chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: PNC10
Symptoms: Impaired healing, Injection site bruising, Injection site discolouration, Injection site reaction, Intensive care
Clinical narrative: First, where the vaccine were administered which wasn't healing, it turned brown. A bruise appeared in her leg, everyday a bruise would come up especially in that area, then red dots appeared in her arms and tongue and a big purple black bruise on her palatal. It took us several days to figure out it was something that was not normal, therefore we took her to the ER in April 6th, 2015 around 3:00am. Her labs results came back with an alarming platelet count of 1k. Labs were repeated after more than 5 nurses tried to draw blood from different areas of her body because non of her veins worked. She was rushed in ambulance to a Hospital with Pediatric Hematology services. She was admitted in ICU and they administered Intravenousl Imuno Globulins. She had an adverse reaction to the treatment and her hemoglobin dropped.
Age: 0.5
Sex: F
Vaccine: PNC10
Symptoms: Platelet count decreased, Rash erythematous, Tongue eruption
Clinical narrative: First, where the vaccine were administered which wasn't healing, it turned brown. A bruise appeared in her leg, everyday a bruise would come up especially in that area, then red dots appeared in her arms and tongue and a big purple black bruise on her palatal. It took us several days to figure out it was something that was not normal, therefore we took her to the ER in April 6th, 2015 around 3:00am. Her labs results came back with an alarming platelet count of 1k. Labs were repeated after more than 5 nurses tried to draw blood from different areas of her body because non of her veins worked. She was rushed in ambulance to a Hospital with Pediatric Hematology services. She was admitted in ICU and they administered Intravenousl Imuno Globulins. She had an adverse reaction to the treatment and her hemoglobin dropped.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Immediate post-injection reaction, Injected limb mobility decreased, Injection site mass, Injection site pain
Clinical narrative: I had a lump at injection site on my left arm. I still do. I was and still am unable to use my left arm to fullest capacity. Very limited mobility. I have terrible pain from injection site up to my neck and down to my hand. I cannot sleep on the side due to terrible discomfort in shoulder. I visited my orthopedic doctor, xrays showed nothing remarkable.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort, Sleep disorder, X-ray limb abnormal
Clinical narrative: I had a lump at injection site on my left arm. I still do. I was and still am unable to use my left arm to fullest capacity. Very limited mobility. I have terrible pain from injection site up to my neck and down to my hand. I cannot sleep on the side due to terrible discomfort in shoulder. I visited my orthopedic doctor, xrays showed nothing remarkable.
Sex: M
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: Information has been received from a Mental Health Therapist concerning a male child of unknown age. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On unknown dates as a child, the patient was vaccinated with M-M-R II for prophylaxis(dose, frequency, route of administration, lot number and expiration date were not reported). The Mental Health Therapist reported the patient would have experienced unspecified side effects (adverse event) At the reporting time, the outcome of the unspecified side effects was unknown. The reporter considered that the the side effects were related to the therapy with M-M-R II as reported that the side effects were "from the M-M-R II vaccination". Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. From 01-MAY-2017 to 23-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M043581 and expiration date on 28-OCT-2018 and the sterile diluent (DILUENT MRK) injection which had a lot number of L007564 and expiration date on 19-NOV-2017,which was not improperly stored. The reporter stated that, the data logger registered that during 36 minutes, the temperature under the vaccine was stored, was -14° Celsius degree to -10° Celsius degree, there was not prior temperature excursion and no adverse effects were reported. This is one of the two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001793:
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a mother's patient concerning to her daughter a 17 year old female patient. The patient's concurrent conditions included allergy to amoxicilin. The patient's concomitant medications included an unspecified pill for birth control. On 08-MAY-2017, the patient received her second dose of GARDASIL 9(strength, dosage schedule, indication, lot number and expiration date were not reported) for prevention of hpv and immediately, the patient experienced pain at the site of injection. The mother also reported that her daughter "continued to experience pain and 10 days after receiving the dose she experienced an egg sized lump at the site of injection". She took her daughter to the physician who recommended applying warm compresses to the site. The mother stated that "the compresses had not helped and her daughter continued to experience the pain and lump". No further information was provided. There was no product quality complaint (PQC) involved. The reporter did not assess the causality between the events and GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information concerning the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose, route of administration were not reported; lot # M033611, expiration date 02-MAR-2018), for prophylaxis. The vaccine underwent a temperature excursion of 31 degrees Fahrenheit or colder (25.2 degrees Fahrenheit) for 16 hours and 48 minutes, for two cycles. No previous temperature excursions were reported. Digital data logger was involved. 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-009507513-1705USA013862: US-009507513-1705USA011701:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information concerning the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route of administration were not reported; lot # M038359, expiration date 13-MAY-2018), for prophylaxis. The vaccine underwent a temperature excursion of 31 degrees Fahrenheit or colder (25.2 degrees Fahrenheit) for 16 hours and 48 minutes, for two cycles. No previous temperature excursions were reported. Digital data logger was involved. 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-009507513-1705USA013861: US-009507513-1705USA011701:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner (reported also as "nurse prescriber") refers to a 25-year-old patient of unknown gender. The patient's medical history, concomitant therapy and concurrent conditions were not provided. On 26-MAY-2017, the patient received an expired dose of GARDASIL lot # K006960, expiry date: 19-FEB-2017, intramuscularly (dose not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions or allergies and concurrent conditions provided. On unknown dates, (starting on or after 09-FEB-2017), the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported) lot # M034583, expiration date: 27-JUL-2018 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT), MRK INJ, lot # M.020945, expiration date: 05-DEC-2018, which was reported as properly stored diluent used to reconstitute improperly stored doses of VARIVAX. The temperature for the VARIVAX stored was 15 to 46 degree Fahrenheit with 2 hours time frame. There was no previous temperature excursion reported. Data logger was involved. No adverse effect was reported. Lot # M020945 has been verified to be a valid lot number for sterile diluent and not valid for varicella virus vaccine live (oka/merck). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were unknown), for prophylaxis. On an unknown date, the patient experienced allergy to PNEUMOVAX 23. The reporter asked if the patient could react to PREVNAR 13. The outcome of the event was unknown. The reporter considered the event to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who was reporting on an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unknown dates, starting on or after 19-MAY-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (dose and route of administration were not reported; lot # M042324, expiration date on 10-JUN-2018), for prophylaxis. Administered doses of vaccine experienced the temperature excursion of 31 degrees Fahrenheit or below for 59 hours. The excursion was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Blepharospasm
Clinical narrative: This spontaneous report was received from a consumer and refers to a 26 year old non-pregnant female patient. The patient's pertinent medical history included abnormal pap smears. She had no drug reactions or allergies. On 09-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, site, route of administration, lot # and expiry date were not specified) for prevention of human papilloma virus (HPV). Concomitant therapies included unknown birth control medication. On 09-FEB-2017, after GARDASIL 9 vaccination, the patient experienced twitch in her eye. The patient did not call her physician and no treatment was given due to the event. After an unknown number of weeks in 2017, the twitching stopped (also reported as "Did AE Improve: No"). The patient did not decide if she was going to receive the additional doses of GARDASIL 9. Product quality complaint (PQC) was not involved. The reporter did not provide the causality assessment between the event and GARDASIL 9.    Additional information is not expected as there was no consent to contact a healthcare provider.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, Nausea, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 53-year-old female patient with hypertension. The patient had no drug reactions or allergies. On 31-MAY-2016, the patient received an expired dose of PNEUMOVAX 23 injected intramuscularly (lot # K020214 with expiration date at 25-MAR-2016; dose and anatomical location were not reported), for prophylaxis. The patient was taking concomitantly carvedilol (COREG), furosemide (LASIX), lisinopril (manufacturer unknown), dabigatran etexilate mesylate (PRADAXA), pantoprazole sodium (PROTONIX), nitroglycerin (manufacturer unknown), fluoxetine hydrochloride (PROZAC) and amlodipine besylate (NORVASC). On 30-AUG-2016, the patient received her second dose PNEUMOVAX 23 injected intramuscularly in the left arm (lot # L005563 with expiration date at 03-NOV-2016; dose was not reported), also for prophylaxis. On 31-AUG-2016, the patient's entire left arm swelled and was warm to the touch. Additionally, the patient was nauseous. She sought medical attention and on the same date she was seen at the clinic in regards to the reaction. No laboratory diagnostic studies were performed. The patient was prescribed promethazine hydrochloride (PHENERGAN) as a treatment for the nausea and cephalexin (KEFLEX) as a treatment in case of infection. On 03-SEP-2016, the patient felt better. On 06-SEP-2016, when the patient was seen at the office, she was recovered. The causality assessment between aforementioned events and the vaccination with PNEUMOVAX 23 was not assessed. Additional information is not expected since the reporter did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist who reported that 2 unknown patients (demographics unknown), received improperly stored ZOSTAVAX 19400 PFU, (lot #M038864, expiration date 12-DEC-2017) (dosage and route of administration not provided). No adverse effects reported. Temperature: Total time in the range 6°F to 14°F Time frame: 2 hours Previous temperature excursion: No "Data logger" involved: Yes No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 30-MAY-2017, the patient was vaccinated with a single dose of VAQTA injection (intramuscularly; lot # M034893), that had expired on 26-MAY-2017. No adverse effects were reported. Additional information is not expected, as there was no consent to contact the reporter.
Sex: U
Vaccine: HIBV, FLUX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 27-APR-2017 from a nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On unspecified dates, the patients were vaccinated with improperly stored injections of LIQUID PEDVAXHIB lot number M036056, expiration date 18-MAY-2019 (strength, dose, route of administration were not reported) for prophylaxis.  The patients' concomitant therapies were not reported. The vaccines were exposed to the following temperature of 32° Fahrenheit (F) to 35°F (lowest temperature was 35°F) for a time frame of 72 hours.  The call was not due to a data logger.  There were no previous temperature excursions. Adverse effects were not reported. This is one of three reports received from the same source. Additional information is not expected as the reporter did not consent for follow-up attempts.; Sender's Comments: US-009507513-1704USA014987: US-009507513-1706USA000259:
Sex: U
Vaccine: HIBV, FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received on 27-APR-2017 from a nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On unspecified dates, the patients were vaccinated with improperly stored injections of LIQUID PEDVAXHIB lot number M036056, expiration date 18-MAY-2019 (strength, dose, route of administration were not reported) for prophylaxis.  The patients' concomitant therapies were not reported. The vaccines were exposed to the following temperature of 32° Fahrenheit (F) to 35°F (lowest temperature was 35°F) for a time frame of 72 hours.  The call was not due to a data logger.  There were no previous temperature excursions. Adverse effects were not reported. This is one of three reports received from the same source. Additional information is not expected as the reporter did not consent for follow-up attempts.; Sender's Comments: US-009507513-1704USA014987: US-009507513-1706USA000259:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 27-APR-2017 from a nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On unspecified dates, the patients were vaccinated with improperly stored injections of GARDASIL 9 lot number M037770, expiration date 01-JUN-2019 (strength, dose, route of administration were not reported) for prophylaxis.  The patients' concomitant therapies were not reported. The vaccines were exposed to the following temperature of 32° Fahrenheit (F) to 35°F (lowest temperature was 35°F) for a time frame of 72 hours.  The call was not due to a data logger.  There were no previous temperature excursions. Adverse effects were not reported. This is one of three reports received from the same source. Additional information is not expected as the reporter did not consent for follow-up attempts.; Sender's Comments:  US-009507513-1704USA014987: US-009507513-1706USA000258:
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 26-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. The patient was going to receive his second dose of M-M-R II and the second dose of VARIVAX on 01-JUN-2017. On 01-JUN-2017, he received his second dose of M-M-R II (dose, route of administration, lot# and expiration date were not provided) and a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) instead of VARIVAX (dose, route of administration, lot# and expiration date were not provided). Additional information is not expected, as there was no consent to contact the reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (lot number, expiration date, dose and route of administration were not reported). Concomitant therapy included sterile diluent used to reconstitute. The PNEUMOVAX 23 was stored at -0.24 degrees Celsius for 124 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. As of 26-MAY-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000822: US-009507513-1706USA000921:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (albumin status unknown; lot number, expiration date, dose and route of administration were not reported). Concomitant therapy included sterile diluent used to reconstitute. The M-M-R II was stored at -0.24 degrees Celsius for 124 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. As of 26-MAY-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000920: US-009507513-1705USA000822:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M031945, expiration date 27-DEC-2017; lot # M044575, expiration date 04-MAY-2018 and lot # M041082, expiration date 04-APR-2018 (doses and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 3 hours and 49 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information is not expected because there was no consent to contact the reporter.; Sender's Comments: US-009507513-1705USA010341:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that on 01-JUN-2017, the patient was vaccinated with an expired dose of VAQTA with lot number M034893 and expiration date on 26-MAY-2017 (dose, dose number, route of administration and anatomical location were not provided) administered for prophylaxis. No side effects were reported.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # L040053, expiration date: 10-MAY-2017) for prophylaxis (dose and route of administration were not informed). No adverse effects were reported.  No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to an young adult female patient of unknown age. It was reported that the patient was not pregnant. The patients medical history, current conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with first injection of VARIVAX injection (dose, lot # and expiry date were not reported) for prophylaxis (reported as because of no history of varicella disease). On an unknown date after receiving the VARIVAX, the developed a rash from the shoulder down to the injection site. The patient stated that she might not go back for the second dose. The event outcome and causality were not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 9 month old female patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 01-JUN-2017, the patient was vaccinated with fourth dose of ROTATEQ, at 9 months of age (strength, dosing details, anatomical location, lot# and expiration date were unknown) for prophylaxis (extra dose administered). No adverse effects were reported. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ (lot: M044395: expiry date: 31-MAY-2018) (incorrect product storage). The vaccine was stored at 32F to 35F for 15 hours. No adverse effects were reported.  There was no prior temperature excursions. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: Information was received on 07-JUN-2017 from a pharmacist regarding a 60 year old female patient. The patient's concurrent conditions and medical history were not reported. On 18-MAY-2017 the patient was vaccinated with ZOSTAVAX lot # M041511 expiration 08-JAN-2018, subcutaneous for prophylaxis which was reconstituted with sterile diluent (STERILE DILUENT) lot # M022416 expiration 17-DEC-2018. Concomitant therapies included duloxetine hydrochloride (CYMBALTA), acetaminophen, hydrocodone bitartrate(NORCO), gabapentin (NEURONTIN), alendronate sodium (FOSAMAX), levothyroxine sodium (LEVOTHYROXINE SODIUM) and alprazolam (ATARAX (ALPRAZOLAM)). The pharmacist reported the patient had an injection site reaction after receiving a dose of ZOSTAVAX reconstituted with sterile diluent (STERILE DILUENT). The pharmacist reported that the patient experienced itching at the injection site which began on an unspecified date a couple of days after the injection. The pharmacist reported that the patient developed a dime sized lump at the injection site on an unspecified date about a couple weeks after the injection. The pharmacist reported that the lump was not painful. The pharmacist reported that the patient appears to be recovering, but the lump is still present and somewhat itchy. The pharmacist also reported that the patient was prescribed azithromycin 500 mg to be taken once every Monday Wednesday and Friday. The pharmacist reported that the patient began taking the azithromycin on an unspecified date after the ZOSTAVAX was administered. The pharmacist reported that she is unaware of the indication for the azithromycin prescription. No additional information is available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Skin ulcer, Swelling
Clinical narrative: Information was received on 07-JUN-2017 from a pharmacist regarding a 60 year old female patient. The patient's concurrent conditions and medical history were not reported. On 18-MAY-2017 the patient was vaccinated with ZOSTAVAX lot # M041511 expiration 08-JAN-2018, subcutaneous for prophylaxis which was reconstituted with sterile diluent (STERILE DILUENT) lot # M022416 expiration 17-DEC-2018. Concomitant therapies included duloxetine hydrochloride (CYMBALTA), acetaminophen, hydrocodone bitartrate(NORCO), gabapentin (NEURONTIN), alendronate sodium (FOSAMAX), levothyroxine sodium (LEVOTHYROXINE SODIUM) and alprazolam (ATARAX (ALPRAZOLAM)). The pharmacist reported the patient had an injection site reaction after receiving a dose of ZOSTAVAX reconstituted with sterile diluent (STERILE DILUENT). The pharmacist reported that the patient experienced itching at the injection site which began on an unspecified date a couple of days after the injection. The pharmacist reported that the patient developed a dime sized lump at the injection site on an unspecified date about a couple weeks after the injection. The pharmacist reported that the lump was not painful. The pharmacist reported that the patient appears to be recovering, but the lump is still present and somewhat itchy. The pharmacist also reported that the patient was prescribed azithromycin 500 mg to be taken once every Monday Wednesday and Friday. The pharmacist reported that the patient began taking the azithromycin on an unspecified date after the ZOSTAVAX was administered. The pharmacist reported that she is unaware of the indication for the azithromycin prescription. No additional information is available. Additional information has been requested.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a 16-month-year old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 14-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred once on 03-FEB-2017, and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837: Original Case : 1704USA009837
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a 17-month-year old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 03-MAY-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred on 03-FEB-2017, and then again on 18-APR-2017, and was detected by a Digital Data Logger. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010916: US-009507513-1704USA009837:
Age: 19.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a 19-year-old old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 17-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred once on 03-FEB-2017, and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837:
Age: 1.67
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a 20-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 16-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred once on 03-FEB-2017, and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837:
Age: 22.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a 22-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 04-MAY-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred on 03-FEB-2017, and then again on 18-APR-2017, and was detected by a Digital Data Logger. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred once on 03-FEB-2017, and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-MAY-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit (°F) and 14 °F for 30 minutes. The reported also stated that two separate temperature excursions took place: the first on 03-FEB-2017 and the second on 18-APR-2017 and that the vaccine was deemed to still be viable. No previous temperature excursion occurred. No product quality complaint was involved. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same source.  Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1704USA009837: US-009507513-1704USA010916: US-009507513-1706USA003474: US-009507513-1706USA003475: US-009507513-1706USA003476: US-009507513-1706USA003477: US-009507513-1706USA003478: US-009507513-1706USA003479: US-009507513-1706USA003480: US-009507513-1706USA003481: US-009507513-1706USA003482: US-009507513-1706USA003483: US-009507513-1706USA003484: US-009507513-1706USA003485: US-009507513-1706USA003486: US-009507513-1706USA003487: US-009507513-1706USA003489:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-FEB-2017, the patient was vaccinated with improperly stored dose of PROQUAD recombinant human albumin (rHA) lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (MRK). Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit (°F) and 14 °F for 30 minutes. The reported also stated that the temperature excursion took place on 03-FEB-2017 and that the vaccine was deemed to still be viable. No previous temperature excursions occurred. No product quality complaint was involved. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received. Follow up information has been received from the nurse by a phone call on 18-MAY-2017. A request was made for patient identifiers and dates of administration for the improperly stored vaccines. The registered nurse asked if there was a form to complete. Additional information has been requested. Sender's Comments: US-009507513-1704USA009837: US-009507513-1704USA010916: US-009507513-1706USA003482: US-009507513-1706USA003483: US-009507513-1706USA003484: US-009507513-1706USA003485: US-009507513-1706USA003486: US-009507513-1706USA003487: US-009507513-1706USA003488: US-009507513-1706USA003474: US-009507513-1706USA003475: US-009507513-1706USA003476: US-009507513-1706USA003477: US-009507513-1706USA003478: US-009507513-1706USA003479: US-009507513-1706USA003480: US-009507513-1706USA003481.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer regarding a female patient of unknown age. No information was provided regarding relevant medical history and concomitant medications. On 13-MAY-2016, the patient had received PREVNAR 13. On 25-MAY-2017, the patient received PNEUMOVAX 23 for prophylaxis (dosing details not reported). On 25-MAY-2017, the patient experienced pain and was unable to move her arm where the vaccine was administered. The pharmacy would be sending the patient to get medical attention. Outcome of the events was reported as not recovered. Causality of the events was reported as related. Additional information has been requested.
Sex: U
Vaccine: HPV4, MENB
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report has been received from  a physician via Pfizer(manufacturer # 2017242573). The physician heard of a patient/cousin of patient(gender unknown) who was vaccinated with a dose of GARDASIL and a dose of TRUMENBA at the same time on an unknown date. Subsequently, on an unknown date the patient developed Guillain-barre syndrome. The outcome of Guillain-barre syndrome was  unknown. Upon internal overview, the Guillain-barre syndrome was considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea, Swollen tongue
Clinical narrative: This spontaneous report was received from a consumer concerning herself, a 70 year old female patient. The patient had no drug reactions or allergies and medical history, as well as no concomitant medications. On 06-JUN-2017 at 3:00 p.m, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On 07-JUN-2017 at 3:00 a.m, the patient woke up and felt lightheaded, nauseous and her tongue was swollen. The patient stated she called for an ambulance and was taken to unspecified emergency room. It was reported that the patient was treated for a possible allergic reaction to PNEUMOVAX 23 (allergy to vaccine) and given diphenhydramine (BENADRYL). At the reporting time, It was reported that the patient was recovering from her symptoms since receiving treatment in the emergency room. It was considered the event of allergy to vaccine to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician (and also a company employee) who is a female patient of unknown age, reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX in triceps instead of deltoid area (dose, lot# and expiration date were not reported). On 07-JUN-2017, reported as yesterday around 3 pm, the patient experienced injection site reaction/ inflammation of about 20 cm by 6 cm, raised, hot at touch and painful. She also experienced headache and general malaise. The outcome was reported as not recovered/not resolved, as the events were continuing at the time of report. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a physician (and also a company employee) who is a female patient of unknown age, reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX in triceps instead of deltoid area (dose, lot# and expiration date were not reported). On 07-JUN-2017, reported as yesterday around 3 pm, the patient experienced injection site reaction/ inflammation of about 20 cm by 6 cm, raised, hot at touch and painful. She also experienced headache and general malaise. The outcome was reported as not recovered/not resolved, as the events were continuing at the time of report. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993, expiration date: 17-OCT-2017, and lot # L044475, expiration date: 12-MAY-2017) intramuscularly (dose and frequency were unspecified) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. It was stated that the vaccines were exposed to a temperature of 9 Celsius degrees for a timeframe of 27 hours. No digital data logger was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA005167.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L014878, expiration date: 17-JAN-2018) intramuscularly (dose and frequency were unspecified) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. It was stated that the vaccines were exposed to a temperature of 9 Celsius degrees for a timeframe of 27 hours. No digital data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005145:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report Was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided.     On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II, for prophylaxis, that underwent a temperature excursion of 9 degrees Celsius during a time frame of 1 hour, (dose, route, dose number, lot number and expiration date were not provided). No adverse effects were reported, no product quality complaint (PQC) was involved. There was no previous temperature excursion and the call was not because a digital data logger. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1706USA005170: US-009507513-1706USA001148: