chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Vision blurred
Clinical narrative: Patient described feeling light-headed and blurred vision immediately following vaccine administration. POD nurse stated patient appeared pale. Patient was assisted to supine position on floor, did not fall or lose consciousness. Patient was observed by EMS, who continued to monitor vital signs over 35-40min. Patient improved and was released from clinic after 35-40min observation with no treatment warranted.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Painful numbing, tingling and swelling in hands.  Chest discomfort and shortness of breath.   Swelling and breathing issues resolved within a few days.  Numbing, tingling and pain in hands is slightly improved but ongoing.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Painful numbing, tingling and swelling in hands.  Chest discomfort and shortness of breath.   Swelling and breathing issues resolved within a few days.  Numbing, tingling and pain in hands is slightly improved but ongoing.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Erythema, Fatigue, Hypoaesthesia
Clinical narrative: Painful numbing, tingling and swelling in hands.  Chest discomfort and shortness of breath.   Swelling and breathing issues resolved within a few days.  Numbing, tingling and pain in hands is slightly improved but ongoing.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Painful respiration, Paraesthesia, Peripheral swelling
Clinical narrative: Painful numbing, tingling and swelling in hands.  Chest discomfort and shortness of breath.   Swelling and breathing issues resolved within a few days.  Numbing, tingling and pain in hands is slightly improved but ongoing.
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: the product underwent the excursion at -52 degree Celsius for 24 hours on 10-MAR-2021 and then was administered to a patient on 12-MAR-2021; VARlVAX was administered to a patient on 03/12/2021, first dose was given in 1998 for his varicella vaccine; This spontaneous report was received from a nurse referring to a 26 years old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   In 1998, first dose was given to the patient for his varicella vaccine (strength, dose, route, lot number, expiration date and indication were not reported). On 12-MAR-2021, the patient was administered with incorrectly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# T017686 has been verified to be a valid lot number, expiration date reported as 21-APR-2022 (also reported as 21-MAY-2022), but upon internal validation established as 21-MAY-2022; strength and route were not reported) at a dose of 0.5 ml for prophylaxis (incorrect product storage, inappropriate schedule of vaccine administered). The vaccine underwent a temperature excursion at - 52 degree Celsius on 10-MAR-2021 for 24 hours. The temperature excursion was recorded by digital data logger, and there was no previous temperature excursion. The outcome of the event was unknown. No additional information was provided.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX which was improperly stored; This spontaneous report was received from a nurse refers to a 12 month old female patient. Her pertinent medical history and drug reactions or allergies were unknown. Concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  On 25-MAR-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # T024286, expiration date 15-JUL-2022, subcutaneously in the left thigh (formulation and dose were not reported) as prophylaxis (product storage error). The temperature excursion was -5.67 degrees Celsius for 30 minutes (also reported as for 46 minutes). There was no previous temperature excursion. A data logger was used to capture the temperature. No additional adverse event was reported. The patient did not require any treatment and recovered from the event. The vaccine was not available for return, it was administered and discarded.  Causality was not provided.
Sex: M
Vaccine: MMRV
Symptoms: Accidental exposure to product, No adverse event, Wrong product administered
Clinical narrative: no additional adverse event have been reported; inadvertantly received a PROQUAD vaccine instead of MMR-II; This spontaneous report as received from a licensed practical nurse (also reported as consumer) refers to a 21 year old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.    On 26-JAN-2021, the patient was inadvertantly vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milligram single dose, lot# T005400 expiration date 12-AUG-2021) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (strength, dose, route, lot# and expiration date were not provided).    The reporter stated that the consumer returned on 26-FEB-2021 and received his second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) at that time. No additional adverse events were reported by the patient.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reports no further AE; Caller states the vaccine was administered yesterday (29-MAR-2021), today the office realized the vaccine expired on 14-MAR-2021; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-MAR-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dosage regimen was not reported), lot # S007813 (rHA) and expiration date 14-MAR-2021 administered as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT).  No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: She reported that a patient received GARDASIL 9 after undergoing an unevaluated temperature excursion.; No further adverse event reported / No additional adverse events.; This spontaneous report was received from a Registered Nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliter (ml) (formulation, strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T007024 has have been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, expiration date reported and upon internal validation established as 23-APR-2022) as prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 50.9 degrees Fahrenheit (F) for a time frame of 0 hours and 39 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Temperature excursion; This spontaneous report has been received from a nurse referring to a 12 month old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T020614 (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 10-FEB-2021, the vaccine was exposed to a temperature range of 35.4 °F during a time frame of 15 minutes.
Sex: U
Vaccine: MMR
Symptoms: Contraindicated product administered, No adverse event, Product use issue
Clinical narrative: the patient is not currently having any side effects; received MMRII live virus vaccine while patient is on Dupixent as it is an immunosuppressant; received MMRII live virus vaccine while patient is on Dupixent as it is an immunosuppressant; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and drug reactions or allergies were not reported. The patient's concomitant therapy included dupilumab (DUPIXENT).  On 05-APR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml (route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis, while the patient was on dupilumab (DUPIXENT) (contraindicated product administered, product use issue) which was an immunosuppressant. The reporter had contacted the patient's dermatologist for clarification and was told it was a recommendation not to give together but not a contraindication. Per the prescribing information, it was contraindicated to administer measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine while the patient is on immunosuppressants or immunocompromised. The patient was not currently having any side effects.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the temperature was above 46 Fahrenheit degrees (F)  (46.73F)  for 46 hours, 5 minutes 0 second; No additional AE/PQC reported at this time; This spontaneous report was received from a nurse, concerning a 6-month-old patient of unknown gender. The patient's historical drugs, historical conditions, and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with the third dose of improperly stored temperature excursion rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number 1707585 and expiration date 21-FEB-2022 were verified as valid) taken orally for prophylaxis.   Moreover, the temperature was above 46 Fahrenheit degrees (F) (46.73F) for 46 hours, 5 minutes 0 seconds, which was detected by digital data logger; with no previous temperature excursion. The recommended range temperature was 36°F to 46°F (2 degrees celsius (°C) to 8 °C).   This is one of the multiple case reported from the same source.; Sender's Comments:  US-009507513-2104USA002044: US-009507513-2104USA002043: US-009507513-2104USA001947: US-009507513-2104USA002045: US-009507513-2104USA002041:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time; This spontaneous report was received from a nurse and refers to a 4-month-old patient of unknown gender. The patient's historical drugs, historical conditions, and concomitant medications were not reported.  On an unknown date the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1707585 and expiration date 21-FEB-2022 were verified as valid) orally, for prophylaxis. It was reported that this was the second dose of the vaccine administered to the patient. The vaccine was improperly stored at 46.73 Fahrenheit degrees for 46 hours, 5 minutes (product storage error), which was detected by digital data logger. No additional adverse event was reported.  This is one of the multiple case reported from the same source.; Sender's Comments:  US-009507513-2104USA002045: US-009507513-2104USA002042: US-009507513-2104USA002044: US-009507513-2104USA001947: US-009507513-2104USA002041:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Exposure via skin contact, Product storage error
Clinical narrative: temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time.; This spontaneous report was received from a nurse concerning a 2-month-old patient of unknown gender. The patient's historical drugs, historical conditions, and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with first dose of improperly stored temperature excursion of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number 1707585 and expiration date 21-FEB-2022 were verified as valid) taken orally for prophylaxis.   Moreover, the temperature was above 46 Fahrenheit degrees (F) (46.73F)  for 46 hours, 5 minutes 0 seconds , which was detected by digital data logger; with no previous temperature excursion. The recommended range temperature was 36°F to 46°F (2 degrees celsius (°C) to 8 °C).   This is one of the multiple case reported from the same source.   ; Sender's Comments:  US-009507513-2104USA002044: US-009507513-2104USA002043: US-009507513-2104USA002042: US-009507513-2104USA001947: US-009507513-2104USA002041:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002495: US-009507513-2104USA002492: US-009507513-2104USA002491: US-009507513-2104USA002490: US-009507513-2104USA002494:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 08-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose and route were not provided; frequency-5; lot# was T028139 and expiration date was 15-FEB-2022) involved a temperature excursion for prophylaxis (product storage error).         The administered dose was involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.; Sender's Comments:  US-009507513-2104USA002470: US-009507513-2104USA003267: US-009507513-2104USA003266: US-009507513-2104USA003268: US-009507513-2104USA003265:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002494: US-009507513-2104USA002492: US-009507513-2104USA002495: US-009507513-2104USA002451: US-009507513-2104USA002491:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002494: US-009507513-2104USA002492: US-009507513-2104USA002495: US-009507513-2104USA002490: US-009507513-2104USA002451:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002494: US-009507513-2104USA002451: US-009507513-2104USA002495: US-009507513-2104USA002490: US-009507513-2104USA002491:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 16-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002451: US-009507513-2104USA002494: US-009507513-2104USA002492: US-009507513-2104USA002495: US-009507513-2104USA002490: US-009507513-2104USA002491:
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Autoimmune disorder, Encephalitis, Fibromyalgia
Clinical narrative: auto-immune problems; encephalitis; fibromyalgia; This spontaneous report was received from a 37-year-old female patient via Pfizer concerning herself. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On an unspecified date in 1989, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (strength, dose, route, lot number and expiration date were not reported) for measles, mumps, and rubella immunization (prophylaxis).      On an unspecified date in 1989, 10 days after onset of therapy, the patient experienced encephalitis followed by fibromyalgia and other autoimmune problems.      The outcome of autoimmune disorder, fibromyalgia and encephalitis was reported as resolving (reported as "after 30 some odd years, she had finally gotten into a health state where she was happy").        The causality between the suspect therapy and the events was not reported.   Upon internal review, the events of encephalitis and autoimmune disorder were considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 18-MAR-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 19-MAR-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 23-MAR-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 01-APR-2021,  the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 01-APR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002850: US-009507513-2104USA002851:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 05-APR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002851:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 06-APR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002850:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 29-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 31-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 02-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 05-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: M
Vaccine: COVID19, UNK
Symptoms: Constipation, Contusion, Fatigue, Gout
Clinical narrative: bruises are darker than normal since he has started Eliquis; Constipation; swollen index finger and swollen toe/determined to be gout; felt lousy; This is a spontaneous report from a contactable consumer, based on information received by Pfizer.  This spontaneous case was reported by a physician and describes the occurrence of GOUT (swollen index finger and swollen toe/determined to be gout), FATIGUE (felt lousy), CONTUSION (bruises are darker than normal since he has started Eliquis) and CONSTIPATION in 92-year-old male patient who received apixaban (Eliquis) tablet (batch no. 1790398) for Venous thromboembolism. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for an unknown indication. The patient's past medical history included Large intestine infection, Hypercoagulability and Constipation. Concurrent medical conditions included Gout. In February 2021, the patient started Eliquis (batch no. 1790398) (Oral) at an unspecified dose twice a day. On an unknown date, the patient started Covid-19 Vaccine (unknown route). On 27-Mar-2021, the patient experienced FATIGUE (felt lousy). On 29-Mar-2021, the patient experienced GOUT (swollen index finger and swollen toe/determined to be gout). On an unknown date, the patient experienced CONTUSION (bruises are darker than normal since he has started Eliquis) and CONSTIPATION. The action taken with Eliquis(Oral) was unknown. At the time of the report, GOUT, CONTUSION and CONSTIPATION outcome was unknown and FATIGUE resolved. For Eliquis(Oral), the reporter did not provide any causality assessments. The reporter stated that he was put on Eliquis for ninety days and has used it for thirty days so far. He has had some issues that require an enema. Concomitant medications included: dark Cherry Extract - started on or after 29-Mar-2021. The reporter stated that he had been taking Eliquis for 45 days for blood clots that stemmed from a colon infection with secondary hypercoagulability. On Saturday 27-Mar-2021, the patient had his second injection of the Pfizer Covid vaccine. After receiving the vaccine, he said he felt lousy and had common side effects for a vaccine that lasted for about 2 days. On 29-Mar-2021 he woke up with a swollen index finger and swollen toe and this was determined to be gout. The gout in his index finger he had before. The patient stated that whenever he got bruises he had noticed that the bruises were darker than normal since he had started Eliquis. The patient also stated that he has had considerable constipation that started before Eliquis, but still persisted at times and he had treated with enemas. Patient was a retired physician.   Follow-up (30Mar2021): This is a follow-up spontaneous report from a contactable physician, based on information received by Pfizer  Most recent follow-up information was received from a physician on 30-Mar-2021 included the following: the event adverse event nos was amended as information on adverse events were received, new events and suspect product added, patient attributes, medical history, product attributes and narrative updated.