chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient reported redness and soreness in arm. Reported redness from her shoulder to her elbow
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis (R) arm. Increased redness at injection site, warm to touch.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anxiety, Computerised tomogram normal, Confusional state, Fatigue, Intentional self-injury
Clinical narrative: Confusion, disoriented, insomnia, didn't know how to get dressed, undressed, urinate, evacuate, complete delirium, headaches, buzz and tingling feeling in brain and all 4 extremities, high B.P., no motivation, disorganized, hard to communicate, hits head.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Confusion, disoriented, insomnia, didn't know how to get dressed, undressed, urinate, evacuate, complete delirium, headaches, buzz and tingling feeling in brain and all 4 extremities, high B.P., no motivation, disorganized, hard to communicate, hits head.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Abnormal behaviour, Anxiety, Apathy, Blood pressure increased, Communication disorder
Clinical narrative: Confusion, disoriented, insomnia, didn't know how to get dressed, undressed, urinate, evacuate, complete delirium, headaches, buzz and tingling feeling in brain and all 4 extremities, high B.P., no motivation, disorganized, hard to communicate, hits head.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Confusional state, Craniocerebral injury, Delirium, Disorientation, Electroencephalogram
Clinical narrative: Confusion, disoriented, insomnia, didn't know how to get dressed, undressed, urinate, evacuate, complete delirium, headaches, buzz and tingling feeling in brain and all 4 extremities, high B.P., no motivation, disorganized, hard to communicate, hits head.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Head injury, Headache, Hypertension, Insomnia, Intentional self-injury
Clinical narrative: Confusion, disoriented, insomnia, didn't know how to get dressed, undressed, urinate, evacuate, complete delirium, headaches, buzz and tingling feeling in brain and all 4 extremities, high B.P., no motivation, disorganized, hard to communicate, hits head.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Loss of personal independence in daily activities, Nuclear magnetic resonance imaging, Paraesthesia, Tinnitus
Clinical narrative: Confusion, disoriented, insomnia, didn't know how to get dressed, undressed, urinate, evacuate, complete delirium, headaches, buzz and tingling feeling in brain and all 4 extremities, high B.P., no motivation, disorganized, hard to communicate, hits head.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Lip swelling, Pruritus, Urticaria
Clinical narrative: Patient waited in store 20 minutes after the injection, had no adverse effects. On her drive home she developed SOB, swelling of the throat, and wheezing.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Pharyngeal oedema, Wheezing
Clinical narrative: Patient waited in store 20 minutes after the injection, had no adverse effects. On her drive home she developed SOB, swelling of the throat, and wheezing.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Exposure during pregnancy, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe shoulder pain on the side of the injection, with symptoms consistent with acute bursitis - limited abduction of the left arm, worsening of pain at night). The injection site was very high and the nurse reported feeling some resistance with the injection and told me to "relax".
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information was received from a licensed practical nurse concerning a 62 year old female patient. No information was received regarding past medical history, concurrent conditions or concomitant medications. On 19-MAY-2017 the adult patient was administered a pediatric dose of VAQTA lot # M036458, expiration date 02-MAR-2018 (dosage and route of administration unknown). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report has been received from a nurse, concerning  an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates,  the reporter stated that he/she was unsure if patients received improperly stored doses of VARIVAX subcutaneous, lot # M042496 and expiration date 11-MAY-2018 (dose was not provided) for prophylaxis and which were reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of 0° Centigrade, time frame of 10 hours and previous temperature excursion of (0° centigrade for 13 hours 30 minutes).  Digital Data logger was involved. report. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a physician assistant via a company representative, concerning to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis and additionally on an unknown date received a dose of M-M-R II (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unspecified date, the patient was then inadvertently administered other dose (reported as a second dose) of VARIVAX (frequency, route of administration, lot # and expiration date were not reported) and other dose (reported as a second dose) of M-M-R II (frequency, route of administration, lot # and expiration date were not reported) on another unspecified date. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored ROTATEQ oral liquid, lot # M040268 with expiration date on 14-MAY-2018 (dose was not reported). The vaccine underwent a temperature excursion of 0 to 1 degree Celsius for 40 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA001279: US-009507513-1706USA001280: US-009507513-1706USA001281: US-009507513-1706USA001282: US-009507513-1706USA001283: US-009507513-1706USA001284:
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unspecified date in 2013, the patient was vaccinated with the first dose of GARDASIL for prophylaxis. The reporter indicated that on 23-MAY-2017, the patient went to the office to receive the second dose in the series. At the reporting time, the patient had not received the dose yet; however the the reporter nurse confirmed that the patient would receive a dose of GARDASIL 9 in the office on 23-MAY-2017 (reported as "today")(interchange of vaccine products). No adverse events were reported. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This is a spontaneous report from a physician regarding a 17-year-old patient of unknown gender who received a dose of PROQUAD on 21-MAR-2017 and 23-MAY-2017 (lot # and expiration date not specified for either dose) for prophylaxis. No adverse event was reported.  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2013, the patient was vaccinated with a single dose of GARDASIL lot # H021861 (route of administration and expiry date were not reported). On 24-MAY-2017, the patient was vaccinated with a single dose of GARDASIL 9 lot # M034195 (route of administration and expiry date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # N005274, expiration date 03-APR-2018 . No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 degrees Celsius for 4 hours 54 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004569: US-009507513-1706USA004570:
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the administrator referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot# M000442, expiration date 31- MAR-2018 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1705USA013001: US-009507513-1705USA012999: US-009507513-1705USA012998: US-009507513-1705USA012997: US-009507513-1705USA012995: US-009507513-1705USA012985: US-009507513-1705USA013000:
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the administrator referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot# M041181 (dose and expiration were not reported). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the administrator referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot# M041181 (dose and expiration were not reported). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1704USA001661:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a Certified Medical Assistant regarding a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On 24-MAY-2017, the patient was administered with an unspecified dose of GARDASIL 9 for prophylaxis (lot # M036059 and expiration date 03-JUN-2019; dosage schedule, anatomical location and route of administration were not reported) that was mixed with a sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a two unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates, the patients were administered an improperly stored doses of VARIVAX injection (lot # M040138 with expiration date at 28-SEP-2018; doses, routes of administration and anatomical locations were not reported), for prophylaxis. On an unknown date, the administered doses of vaccine were exposed to a temperature of 6 degrees Fahrenheit (F) for 4 minutes. There was also reported a previous temperature excursion including exposure to a temperature of 12 degrees Fahrenheit (F) for 3 minutes (date unspecified). Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004566:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Medical Assistant, concerning a patient of an unknown age and gender.  The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 05-MAY-2017, the patient was vaccinated with a dose of PROQUAD lot number M033908 with expiration date in 16-JAN-2018 (dose, anatomical location and route of administration were not provided), reconstituted with a sterile water diluent (DILUENT MRK INJ) for prophylaxis, instead of the scheduled vaccination with M-M-R II (dose, dose number, lot  number and expiration date were not provided) for prophylaxis. The medical assistant stated that it was a medication error in which she grabbed the wrong vial. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates between 19-APR-2017 and 23-MAY-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L042219 with expiration date 02-JUN-2019 and lot # M007311 with expiration date 30-NOV-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 24 hours. A Digital Data logger was not involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA014464: US-009507513-1705USA014496: US-009507513-1705USA014494: US-009507513-1705USA014495:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (who was also an immunization official) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced an unspecified temperature excursion. It was not reported whether a data logger was involved or if there were previous temperature excursions. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004571: US-009507513-1706USA004572: US-009507513-1706USA004573:
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Induration, Injection site swelling, Nodule
Clinical narrative: This spontaneous report was received from a nurse and refers to a 23-year-old female patient. The patient did not have any concurrent conditions, medical history, drug reactions or allergies and did not take any concomitant medications. On 31-MAR-2017, the patient was vaccinated with her first dose of GARDASIL 9 injection, intramuscularly, lot # M032650, expiration date: 31-MAR-2019 (dose was not reported). On an unknown date in April 2017, the patient developed swelling at the injection site that was "as big as a golf ball". The patient returned for a follow up appointment on 30-MAY-2017 and the nurse stated that the patient had "a hard knot under the skin" on that day. No laboratory diagnostics studies were performed. The outcome of the events was reported as recovering. The causality between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 that had expired on 27-MAY-2017, lot # M014929 (exact dose, route of administration and anatomical location were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates, the patients were administered an improperly stored doses of PROQUAD (albumin status: recombinant human albumin, rHA) injection (lot # M040141 with expiration date at 27-MAR-2018, lot # M022403 with expiration date at 01-NOV-2017 and lot # M036158 with expiration date at 12-FEB-2018; for prophylaxis; doses, routes of administration and anatomical locations were not reported), which were reconstituted with properly stored sterile diluent (STERILE DILUENT) (strength, dose, lot # and expiration date were not reported). On an unknown date, the administered doses of vaccine were exposed to a temperature from -14 degrees Celsius (C) to -10 degrees Celsius (C) for 2 hours and 33 minutes. There was no previous temperature excursion. Data logger was used to track the temperature. No adverse reactions were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative, referring to an 85 year old female patient. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medications included sterile diluent (STERILE DILUENT). On 07-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, anatomical location, route of administration, lot # and expiration date were not provided) for prophylaxis. On 24-APR-2017, the patient was admitted to an unspecified hospital due to a "lack of efficacy with ZOSTAVAX". On an unspecified date during hospitalization, the patient was given gabapentin as a treatment for the event. At the reporting time, the outcome of the event was not provided and it was unknown if the patient was discharged from the hospital. Additionally, reporter's causality assessment between vaccination failure and  ZOSTAVAX was not provided. The lack of efficacy was considered serious as it led to hospitalization. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 31-MAY-2017, the patient was vaccinated with a dose of improperly stored VAQTA lot # N005274 with an expiration date of 03-APR-2018, intramuscularly, in the right arm (exact dose was not provided) and a dose of RECOMBIVAX HB lot # M035487 with an expiration date of 23-FEB-2019, intramuscularly, in the right arm (exact dose was not provided). Administered doses of vaccines underwent a temperature excursion of 35 degrees Fahrenheit (F) for 50 minutes which was detected by a digital data logger. There was a previous excursion reported of 33 F for 4 hours. No adverse event occurred. No product quality (PQC) complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004575:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a multiple unspecified patients of unknown age and gender. The patients' concomitant therapy, medical history, concurrent conditions, drug and allergy history were not reported.     On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ lot # M041765 with expiration date on 05-MAY-2018 and lot # M040268 with expiration date on 14-MAY-2018, orally (dose was not provided) for prophylaxis.  No adverse effects were reported. On an unspecified day, the data logger registered that during 30 minutes, the temperature under the vaccine stored was 47° to 77° Fahrenheit (9° to 25° Celcius), there was previous temperature excursion during 7 hours under the same temperatures. This is one of the two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001844:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (manufacturer unknown) that was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine was exposed to the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes and -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous temperature excursions. Digital Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA008347:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent (manufacturer unknown), which was used to reconstitute the vaccine. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous temperature excursions reported. Data logger was involved.  No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA008347:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent (manufacturer unknown), which was used to reconstitute the vaccine. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous temperature excursions reported. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent, which was used to reconstitute the vaccine. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous temperature excursions reported. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA008347:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent, which was used to reconstitute the vaccine. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous temperature excursions reported. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored GARDASIL 9, lot # M041990 with expiration date on 28-JUN-2019 and lot # N000326 with expiration date on 14-OCT-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0 to 1 degree Celsius for 40 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001280: US-009507513-1706USA001284: US-009507513-1706USA001282: US-009507513-1706USA001283: US-009507513-1706USA001279: US-009507513-1706USA001281:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB, lot # N000238 with expiration date on 25-OCT-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0 to 1 degree Celsius for 40 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011819: US-009507513-1706USA001284: US-009507513-1706USA001282: US-009507513-1706USA001283: US-009507513-1706USA001279: US-009507513-1706USA001281:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23, lot # N003993 with expiration date on 20-OCT-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0 to 1 degree Celsius for 40 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001280: US-009507513-1706USA001284: US-009507513-1706USA001282: US-009507513-1706USA001283: US-009507513-1706USA001279: US-009507513-1705USA011819:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VAQTA, lot # M038572 with expiration date on 11-MAR-2018 and lot # M047658 with expiration date on 28-OCT-2017 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0 to 1 degree Celsius for 40 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001280: US-009507513-1706USA001284: US-009507513-1705USA011819: US-009507513-1706USA001283: US-009507513-1706USA001279: US-009507513-1706USA001281:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX, lot # M027347 with expiration date on 01-JUN-2018 (dose and route of administration were not reported) reconstituted with properly stored concomitant of sterile diluent (MERCK). The vaccine underwent a temperature excursion of -14 to -10 degree Celsius for 204 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001280: US-009507513-1706USA001284: US-009507513-1706USA001282: US-009507513-1705USA011819: US-009507513-1706USA001279: US-009507513-1706USA001281:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received form an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, unknown number of patients were probably vaccinated with improperly stored doses of VAQTA (lot# and expiration date not specified; dose, route, site of administration unknown) for prophylaxis. It was reported that VAQTA lot # K005958 (reported expiration date 09-FEB-2017, but auto generated expiration date 09-FEB-2016), lot # K018182 (expiration date 12-FEB-2017), lot # K019560 (expiration date 02-JUN-2017), lot # reported as WK747 (expiration date 21-AUG-2017) and lot # L039659 (expiration date 15-MAR-2017) underwent a temperature excursion in 2015. From May 2015 to December 2015, the minimal/maximal temperature was 33/46, 32/46, 32/ 47, 31/48, 32/47, 32/48, 32/48 and 31/56 (units not provided) respectively. The lot number L039659 (expiration date 15-MAR-2017), L023936 (expiration date 15-MAR-2017), M018644 (expiration date not reported but auto generated as 20-SEP-2017), M022924 (expiration date 24-JAN-2018), M027879 (expiration date 24-JAN-2018) underwent a temperature excursion in 2016. In January to September, November and December of 2016, the minimal/maximal temperature was 31/49, 31/49, 30/ 86, 31/75, 30/49, 27/86, 29/86, 26/51, 28/54, 24/49 and 24/53 (units not provided) respectively. There was no VAQTA lot number reported in 2017 temperature excursions.  This is one of several reports received from the same source. Additional information has been requested. ; Sender's Comments:  US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case : 1705USA004287 US-009507513-1706USA001292: US-009507513-1706USA001290: US-009507513-1706USA001289: US-009507513-1706USA001288: US-009507513-1706USA001291:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received form an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, unknown number of patients were probably vaccinated with improperly stored doses of GARDASIL 9 (lot# and expiration date not specified; dose, route, site of administration unknown) for prophylaxis. It was reported that GARDASIL 9 lot # L000610 (expiration date 31-JAN-2017), lot # reported as L031429 (expiration date 21-JUL-2017), L025737 (expiration date 28-JUL-2017) and L016428 (expiration date 30-JUL-2017) underwent a temperature excursion in 2015. From May 2015 to December 2015, the minimal/maximal temperature was 33/46, 32/46, 32/ 47, 31/48, 32/47, 32/48, 32/48 and 31/56 (units not provided) respectively. The lot number L016428 (expiration date 30-JUL-2017), L019297 (expiration date 18-AUG-2017), L044475 (expiration date 12-MAY-2017), M005714 (expiration date 03-OCT-2017), M011117 (expiration date 07-DEC-2017), M009378 (expiration date not provided), M026306 (expiration date 30-APR-2018) and M017983 (expiration date 30-MAY-2018) underwent a temperature excursion in 2016. In January to September, November and December of 2016, the minimal/maximal temperature was 31/49, 31/49, 30/ 86, 31/75, 30/49, 27/86, 29/86, 26/51, 28/54, 24/49 and 24/53 (units not provided) respectively. There was no GARDASIL 9 lot number reported in 2017 temperature excursions.  This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case : 1705USA004287 US-009507513-1706USA001287: US-009507513-1706USA001288: US-009507513-1706USA001289: US-009507513-1706USA001290: US-009507513-1706USA001291:
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant medication was not reported. The pharmacist reported that a patient received a PNEUMOVAX 23 (dose 1, exact dose, route, lot# and expiration unknown) in January 2017 and that the same patient received another PNEUMOVAX 23 (dose 2, exact dose, route, lot# and expiration unknown) for prophylaxis (inappropriate schedule of drug administration) on a recent unspecified date in 2017. No adverse effect reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug allergies were not reported.  The registered nurse reported that on 10-MAY-2017 the patient was inadvertently vaccinated with expired dose of PROQUAD Human serum albumin (HSA)(lot # L024497, expiry date : 01-JAN-2017), for prophylaxis (expired product administered). Concomitant therapies included sterile diluent(Manufacturer Unknown) (Lot# and expiration date was unknown by the reporter). There was no previous temperature excursions . No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Nurse reported patient received improperly stored VARIVAX (lot # M046005, expiry date: 18-NOV-2018) on 30-MAY-2017 (incorrect product storage). The vaccine was exposed to 15"F to 46"F (22.1F) for one hour. There was no previous temperature excursion. The call was because of data logger. Concomitant medication included a sterile water diluent. Nurse could not provide the lot and expiration for the properly stored sterile water diluent used to reconstitute the dose of VARIVAX. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004576:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report was received from a consumer regarding her 1 year old male son. His medical history and concomitant medications were unknown. His concurrent drug reactions/allergies were reported with ceftriaxone (ROCEPHIN). On an unknown date in 2014, the patient was vaccinated at the age of 1 year with VARIVAX (dose, route, lot number and expiration date unknown) to prevent chickenpox. On an unknown date in 2014, immediately after vaccination, he developed "a red welt on his leg" at the injection site where VARIVAX was administered (vaccination site urticaria). The patient did not receive treatment for the event. The patient sought medical attention (office visit) and was not hospitalized for the event. The outcome of vaccination site urticaria was reported as recovered/resolved on the same day. The consumer reported that the patient was currently 4 year old. The reporter did not have any further details to provide. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: This report was received from Novartis and was assigned manufacturer report number PHEH2017US016177_OS for a pneumonia shot (manufacture unknown). Information has been received from a currently 60 year old female patient concerning herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2015 the patient was vaccinated with pneumococcal vaccine, (23-valent) (manufacture unknown) for prophylaxis (dose, frequency, route, lot# and expiration date were not reported). However, it did not work. The outcome of vaccination failure was not reported. Causality between vaccination failure and the product was not reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Choking, Oral administration complication
Clinical narrative: This spontaneous report has been received from a a nurse who was also the patient's mother and refers to a 2 month old female patient. The patient's concurrent conditions included dysphagia diagnosed at birth. The patient had no concomitant medications nor drug reactions or allergies. On an unknown date in 2017 (at 2 months old), the patient was vaccinated with the first dose of ROTATEQ orally (dose, lot # and expiration date were not reported) and on 02-JUN-2017 (at 4 months old), the patient received the second dose of ROTATEQ orally (dose, lot # and expiration date were not reported). The patient began choking on the vaccine when she received it at 2 months old on an unknown date in 2017 and when she received it at 4 months old on 02-JUN-2017. No treatment was given for the adverse events. There were no lab diagnostic studies performed. The patient sought medical attention as the events occurred in physician office. No product quality complaint was involved. The outcome of the events of choking was recovered on unknown date in 2017 and on an unknown date in June 2017. The relatedness between the events and ROTATEQ was not reported. Upon internal review, the events of choking were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-JUN-2017, the patient was vaccinated with an expired dose of M-M-R II (for prophylaxis, lot # L019989, expiration date 01-JUN-2017, subcutaneously; dose was not reported) that was reconstituted with sterile diluent (lot # reported as M010691, expiration date 03-SEP-2018). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to two patients (twins) of an unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 05-JUN-2017, the patients were vaccinated with doses of PROQUAD injection (dose, route of administration, lot# and expiry date were not reported) for prophylaxis and VARIVAX injection, lot# M028546, expiry date 07-AUG-2018 (dose and route of administration were not reported) for prophylaxis. Sterile diluent (lot# and expiration date were not provided) was used to reconstitute the vaccine. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-JUN-2017, the patient received an expired dose of RECOMBIVAX HB injection (lot # L018500 with expiration date at 13-APR-2017; dose, route of administration and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.