chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Scab
Clinical narrative: Next day: 10/06/14 Body ache, chills, severe headache, insomnia, severe puffy eyes (eyelids completely covered eyes), eye redness, yellow crust discharge - Patient went to acute care. Patient came back to Pharmacy on 10/8/14. Symptoms gone and she reported no more ADR's.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local reaction to arm, presenting red, slightly swollen by a 4"x4" diameter around injection site. Symptoms present x 3 days before resolving. Patient had no fever or other symptoms during this time. Home care, ADVIL, 10 mg to aid with symptoms.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Irritability, Retching, Vomiting
Clinical narrative: Mom reported that within x 2 hrs (1:30 pm) post vaccination, patient became extremely irritable, drawing up his legs, gagging and vomiting intermittently along with inconsolable crying. At 4:15 she took him to the M.D. for reevaluation - at which point he had stopped crying. As of 10-8-14 0845 he  had slept the night, but she verbalized he continues to intermittently vomit. No bloody stools noted. 10-8-14 1830 mom reports patient still intermittently vomiting, but no further crying episodes.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Laboratory test, Myalgia, Pain, Pyrexia
Clinical narrative: Fever/chills, body and muscle pain, congestion/wheezing.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Respiratory tract congestion, Wheezing
Clinical narrative: Fever/chills, body and muscle pain, congestion/wheezing.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date (also reported as when the patient was 64 years old) the patient was vaccinated with ZOSTAVAX, (dose, route and frequency were not reported). Concomitant medications were not reported. The reporter stated that on an unknown date (a couple of weeks ago and also 6-7 yrs ago) the patient was diagnosed with shingles. The outcome event was unknown. The causality of events was not reported. The company representative stated that she did not have much patient specific information, therefore many fields remain unspecified by reporter and NA. VZV packet declined. Patient sought medical attention required. No product quality complaint (PQC) was reported. No further information was reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 49 year old female patient with no medical history. The patient had an unspecified reaction to tetanus toxoid on an unknown date. On 02-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # K004930 with expiry date: 16-MAR-2015; strength, dose and route of administration unspecified) indication reported as: "requested to receive shot". The patient did not take any concomitant medication. In October 2014 (exact date unknown), the patient experienced a swollen and red arm from the deltoid to the elbow. The patient sought medical attention via visiting the physician. No laboratory test were performed. The outcome of the events was reported as not recovered at the time of report. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Vaccination complication
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient was not pregnant. Drug allergies included: unspecified reaction to fluticasone. On 26-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J013555;expiry: 02-MAY-215. Concomitant therapies included megestrol acetate, pyridostigmine bromide, clopidogrel, glycopyrrolate, levothyroxine sodium (manufacturer unknown), omeprazole (manufacturer unknown), montelukast sodium (manufacturer unknown), metoprolol, albuterol sulfate (manufacturer unknown), SPIRIVA and VENTOLIN. Approximately on an unknown date in September 2014 pharmacist received PNEUMOVAX 23 on 26-SEP-2014 and had a reaction to it. Pharmacist reported that patient had a red color under her skin which ran down to her elbow and settled there. Pharmacist reported it looked like a capillary thing and patient said it itched. Treatment given was BENADRYL and cold compresses. Pharmacist inquired if PLAVIX interacted with PNEUMOVAX 23 since patient had that reaction. The outcome of the events was reported as recovering/resolving. Patient sought medical attention and went to pharmacist. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 29-SEP-2014, the patient was inadvertent vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneously instead of ZOSTAVAX. No adverse experience reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies was specified. Medical assistant reported that since April 2014 GARDASIL (lot#, dose, route, strength not repored) was improperly stored and on an unknown date in approximately 2014 the patient was vaccinated with GARDASIL. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. The outcome of is unknown. This is one of the three reports received from the same reporter (MARRS # 1409USA013208 and 1410USA004354). Additioal information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies was specified. Medical assistant reported that since April 2014, RECOMBIVAX HB (lot#, dose, route, strength not reported) was improperly stored and on an unknown date in approximately 2014 the patient was vaccinated with RECOMBIVAX HB. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. The outcome of is unknown. This is one of the three reports received from the same reporter (MARRS # 1409USA013208 and 1410USA004355). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies was specified. Medical assistant reported that since April 2014 VAQTA (lot#, dose, route not reported, strength reported as 25/0.5, unit not reported) was improperly stored and on an unknown date in approximately 2014 the patient was vaccinated with VAQTA. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. The outcome of is unknown. This is one of the three reports received from the same reporter (MARRS # 1410USA004354 and 1410USA004355). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient (the physician's wife) of unknown demographics. No information about medical history, drug reactions and allergies was specified. Physician reports that he administered a dose of ZOSTAVAX (lot#, dose, route not reported) to his wife, about 5 years ago (in approximately 2009) that was exposed to temperature outside of the proper storage range. No concomitant medications were reported. Physician states that his wife did not experience any adverse effects from the administration. There was no product quality complaint. The outcome was unknown. This is one of the two reports received from the same reporter (MARRS# 1409USA013224). Additional information has bee requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 07-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot# not reported, expiration date 20-SEP-2014, dose, route, indication not reported). No adverse effects were reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 79 year old male patient (the physician himself is the patient). No information about medical history, drug reactions and allergies was specified. Physician reports that he administered a dose of ZOSTAVAX (lot #, dose, route not reported) about 5 years ago that was exposed to temperature outside of the proper storage range. No concomitant medications were reported. Physician states he experienced an episode of shingles about 4 years ago. Physician states that "the bout of shingles was very mild" and "went away on its own after a only a few days" (recovered). There was no product quality complaint. No treatment was given, no lab diagnostics were done. Patient did not seek medical attention. The causality of the event episode of shingles was unknown. This is one of the two reports received from the same reporter (MARRS # 1410USA004305). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to unspecified patients of unknown age. On an unknown date, patients missed a dose of ZOSTAVAX (lot #, expiration date, dose, route not reported) because the only ZOSTAVAX which was available at the clinic looked unusual and could not be used (PQC files, the exact number of patients which were unable to begin ZOSTAVAX therapy on schedule because of product quality issue was not specified). No adverse effects were reported. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt complained of golf sized bump on site with intense itch, burn, and pain. Also complaint of shortness of breath.
Age: 40.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Blister, Laceration, Polymerase chain reaction, Skin lesion
Clinical narrative: This spontaneous report as received from a nurse refers to a 40 year old female patient. No information about medical history, drug reactions and allergies was specified. Nurse stated that a pharmacist was administering ZOSTAVAX (lot #, expiry unknown, dose unspecified) on 08-SEP-2014 to an unspecified patient and the ZOSTAVAX accidentally "shot into the pharmacist's face". No concomitant medications were reported. The pharmacist is complaining that she developed blisters on her face on an unspecified date. The pharmacist was seen by her unspecified family doctor regarding the blisters on an unspecified date. The family doctor "did an unspecified culture on the blisters" on an unspecified date. No lab results have been provided. Varicella zoster virus (VZV) packet offered and sent. On 25-SEP-2014 at 09:30, the pharmacist, was going to be examined for a specimen collection of fluid-filled vesicles on her face. Attempted to connect the nurse to VZVID contacts for guidance on appropriate materials to use for specimen collection for VZVID. On 25-SEP-2014 at 15:39, nurse called to provide additional adverse event information. Nurse stated that the correct information as to what occurred on 08-SEP02014. She stated that the pharmacist was withdrawing the ZOSTAVAX vaccine from the vial before giving to the patient and the vaccine went onto her left hand not her face. The pharmacist developed small lacerations on her left hand and not her face. On 30-SEP-2014, the nurse stated that the patient is coming back to the office today, reporting that she has additional vesicles on her face. The nurse is inquiring if she should collect additional specimen samples to send to for testing for VZV. She inquired, how soon will the results be available from the specimen I sent to the lab. VZV packet re-faxed to the nurse. Left a voicemail message for the Clinical Safety Risk Management (CSRM) representative, and this service request will be e-mailed to the department and nurse would be called. On 06-OCT-2014, nurse reported that the patient continues to have new breakout lesions. Unspecified where the new lesions are located. The patient would be coming to the office tomorrow (07-OCT-2014) for an appointment. No intervention was done to prevent serious criteria as there was none. There was no product quality complaint. The outcome of the events was reported as not recovered/not resolved. The causality of the events was not reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella virus test
Clinical narrative: This spontaneous report as received from a nurse refers to a 40 year old female patient. No information about medical history, drug reactions and allergies was specified. Nurse stated that a pharmacist was administering ZOSTAVAX (lot #, expiry unknown, dose unspecified) on 08-SEP-2014 to an unspecified patient and the ZOSTAVAX accidentally "shot into the pharmacist's face". No concomitant medications were reported. The pharmacist is complaining that she developed blisters on her face on an unspecified date. The pharmacist was seen by her unspecified family doctor regarding the blisters on an unspecified date. The family doctor "did an unspecified culture on the blisters" on an unspecified date. No lab results have been provided. Varicella zoster virus (VZV) packet offered and sent. On 25-SEP-2014 at 09:30, the pharmacist, was going to be examined for a specimen collection of fluid-filled vesicles on her face. Attempted to connect the nurse to VZVID contacts for guidance on appropriate materials to use for specimen collection for VZVID. On 25-SEP-2014 at 15:39, nurse called to provide additional adverse event information. Nurse stated that the correct information as to what occurred on 08-SEP02014. She stated that the pharmacist was withdrawing the ZOSTAVAX vaccine from the vial before giving to the patient and the vaccine went onto her left hand not her face. The pharmacist developed small lacerations on her left hand and not her face. On 30-SEP-2014, the nurse stated that the patient is coming back to the office today, reporting that she has additional vesicles on her face. The nurse is inquiring if she should collect additional specimen samples to send to for testing for VZV. She inquired, how soon will the results be available from the specimen I sent to the lab. VZV packet re-faxed to the nurse. Left a voicemail message for the Clinical Safety Risk Management (CSRM) representative, and this service request will be e-mailed to the department and nurse would be called. On 06-OCT-2014, nurse reported that the patient continues to have new breakout lesions. Unspecified where the new lesions are located. The patient would be coming to the office tomorrow (07-OCT-2014) for an appointment. No intervention was done to prevent serious criteria as there was none. There was no product quality complaint. The outcome of the events was reported as not recovered/not resolved. The causality of the events was not reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Blister, Exposure via skin contact, Laceration, Polymerase chain reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 40 year old female patient. No information about medical history, drug reactions and allergies was specified. Nurse stated that a pharmacist was administering ZOSTAVAX (lot #, expiry unknown, dose unspecified) on 08-SEP-2014 to an unspecified patient and the ZOSTAVAX accidentally "shot into the pharmacist's face". No concomitant medications were reported. The pharmacist is complaining that she developed blisters on her face on an unspecified date. The pharmacist was seen by her unspecified family doctor regarding the blisters on an unspecified date. The family doctor "did an unspecified culture on the blisters" on an unspecified date. No lab results have been provided. Varicella zoster virus (VZV) packet offered and sent. On 25-SEP-2014 at 09:30, the pharmacist, was going to be examined for a specimen collection of fluid-filled vesicles on her face. Attempted to connect the nurse to VZVID contacts for guidance on appropriate materials to use for specimen collection for VZVID. On 25-SEP-2014 at 15:39, nurse called to provide additional adverse event information. Nurse stated that the correct information as to what occurred on 08-SEP02014. She stated that the pharmacist was withdrawing the ZOSTAVAX vaccine from the vial before giving to the patient and the vaccine went onto her left hand not her face. The pharmacist developed small lacerations on her left hand and not her face. On 30-SEP-2014, the nurse stated that the patient is coming back to the office today, reporting that she has additional vesicles on her face. The nurse is inquiring if she should collect additional specimen samples to send to for testing for VZV. She inquired, how soon will the results be available from the specimen I sent to the lab. VZV packet re-faxed to the nurse. Left a voicemail message for the Clinical Safety Risk Management (CSRM) representative, and this service request will be e-mailed to the department and nurse would be called. On 06-OCT-2014, nurse reported that the patient continues to have new breakout lesions. Unspecified where the new lesions are located. The patient would be coming to the office tomorrow (07-OCT-2014) for an appointment. No intervention was done to prevent serious criteria as there was none. There was no product quality complaint. The outcome of the events was reported as not recovered/not resolved. The causality of the events was not reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Scab, Skin culture, Skin lesion
Clinical narrative: This spontaneous report as received from a nurse refers to a 40 year old female patient. No information about medical history, drug reactions and allergies was specified. Nurse stated that a pharmacist was administering ZOSTAVAX (lot #, expiry unknown, dose unspecified) on 08-SEP-2014 to an unspecified patient and the ZOSTAVAX accidentally "shot into the pharmacist's face". No concomitant medications were reported. The pharmacist is complaining that she developed blisters on her face on an unspecified date. The pharmacist was seen by her unspecified family doctor regarding the blisters on an unspecified date. The family doctor "did an unspecified culture on the blisters" on an unspecified date. No lab results have been provided. Varicella zoster virus (VZV) packet offered and sent. On 25-SEP-2014 at 09:30, the pharmacist, was going to be examined for a specimen collection of fluid-filled vesicles on her face. Attempted to connect the nurse to VZVID contacts for guidance on appropriate materials to use for specimen collection for VZVID. On 25-SEP-2014 at 15:39, nurse called to provide additional adverse event information. Nurse stated that the correct information as to what occurred on 08-SEP02014. She stated that the pharmacist was withdrawing the ZOSTAVAX vaccine from the vial before giving to the patient and the vaccine went onto her left hand not her face. The pharmacist developed small lacerations on her left hand and not her face. On 30-SEP-2014, the nurse stated that the patient is coming back to the office today, reporting that she has additional vesicles on her face. The nurse is inquiring if she should collect additional specimen samples to send to for testing for VZV. She inquired, how soon will the results be available from the specimen I sent to the lab. VZV packet re-faxed to the nurse. Left a voicemail message for the Clinical Safety Risk Management (CSRM) representative, and this service request will be e-mailed to the department and nurse would be called. On 06-OCT-2014, nurse reported that the patient continues to have new breakout lesions. Unspecified where the new lesions are located. The patient would be coming to the office tomorrow (07-OCT-2014) for an appointment. No intervention was done to prevent serious criteria as there was none. There was no product quality complaint. The outcome of the events was reported as not recovered/not resolved. The causality of the events was not reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a nurse refers to a 40 year old female patient. No information about medical history, drug reactions and allergies was specified. Nurse stated that a pharmacist was administering ZOSTAVAX (lot #, expiry unknown, dose unspecified) on 08-SEP-2014 to an unspecified patient and the ZOSTAVAX accidentally "shot into the pharmacist's face". No concomitant medications were reported. The pharmacist is complaining that she developed blisters on her face on an unspecified date. The pharmacist was seen by her unspecified family doctor regarding the blisters on an unspecified date. The family doctor "did an unspecified culture on the blisters" on an unspecified date. No lab results have been provided. Varicella zoster virus (VZV) packet offered and sent. On 25-SEP-2014 at 09:30, the pharmacist, was going to be examined for a specimen collection of fluid-filled vesicles on her face. Attempted to connect the nurse to VZVID contacts for guidance on appropriate materials to use for specimen collection for VZVID. On 25-SEP-2014 at 15:39, nurse called to provide additional adverse event information. Nurse stated that the correct information as to what occurred on 08-SEP02014. She stated that the pharmacist was withdrawing the ZOSTAVAX vaccine from the vial before giving to the patient and the vaccine went onto her left hand not her face. The pharmacist developed small lacerations on her left hand and not her face. On 30-SEP-2014, the nurse stated that the patient is coming back to the office today, reporting that she has additional vesicles on her face. The nurse is inquiring if she should collect additional specimen samples to send to for testing for VZV. She inquired, how soon will the results be available from the specimen I sent to the lab. VZV packet re-faxed to the nurse. Left a voicemail message for the Clinical Safety Risk Management (CSRM) representative, and this service request will be e-mailed to the department and nurse would be called. On 06-OCT-2014, nurse reported that the patient continues to have new breakout lesions. Unspecified where the new lesions are located. The patient would be coming to the office tomorrow (07-OCT-2014) for an appointment. No intervention was done to prevent serious criteria as there was none. There was no product quality complaint. The outcome of the events was reported as not recovered/not resolved. The causality of the events was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. On 20-SEP-2014 those patients were vaccinated with an expired dose of PNEUMOVAX 23 (lot # H010515, expiration date 13-FEB-2014, dose, units, route of administration, anatomical location were not reported). No adverse effects reported. Follow up information has been received from the pharmacist who stated that 66 year old female patient received expired PNEUMOVAX 23 vaccination on 21-SEP-2014. It was a visiting pharmacist that did the vaccination. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 11-AUG-2014 the patients were vaccinated with MMR II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 25-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) Lot number: J0013315 expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report was received from a physician concerning his daughter of unknown age. On an unknown date, sometime in the mid to late 90's the patient was vaccinated with a dose of (Merck) VARIVAX (route, lot number and expiration date were not provided). Physician reported that his daughter experienced blister at the injection site sometime in the mid to late 90's. The patient had since recovered also sometime in the mid to late 90's. She did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age reporting of herself. Concomitant medications, medical history, drug reactions and allergies were not reported. In 2011, "3 years ago", the patient was vaccinated with ZOSTAVAX (dose, route, lot number were not reported) and ended up getting shingles (on an unspecified date). The outcome of getting shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 28-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. On 05-OCT-2014 the patient was vaccinated with expired PNEUMOVAX 23 (strength, route not reported) lot # H021941, expiration date 11-JUL-2014. 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: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 23-JUL-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: There is a red, warm and raised red area about 2-3 in from where I received the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with ZOSTAVAX lot # J001694 and expiry date: 08-MAY-2014 (dose and route not reported). On 25-SEP-2014 the patient received an expired dose of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and lot # were not reported). Concomitant medication was not reported. On an unknown date also reported as "shortly after receiving ZOSTAVAX", the patient experienced V1 eruption. Product quality complaint (PQC) was not involved. The outcome of V1 eruption shortly after receiving ZOSTAVAX was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLU3, HEP, PPV
Symptoms: Asthenia, Hyperglycaemia, Neuropathy peripheral, Paraesthesia, Vaccination complication
Clinical narrative: Adverse reaction to vaccination. Hyperglycemia, Paraesthesia (Neuropathy), Weakness.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Contusion, Erythema, Local swelling, Mobility decreased
Clinical narrative: I got the FLUVIRIN shot and in 1 hr. arm swelled 2x size - turned red - itched terrible - whole arm and shoulder had bone pain - fever 101.9 - bicept briusing hand size was unable to use my left arm for 5 days it has been 10 days and my shoulder is still sore-like a deep bone pain. I can use my arm now - but is still bruised.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pruritus, Pyrexia
Clinical narrative: I got the FLUVIRIN shot and in 1 hr. arm swelled 2x size - turned red - itched terrible - whole arm and shoulder had bone pain - fever 101.9 - bicept briusing hand size was unable to use my left arm for 5 days it has been 10 days and my shoulder is still sore-like a deep bone pain. I can use my arm now - but is still bruised.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Local swelling, Tenderness
Clinical narrative: Left arm cellulitis - TDAP, MENACTRA given. Arm swelling evening of vaccines. Next AM red and tender as well.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Injection site erythema, Injection site streaking, Injection site swelling, Nodule
Clinical narrative: At 6 month vaccine visit mom reported with last vaccines (7/22/14) (L) leg had swelling redness and blue streaks occur about one hour after vaccinations. The blue streaks lasted approx 1 hour. Infant had nonstop crying for approx 20 min- knots stayed for several weeks.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The patient's pertinent medical history was not provided. On 30-SEP-2014, the patient was vaccinated with ZOSTAVAX lot # K000727, expiration date: 30-JAN-2015, 0.65 ml, subcutaneous. Concomitant therapies included meloxicam (manufacturer unspecified), VALATAN, timolol maleate (manufacturer unspecified), lisinopril (manufacturer unspecified), hydrochlorothiazide (manufacturer unspecified), allopurinol, cyclobenzaprine hydrochloride and alendronate sodium (manufacturer unspecified). On approximately 01-OCT-2014 (reported as the symptoms have persisted for 7 days as of 08-OCT-2014, also reported as on an unspecified date), the patient experienced redness, pain and itchiness. The reporter stated that there was no rash or rash-like symptoms involved. The outcome of redness, itchiness and pain was reported as not recovered/not resolved. The relatedness between the events and the ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (dose, route and lot # not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with ROTATEQ oral (dose and lot # not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 03-JUN-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB 2.5/0.5 (units not provided) injection, administered intramuscularly at a dose of 0.5 ml (indication, lot# and expiry date unspecified), then with the second dose on 17-SEP-2013 and with the third dose on 10-JAN-2014. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as the reporting nurse did not grant permission to contact her.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 31-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with GARDASIL (dose, route and lot # not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient started therapy with ZOSTAVAX (route, dose, frequency and lot # not reported). It was reported that the patient received 2 doses of ZOSTAVAX 1 month apart (dates unspecified). No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with M-M-R II (dose, route and lot # not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left thigh was swollen, red and hot to the touch. Warm/cold compresses, massages as needed.
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. On 06-JUN-2011 the patient was vaccinated with ZOSTAVAX (19400 PFU) (route not reported). The reporter stated that the patient informed him that on an unknown date the patient experienced neuropathy in his feet and the patient asked pharmacist if ZOSTAVAX can cause neuropathy. The pharmacist did not know the patient's medical history, or if the patient ever had shingles and also if the patient experienced any other adverse effects. The pharmacist declined to provide any additional information until after he speaks with the patient who was awaiting his return phone call. The outcome of neuropathy in his feet is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 07-AUG-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Injection site erythema, Injection site warmth, Pruritus generalised
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 50 year old female patient with sulfa allergy. On 24-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number not reported) lot # K003597, expiration date 12-MAR-2015, 0.65 ml, subcutaneous in the left arm. Historical drug included sulfa. Patient was not on concomitant therapies at the time of the report. The pharmacist reported that when the patient awakened on 25-SEP-2014 (reported as yesterday), experiencing a headache, for which she took TYLENOL. The pharmacist stated that when the patient was preparing for work on 26-SEP-2014 (reported as today), she felt "itchy all over (her) body". The pharmacist reported that when the patient was putting on her deodorant, she noticed that her left armpit was painful. Then noticed that her left deltoid region, where she received her dose of ZOSTAVAX, was red in a 6 cm by 4 cm area. The injection site area was warm, but not swollen. On 26-SEP-2014, the outcome was reported as recovered (reported as she was not in any distress). Patient did not seek for medical attention or performed any lab diagnostics studies. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea
Clinical narrative: SOB, dizzy, lightheaded.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous reprot as received from a registered nurse reders to an unspecified number of patients (demographics unknown). On unknown dates, the patients were vaccianted with (Oka/Merck) VARIVAX vial (1350 U) (dose, route and lot numbers were not repored) that was exposed to a high temperature of 20.3 degrees F for short periods of time during what the nurse believed to be defrost cycles. No adverse effect reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Alopecia, Burning sensation, Erythema, Laboratory test
Clinical narrative: Pt was seen in our office 5/27/14. Mother states 1 week before pt had hair loss, redness and burning. Pt was also seen in our office 6/10/14, 7/30/14, 8/3/14. Pt has also been seen at other medical facility.
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a nurse refers female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL injection, (lot number, route and expiration date were not provided) for prevention of HPV. The nurse reported that on an unknown date in June 2014, the patient experienced small red bumps. At the time of the report, the patient outcome was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site bruising
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On 27-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J004310, expiry date: 12-JUL-2014 in the inner aspect of her left forearm (route was not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced bruising at the injection site. On an unknown date, the bruising at the injection site resolved with no further difficulties. The patient did not seek medical attention regarding this experience until 30-SEP-2014, when she asked the pharmacist if she should receive another dose of ZOSTAVAX. A second dose of ZOSTAVAX had not been administered to the patient. Causality between ZOSTAVAX and bruising at the injection site was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on 12-AUG-2014 the patients were vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J013315, expiration date: 18-OCT-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect dose administered
Clinical narrative: Verbal order for TDAP was given, then injection was given. Subsequent review of NGen showed TDAP 4 wks prior, so pt had an extra dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 19-SEP-2014, the patient was vaccinated with an improperly stored ZOSTAVAX Lot Number J014811, Expiration date: 21-FEB-2015 (also reported as 21-FEB-2014) (dose and route were not reported). No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-SEP-2014, the patient was vaccinated with an improperly stored ZOSTAVAX (dose and route of administration were unknown), lot number J014811, expiration date: 21-FEB-2015 (also reported as 21-FEB-2014). No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unkonwn age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PROQUAD (Merck). Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that improperly stored PROQUAD (Merck) about 6-7 doses) were administered to patients (on an unknown date). No adverse effects reported. This is one of two reports from the same source. Additional information has been requested.