chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, who referred to an unknown number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients were administered improperly stored doses of LIQUID PEDVAXHIB (dose, route of administration and anatomical location were not reported) as prophylaxis on the following dates: with lot# M001813 and expiration date of 14-OCT-2018 on 07-JUL-2016, 08-JUL-2016, 14-JUL-2016, 15-JUL-2016, each day from 18-JUL-2016 till 22-JUL-2016, on 25-JUL-2016 and 26-JUL-2016; with lot# N000236 and expiration date: 24-OCT-2019 on 06-APR-2017, each day from 23-MAY-2017 till 26-JUL-2017, 30-MAY-2017, 02-JUN-2017 and 06-JUN-2017; with lot# M046133 and expiration date: 26-SEP-2019 on 12-AUG-2016, 11-APR-2017, 12-APR-2017, 17-APR-2017 and 18-APR-2017; with lot# M034189 and expiration date: 23-MAY-2019 on 21-MAR-2017, 24-MAR-2017 and 30-MAR-2017; with lot# M036058 and expiration date: 19-MAY-2019 on 27-FEB-2017 and 01-MAR-2017; with lot# 032149 and expiration date: 27-DEC-2016; with lot# L051123 and expiration date: 13-OCT-2018 on 23-AUG-2016. The doses of vaccine with lot# M001813 were stored for 8 hours at the following temperatures: on 07-JUL-2016 at 9.4 degrees Celsius (C), on 08-JUL:-2016 at 14C, on 14-JUL-2016 at 9.1C, on 15-JUL-2016 at 9C, on 18-JUL-2016 at 15C, on 19-JUL-2016 at 10C, on 20-JUL-2016 at 34.9 degrees Fahrenheit (F), on 21-JUL-2016 at 34.5F, on 22-JUL-2016 at 34.5F, on 25-JUL-2016 at 34.4F and on 26-JUL-2016 at 47.5F; with lot# N000236 for 8 hours at the following temperatures: on 06-APR-2017 and 06-JUN-2017 at 35.8F, on 23-MAY-2017, 26-MAY-2017 and 30-MAY-2017 at 35.2F, on 24-MAY-2017 and 25-MAY-2017 at 35.3F, on 02-JUN-2017 at 47.3F; lot# M046133 for 8 hours at the following temperatures: on 11-APR-2017 and 18-APR-2017 at 35.2F, on 12-APR-2017 at 35.5F and on 17-APR-2017 at 35.4F; with lot# M034189 for 8 hours at the following temperatures: on 21-MAR-2017 at 35.9F and on 24-APR-2017 at 34.2F; with lot# M036058 for 8 hours at the following temperatures: on 27-FEB-2017 at 34.7F and on 01-MAR-2017 at 35.8F; with lot# M032149 on 27-DEC-2016 at 32.7F for 8 hours; with lot# L051123 on 23-AUG-2016 at 34.9F for 8 hours and with lot# M046133 on 12-AUG-2016 at 33.8F for 8 hours. All temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. It was also reported that several improperly stored doses of LIQUID PEDVAXHIB with the above mentioned lot# and expiration dates were not administered to patients. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004143: US-009507513-1706USA006151: US-009507513-1706USA006149: US-009507513-1706USA006150: US-009507513-1706USA006146: US-009507513-1706USA006148:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II. Additional information is not expected since all scheduled correspondence was received. Sender's Comments: US-009507513-1706USA006147: US-009507513-1706USA006151: US-009507513-1706USA004143: US-009507513-1706USA006150: US-009507513-1706USA006146: US-009507513-1706USA006148.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with ROTATEQ lot # M031651, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information is not expected. Sender's Comments: US-009507513-1706USA004143.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On 01-SEP-2016 the patients were vaccinated with VARIVAX lot # M009766, expiry date 23-FEB-2018. On 01-SEP-2016, 1 day after onset of therapy the patient experienced incorrect product storage. The VARIVAX was reconstituted with properly stored sterile diluent. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. There was previous temperature excursion (no details were provided). A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006147: US-009507513-1706USA004143: US-009507513-1706USA006149: US-009507513-1706USA006150: US-009507513-1706USA006146: US-009507513-1706USA006148.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 year old patient. On January 2000, at the age of 11 months the patient was vaccinated with VARIVAX (lot #, expiration date, dose and route of administration were not reported) for prophylaxis. On an unspecified date in 2009, the patient has received second dose of VARIVAX (lot #, expiration date, dose and route of administration were not reported) for prophylaxis. On 15-JUN-2017, the patient has received third dose of VARIVAX lot # L029466, expiration date 06-SEP-2017 and as reporter refers "it was given intramuscularly rather than subcutaneously". No adverse effects were reported.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Headache, Mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a 76 years old female patient, referring to herself. The patients medical history included a spinal fusion and her current conditions included high blood pressure. The patient's was allergic to "tons of stuff" including penicillin and codeine; with the last one her reaction was really bad, she stated "I saw a light and heard the nurses all around me".  On an unspecified date in 2017 (reported as recently before the events), the patient was vaccinated with PNEUMOVAX 23 injection, lot number M006922, intramuscularly (dose, frequency and expiration date were not reported), for pneumococcal prevention.  The patient stated that she had received unknown vaccinations for pneumococcal prevention, on unspecified times in the past; maybe 4 times.  Concomitant therapies included gabapentin and metoprolol. On 14-JUN-2017, the patient developed pain/soreness under her arm; this pain was severe, where she could not lift her arm (movement disorder). The patient stated that it felt like the pain was reaching the breast tissue (breast pain) and her spine down to the bra line only, not entire spine (pain in thoracic spine); there was pain in the right lung, too.  The patient also started coughing up yellow (productive cough).  Additionally, she was experiencing a headache since the vaccination and she was "aching all over" (generalized aching).  Patient questioned if there anything wrong with the PNEUMOVAX 23 lot to produce this effect. The physician recomended treatment with acetaminophen (TYLENOL), which reduced in some small the pain. The patient considered this reactions as "severe and scary", as she had been in the doctor's office prior to vaccination, in order to be evaluated for breast cancer (unspecified results). The patient's outcome was reported as not recovered. The causality assessment between PNEUMOVAX 23, pain in extremity, headache, generalized aching, movement disorder, pain in thoracic spine, productive cough, pulmonary pain and breast pain was not reported. Additional information is not expected as there is no consent for follow-up.
Sex: F
Vaccine: PPV
Symptoms: Productive cough, Pulmonary pain, Spinal pain
Clinical narrative: This spontaneous report was received from a 76 years old female patient, referring to herself. The patients medical history included a spinal fusion and her current conditions included high blood pressure. The patient's was allergic to "tons of stuff" including penicillin and codeine; with the last one her reaction was really bad, she stated "I saw a light and heard the nurses all around me".  On an unspecified date in 2017 (reported as recently before the events), the patient was vaccinated with PNEUMOVAX 23 injection, lot number M006922, intramuscularly (dose, frequency and expiration date were not reported), for pneumococcal prevention.  The patient stated that she had received unknown vaccinations for pneumococcal prevention, on unspecified times in the past; maybe 4 times.  Concomitant therapies included gabapentin and metoprolol. On 14-JUN-2017, the patient developed pain/soreness under her arm; this pain was severe, where she could not lift her arm (movement disorder). The patient stated that it felt like the pain was reaching the breast tissue (breast pain) and her spine down to the bra line only, not entire spine (pain in thoracic spine); there was pain in the right lung, too.  The patient also started coughing up yellow (productive cough).  Additionally, she was experiencing a headache since the vaccination and she was "aching all over" (generalized aching).  Patient questioned if there anything wrong with the PNEUMOVAX 23 lot to produce this effect. The physician recomended treatment with acetaminophen (TYLENOL), which reduced in some small the pain. The patient considered this reactions as "severe and scary", as she had been in the doctor's office prior to vaccination, in order to be evaluated for breast cancer (unspecified results). The patient's outcome was reported as not recovered. The causality assessment between PNEUMOVAX 23, pain in extremity, headache, generalized aching, movement disorder, pain in thoracic spine, productive cough, pulmonary pain and breast pain was not reported. Additional information is not expected as there is no consent for follow-up.
Sex: U
Vaccine: VARCEL
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. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients might have received doses of improperly stored VARIVAX injection, lot # M041513 with expiration date on 11-OCT-2018 and lot # M046004 with expiration date on 18-NOV-2018 (doses and route of administration were not reported). The administered doses of vaccines were reconstituted with sterile diluent (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 10 minutes and an excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 4 hours 40 minutes. Administered doses of VARIVAX lot # M041513 with expiration date on 11-OCT-2018 underwent previous temperature excursions: an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 2 hours and an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 30 minutes. A digital data logger was involved in recording the excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA011480: US-009507513-1706USA011481.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered nurse refers to 3 patients of an unknown age and gender. the patients' concurrent conditions, medical history, concomitant therapies, drug reactions or allergies were not provided. On an unknown date in June 2017 (reported as "within last week"), the patients were vaccinated with PNEUMOVAX 23 lot # M043424, expiration date June 2018 (strength, dose, route and anatomical location were not provided) for prophylaxis. On an unknown date in June 2017, the patients experienced redness around the injection site and entire upper arm where injection was administered. The patients sought medical attention. The outcome of the aforementioned events was not provided. No product quality complaint was involved. The causality assessment between the events and PNEUMOVAX 23 was not provided. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1707USA000399:
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pneumonia, Swelling
Clinical narrative: Information has been received from a 35 year old female pharmacist who was also the patient via a company representative referring to the pharmacist herself. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date when she was 35 years old, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date the patient experienced pneumonia. Then a year later she got another dose and a year after that she got another dose and kept getting pneumonia on unspecified date. On unknown dates the patient experienced severe reaction, swelling and her arm was extremely painful. It was unknown after which dose the pharmacist experienced the severe reaction, swelling and arm pain. The outcome of the events was reported as recovered. Upon internal review, pneumonia was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 17 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL for prophylaxis, when she was 12 years old, then on 21-JUN-2017, the patient was vaccinated with a dose of GARDASIL 9. No adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a physician (who is also the patient) via a company representative reporting on himself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unspecified date in 2014 (reported as: "about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 14-JUN-2017 (reported as. "about one week ago"), the patient developed a case of shingles. On an unspecified date, the patient experienced a classic dermatomal rash, from front to back on the right hand side of his body". The patient received treatment with unspecified antiviral medication. The case did not involve cancer or overdose. No product quality complaint was involved. At the time of the report, the outcome of shingles and rash was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M044032 and  expiration date 03-JUL-2019 (route, dose, dose number frequency and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit  for 108 hours and 32 to 42 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005600: US-009507513-1706USA011006:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M042172 and expiration date 08-JUN-2018, lot # M039067 and expiration date 18-APR-2018, lot # M044395 and expiration date 31-MAY-2018 (route, dose, dose number frequency and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 108 hours and 32 to 42 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011005: US-009507513-1706USA005600.
Sex: U
Vaccine: MMRV
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. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients may have received doses of improperly stored (albumin status: rHA- recombinant human albumin) PROQUAD injection, lot # M033215 with expiration date on 09-JAN-2018, lot # M040142 with expiration date on 27-MAR-2018 and lot # M042501 with expiration date on 17-APR-2018 (doses and route of administration were not reported). The administered doses of vaccines were reconstituted with STERILE DILUENT (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 10 minutes and also an excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 4 hours 40 minutes. Administered doses underwent previous temperature excursions: an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 2 hours and an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 30 minutes. A digital data logger was involved in recording the excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA011481: US-009507513-1706USA008591.
Sex: U
Vaccine: VARZOS
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. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients might have received doses of improperly stored ZOSTAVAX injection, lot # M037014 with expiration date on 22-NOV-2018 and lot # M035149 with expiration date on 31-OCT-2017 (doses and route of administration were not reported). The administered doses of vaccines were reconstituted with sterile diluent (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 10 minutes and also an excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 4 hours 40 minutes. Administered doses underwent previous temperature excursions: an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 2 hours and an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 30 minutes. A digital data logger was involved in recording the excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA011480: US-009507513-1706USA008591.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-JUN-2017, the patient was vaccinated with improperly stored GARDASIL 9 (lot number M041990, expiration date 28-JUN-2019; dose and route of administration were not reported). The vaccine was exposed to a temperature in the range between 0 to 1 Celsius degrees for 4 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. the patient's concurrent conditions, medical history, concomitant therapies, drug reactions or allergies were not provided. On an unknown date in June 2017 (reported as "within last week"), the patient was vaccinated with PNEUMOVAX23 lot # M043424, expiration date June 2018 (strength, dose, route and anatomical location were not provided) for prophylaxis. On an unknown date in June 2017, the patient was diagnosed with cellulitis. The patient sought medical attention and was prescribed unspecified antibiotics. The outcome of the aforementioned event was not provided. No product quality complaint was involved. The causality assessment between the event and PNEUMOVAX23 was not provided. Upon internal review the event cellulitis was considered as medically significant. This is one of two reports received form the same source.; Sender's Comments: US-009507513-1706USA010035:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with VARIVAX, lot # M024683 with expiry date on 18-MAY-2018, lot # M023380 with expiry date on 11-MAY-2018 and lot # L021215 with expiry date on 10-JUN-2017 (dose and route of administration were not reported) for prophylaxis. Administered doses of vaccines experienced an excursion of unknown temperature for 48 hours. The previous temperature excursion of 10 degrees Fahrenheit for 19 hours was also reported (it was unknown if the vaccines which experienced previous excursion were administered to the patients). Data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000401: US-009507513-1706USA003359.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with PROQUAD, lot # M049123 with expiry date on 13-JUN-2018, lot # M038228 with expiry date on 06-MAR-2018 and lot # M033209 with expiry date on 09-JAN-2018 (dose and route of administration were not reported) for prophylaxis. Administered doses of vaccines experienced an excursion of unknown temperature for 48 hours. The previous temperature excursion of 10 degrees Fahrenheit for 19 hours was also reported (it was unknown if the vaccines which experienced previous excursion were administered to the patients). Data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003359: US-009507513-1707USA000400.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 17-MAY-2017 the patient was vaccinated with incorrectly storage VARIVAX lot # L050560 with an expiration date 14-DEC-2017 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000408: US-009507513-1707USA000412: US-009507513-1707USA000410: US-009507513-1707USA000411: US-009507513-1706USA004091: US-009507513-1707USA000409.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 06-JUN-2017 the patient was vaccinated with an improperly stored dose of VARIVAX lot # L040419 with an expiration date 14-OCT-2017 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004091: US-009507513-1707USA000412: US-009507513-1707USA000410: US-009507513-1707USA000411: US-009507513-1707USA000407: US-009507513-1707USA000409:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 02-JUN-2017, the patient was vaccinated with PROQUAD lot # reported as  M019232 and expiration date 17-OCT-2017 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000408: US-009507513-1707USA000412: US-009507513-1707USA000410: US-009507513-1707USA000411: US-009507513-1707USA000407: US-009507513-1706USA004091.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-MAY-2017 the patient was vaccinated with improperly stored dose of VARIVAX lot # L040419 with an expiration date 14-OCT-2017 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000408: US-009507513-1707USA000412: US-009507513-1706USA004091: US-009507513-1707USA000411: US-009507513-1707USA000407: US-009507513-1707USA000409.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 25-MAY-2017 the patient was vaccinated with an improperly stored dose of VARIVAX lot # L040419 with an expiration date 14-OCT-2017for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000408: US-009507513-1707USA000412: US-009507513-1707USA000410: US-009507513-1706USA004091: US-009507513-1707USA000407: US-009507513-1707USA000409:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 06-JUN-2017 the patient was vaccinated with a dose of improperly stored VARIVAX lot # L040419 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000408: US-009507513-1706USA004091: US-009507513-1707USA000410: US-009507513-1707USA000411: US-009507513-1707USA000407: US-009507513-1707USA000409.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No information on the patients' pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with VARIVAX, lot # M041513 with expiry date on 11-OCT-2018, lot # M038856 with expiry date on 14-SEP-2018, lot # M047660 with expiry date on 02-DEC-2018 and lot # N000682 with expiry date on 06-JAN-2019. The doses of vaccine were reconstituted with properly stored sterile diluent. Administered doses of vaccine experienced a temperature excursion between 15 and 46 degrees Fahrenheit for 1 hours 28 minutes. There was no previous temperature excursion reported. Data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004066.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions allergies or concomitant therapies were provided. From 10-MAR-2017 to 09-JUN-2017, the patients were vaccinated with unspecified improperly stored doses of PEDVAXHIB for prophylaxis (lot # M036057 with an expiration date of 18-MAY-2019) (dose, route and anatomical location were not reported). The administered doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit  to 35 degrees Fahrenheit for 72 hours, no data logger was involved and no previous temperature excursions were reported. There was no adverse reactions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1706USA005041.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Extra dose administered, Irritability, Pyrexia
Clinical narrative: The nurse misread my daughters chart and administered the PCV-13 and Dtap-HepB-IPV (Pediarix) a second time in a three week period. She had received these two vaccinations on 5/23/17 and due to the nurse's error, received them again 6/14/17. Because of this, my daughter had a higher than normal fever (102.3*F) caused by the vaccinations and remained irritable and fussy for over a week. Also, one of the vaccines was administered into her right thigh (not sure which one), but is mislabeled on her vaccine record.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Child was given only the diluent component of vaccine. Vaccine was not reconstituted prior to administration. Child has not suffered any adverse reaction at this time. Parent being contacted to bring child in for re-administration of vaccine.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L040054 exp 26-DEC-2017 exposed to 47°F to 77°F for 20 hours. No adverse event was reported. Data logger was not involved. Additional information has been requested. Sender's Comments: US-009507513-1707USA000447.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUN-2017, the patients were vaccinated with an improperly stored dose of VAQTA (lot # N005274, expiration date: 03-APR-2018) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 Celsius degree for 1 hour 19 minutes. This is one of three cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA005015: US-009507513-1706USA005016.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # M040423, expiration date: 03-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 Celsius degree for 1 hour 19 minutes. This is one of three cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005015: US-009507513-1706USA004996:
Sex: F
Vaccine: VARZOS
Symptoms: Limb injury
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Her relevant medical history, relevant concomitant medications and past drug history are unknown. On an unknown date, two weeks ago in 2017, the patient received an unknown dose of ZOSTAVAX for prophylaxis. On 11-JUN-2017, the patient experienced stepped on a nail, so she would need to get a tetanus shot. Relevant lab data was unknown. As of 11-JUN-2017, it was unknown if the patient would get ZOSTAVAX again and the outcome of stepping on a nail was unknown. The lot number and expiration date were not requested because the pharmacist did not have time to provide any other information. The causality was not reported.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site induration, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a pharmacist via Pfizer (other company #: 2017235407) referring to a 41 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. The patient had PREVNAR 13 injection on 21-MAY-2017. However, the pharmacist stated the patient actually received a PNEUMOVAX 23 not PREVNAR 13 (wrong vaccine administered). On that date, the patient was vaccinated with PNEUMOVAX 23 (lot # M042785, NDC # 00006473900, expiry date: ??-JUN-2018, 0.5 ml prefilled syringe in the left arm, route unknown) as routine vaccination. On an unknown date in May 2017, the patient developed an allergic reaction described as her arms were feeling pain, swelling and hot to touch. No itching noted. At the time of the report, it was still sore, hard to touch and still hot at injection site area, arms to shoulder. She was in a lot of pain. The reporter stated this was just a side effect. Action taken with the vaccine was not applicable.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist via Pfizer (other company #: 2017235407) referring to a 41 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. The patient had PREVNAR 13 injection on 21-MAY-2017. However, the pharmacist stated the patient actually received a PNEUMOVAX 23 not PREVNAR 13 (wrong vaccine administered). On that date, the patient was vaccinated with PNEUMOVAX 23 (lot # M042785, NDC # 00006473900, expiry date: ??-JUN-2018, 0.5 ml prefilled syringe in the left arm, route unknown) as routine vaccination. On an unknown date in May 2017, the patient developed an allergic reaction described as her arms were feeling pain, swelling and hot to touch. No itching noted. At the time of the report, it was still sore, hard to touch and still hot at injection site area, arms to shoulder. She was in a lot of pain. The reporter stated this was just a side effect. Action taken with the vaccine was not applicable.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pruritus, Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to himself/herself. On 06-JUN-2017 shortly after 12:00 PM, the patient was vaccinated with ZOSTAVAX in the left arm for prophylaxis. On 08-JUN-2017 at 13:00, the patient experienced injection site pruritus, nausea, dizziness and injection site erythema. The outcome of dizziness, nausea, injection site erythema and injection site pruritus was reported as recovered/resolved following a 2 hour nap. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a pharmacist via Pfizer (other company #: 2017241216) referring to a male patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot #, strength, dose and route unknown) for prophylaxis. On an unknown date, the patient experienced extreme limitation of arm movement and pain in vaccinated arm that lasted 2-3 days, then it resolved itself and was put out of commission for 2-3 days. The outcome of extreme limitation of arm movement was not reported. Action taken with the vaccine was not applicable. The causality assessment was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA lot # M036459 for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to VAQTA.; Sender's Comments: US-009507513-1707USA000533: US-009507513-1707USA000534: US-009507513-1707USA000535: US-009507513-1707USA000536:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On FEB-2017 the patient was vaccinated with VAQTA for prophylaxis. On FEB-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1707USA000481: US-009507513-1707USA000479: US-009507513-1707USA000480.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Carpal tunnel syndrome, Erythema, Grip strength decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a 24 year old female patient. The patient's medical history included drug allergy to amoxicillin and MACROBID. On 12-JUN-2017, the patient was intramuscularly vaccinated with first dose of GARDASIL 9 in left deltoid lot # M041212 exp 21-JUN-2019 as routine vaccination. Concomitant therapies included vitamin D. On 12-JUN-2017, the patient began to experience redness, tingling, burning, swelling, and pain in both hands "within 2 hours" of receiving the dose of GARDASIL 9. The physician called this adverse experience "induced carpal tunnel." The patient sought medical attention by consulting the physician today, 13-JUN-2017. He recommended that the patient take an unspecified anti-inflammatory medication, BENADRYL, and wear a wrist splint. At the time of this call, the patient has not initiated these recommended treatments. The physician reports that the patient had difficulty gripping her steering wheel of her car today. The patient was at the time of the report sitting in his office with her hands on her lap, palms up, and her hands are "red in color." During the same visit in which the patient received GARDASIL 9 on 12-JUN-2017, the patient was prescribed DIFLUCAN for an unrelated health reason that pre-existed the GARDASIL 9. The physician did not know, at the time of this report, if the patient has taken any DIFLUCAN. The outcome of the event was not recovered. The relatedness between the event and the vaccination was not reported.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 24 year old female patient. The patient's medical history included drug allergy to amoxicillin and MACROBID. On 12-JUN-2017, the patient was intramuscularly vaccinated with first dose of GARDASIL 9 in left deltoid lot # M041212 exp 21-JUN-2019 as routine vaccination. Concomitant therapies included vitamin D. On 12-JUN-2017, the patient began to experience redness, tingling, burning, swelling, and pain in both hands "within 2 hours" of receiving the dose of GARDASIL 9. The physician called this adverse experience "induced carpal tunnel." The patient sought medical attention by consulting the physician today, 13-JUN-2017. He recommended that the patient take an unspecified anti-inflammatory medication, BENADRYL, and wear a wrist splint. At the time of this call, the patient has not initiated these recommended treatments. The physician reports that the patient had difficulty gripping her steering wheel of her car today. The patient was at the time of the report sitting in his office with her hands on her lap, palms up, and her hands are "red in color." During the same visit in which the patient received GARDASIL 9 on 12-JUN-2017, the patient was prescribed DIFLUCAN for an unrelated health reason that pre-existed the GARDASIL 9. The physician did not know, at the time of this report, if the patient has taken any DIFLUCAN. The outcome of the event was not recovered. The relatedness between the event and the vaccination was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies included sterile diluent. On 24-JAN-2017, the patient was vaccinated with ZOSTAVAX lot # M035695 (dose, frequency, route of administration, expiration date were not reported). On 13-JUN-2017, the patient was vaccinated with ZOSTAVAX lot # N009167, expiration date 28-FB-2018 (dose and route of administration not provided). No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-year-old female patient. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 08-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular injection (dose, lot number and expiration date were not reported). On the same day, the patient experienced bilateral numbness in legs, which lasted for the remainder of the day (it was not specified at what time the vaccine was administered). The patient recovered from the event on 09-JUN-2017 (reported as "the next day"), without any treatment. No lab diagnostic studies were performed. No further doses of GARDASIL 9 were given to de patient. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.