chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a male patient of unknown age. The medical history, concomitant medication and drug reactions/allergies were not provided. On 26-AUG-2013, the patient received his first dose of GARDASIL (lot#, expired date, dose were unknown) for prophylaxis. On 12-OCT-2016 and 12-DEC-2016, the patient received his second and third doses of GARDASIL 9 (lot #, expired date and dose were unknown for the second dose; lot # M032650, expired date on 31-MAR-2019 and dose was unknown for the third dose) for prophylaxis, respectively. No adverse effect was reported. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: FLU4, HIBV, MMR, PPV, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history or drug reactions/allergies were not provided. On 12-DEC-2016 the patient was vaccinated with an expired dose of VARIVAX (lot # K018964, expiration date 15-OCT-2016; dose and route unknown) for prophylaxis. The healthcare worker reported this dose of VARIVAX was always properly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to unspecified patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that on unspecified dates, multiple, unspecified patients received improperly stored doses of GARDASIL 9 (lot: M009378 expiry: 23-APR-2018 and lot: M024261; expiry: 30-JUL-2018). No adverse effects reported. There had been three temperature excursions for GARDASIL 9 (lot: M009378; expiry: 23-APR-2018) 35F for 6 days, 35F for 5 minutes and 35F for 5 minutes. There had been two temperature excursions for GARDASIL 9 (lot: M024261; expiry: 30-JUL-2018) 35F for 5 minutes and 35F for 5 minutes. Additional information has been requested. Sender's Comments: US-009507513-1612USA007769: same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age. Pertinent medical history, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # M033907, expiry date 20-JUL-2018 for prophylaxis at 75 F temperature and was call because of a data logger (incorrect product storage). No adverse effects were reported (no adverse event). Lot number M033907 has been verified to be a valid lot number for VARIVAX. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-DEC-2016, the patient was vaccinated with an expired dose of ROTATEQ (lot # reported as K010223, expiration date 13-MAY-2016; dose was not reported, orally). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose, route and site of administration were not reported) for prophylaxis. Concomitant medications were not reported. On an unknown date, the patient experienced soreness, tenderness and redness closer to the elbow, not the injection site. No treatment was given for the adverse events. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored with VARIVAX (dosing details were not reported) (lot # M025865, expiry date: 24-MAY-2018) for prophylaxis, which was stored at a temperature of -14.24°C for 30 minutes. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact. Sender's Comments: US-009507513-1612USA008789.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Reaction to preservatives
Clinical narrative: This initial report was received from a nurse via other company, concerning 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 PNEUMOVAX 23 for prophylaxis (dose, strength, dose number, route of administration and lot number were not reported). On an unknown date, the patient experienced an allergic reaction to preservatives in PNEUMOVAX 23. At the reporting time, the outcome of the reported event was unknown. The reporter considered the event to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Death
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown demographics. No medical history, concurrent conditions, concomitant medications or past drugs of the patient were reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot #, expiry date and dosing details were not reported). Later, on an unspecified date, two weeks after administration of PNEUMOVAX23, the patient died in an unspecified location from an unspecified cause. Causality assessment was not provided. Upon internal review, the event, death was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: unknown cause of death.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from two medical assistants and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016 (reported as from 15-OCT-2016 through 14-DEC-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M028323, expiration date 26-SEP-2018; site, doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 48.48 Fahrenheit degrees (F) for 36 hours and 32 minutes before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA008782.
Sex: M
Vaccine: HPVX
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a healthcare professional via a company representative refers to her son of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second shot in the human papillomavirus vaccination series with an unidentified Merck hpv vaccine (it was unknown if it was GARDASIL or GARDASIL 9, lot number was not provided). The reporter stated that when the patient was about to get the unidentified Merck hpv vaccine, the nurse that was administering stated that it may hurt more than other vaccinations because it contains more protein. On an unknown date, at an unspecified time after administration of unidentified Merck hpv vaccine, the patient reported pain at the injection site that lasted for an unspecified amount of time. The patient was fully recovered from the adverse event on an unknown date. The relatedness between the adverse event and unidentified Merck hpv vaccine was not provided. 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 unspecified patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that on unspecified dates, multiple, unspecified patients received improperly stored doses of ROTATEQ (lot: M031802; expiry: 09-NOV-2017 and lot: M011832; expiry: 25-JAN-2018). No adverse effects reported. There had been three excursions for ROTATEQ (lot: M031802; expiry: 09-NOV-2017); 35F for 6 days, 35F for 5 minutes and 35F for 5 minutes. There had been two excursions for ROTATEQ (lot: M011832; expiry: 25-JAN-2018); 35F for 5 minutes and 35F for 5 minutes. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA006670:same reporter.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown gender. The patient's pertinent medical, concurrent conditions and concomitant medications were not reported. No drug reactions or allergies were reported. On 13-DEC-2016 the patient was vaccinated with expired dose of VARIVAX (dosing details were not reported) (lot # K016131 expiry date: 13-DEC-2016) for prophylaxis (expired vaccine used). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No information regarding their concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, injection (lot# L012034, expiration date: 07-APR-2017; lot# L013825, expiration date: 21-APR-2017; doses and routes of administration were not provided). There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion of -13.5 degrees Celsius for 1 hour and 13 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of two report received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1612USA001155:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that unspecified patients were administered improperly stored vaccines RECOMBIVAX HB (lot: M020926; expiry date: 11-AUG-2018) on an unspecified date. No adverse effects were reported. The vaccine was stored at 35.52F for 8 hours and 2 minutes. There was no previous temperature excursion and the call was because of digital data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006359: same reporter.
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 unknown number of patients of unknown age and gender. On unknown dates, the patients received an improperly stored dose of GARDASIL 9 (lot number M016193, expiration date 24-APR-2018, lot number M017983, expiration date 30-MAY-2018) (dose and route not reported). The temperature excursion was 34.02 Fahrenheit for 8 hours. There were no previous temperature excursions. This was reported because of a data logger. No adverse events have been reported.     This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1611USA010428.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M024677, expiry date 18-MAY-2018; dose and route were not reported). The dose was stored under temperature of -11 Celsius degrees for 8 hours and 30 minutes. The previous temperature excursion was -9.3 Celsius degrees for 8 hours and 30 minutes and -10.6 Celsius degrees for 4 hours. The call was because of a data logger. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA001139:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from two medical assistants and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016 (reported as from 15-OCT-2016 through 14-DEC-2016), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M005732, expiration date 19-OCT-2017; doses were not reported, orally). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 48.48 Fahrenheit degrees (F) for 36 hours and 32 minutes before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007664:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of M-M-R II lot# L015279 with expiration date 30-APR-2017 (dose and route of administration were not reported). Administered doses of M-M-R II experienced a temperature excursion at 47 Fahrenheit degrees for 1 hour, with a prior excursion at 33 Fahrenheit degrees for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008787: US-009507513-1612USA003962:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of ROTATEQ lot# L020861 with expiration date 25-JAN-2017, orally (dose was not reported). Administered doses of ROTATEQ experienced a temperature excursion at 47 Fahrenheit degrees for 1 hour, with a prior excursion at 33 Fahrenheit degrees for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003962: US-009507513-1612USA008786:
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 52-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-DEC-2016, the patient was inadvertently vaccinated with PROQUAD (lot # M012986, expiration date was not provided) (dose and route of administration were not provided). The patient was scheduled to receive VARIVAX. No adverse effects were reported. Product quality complaint was not involved. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA001689.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse effects were reported; improperly stored PROQUAD were administered to unspcified patients; This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored with PROQUAD (dosing details were not reported) (lot # M022399, expiry date: 01-NOV-2017) for prophylaxis, which was stored at a temperature of -14.24 °C for 30 minutes (incorrect product storage). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.; Sender's Comments: US-009507513-1612USA007119:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an administrator referring to unspecified patients of unknown ages and genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (strength, dose number, route, lot number and expiration date were not provided) or prophylaxis. The vaccines experienced the temperature excursions, no product quality complaint was involved. It was reported that the vaccine GARDASIL 9 was not supported. Also the reporter was not sure if the vaccine was administered or not. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1612USA003396: US-009507513-1612USA008792.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an administrator referring to unspecified patients of unknown ages and genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally (strength, dose number, lot number and expiration date were not provided) or prophylaxis. The vaccines experienced temperature excursions. Furthermore, no product quality complaint was involved. It was reported that the vaccine ROTATEQ was supported. Also the reporter was not sure if the vaccine was administered or not. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1612USA008791: US-009507513-1612USA003396.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple (unspecified how many) unidentified patients of unknown ages and genders. No information about the patients' medical history, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On an unknown dates, the patients were vaccinated with incorrectly stored doses of VAQTA (lot number M027879, expiry date: 24-JAN-2018 and lot number: M036459, expiry date: 18-JAN-2018, dose and route of administration were not reported). No adverse effects were reported. Digital Data Logger was involved, the storage temperature was reported as 48.52 degrees Fahrenheit in a 20-minute timeframe. On an unknown date. No previous temperature excursion was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008795: US-009507513-1611USA013978.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple (unspecified how many) unidentified patients of unknown ages and genders. No information about the patients' medical history, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On an unknown dates, the patients were vaccinated with incorrectly stored doses of PEDVAXHIB (lot number: M020100, expiry date 07-MAR-2019, dose and route of administration were not reported). No adverse effects were reported. Digital Data Logger was involved, the storage temperature was reported as 48.52 degrees Fahrenheit in a 20-minute timeframe, on an unknown date. No previous temperature excursion was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA013978: US-009507513-1612USA008794.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an 11 year old patient of unknown gender. On 10-OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M021407 with expiration date of 30-APR-2018; dosage, frequency and route of administration were unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA009046.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 14 year old patient of unknown gender. On 10-OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M021407 with expiration date of 30-APR-2018; dosage, frequency and route of administration were unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA009046.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 12 year old patient of unknown gender. On 12-OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M021407 with expiration date of 30-APR-2018; dosage, frequency and route of administration were unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA009046.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning 4 month old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 22-NOV-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB for prophylaxis (lot number L051123 with an expiration date of 13-OCT-2018) (dose, frequency, route of administration and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 degree Celsius (C) for a time frame of 48 hours. A digital data logger was involved. There were no previous temperature excursions. Furthermore, no product quality complaint was involved. No other suspect or concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning 12 month old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 03-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB for prophylaxis (lot number L051123 with an expiration date of 13-OCT-2018) (dose, frequency, route of administration and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 degree Celsius (C) for a time frame of 48 hours. A digital data logger was involved. There were no previous temperature excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse regarding patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-SEP-2016, patient was vaccinated with improperly stored GARDASIL 9 injection (lot # M009378, expiration date 23-APR-2018) for prophylaxis (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected, as no additional information is available. Sender's Comments: US-009507513-1612USA009000: US-009507513-1612USA009001: US-009507513-1610USA002776.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-SEP-2016, patient was vaccinated with improperly stored GARDASIL 9 injection (lot # M009378, expiration date 23-APR-2018) for prophylaxis (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected, as no additional information is available. Sender's Comments: US-009507513-1612USA008999: US-009507513-1612USA009001: US-009507513-1610USA002776.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-SEP-2016, patient was vaccinated with improperly stored GARDASIL 9 injection (lot # M009378, expiration date 23-APR-2018) for prophylaxis (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected, as no additional information is available.; Sender's Comments: US-009507513-1612USA008999: US-009507513-1612USA009000: US-009507513-1610USA002776.
Age: 72.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the second dose of PREVNAR 13, via an unspecified route of administration at single dose on 05Dec2016 15:30 for immunisation. The was given the flu shot in one arm and the PREVNAR 13 in the other arm. Medical history included colon cancer from Aug2015 to 03Sep2015, intraductal proliferative breast lesion on 16Jan2016, breast hyperplasia, hypothyroidism, dry eye, breast cancer, depression, anxiety, appetite disorder, sleep disorder. Concomitant medication included influenza vaccine on 05Dec2016 15:30 for immunisation, anastrozole (ARIMIDEX) from Oct2016 and ongoing for anti estrogen for breast cancer, levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing for hypothyroidism, diazepam (VALIUM) from an unspecified date and ongoing  for depression and anxiety, mirtazapine (REMERON) from Feb2016 and ongoing for depression, anxiety, appetite and to sleep, diphenhydramine hydrochloride, paracetamol (TYLENOL PM) from Feb2016 and ongoing for sleep, escitalopram oxalate (LEXAPRO) from 2016 and ongoing, colecalciferol (VITAMIN D3) from an unspecified date and ongoing for low vitamin D, polycarbophil calcium (FIBER) from an unspecified date and ongoing for bowels. The patient may have received the first dose for immunization. On 06Dec2016, the patient experienced nausea, diarrhea, abdominal discomfort with outcome of not recovered. May have taken the PREVNAR 13 twice within 12 months.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash beginning on arm, continuing to chest and back of left side only.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Blood lactic acid increased, Chills, Headache, Influenza virus test negative, Myalgia
Clinical narrative: Fever, rigors, nausea, vomiting, severe headache, diffuse myalgias.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Fever, rigors, nausea, vomiting, severe headache, diffuse myalgias.
Age: 0.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, IPV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Flu shot given too early.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Hyperhidrosis, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain, swelling and sweating.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Patient experienced orgasmic cephalia within 24 hours of receiving influenza vacc.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Transient global amnesia
Clinical narrative: Transient global amnesia diagnosed by emergency room visit. Patient completely recovered by the next day.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Dry skin, Eczema, Psoriasis, Rash
Clinical narrative: Patient developed a rash about 3 inches from injection site. The rash was about 1-2 inches in diameter. She asked what I thought. I said it looks like dry skin/eczema or psoriasis. She said she had psoriasis but this looked different.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Pt came in 12/16/16 to report her arm was red and some around site where vaccine was administered. Viewed arm and verified arm has circle (diameter approximately 2 inches) around vaccine admin site.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, Blood glucose increased, Clostridium test, Diabetes mellitus, Diarrhoea
Clinical narrative: Patient presented to the ER 12/16/16 seen in outpatient office 12/15/16 given PNEUMOVAX 23 vaccine and was admitted to the hospital-This patient is a 46 y.o M who has a history of DM type 2 who presents complaining of fever, nausea, diarrhea, myalgias, and headache for the past 24 hours. He feels mildly short of breath "like I keep having to take a deep breath every now and then." The patient had his first ever pneumonia shot into the left deltoid muscle yesterday at 1000. He has mild soreness in the left upper arm but no rashes or significant pain. He rates his total level of pain at a 5/10 at this time. No complaints of cough or vomiting. No abdominal pain or chest pain. Treatment:IV fluid, consult Infectious Disease, IV antibiotics Vancomycin, negative blood cultures.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Patient presented to the ER 12/16/16 seen in outpatient office 12/15/16 given PNEUMOVAX 23 vaccine and was admitted to the hospital-This patient is a 46 y.o M who has a history of DM type 2 who presents complaining of fever, nausea, diarrhea, myalgias, and headache for the past 24 hours. He feels mildly short of breath "like I keep having to take a deep breath every now and then." The patient had his first ever pneumonia shot into the left deltoid muscle yesterday at 1000. He has mild soreness in the left upper arm but no rashes or significant pain. He rates his total level of pain at a 5/10 at this time. No complaints of cough or vomiting. No abdominal pain or chest pain. Treatment:IV fluid, consult Infectious Disease, IV antibiotics Vancomycin, negative blood cultures.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient presented to the ER 12/16/16 seen in outpatient office 12/15/16 given PNEUMOVAX 23 vaccine and was admitted to the hospital-This patient is a 46 y.o M who has a history of DM type 2 who presents complaining of fever, nausea, diarrhea, myalgias, and headache for the past 24 hours. He feels mildly short of breath "like I keep having to take a deep breath every now and then." The patient had his first ever pneumonia shot into the left deltoid muscle yesterday at 1000. He has mild soreness in the left upper arm but no rashes or significant pain. He rates his total level of pain at a 5/10 at this time. No complaints of cough or vomiting. No abdominal pain or chest pain. Treatment:IV fluid, consult Infectious Disease, IV antibiotics Vancomycin, negative blood cultures.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Injection site nodule, Malaise, Pain in extremity
Clinical narrative: Feverish in evening, 12/10 102.6 temp, general ill feeling, innoculated arm swollen, very red and very sore. 12/11 temp 101, still very ill feeling.  12/12 feeling much better but weakish.  Resume normal duties 12/15. 12/19 Arm still sore and hard knot at innoculation site.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Feverish in evening, 12/10 102.6 temp, general ill feeling, innoculated arm swollen, very red and very sore. 12/11 temp 101, still very ill feeling.  12/12 feeling much better but weakish.  Resume normal duties 12/15. 12/19 Arm still sore and hard knot at innoculation site.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ATTENUVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, five days after vaccination with ATTENUVAX, the patient was vaccinated with a dose of M-M-R II, subcutaneously (dose, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information is not expected, because there was no consent to contact physician.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown date in 1991, the patient was vaccinated with a dose of RECOMBIVAX HB 10/1.0 mcrg/ml injection, intramuscularly in her hip for prophylaxis (dose, lot# and expiration date were not reported).  On an unknown date, the patient had unspecified immunity testing for hepatitis B virus performed, with a negative result. Product quality complain was not reported.      The outcome of of the event was not reported. The relatedness between the event and RECOMBIVAX HB was not reported.  Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Information has been received from an unspecified reporter via a Merck employee referring to a more than 65 year old male patient. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# reported as 2568254242 (invalid), dose, route, and expiration date were unknown) for prophylaxis. Another flu vaccine was also vaccinated in the same arm on the same day. On an unknown date, the patient's arm swelled up and he experienced a fever. The patient did not seek medical attention and had no treatment. The outcome of the events was recovered. Causality was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Information has been received from a 73 year old female patient concerning herself. Concomitant therapies included atenolol. Concurrent condition included fibromyalgia. Drug reactions/allergies included penicillin and erythromycin. There has no other medical history. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX (1 time vaccine, strength, dose, route, lot # and expiration date were unknown) for preventing the shingles. The patient stated she got the vaccine 2 years ago but on 16-NOV-2016 she began to experience pain. She then realized she had 3 shingle spots in the left breast which later spread all the way to her sternum (vaccination failure). She sought medical attention from 2 different doctors. The first doctor prescribed acyclovir for the pain. Two days later another doctor prescribed ibuprofen and gabapentin 300 mg. The shingles were causing her to have very intense pain, burning sensation and stings. The outcome of the events was unknown. The causality assessment between the events and ZOSTAVAX was unknown. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions, allergies and concomitant therapies was provided. On an unknown dates, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M031557, expiration date: 07-APR-2019 (dose and site of injection were not reported). All doses were administered before labeled expiration dates. The GARDASIL 9 was exposed to 34.7 degrees Fahrenheit for 40 minutes. The temperatures were logged with digital data logger and there were no previous temperature excursions. No adverse effects were reported. Product quality compliant was not involved. This one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006441.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant therapies were no reported. On an unknown date, the patients have been administered with improperly (stored 3 unspecified) doses of ZOSTAVAX (dosage scheduled and route of administration were not provided) lot # M036297, expiration date 14-NOV-2017, for prophylaxis. It was reported that the temperature excursion was for 144 hours 15 minutes at 3° degrees C. There was no previous temperature excursion  or data logger issue. No adverse effects were reported. No product quality complaint was involved. 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 practitioner and refers to multiple unspecified patients of unknown age and gender. No information about the patients's medical history, concurrent conditions, drug reactions, allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (of lot # M026306 with an expiration date on 30-APR-2018 or of lot# M024261 with an expiration date on 30-JUL-2018 or of unknown lot # and expiration dates; dose and route of administration were not provided). The details of temperature excursion were unknown. The reporter stated that the temperature went "below range" to an unspecified temperature for an unspecified amount of time. No adverse effects were reported. The temperature was logged by digital data logger and there were no previous excursions. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions, allergies and concomitant therapies was provided. On an unknown dates, the patients might have been vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L008660, expiration date: 10-NOV-2016 (dose and site of injection were not reported). All doses were administered before labeled expiration dates. The RECOMBIVAX HB was exposed to 34.7 degrees Fahrenheit for 56 minutes. The temperatures were logged with digital data logger and there were no previous temperature excursions. No adverse effects were reported.  Product quality compliant was not involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1612USA003244:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent  medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unspecified dates between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# reported as M021407, expiration date: 30-APR-2018 (dose and site of injection were not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursion took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016"). On 13-DEC-2016 (also reported as "recent"), another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of GARDASIL 9 were administered following the recent temperature excursion. Digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007250: US-009507513-1612USA007251: US-009507513-1612USA007248: US-009507513-1612USA007249.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# L046320, expiration date 29-SEP-2017 (dose was not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursions took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016"). On 13-DEC-2016, another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of ROTATEQ were administered following the recent temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007250: US-009507513-1612USA007251: US-009507513-1612USA007249: US-009507513-1612USA007121.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 injection, lot# M018624, expiration date 28-MAY-2017 (dose, route and site of administration were not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursions took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016"). On 13-DEC-2016, another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of PNEUMOVAX23 were administered following the recent temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007250: US-009507513-1612USA007251: US-009507513-1612USA007248: US-009507513-1612USA007121.