousness of the event was not reported, but events shortness of breath and chest discomfort were upgraded as medically significant as per information available on the source documents. The causality of the events was not reported.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHEH2014US023147 is an initial spontaneous report received from a nurse on 14 Nov 2014. This report refers to a 47 years old male patient. His medical history included sickness over the weekend prior to vaccination. His current condition included allergy to BACTRIM. His concomitant medications were not reported. His vaccination history included prior administration of FLUVIRIN, (batch number: not reported) and FLUZONE, (other manufacturer, batch number: not reported) which were well tolerated. He was vaccinated with FLUVIRIN, (batch number: 146505) intramuscularly on 10 Nov 2014. It was reported that approximately 1 hour after vaccination; he experienced diaphoresis, vertigo, shortness of breath, chest pressure, severe nausea and vomiting. The nurse reported that he did not receive any other vaccination on that day. The events outcome was unknown. The seriousness of the event was not reported, but events shortness of breath and chest discomfort were upgraded as medically significant as per information available on the source documents. The causality of the events was not reported.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis, Nausea, Vertigo
Clinical narrative: Case number PHEH2014US023147 is an initial spontaneous report received from a nurse on 14 Nov 2014. This report refers to a 47 years old male patient. His medical history included sickness over the weekend prior to vaccination. His current condition included allergy to BACTRIM. His concomitant medications were not reported. His vaccination history included prior administration of FLUVIRIN, (batch number: not reported) and FLUZONE, (other manufacturer, batch number: not reported) which were well tolerated. He was vaccinated with FLUVIRIN, (batch number: 146505) intramuscularly on 10 Nov 2014. It was reported that approximately 1 hour after vaccination; he experienced diaphoresis, vertigo, shortness of breath, chest pressure, severe nausea and vomiting. The nurse reported that he did not receive any other vaccination on that day. The events outcome was unknown. The seriousness of the event was not reported, but events shortness of breath and chest discomfort were upgraded as medically significant as per information available on the source documents. The causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No medical history or concurrent conditions were reported. On 22-SEP-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous route (1 time shot; Lot number: K007984). Co-suspect or concomitant therapies were reported. On approximately 2014, reported as "after receiving ZOSTAVAX", the patient experienced rash 2 inches in diameter at the injection site. Patient sought medical attention. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Follow up information has been received from the pharmacist on 21-NOV-2014. On 22-SEP-2014, at 2:00 PM, the patient was vaccinated with the first dose of ZOSTAVAX (lot # K007984, dose not reported), subcutaneous (SC) in the right deltoid and the first dose of FLUVIRIN (lot# 141101, dose not reported, Novartis), intramuscular (IM) in left deltoid at the pharmacy. After received ZOSTAVAX, later after at 2:00 PM on 22-SEP-2014, the patient developed red itchy, hot rash, so the patient went to MD care and received CIPRO. On 23-SEP-2014 (reported as next day), the patient experienced larger rash and blister and admitted to hospital for suspected cellulitis. The outcome of itchy, hot rash, blister and cellulitis was recovered on an unspecified date in 2014. Additional information is not expected. Patient, product, event and narrative were updated.
Age: 66.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Blister, Cellulitis, Injection site rash, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No medical history or concurrent conditions were reported. On 22-SEP-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous route (1 time shot; Lot number: K007984). Co-suspect or concomitant therapies were reported. On approximately 2014, reported as "after receiving ZOSTAVAX", the patient experienced rash 2 inches in diameter at the injection site. Patient sought medical attention. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Follow up information has been received from the pharmacist on 21-NOV-2014. On 22-SEP-2014, at 2:00 PM, the patient was vaccinated with the first dose of ZOSTAVAX (lot # K007984, dose not reported), subcutaneous (SC) in the right deltoid and the first dose of FLUVIRIN (lot# 141101, dose not reported, Novartis), intramuscular (IM) in left deltoid at the pharmacy. After received ZOSTAVAX, later after at 2:00 PM on 22-SEP-2014, the patient developed red itchy, hot rash, so the patient went to MD care and received CIPRO. On 23-SEP-2014 (reported as next day), the patient experienced larger rash and blister and admitted to hospital for suspected cellulitis. The outcome of itchy, hot rash, blister and cellulitis was recovered on an unspecified date in 2014. Additional information is not expected. Patient, product, event and narrative were updated.
Age: 66.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No medical history or concurrent conditions were reported. On 22-SEP-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous route (1 time shot; Lot number: K007984). Co-suspect or concomitant therapies were reported. On approximately 2014, reported as "after receiving ZOSTAVAX", the patient experienced rash 2 inches in diameter at the injection site. Patient sought medical attention. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Follow up information has been received from the pharmacist on 21-NOV-2014. On 22-SEP-2014, at 2:00 PM, the patient was vaccinated with the first dose of ZOSTAVAX (lot # K007984, dose not reported), subcutaneous (SC) in the right deltoid and the first dose of FLUVIRIN (lot# 141101, dose not reported, Novartis), intramuscular (IM) in left deltoid at the pharmacy. After received ZOSTAVAX, later after at 2:00 PM on 22-SEP-2014, the patient developed red itchy, hot rash, so the patient went to MD care and received CIPRO. On 23-SEP-2014 (reported as next day), the patient experienced larger rash and blister and admitted to hospital for suspected cellulitis. The outcome of itchy, hot rash, blister and cellulitis was recovered on an unspecified date in 2014. Additional information is not expected. Patient, product, event and narrative were updated.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Anuria, Blood pressure decreased, Diarrhoea, Haematochezia, Intensive care
Clinical narrative: This spontaneous report as received from a nurse practitioner (also reported as: administrator) via company representative refers to a 80 year old female patient with celiac disease. On 20-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, anatomical location, route of administration were not reported, lot# reported as: K010523). Other suspect therapies included high dose of influenza virus vaccine administered on the same day, in the afternoon, during well-visit with a doctor. Then the patient went out to dinner. Later that night (20-NOV-2014), the patient experienced severe GI (gastrointestinal) symptoms such as bloody stool, diarrhea, low blood pressure and went into shock. The patient was rushed to the hospital where she was placed in intensive care unit (November 2014). The outcome of the events was not reported. The relatedness between the therapy with PNEUMOVAX 23 and the events was not reported. Upon internal review the event of shock was determined to be medically significant. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Laboratory test, Mucous stools, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner (also reported as: administrator) via company representative refers to a 80 year old female patient with celiac disease. On 20-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, anatomical location, route of administration were not reported, lot# reported as: K010523). Other suspect therapies included high dose of influenza virus vaccine administered on the same day, in the afternoon, during well-visit with a doctor. Then the patient went out to dinner. Later that night (20-NOV-2014), the patient experienced severe GI (gastrointestinal) symptoms such as bloody stool, diarrhea, low blood pressure and went into shock. The patient was rushed to the hospital where she was placed in intensive care unit (November 2014). The outcome of the events was not reported. The relatedness between the therapy with PNEUMOVAX 23 and the events was not reported. Upon internal review the event of shock was determined to be medically significant. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Mucous stools
Clinical narrative: This spontaneous report as received from a nurse practitioner (also reported as: administrator) via company representative refers to a 80 year old female patient with celiac disease. On 20-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, anatomical location, route of administration were not reported, lot# reported as: K010523). Other suspect therapies included high dose of influenza virus vaccine administered on the same day, in the afternoon, during well-visit with a doctor. Then the patient went out to dinner. Later that night (20-NOV-2014), the patient experienced severe GI (gastrointestinal) symptoms such as bloody stool, diarrhea, low blood pressure and went into shock. The patient was rushed to the hospital where she was placed in intensive care unit (November 2014). The outcome of the events was not reported. The relatedness between the therapy with PNEUMOVAX 23 and the events was not reported. Upon internal review the event of shock was determined to be medically significant. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Diarrhoea, Gastrointestinal disorder, Haematochezia, Hypotension, Intensive care
Clinical narrative: This spontaneous report as received from a nurse practitioner (also reported as: administrator) via company representative refers to a 80 year old female patient with celiac disease. On 20-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, anatomical location, route of administration were not reported, lot# reported as: K010523). Other suspect therapies included high dose of influenza virus vaccine administered on the same day, in the afternoon, during well-visit with a doctor. Then the patient went out to dinner. Later that night (20-NOV-2014), the patient experienced severe GI (gastrointestinal) symptoms such as bloody stool, diarrhea, low blood pressure and went into shock. The patient was rushed to the hospital where she was placed in intensive care unit (November 2014). The outcome of the events was not reported. The relatedness between the therapy with PNEUMOVAX 23 and the events was not reported. Upon internal review the event of shock was determined to be medically significant. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Shock
Clinical narrative: This spontaneous report as received from a nurse practitioner (also reported as: administrator) via company representative refers to a 80 year old female patient with celiac disease. On 20-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, anatomical location, route of administration were not reported, lot# reported as: K010523). Other suspect therapies included high dose of influenza virus vaccine administered on the same day, in the afternoon, during well-visit with a doctor. Then the patient went out to dinner. Later that night (20-NOV-2014), the patient experienced severe GI (gastrointestinal) symptoms such as bloody stool, diarrhea, low blood pressure and went into shock. The patient was rushed to the hospital where she was placed in intensive care unit (November 2014). The outcome of the events was not reported. The relatedness between the therapy with PNEUMOVAX 23 and the events was not reported. Upon internal review the event of shock was determined to be medically significant. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, FLUC3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a healthcare student refers to a 42 year old female patient, hospitalized for alcohol withdrawal and possible pneumonia. Patient's medical history included immunization in approximately 2007 (also reported as seven years earlier) with unspecified pneumococcal vaccine with none reaction. On 05-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscular, in the right arm, lot # K008409, expiration date on 31-MAR-2016. Concomitant therapies included FLUCELVAX administered on 05-NOV-2014 on left arm, and unspecified psychiatric medications. On 06-NOV-2014, the patient experienced swelling, pain and redness at the injection site that worsened after receiving PNEUMOVAX 23. Swelling, pain and redness at injection site had improved on 07-NOV-2014. The adverse events were treated with BENADRYL and TYLENOL. There were not laboratories diagnostics performed. The healthcare student requested a lot# check. This is one of several cases received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hallucination, Influenza like illness
Clinical narrative: Patient described flu like symptoms, and hallucinations.
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Allergy test, Pruritus, Urticaria
Clinical narrative: Pt was administered a typhoid VI injection and approx 30 minutes came into the clinic complaining of severe itching and hives.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site inflammation, Injection site nodule, Injection site swelling, Pain in extremity
Clinical narrative: Injection site was inflamed and arm below injection site was swollen and had a big knot. Overnight Friday Nov.21-Saturday Nov.22 my left arm was painful, numb and tingling from shoulder to fingertips, which persisted into the following day but not with the severity of the night. Went to emergency since clinic was closed. Was treated, released and given RX for antibiotics.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Injection site was inflamed and arm below injection site was swollen and had a big knot. Overnight Friday Nov.21-Saturday Nov.22 my left arm was painful, numb and tingling from shoulder to fingertips, which persisted into the following day but not with the severity of the night. Went to emergency since clinic was closed. Was treated, released and given RX for antibiotics.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Swelling, Type III immune complex mediated reaction
Clinical narrative: Office visit notes from provider of 11/18/14:  History:  Onset: 4 days ago.  It occurs intermittently and is improving. Location: left upper arm. The pain is aching. Associated symptoms include swelling. Additional information: pain just with movement, no med taken. Had Tdap injection in Saturday after cutting hand in can lid. Had injection around 6 pm in Saturday  sx of pain and swelling in L arm started Sunday PM, Monday noticed pain radiated to neck  was stiff. Is feeling much better today, sx seem to be resolving. Assessment: Arthus reaction. Reviewed symptomatic treatment measures and emergency precautions reviewed, may take OTC ibuprofen 2 tablets three time daily. I called on 11/26/14 and was told left upper shoulder/neck area fully resolved by the weekend (22nd).