chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site scar, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report has been received from the patient's mother referring to a 4 year old male patient. The patient did not have medical history, drug reactions or allergies or concomitant medications. Information regarding the patient's concurrent conditions was not reported. On 30-AUG-2017, the patient was vaccinated with PROQUAD lot # N008825 and expiration date 30-AUG-2019, by subcutaneous route (strength, dose and anatomical location were not provided) for prophylaxis. On 31-AUG-2017, the patient developed red swelling, "hot to the touch" at injection site (Vaccination site erythema, swelling and warmth) which size was an inch in diameter also a "mound" swelling the size of a tennis ball developed on the patient's thigh (was not specified if was left or rigth thigh)(Local swelling) . It was also mentioned that in September 2017 (reported as the following days) the swelling at injection site and the thigh area subsided, but both became very itchy (vaccination site pruritus and pruritus) and as result the patient has scratches and scars in those areas. At the reporting time the outcome of Vaccination site pruritus, Pruritus,Scratch, Vaccination site scar , scar, vaccination site erythema and vaccination site warmth was reported as recovering. The causality assessment between the PROQUAD and the events was not reported. The patient sought medical attention and unspecified treatment was given for the adverse events, none laboratories were performed. Additionally, the reporter requested the lot check.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Scratch
Clinical narrative: This spontaneous report has been received from the patient's mother referring to a 4 year old male patient. The patient did not have medical history, drug reactions or allergies or concomitant medications. Information regarding the patient's concurrent conditions was not reported. On 30-AUG-2017, the patient was vaccinated with PROQUAD lot # N008825 and expiration date 30-AUG-2019, by subcutaneous route (strength, dose and anatomical location were not provided) for prophylaxis. On 31-AUG-2017, the patient developed red swelling, "hot to the touch" at injection site (Vaccination site erythema, swelling and warmth) which size was an inch in diameter also a "mound" swelling the size of a tennis ball developed on the patient's thigh (was not specified if was left or rigth thigh)(Local swelling) . It was also mentioned that in September 2017 (reported as the following days) the swelling at injection site and the thigh area subsided, but both became very itchy (vaccination site pruritus and pruritus) and as result the patient has scratches and scars in those areas. At the reporting time the outcome of Vaccination site pruritus, Pruritus,Scratch, Vaccination site scar , scar, vaccination site erythema and vaccination site warmth was reported as recovering. The causality assessment between the PROQUAD and the events was not reported. The patient sought medical attention and unspecified treatment was given for the adverse events, none laboratories were performed. Additionally, the reporter requested the lot check.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 69 year old female patient with asthma and without any drug reaction/allergies. The patient's medical history included migraine. Concomitant therapies included TRADJENTA and ADVAIR. On 05-SEP-2017, the patient received a dose of PNEUMOVAX 23 intramuscularly, Lot # M004318 expired on 12-OCT-2017, for prophylaxis (strength not reported). On 05-SEP-2017, reported as later on evening, the patient developed redness and swelling at the PNEUMOVAX 23 injection site and a fever. The patient went to the pharmacy, on this same date, and reported the above symptoms to another pharmacist. On evening of 06-SEP-2017, the redness started moving down the patient's arm, being between her elbow and her shoulder and was warm to the touch. The next day, on 07-SEP-2017, the patient was seen in the pharmacy, in order to report that the redness started moving. There was no any laboratory study performed and the patient did not received any treatment for the adverse events reported. At the reporting time, the patient was not recovered of erythema, pyrexia, injection site swelling, injection site erythema and feeling hot. The causality assessment between these events and vaccination with PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-SEP-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported) and on 07-SEP-2017, the patient was vaccinated with the second dose of GARDASIL 9 lot # M044717, expiration date 19-JUL-2019 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint has been filled.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 11-SEP-2017, the patient was vaccinated with a properly stored by expired dose of ZOSTAVAX lot number M042503 with expiration date 18-AUG-2017 (dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported.
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 nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unknown date in 2013, the patient was vaccinated with the first dose of GARDASIL (strength, route, anatomical location, lot # and expiration date were not reported) for prophylaxis; then, on 09-FEB-2017, the patient was vaccinated with the second dose of GARDASIL (strength, route, anatomical location, lot # and expiration date were not reported) for prophylaxis; and finally, on 10-MAR-2017, the patient was vaccinated with the third dose of GARDASIL 9 (strength, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a vaccine coordinator referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 12-SEP-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot# N012617, expiration date 18-OCT-2018 (strength and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent (STERILE MRK) lot# N006325, expiration date 07-AUG-2019, used for reconstitution which did not undergo a temperature excursion. The doses of PROQUAD, were exposed to a temperature excursion of 6 Fahrenheit (°F) to 14°F for 2 hours, and 15°F to 46°F for one hour, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 27 year old female patient. The patient's medical history included wisdom teeth removal. The patient's concurrent conditions included depression and muscular dystrophy included. The patient did not have concomitant therapies or drug reactions or allergies. The patient stated that on an unknown date, she may had been vaccinated in M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 22-AUG-2017, titers were drawn and the result was that the patient had sub-therapeutic titers. The outcome of antibody test negative was reported as not resolved. The causality assessment between vaccination with M-M-R II and the event was not reported.
Age: 44.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Fatigue, Influenza like illness, Pain, Product name confusion
Clinical narrative: This spontaneous report was received from a nurse referring to a 44 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as "none". The patient's concurrent conditions were not provided. On 12-AUG-2017, the patient was vaccinated with a dose PROQUAD, subcutaneous, for "vaccination" (dose, lot # and expiration date were not reported). Other suspect therapies included M-M-R II (dose, route, lot # and expiration date were not reported). Concomitant therapies included sterile diluent (STERILE DILUENT). On 15-AUG-2017 (reported as "3 to 4 days after injection") , the patient experienced influenza like symptoms, was achy and fatigued. No treatment was given for the adverse events. The reporting nurse stated that "the confusion was human error, and that the person administering the dose though they were giving M-M-R II"(product name confusion). At the time of reporting the outcome of the adverse events was reported as recovered. A product quality complaint was not involved. The causality assessment between the adverse events and the suspect therapies was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old non-pregnant female patient. The patient's concurrent conditions included high blood pressure and high cholesterol. The patient did not have any known allergies or reactions. There was no information about patient's historical conditions. Concomitant medications included unspecified medications for blood pressure and high cholesterol. On 25-MAR-2017, the patient was vaccinated with ZOSTAVAX, subcutaneously, for prophylaxis (dose, lot number and expiration date were not reported). Approximately later on the same date (reported as shortly after receipt of the vaccine), she developed an injection site reaction. On an unspecified date, the patient visited her physician who prescribed her both oral steroids (unspecified) as well as a steroidal cream (unspecified) and within 10 days, the reaction was resolved. On 13-SEP-2017, the patient went to the pharmacy and it was noted that the injection site reaction has resurfaced in the same place. She went again to the physician on the same day, which again prescribed her stronger oral steroids (unspecified) as well as a steroidal cream (unspecified), but did not provide her with a diagnosis. No laboratory tests were performed. The outcome of the event was not recovered. No product quality complaint was involved. The causal relationship between the event and therapy with ZOSTAVAX were not reported.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 34 year old female patient. The patient had no pertinent medical history or drug reactions or allergies. On an unknown date (reported as "as a child"), the patient was vaccinated with M-M-R II injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On an unknown date (reported as "recently"), the patient had titers drawn for school which came back negative (date was not specified). It was reported that the school required her to receive the revaccination with M-M-R II. The patient sought medical attention (unspecified how). No treatment was given due to the event. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and M-M-R II. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (exact dose and route of administration were not reported; lot # N012492 with the expiration date of 17-MAR-2018), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No adverse effects were reported. The administered dose of ZOSTAVAX experienced a temperature excursion between 15 and 46 Fahrenheit degrees for 28 hours and 14 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown) lot number L028090, expiration date on 26-MAR-2018. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L044526, expiration date on 09-NOV-2017 (strength, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccine had a temperature excursion of 15° Fahrenheit (F) to 46°F during a time frame of 3 hours. It was confirmed that no previous temperature excursions occurred and a digital data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified amount of patients of unknown age and gender. The patients' medical history or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (lot number: M045393, expiration date: 14-NOV-2018; and lot number reported as "N049212", expiration date: 16-DEC-2018) for prophylaxis. M-M-R II was reconstituted with sterile diluent (manufacturer unknown). According to the reporter, the doses were exposed to a temperature between 47 degrees Fahrenheit (F) to 77 F for 72 hours. No adverse effects were reported. A digital data logger was involved. Lot number N049212 is an invalid lot number for M-M-R II.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # N009773 expiration date: 20-SEP-2018 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. It was stated by the reporter that the incorrect product storage had a time frame of 2 hours between  6° F and 14° F (6.3°F); and the call was given because of a data logger. Previous temperature excursions had not occurred. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008263:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N008829 expiration date: 16-MAR-2019 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. It was stated by the reporter that the incorrect product storage had a time frame of 2 hours between  6° F and 14° F (6.3°F); and the call was given because of a data logger. Previous temperature excursions had not occurred. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008034:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a vaccine coordinator, referring to unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported in any patients. The vaccines had a temperature excursion of 7.52 Fahrenheit (F) for 24 hours. It was reported that the vaccines had a previous temperature excursion of 5.5 F for 1 hour and a digital data logger was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. Medical history and drug reactions or allergies for the patients involved were not reported. On an unknown date the patients were vaccinated with ROTATEQ, orally, lot number: M016238 (Expiration date: 07-DEC-2017) and M025569 (Expiration date: 18-JAN-2018), for prophylaxis(strength, dose or units were not provided). There was digital data logger involved. The nurse reported that on an unknown date multiple doses of improperly stored ROTATEQ were administered to multiple unspecified patients, with the characteristics were the following: - Temperature: 32°F to 35°F - Time frame: 8 hours. Previous temperature excursion: No. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007951.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot# M049127 with expiration date 15-DEC-2018, lot# N012487 with expiration date 20-APR-2017, and lot#  N017396 with expiration date 07-JUN-2019, for prophylaxis.  Concomitant therapies included sterile diluent (STERILE MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F during a time frame of 1 hour and 50 minutes and 15°F to 46°F for 6 hours and 15 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On AUG-2017 the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On AUG-2017 the patient experienced incorrect dose administered and drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of incorrect dose administered, no adverse event and drug administered to patient of inappropriate age is unknown. The reporter considered incorrect dose administered, drug administered to patient of inappropriate age and no adverse event to be not related to RECOMBIVAX HB.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M036295, expiration date 13-FEB-2018, rHA status (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MRK). On 04-JUN-2017, the vaccines were exposed to temperature ranges between 6° Fahrenheit (F) to 14° during a time frame of 1 hour 20 minutes. There was not previous temperature excursion, the temperature excursion was called by a data logger. Adverse effects were not reported. This is one of two reports from the same source. Sender's Comments: US-009507513-1709USA008666.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Headache, Hypoaesthesia, Injection site erythema, Paraesthesia
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 16-SEP-2017, the patient was vaccinated with an expired dose of with ZOSTAVAX, lot # reported as L00722, expiration date 03-JUN-2016 (dose, dose number, route of administration were not provided) for prophylaxis. On the same date, within 15 minutes of receiving the vaccine, the patient experienced some numbness and tingling on right side of head down to the cheeks, and redness at the site of injection. On 18-SEP-2017, the patient had a headache. At the time of report, the outcome of hypoaesthesia, paraesthesia, injection site erythema and headache was unknown. The causality assessment between the events and the vaccination with ZOSTAVAX was not reported. Lot number L00722 is an invalid lot number for ZOSTAVAX.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 18-SEP-2017, the patient was administered 1 dose of expired RECOMBIVAX HB (expiration date 15-SEP-2017, lot number M013639). No adverse effects reported.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: This initial spontaneous report was received from a physician via a company field representative referring to a male patient in his 60's. Medical history, concurrent conditions and concomitant medications were unknown by the reporter. On unspecified Wednesday, the patient received PNEUMOVAX 23 (dose, route and lot # not provided). The patient developed Guillain-Barre syndrome five days later (also reported as "about two weeks ago" on 18-SEP-2017). The patient was hospitalized and passed away within the week after receiving unspecified treatment. The cause of death was Guillain-Barre syndrome. Causality assessment was not provided. The field representative found out that there may be legal action taken. Upon internal review, Guillain-Barre syndrome was considered medically significant. The physician felt Guillain-Barre syndrome was life-threatening. Additional information will not be requested as the reporter did not provide consent to be contacted. Reported Cause(s) of Death: Guillain-Barre syndrome.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 injection, lot number N011867, expiration date 08-NOV-2018) for prophylaxis. The temperature of excursion with PNEUMOVAX 23 was 47 to 77 Fahrenheit degrees during 1 hour and 38 minutes. No previous of temperature excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from  the same reporter. Sender's Comments: US-009507513-1709USA009546.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M037248 with expiration date on 21-FEB-2019 (dose and route of administration were not provided) for prophylaxis; or with improperly stored ROTATEQ orally, lot # M041814 with expiration date on 27-JUN-2018 and lot # M041184 with expiration date on 31-MAY-2018 (dose was not provided) for prophylaxis. The doses of RECOMBIVAX HB and ROTATEQ were exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C (13.5°C), during a time frame of 5 hours 47 minutes, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1709USA009285.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M003701, expiration date 01-NOV-2019 and lot # N003700, expiration date 01-NOV-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. Lot number M003701 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA005606: US-009507513-1709USA009438.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M003701, expiration date 01-NOV-2019 and lot # N003700, expiration date 01-NOV-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. Lot number M003701 is an invalid lot number for haemophilus B conjugate vaccine (meningococcal protein conjugate). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA005606: US-009507513-1709USA009435: US-009507513-1709USA009438.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M003701, expiration date 01-NOV-2019 and lot # N003700, expiration date 01-NOV-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. Lot number M003701 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA005606: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005796, expiration date 26-MAY-2018) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA005606.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005796, expiration date 26-MAY-2018) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA005606: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005796, expiration date 26-MAY-2018) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA005606: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005796, expiration date 26-MAY-2018) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA005606: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005796, expiration date 26-MAY-2018) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA005606: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L043704, expiration date 04-NOV-2017) (dose and route were not reported) for prophylaxis. Concomitant therapy included sterile diluent. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA005606: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009438: US-009507513-1709USA009435:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 injection, lot number M044717, expiration date 19-JUL-2019) for prophylaxis. The temperature of excursion with GARDASIL 9 was 47 to 77 Fahrenheit degrees during 1 hour and 38 minutes. No previous of temperature excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA009380.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unknown number of improperly stored doses of PEDVAXHIB lot number M007762 with expiration date of 07-DEC-2018 and lot number L012838 with expiration date of 10-MAR-2018, for prophylaxis (strength, dosage schedule, route and anatomical location were not reported). The administered doses experienced a temperature excursion of 60 degree Fahrenheit for 4 weeks; data logger was involved. No previous temperature excursion was reported. No adverse events were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA008052: US-009507513-1709USA009559.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Information has been received from a medical assistant concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. Since 06-SEP-2017, the patients were vaccinated with PEDVAXHIB (lot # N000235 with expiration date 26-OCT-2019) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 1 hour and 20 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA009338.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to four unspecified patient of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On 30-AUG-2017, the patient vaccinated with the improperly stored M-M-R II recombinant human albumin (RHA) (lot # M002418, expiration date of 12-JAN-2018, route, dose and dose# unknown)  reconstituted with properly stored sterile diluent (manufacturer unknown), for prophylaxis. All the M-M-R II recombinant human albumin (RHA) were administrated after the previous excursion. No adverse effects were reported. The administered doses of vaccine was underwent the temperature excursion from 47 to 77 degrees Fahrenheit for 10 hours 30 minutes. The previous temperature excursions was reported as from 47 to 77 degrees Fahrenheit for 2 hours. Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1709USA009699: US-009507513-1709USA009700: US-009507513-1709USA000552.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 30-AUG-2017, the patient vaccinated with the improperly stored VARIVAX (lot # M010481, expiration date of 01-MAR-2018; route, dose and frequency were unknown) reconstituted with properly stored sterile diluent (manufacturer unknown), for prophylaxis (incorrect product storage). No adverse effects were reported. The administered doses of vaccine was underwent the temperature excursion from 47 to 77 degrees Fahrenheit for 10 hours 30 minutes. The previous temperature excursions was reported as from 47 to 77 degrees Fahrenheit for 2 hours. Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of four reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000552: US-009507513-1709USA009700: US-009507513-1709USA009698:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to four unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On 30-AUG-2017, the patients vaccinated with the improperly stored VARIVAX (lot # N000682, expiration date of 06-JAN-2019; route, dose and frequency were unknown) reconstituted with properly stored sterile diluent (manufacturer unknown), for prophylaxis (incorrect product storage). No adverse effects were reported. The administered doses of vaccine was underwent the temperature excursion from 47 to 77 degrees Fahrenheit for 2 hours. No previous temperature excursions was reported. Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1709USA009699: US-009507513-1709USA000552: US-009507513-1709USA009698.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Mom describes adverse event as left hand pain and joint pain; along with redness, swelling, itching and pain in the thumb and 5th digit. Per mom symptoms lasted 24 hours.
Age: 5.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Headache, Lacrimation increased, Pyrexia, Rash
Clinical narrative: Mother states the child began a fever of 104 on Friday 9/15/17 with rash on face. C/O headache, watery eyes. This lasted until 9/17/17 but the rash was still present as of 9/19/17. Mother called pediatrician.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Pt has confirmed chicken pox.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster in a previously vaccinated person. Symptom onset began 6/27/2017, consisted of a painful unilateral 1 dermatome rash lasting less than 4 weeks.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PEDVAXHIB (dose and route unknown, lot # M047666, expiration date 24-OCT-2019) for prophylaxis. The vaccine was improperly stored at 32 to 35 degrees Fahrenheit (35.4 degrees Fahrenheit) for 1 hour. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. No Product quality complaint (PQC) was presented. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000777.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored ROTATEQ (dose and route unknown, lot # M043836, expiration date 17-JUN -2018) for prophylaxis. The vaccine was improperly stored at 32 to 35 degrees Fahrenheit (35.4 degrees Fahrenheit) for 1 hour. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. No Product quality complaint (PQC) was presented. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000584.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to fifteen patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 29-AUG-2017 through 18-SEP-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N010497 with an expiration date on 15-JAN-2020 and lot# M042853 with an expiration date on 17-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 1 hour. Data logger was not involved. There were no previous excursions reported.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Chest discomfort, Eye swelling, Pharyngeal oedema, Urticaria
Clinical narrative: This spontaneous report as received from a nurse who was also a patient's mother refers to a 19-year-old male patient. The patient had no pertinent medical history, drug reactions, or allergies. His concomitant medications included prednisone (manufacturer unknown). On 24-AUG-2017, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided). On 27-AUG-2017, the patient experienced developed hives all over his body the size of a coffee saucer, chest tightness and throat swelling. On the same day, the patient went to emergency room (ER) and received 1 dose of epinephrine, BENADRYL, and an unspecified steroid. On 28-AUG-2017, the patient went back to the ER because his eye was swollen shut and he developed new hives around his ear. He received intravenous BENADRYL, intravenous unspecified fluids, and an unspecified steroid medication. The patient was not hospitalized and had no laboratory diagnostic studies performed. On an unknown date in 2017, the patient recovered from all adverse events. The relatedness between the adverse events and GARDASIL 9 was not provided. The reporter considered the adverse events to be life threatening.