chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient was not pregnant. On 02-SEP-2014 the patient was vaccinated with a expired dose of PNEUMOVAX 23 (lot # J006242, expiration date 03-AUG-2014 dose 0.5 ml, frequency was unknown) in the arm which was expired. Concomitant therapies included FLUVIRON. The patient did not seek for medical attention. The patient did not mention experiencing any side effects or follow up with the pharmacy at the time of reporting. This adverse event will be forwarded to the Medical Team for examination. 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 nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified number of patients were administered doses of GARDASIL injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 12-AUG-2014, an unknown number of patients were vaccinated with improperly stored single dose of PNEUMOVAX 23 (lot#, dose number and route were unspecified). No adverse effect was noted. This is one of several reports received from the same reporter. Follow up information has been received from the office manager regarding the patients. The office manager was able to share the lot# J008799 (expiration date 16-APR-2015) for PNEUMOVAX 23 that experienced a temperature excursion. The office manager had no patients' information or dates of vaccination available to share at this time. This is one of several reports received from the same office manager. 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 an unknown number of patients. On unknown dates the patients were vaccinated with ROTATEQ (lot #, expiration date and dose unspecified), oral for prophylaxis that had been improperly stored. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refer to an unspecified patient of unknown age. On 16-SEP-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB adult, lot # J014312, Expiration Date 07-SEP-2014 (dose, frequency and route unknown). No adverse effect reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a 13 year old female patient without pregnant via company representative refers to herself. The patient had no pertinent medical history or drug reactions/allergies. In March 2014 ("6 months ago"), the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, injection in the arm deltoid intramuscularly (lo#, expiration date and strength not reported). In May 2014, the patient was vaccinated with the second dose of GARDASIL, 0.5 ml, injection in the arm deltoid intramuscularly (lot#, expiration date and strength not reported). There was no concomitant medication. The patient stated that she started losing her hair after receiving her first shot of GARDASIL, 6 months ago (In March 2014). The patient received the second shot in May 2014 and continued to lose her hair. The patient didn't seek medical attention. No lab diagnostics studies were performed. The outcome of losing her hair was reported as not recovered. 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 nurse practitioner refers of unknown age and gender. On 24-SEP-2014 the patient was inadvertently vaccinated with expired PNEUMOVAX23, injection, 0.5 ml, intramuscular (IM), lot # J009827 that had expired on 10-AUG-2014. Concomitant therapy was not reported. No adverse effects reported. This is one of several reports from the same source. 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 nurse refers to a patient of unknown age and gender. On 02-SEP-2014 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, frequency, lot # and indication were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 month old patient of unknown gender. On 26-SEP-2014 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were not provided). No adverse effects reported. 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 nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that unknown number of doses of (Oka/Merck) VARIVAX (0.5 ml, subcutaneous ) that had been exposed to 18 degrees F for 14 hours were administered. Pertinent medical history and concomitant medications were unspecified by reporter. No adverse effect reported. The outcome of the events was unknown. No other information was available. This is one of several reports received 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 patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored ZOSTAVAX vial 19400 PFU (dose, route, lot # and expired date were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a three unspecified patients of unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with a dose of GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. Follow-up information has been received from the reporting medical assistant, who provided patient's identifiers (age and gender), dates of vaccinations and lot numbers. This report concerns a 66 years old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. It was reported that the PNEUMOVAX 23 underwent the temperature excursion on 08-AUG-2014. On 15-AUG-2014, the patient received a dose of PNEUMOVAX 23 which underwent temperature excursion (dose, site and route of administration unknown; lot# J008799, expiration date 16-APR-2014). This is one of several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a three unspecified patients of unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with a doses of GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. Follow-up information has been received from the reporting medical assistant, who provided patients' identifiers (age and gender), dates of vaccinations and lot numbers. This report concerns a 67 year old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. It was reported that the PNEUMOVAX23 underwent the temperature excursion on 08-AUG-2014. On 21-AUG-2014, the patient received a dose of PNEUMOVAX23 which underwent temperature excursion (dose, site and route of administration unknown; lot# J008799, expiration date 16-APR-2014). This is one of several reports 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 healthcare worker refers to a patient of unknown age, gender and demographics. Patient's current condition and medical history was not reported. On 05-SEP-2014, the patient was vaccinated with PNEUMOVAX23 injection (dose and units not provided), lot # J004080 (expiration date: 22-AUG-2014), intramuscularly for an unknown indication. No concomitant medication has been reported. On 05-SEP-2014, the patient received expired dose of PNEUMOVAX23. On an unknown date in September 2014, the patient experienced no adverse effects. There was no product quality complaint involved. The outcome of the events was not reported. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 23-SEP-2014. Demographic details for each patient were provided. This report referred to a 7-month old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the first dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 22-JAN-2014 at 3:20 PM, and the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 20-FEB-2014 at 4:00 PM. It was reported that these doses were spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). It was also reported that vaccination repeat was declined. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
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 unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified number of patients were administered doses of VARIVAX (Merck) injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 23-SEP-2014. Demographic details for each patient ere provided. This report referred to a 6-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 10-JAN-2014 at 3:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00AM). The parents of the patient were going to consult with physician, and declined to repeat the dose1. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 0.53
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 8-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 15-JAN-2014. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician and declined to repeat the dose. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Vaccine positive rechallenge
Clinical narrative: This spontaneous report was received from a registered nurse via field employee refers to a currently 18 year old female patient. The patient's concurrent conditions included some mental health issues. On an unspecified date in 2010, the patient was vaccinated with the first dose of GARDASIL and the schedule was complete in 2011. After each dose of GARDASIL the patient had a stomach ache (2010 and 2011). No treatment was given for the adverse event. The patient did not seek any medical attention. The outcome of patient had stomach ache was reported as recovered/resolved. 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 nurse refers to a patient of unknown age and gender. On 24-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot # and expired date were not reported) that was improperly stored at 77F for a presently unknown time frame. Concomitant therapy was not reported. No adverse effects reported. 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 unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified number of patients were administered doses of PROQUAD (Merck) injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 76 year old patient of unknown gender. No concurrent conditions or medical history were provided. Patient was chicken pox naive (was never sick with chicken pox). On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) injection (dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. Eight weeks later (date unspecified), the patient received a second injection of VARIVAX (Merck). No adverse effects were noted. Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 18 month old patient of unknown gender. Medical history and drug reactions or allergies were not specified. On 11-SEP-2014, the patient inaddvertently received one dose of GARDASIL injection (route and lot number were not reported). No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information hade been unsuccessful. Follow up information has been received on 23-SEP-2014. Demographic details for each patient were provided. This report referred to a 4-months old female patient, with no know drug allergies and no illness at time of vaccination. The patient was vaccinated with the first dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 31-JAN-2014 at 11:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient did not repeat the vaccine. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-SEP-2014 the patient was vaccinated with a M-M-R II lot # reported as J014875 (therapy type, dose, route, and expiration date were not reported) that had been improperly stored. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 15 year old female patient. On 11-SEP-2014 the patient was inadvertently vaccinated with ZOSTAVAX. No adverse effects reported. The outcome was unknown. Additional 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 nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified number of patients were administered doses of RECOMBIVAX HB injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On unknown dates the patient were vaccinated with a dose of 0.5 ml LIQUID PEDVAXHIB (lot#, expiration date unspecified), intramuscular at 2 months of age, 4 months of age and 7 months of age. No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer refers to her husband of unknown age. On 18-SEP-2014 the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route unspecified). On 18-SEP-2014, the patient developed a rash around the mouth area. The patient had sought medical attention. VALTREX was given for treatment. The outcome of a rash around the mouth area was reported as recovered in September 2014. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report a received from a registered nurse refers to a patient of unknown age and gender. On 05-OCT-2009, the patient was vaccinated with the first 0.5 ml dose of (Oka/Merck) VARIVAX (lot # not reported) subcutaneously, on 13-JAN-2014, the patient received the second 0.5 ml dose of (Oka/Merck) VARIVAX (lot # not reported) subcutaneously and on 23-SEP-2014 the patient received a third 0.5 ml dose of (Oka/Merck) VARIVAX (lot # not reported) subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist concerning an approximately 73 year old female patient who on 19-SEP-2014, was vaccinated with a dose of ZOSTAVAX (batch and lot No. K003595, exp. 07-FEB-2015), 0.65 ml, subcutaneous in the left arm for vaccination. Concomitant therapies included MICARDIS, PEPCID, ATIVAN, LASIX, vitamin D and METAMINE. In September 2014 the patient called the pharmacist to report that she had 2 red, itchy spots at the injection site of her left arm. No treatment was received. The outcome of she has 2 red, itchy spots at the injection site of her left arm was reported as not recovered. Relationship between 2 red spots at injection site and therapy with ZOSTAVAX was not reported. Additional information is not expected since pharmacist did not give consent for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The nurse reported that since unspecified date, the improperly stored VARIVAX (Merck) injection (dose, route of administration, indication, lot# and expiry date unspecified) was administered to those patients. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On 05-SEP-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB (5/0.5 microgram/ml injection, lot # 1741AA, expiration date 27-JUN-2014, 0.5 ml) intramuscularly. No adverse effect was reported. The patient did not seek for medical attention. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a three unspecified patients on unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. Follow-up information has been received from the reporting medical assistant, who provided patient's identifiers (age and gender), dates of vaccinations and lot numbers. This report concerns a 53 years old male patient. No information on his medical history, concurrent conditions or concomitant drugs was provided. It was reported that the PNEUMOVAX 23 underwent the temperature excursion on 08-AUG-2014. On 02-SEP-2014, the patient received a dose of PNEUMOVAX 23 which underwent temperature excursion (dose, site and route of administration unknown; lot# J008799, expiration date 16-APR-2014). This is one of several reports 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 healthcare worker refers to a 6 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with ROTATEQ (dosage information unknown). No concomitant medication was reported. The patients were vaccinated with improperly stored ROTATEQ which were exposed to 48 degree Fahrenheit for 35 minutes. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 0 day (neonate) old male patient. On 12-JUL-2014 the patient was vaccinated with the first dose of a RECOMBIVAX HB lot # J012520, intramuscular. The storage temperature of RECOMBIVAX HB was between 0 and 1 degrees, on 18 different episode between 14-MAY-2014 and 21-JUL-2014. The registered nurse reported that it was no possible to identify how long the temperatures were down because it was not documented accordingly since all recorded temperatures at morning and at night were within 2 and 8 degrees. It was reported that the vaccine was removed once the problem was identified and it had not been used after 21-JUL-2014. There were no adverse events reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 11-SEP-2014 the patient was vaccinated with VARIVAX (Merck), subcutaneous, that was improperly stored (dose, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 7-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the first dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 16-JAN-2014, when the patient was 5 months old. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient had consulted with physician and did not repeat the vaccine dose. No adverse event was reported for the patient. The outcome was reported by the reporter as recovered on 26-MAR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Screaming
Clinical narrative: Screaming reaction 9 days after PENTACEL immunization.
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 unknown age and gender. The reporter stated that unknown number of doses of PROQUAD (Merck) (dose and route of administration was unknown) that had been exposed to 18 degrees F for 14 hours were administered. Pertinent medical history and concomitant medications were unspecified by the reporter. No adverse effect reported. The outcome of the events was unkonwn. No other information was available. This is one of several reports received from the same source. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Lymphadenitis, Pain, Swelling
Clinical narrative: Patient went to urgent care - soreness and swelling under left deltoid - ARNP gave prescription for ibuprofen 600 mg and to place hot compress on site - left axillary lymphadenitis.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Headache, Local swelling, Nausea
Clinical narrative: Patient experienced swelling of arm starting 1.5 hours after vaccination with redness. Also reported severe headache, chills and nausea without vomiting. Used heat blanket for chills, other symptoms resolve without treatment.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: 5" x 3" indurated, red, hot and itchy firmness in left arm - site of injection. Fatigue and nausea 9/23/14.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: 5" x 3" indurated, red, hot and itchy firmness in left arm - site of injection. Fatigue and nausea 9/23/14.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Approx 26-30 hrs following administration of vaccines pt presents with 8.5 cm x 7 cm indurated, erythematous, warm area (L) upper extremity at deltoid and 4 cm x 2.5 cm of induration and erythema (R) posterior upper arm. Both areas tender to touch and pruritic. MOC notified rxn 8 hours prior to OV.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 24-SEP-2014, the patient was vaccinated with an expired dose of M-M-R II (lot # H017437 exp 20-SEP-2014) (dose and route not reported). No adverse effect was reported. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 5-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 27-FEB-2014 at 09:16 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Revaccination was declined. No adverse event was reported for the patient. Outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 80.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Rash, Rash pruritic, Varicella
Clinical narrative: This spontaneous report was received from a pharmacist and a field representative refers to a female patient of approximately 81 years of age. There was no relevant medical history of the patient reported. The patient had a history of codeine allergy. It was reported that the patient had never experienced chicken pox. On 06-SEP-2014 the patient was vaccinated with ZOSTAVAX (lot # K003596, expiration date: 12-MAR-2014) (strength, dose number and site of administration were not reported) subcutaneous. Other suspect therapies included a high dose influenza virus vaccine (unspecified) (reported as an unspecified high dose flu shot) administered on the same date (strength, dose number, route, site of administration, lot number and expiration dates were not reported). Concomitant therapies included unspecified proton pump inhibitors (PPIs). The patient called the pharmacist on 22-SEP-2014, and reported that on an unkonwn date in September 2014 (reported as within the last few days) she patient experienced itchy bumps on her legs, upper thighs, arms, knees and her waistline and it is one sided. The pharmacist advised the patient to treat with BENADRYL and to follow up with her primary care physician. There were no lab diagnostic studies performed. The patient sought medical attention by calling the pharmacist. There was no product quality complaint (PQC) involved. The outcome of itchy bumps on her leg, upper thighs, arms, knees and waistline and it is one sided was reported as not recovered at the time of the report. The causality of the events was not provided. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist and a field representative refers to a female patient of approximately 81 years of age. There was no relevant medical history of the patient reported. The patient had a history of codeine allergy. It was reported that the patient had never experienced chicken pox. On 06-SEP-2014 the patient was vaccinated with ZOSTAVAX (lot # K003596, expiration date: 12-MAR-2014) (strength, dose number and site of administration were not reported) subcutaneous. Other suspect therapies included a high dose influenza virus vaccine (unspecified) (reported as an unspecified high dose flu shot) administered on the same date (strength, dose number, route, site of administration, lot number and expiration dates were not reported). Concomitant therapies included unspecified proton pump inhibitors (PPIs). The patient called the pharmacist on 22-SEP-2014, and reported that on an unkonwn date in September 2014 (reported as within the last few days) she patient experienced itchy bumps on her legs, upper thighs, arms, knees and her waistline and it is one sided. The pharmacist advised the patient to treat with BENADRYL and to follow up with her primary care physician. There were no lab diagnostic studies performed. The patient sought medical attention by calling the pharmacist. There was no product quality complaint (PQC) involved. The outcome of itchy bumps on her leg, upper thighs, arms, knees and waistline and it is one sided was reported as not recovered at the time of the report. The causality of the events was not provided. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Patient says he had soreness and pain shortly after receiving the vaccination. A little redness and mild swelling around the area developed the next day. After being advised to apply ice and taking BENADRYL he says all symptoms have resolved.
Age: 12.0
Sex: M
Vaccine: MMR, TD
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a medical assistant via a representative refers to her 12 year old son. Her son experienced this same "shingles-like rash" on his torso, no matter what type of vaccine he received; and it always occurred seven days after the vaccine had been administered. On an unknown date the patient was vaccinated with M-M-R II (lot#, strength, dosage, frequency and route unknown). Other suspect therapies included Td (manufacturer, lot#, strength, dosage, frequency, route and indication unknown). On an unknown date the patient experienced a "shingles-like rash" on his torso after receiving the M-M-R II and the Td. The patient had been referred to an allergist to find out if he was allergic to any component of the M-M-R II and the Td most recently administered. The outcome of the event was unknown. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Herpes zoster, Rash papular, Rash vesicular
Clinical narrative: Right patch of red papular area on upper shoulder, one area w vesicular some other red area under the arm/chest. Rx: Acyclovir. Dx: shingles.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-SEP-2014 the patient was vaccinated with a MMR II lot # reported as J014875 (therapy type, dose, route, and expiration date were not reported) that had been improperly stored. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a  4-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 10-FEB-2014 at 11:30 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient was revaccinated on 07-APR-2014 with no change. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 75 year old Female patient. The patient's medical history and current conditions are not reported. On 10-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the left arm (lot # J009827 and expiry date 10-AUG-2014). Other suspect therapy includes AFLURIA in the left arm, different site. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. No adverse effects reported. Product quality complaint was not reported. The outcome of the events is unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via publicist employee refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date in 2014 the patient was vaccinated with PNEUMOVAX 23 (dose and route unspecified). The patient denied any prior vaccination with PNEUMOVAX 23 when asked by the pharmacist. After administering the PNEUMOVAX 23, the pharmacist received a call from unspecified physician stating that the patient received PNEUMOVAX 23 vaccine in 2013 (date unspecified). No adverse effects were reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Crying, Pain
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 9 year old male patient. On an unknown date, the patient was vaccinated with an adult dose of VAQTA injection, (dose, route, lot# and expired date were not reported) instead of the pediatric dose of VAQTA. Concomitant therapy was not reported. The patient was experiencing soreness and cried a lot more than normal when he was initially injected with the adult dose of VAQTA. The outcome of adverse events was not reported. The relationship between adverse events and VAQTA was not reported. 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 pharmacist refers to patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot # and expired date were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Hypersensitivity, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. On an unknown date in last flu season, 2013 the unspecified patient was vaccinated with a dose of ZOSTAVAX in the arm (dose, dose number, route and lot# not reported). On an unknown date in 2013, the patient's whole arm "blew up", and the patient was diagnosed by the primary care provider as having an allergic reaction to the ZOSTAVAX. The outcome of event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On an unspecified date in 2009 (reported as "sometime in 2009") the patient was vaccinated with the first dose of GARDASIL. On 25-SEP-2014, the patient wanted to receive the second dose of GARDASIL which would be late. No symptoms reported. At the time of the report action taken with GARDASIL was not reported. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever up to 104 degrees starting within 24 hrs of being vaccinated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, Product label confusion
Clinical narrative: This spontaneous report as received from a nursing assistant. No patient is involved. On an unknown date, there was product confusion between the color of the vial of (Merck) VARIVAX and the color of the diluent that (Merck) VARIVAX comes with. The colors of the labels were similar. Because of the color confusion the (Merck) VARIVAX was accidentally left out of temperature range as it was believed to be the diluent. A product quality complaint (PQC) was not identified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown demographics who was hospitalized. No concurrent conditions or medical history were provided. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, frequency, route of administration, indication, lot# and expiry date unspecified). It was reported that the vaccine was administered two weeks after expiration. No concomitant medications were reported. The patient did not experience any adverse events after administration of the expired ZOSTAVAX. The patient received ZOSTAVAX while at hospital, for an unspecified time. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Headache, Laboratory test, Pain, Pyrexia
Clinical narrative: Approximately 10 hours after vaccine, developed severe body aches, headache with fever 102 degrees oral. Persisted through 9/25/14; fever broke at 4:00 pm then returned that evening to 100.2 degrees. Seen by private doctor who indicated apparent reaction to influenza vaccine. Obtained lab work and chest x-ray (results not available to us as employer).
Sex: U
Vaccine: PPV
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 unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown ate, unspecified number of patients were administered doses of PNEUMOVAX 23 injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were 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 received from a pharmacist refers to a patient of unknown age and gender. On 19-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # H009826, expiration date: 11-FEB-2014), 0.5 ml. There was no concomitant medication reported. The patient received an expired dose of PNEUMOVAX 23. No symptoms were reported. No product quality complaint (PQC) was reported. Additional information has been requested.