chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:21, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 10:51, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 10:31, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:20, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: his spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 09:51, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 11:15, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237:  US-009507513-1704USA000485: US-009507513-1704USA000486:  US-009507513-1704USA000487: US-009507513-1704USA000488:  US-009507513-1704USA000489: US-009507513-1704USA000490:  US-009507513-1704USA000491: US-009507513-1704USA000492:  US-009507513-1704USA000493: US-009507513-1704USA000494:  US-009507513-1704USA000496: US-009507513-1704USA000497:  US-009507513-1704USA000498: US-009507513-1704USA000499:  US-009507513-1704USA000500: US-009507513-1704USA000501:  US-009507513-1704USA000502: US-009507513-1704USA000503:  US-009507513-1704USA000504: US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 10:28, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 09:12, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 09:53, the patient was vaccinated with improperly stored zoster vaccine live (ZOSTAVAX) injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000505: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 09:32, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000237:  US-009507513-1704USA000485:  US-009507513-1704USA000486:  US-009507513-1704USA000487:  US-009507513-1704USA000488:  US-009507513-1704USA000489:  US-009507513-1704USA000490:  US-009507513-1704USA000491:  US-009507513-1704USA000492:  US-009507513-1704USA000493:  US-009507513-1704USA000494:  US-009507513-1704USA000495:  US-009507513-1704USA000496:  US-009507513-1704USA000497:  US-009507513-1704USA000498:  US-009507513-1704USA000500:  US-009507513-1704USA000501:  US-009507513-1704USA000502:  US-009507513-1704USA000503:  US-009507513-1704USA000504:  US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 09:13, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:46, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:35, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:04, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000237:  US-009507513-1704USA000485:  US-009507513-1704USA000486:  US-009507513-1704USA000487:  US-009507513-1704USA000488:  US-009507513-1704USA000489:  US-009507513-1704USA000490:  US-009507513-1704USA000491:  US-009507513-1704USA000492:  US-009507513-1704USA000493:  US-009507513-1704USA000494:  US-009507513-1704USA000495:  US-009507513-1704USA000496:  US-009507513-1704USA000497:  US-009507513-1704USA000498:  US-009507513-1704USA000499:  US-009507513-1704USA000500:  US-009507513-1704USA000501:  US-009507513-1704USA000502:  US-009507513-1704USA000504:  US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:26, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1702USA000237:  US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000505:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:32, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 31-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot number L035687 and expiration date 16-FEB-2017 (dose and route were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, who was also a vaccine coordinator, referring to 19 unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD with lot # M032496 and expiration date on 02-JAN-2018 (anatomical route of vaccination was not provided) for prophylaxis. The reporter stated that, PROQUAD, was exposed to a temperature excursion of 15 °F to 46 °F (42 °F) for a 6 hours time frame. Furthermore it was stated that, PROQUAD was not expose to any previous temperature excursions and that the call was made due to a data logger. No adverse effects were reported and no product quality issue was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71 year old female patient. The patient did not have any known medical history, allergies or reactions. On 01-MAR-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU intramuscular route for prophylaxis (dose, lot number and expiration date were not reported), the vaccine was reconstituted with the sterile diluent(DILUENT MRK) intramuscular route for vaccination (strength, lot number and expiration date were not reported). Concomitant medications were not provided. On approximately 04-MAR-2017 (reported as "3 days later"), the patient developed an unspecified rash. An unspecified treatment was given for the adverse event but no laboratory tests were performed. The patient sought medical attention by visiting the pharmacist. The outcome of rash was reported as not recovered. The relatedness between the event and the suspect therapies was not provided by the reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Blister, Rash, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71 year old female patient. The patient did not have any known medical history, allergies or reactions. On 01-MAR-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU intramuscular route for prophylaxis (dose, lot number and expiration date were not reported), the vaccine was reconstituted with the sterile diluent(DILUENT MRK) intramuscular route for vaccination (strength, lot number and expiration date were not reported). Concomitant medications were not provided. On approximately 04-MAR-2017 (reported as "3 days later"), the patient developed an unspecified rash. An unspecified treatment was given for the adverse event but no laboratory tests were performed. The patient sought medical attention by visiting the pharmacist. The outcome of rash was reported as not recovered. The relatedness between the event and the suspect therapies was not provided by the reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Rash
Clinical narrative: Pt developed a blister rash on her right shin 3 days after receiving the ZOSTAVAX administered 3/1/17. She is also developing another similar rash on her left shin and side abdomen. She describes it as itchy, initially blistering, and painful. She has taken an unspecified itch pain relief cream and it helped somewhat. Blisters have subsided but painful rash persists.
Age: 71.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Blister, Rash, Rash pruritic, Rash vesicular
Clinical narrative: Pt developed a blister rash on her right shin 3 days after receiving the ZOSTAVAX administered 3/1/17. She is also developing another similar rash on her left shin and side abdomen. She describes it as itchy, initially blistering, and painful. She has taken an unspecified itch pain relief cream and it helped somewhat. Blisters have subsided but painful rash persists.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 30-MAR-2017, the patient was vaccinated with an unspecified improperly stored dose of PEDVAXHIB for prophylaxis (lot # M032150 with an expiration date of 21-APR-2019) (dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. The dose of the vaccine experienced a temperature excursion from 32 Fahrenheit (F) to 35 F for 19 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Myocardial infarction, Pneumonia
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 00398291). A contactable pharmacist reported that a female patient of an unknown age and race received PREVNAR 13 at single dose on unknown date for immunization via an unspecified route of administration. Concomitant medications were not reported. The patient developed pneumonia on an unknown date, three months after administration of vaccine. Pharmacist reported the pneumonia was caused by complications of a heart attack; however, pharmacist was uncertain whether patient experienced the heart attack prior to or after administration of PREVNAR 13. The outcome of the event was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Papule, Pruritus, Urticaria, Vomiting
Clinical narrative: Complained of feet itching 10 minutes after vaccines.  Itching progressed up body to abdomen, axilla, and neck. Pinpoint papules occurred over the same areas that then increased to multi sized hives.  Administered 50mg of Benadryl orally @12:25pm.  Stomach cramps and an episode of vomiting occurred at 12:30PM.  Epinephrine 0.15ml was administered SQ at 12:35PM .  No respiratory distress or swelling.  Patient was transported to ER via ambulance at 12:48 PM.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Arm Pain, painful to life arm. Nauseated from the pain.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Blister, Contusion, Haemoglobin increased, Injection site bruising, Injection site swelling
Clinical narrative: Hives on face, back, legs, and arms. Intense itching, fever of 102 F, swelling of face. Medicated with OTC benadryl, tylenol, and prescribed oral steroids. Reaction worsened causing fluid filled blisters, mottling, and bruising/swelling on legs and arms. Reaction lasted approximately eight days.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Skin discolouration, Swelling face
Clinical narrative: Hives on face, back, legs, and arms. Intense itching, fever of 102 F, swelling of face. Medicated with OTC benadryl, tylenol, and prescribed oral steroids. Reaction worsened causing fluid filled blisters, mottling, and bruising/swelling on legs and arms. Reaction lasted approximately eight days.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on face, back, legs, and arms. Intense itching, fever of 102 F, swelling of face. Medicated with OTC benadryl, tylenol, and prescribed oral steroids. Reaction worsened causing fluid filled blisters, mottling, and bruising/swelling on legs and arms. Reaction lasted approximately eight days.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Blister, Contusion, Full blood count, Haemoglobin increased, Livedo reticularis
Clinical narrative: Hives on face, back, legs, and arms. Intense itching, fever of 102 F, swelling of face. Medicated with OTC benadryl, tylenol, and prescribed oral steroids. Reaction worsened causing fluid filled blisters, mottling, and bruising/swelling on legs and arms. Reaction lasted approximately eight days.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, MMR, VARCEL, DTAP, FLUX, HIBV, MMR, VARCEL
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Swelling face, Urticaria
Clinical narrative: Hives on face, back, legs, and arms. Intense itching, fever of 102 F, swelling of face. Medicated with OTC benadryl, tylenol, and prescribed oral steroids. Reaction worsened causing fluid filled blisters, mottling, and bruising/swelling on legs and arms. Reaction lasted approximately eight days.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Tenderness
Clinical narrative: Warm, red, tender, pain with arm movement.
Age: 0.17
Sex: F
Vaccine: RVX
Symptoms: Abnormal faeces, Bowel movement irregularity, Faeces discoloured, Flatulence
Clinical narrative: Irregular bowel movements from prior to vaccine.  Consistency, color and odor of stools changed.  Patient is exclusively breastfed prior stools had light odor and were yellow seedy.  Following vaccine the stools were every 3rd day,  foul smelling and dark green in color with no seed consistency.  Additionally patient had foul smelling gas.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site cellulitis, Injection site pain, Nausea, Neck pain
Clinical narrative: Patient complained of neck pain, headache 7/10, nausea, painful injection site.  Later admitted to ED, dx with cellulitis from injection site.
Age: 88.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Malaise, Myalgia, Pain
Clinical narrative: Muscle soreness, pain, and feeling "sick".
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Influenza virus test negative, Oropharyngeal pain, Pain
Clinical narrative: Began with a sore throat, progressed throughout the day to headache, severe body aches, chills, and a fever of 103.8. Took to clinic- strep and flu test were negative (strep culture sent out) called primary and was advised to continue ibuprofen 3x day and add Zyrtec for 1 week- was said to be having a reaction to vaccination.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Streptococcus test negative, Vaccination complication
Clinical narrative: Began with a sore throat, progressed throughout the day to headache, severe body aches, chills, and a fever of 103.8. Took to clinic- strep and flu test were negative (strep culture sent out) called primary and was advised to continue ibuprofen 3x day and add Zyrtec for 1 week- was said to be having a reaction to vaccination.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Headache, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Arm warm at the injection site. Site elevated .25x.25 cm. Temperature 99.4 with intermittent headaches and arm is very sore.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Flatulence, Headache
Clinical narrative: Vaccine administered in the late morning/early afternoon. Later in the afternoon and into the evening, patient suffered from upset stomach (gas, diarrhea). Around 2:30AM, he awoke sweating, with a fever (99.6) and chills/shivering. The fever lasted into the day. In the late morning it was 99.9. Around 6PM it was 103. He has also been experiencing a headache and soreness at the site of the injection.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: Vaccine administered in the late morning/early afternoon. Later in the afternoon and into the evening, patient suffered from upset stomach (gas, diarrhea). Around 2:30AM, he awoke sweating, with a fever (99.6) and chills/shivering. The fever lasted into the day. In the late morning it was 99.9. Around 6PM it was 103. He has also been experiencing a headache and soreness at the site of the injection.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Febrile convulsion, Heart rate increased, Lethargy, Muscle twitching, Pyrexia
Clinical narrative: Lethargic, small body twitches, 104 degree fever which led to febrile seizure, heart rate of 175+ sustained for over 1 hour.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphemia
Clinical narrative: Parents report pt started stuttering 10-15 mins after receiving vaccine.
Age: 33.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Muscle tightness, Paraesthesia
Clinical narrative: Patient telephoned clinic on 03/16/2017 to report an adverse reaction to vaccine administered on 2/9/2017, stating he experienced swelling and redness at the injection site on his right arm. Went on to say he had flu-like symptoms and muscle tightness and "tingling" about a week after the injection. States all symptoms have resolved.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Hypoaesthesia, Laboratory test, Nausea
Clinical narrative: Headache, Nausea, fever, chills, tingling/numbness in her fingers and toes, Neuropathy hands, feet and pineal area.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Neuropathy peripheral, Paraesthesia, Pyrexia
Clinical narrative: Headache, Nausea, fever, chills, tingling/numbness in her fingers and toes, Neuropathy hands, feet and pineal area.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash generalised, Vomiting
Clinical narrative: Patient woke in am 4-3-17 with rash all over. Had vomiting and diarrhea over weekend (so did other family members). Grandmother states patient had low grade fever on 04-02-17.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Loss of personal independence in daily activities, Migraine
Clinical narrative: Had 2nd GARDASIL vaccine at 1pm, numbing and tingling in upper back (side of shot), elbow numb and wrist hurting. She couldn't put on her jacket. Pain in arm and back ended at 3pm. At 6pm started migraine symptoms, by 9 pm symptoms were "worse than a migraine" requiring a MD call and suggestion to go to ER for evaluation. 800mg of MOTRIN, didn't help.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Had 2nd GARDASIL vaccine at 1pm, numbing and tingling in upper back (side of shot), elbow numb and wrist hurting. She couldn't put on her jacket. Pain in arm and back ended at 3pm. At 6pm started migraine symptoms, by 9 pm symptoms were "worse than a migraine" requiring a MD call and suggestion to go to ER for evaluation. 800mg of MOTRIN, didn't help.
Age: 17.0
Sex: U
Vaccine: MENB
Symptoms: Body temperature increased, Fatigue, Granulocyte percentage, Haematocrit normal, Haemoglobin normal
Clinical narrative: 5 hours after TRUMENBA fatigue myalgia neck pain temp 100.5
Age: 17.0
Sex: U
Vaccine: MENB
Symptoms: Influenza virus test negative, Lymphocyte percentage decreased, Monocyte percentage, Myalgia, Neck pain
Clinical narrative: 5 hours after TRUMENBA fatigue myalgia neck pain temp 100.5
Age: 17.0
Sex: U
Vaccine: MENB
Symptoms: Platelet count normal, Streptococcus test negative, White blood cell count increased
Clinical narrative: 5 hours after TRUMENBA fatigue myalgia neck pain temp 100.5
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Fall, Gait disturbance, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Experienced 103 fever, delirious stumbling, falling, site was raised, red, and feverish occurred 48 hrs after administered.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Patient noted on the following day redness on injection site. Then on 4/4/17 she noticed redness had spread to a bigger area of arm, it felt warm and had hard knot on injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised erythematous area 5x4cm on (L) upper arm at site of DTAP. Not tender or warm.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash generalised
Clinical narrative: Child received vaccine on 3/21/17-Developed whole body rash 4d later.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient has a fever, chills and is achy.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: N/A Patient given expired PNEUMOVAX 23 no adverse.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Inflammation, Rash, Urticaria
Clinical narrative: Hives, rash, inflammation of left arm, upper left of left hand.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Band neutrophil count decreased, Otitis media, Pyrexia, Red blood cell sedimentation rate normal, Synovitis
Clinical narrative: 12 mo. with URI and OM seen with fever and refuses to bear wt. Dx: (L) toxic synovitis at hip.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Ultrasound liver normal, Upper respiratory tract infection, Weight bearing difficulty, White blood cell count increased
Clinical narrative: 12 mo. with URI and OM seen with fever and refuses to bear wt. Dx: (L) toxic synovitis at hip.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Body temperature increased, Injection site warmth, Loss of personal independence in daily activities
Clinical narrative: Mild warm to touch at site (Right deltoid) where vaccine was given. Low grade temperature, Nurse contacted and patient was placed on sports restrictions with TYLENOL/Ibuprofen given every 4 hours if needed. Patient will be monitored.
Age: 65.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site streaking, Injection site warmth
Clinical narrative: Red lump with red (faint) streak down arm on Right arm when reported on 4/3 Patient updated office on 4/4 and had some improvement in redness at site but area still warm.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Feeling jittery, Immediate post-injection reaction, Nausea
Clinical narrative: 3/3/2017 at 1140am - Patient began to feel nauseous immediately following injection. Sat down and began to feel better so she returned to work. Began feeling dizzy after returning to office followed by jittery. Taken to blood drive after feeling better but then vomited. "Jittery, hot, lightheaded."
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: 3/3/2017 at 1140am - Patient began to feel nauseous immediately following injection. Sat down and began to feel better so she returned to work. Began feeling dizzy after returning to office followed by jittery. Taken to blood drive after feeling better but then vomited. "Jittery, hot, lightheaded."
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Redness noted same night vaccines given. Seen in office 3 days later with 3 1/2" x 3" large raised circular reddened area over half of (R) deltoid; area sl. warm, non-tender. (L) arm with red papular round rash (also on abx for BADM). Tx: BENADRYL, 2.5% hydrocortisone cream BID x 7.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash papular
Clinical narrative: Redness noted same night vaccines given. Seen in office 3 days later with 3 1/2" x 3" large raised circular reddened area over half of (R) deltoid; area sl. warm, non-tender. (L) arm with red papular round rash (also on abx for BADM). Tx: BENADRYL, 2.5% hydrocortisone cream BID x 7.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis
Age: 1.08
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Autism spectrum disorder, Cytogenetic analysis, Electroencephalogram, Exanthema subitum, Nuclear magnetic resonance imaging
Clinical narrative: Mother specifies that after the vaccination the girl had high fever and was evaluated by a doctor who diagnosed her with a throat infection but another pediatrician diagnosed her with infantum roseola. Mother states that the convulsions continue and her geneticist told her she had a 4% of autism.
Age: 1.08
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pharyngitis, Pyrexia, Seizure
Clinical narrative: Mother specifies that after the vaccination the girl had high fever and was evaluated by a doctor who diagnosed her with a throat infection but another pediatrician diagnosed her with infantum roseola. Mother states that the convulsions continue and her geneticist told her she had a 4% of autism.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Patient got a fever and a red mark from vaccine. We monitored and by 6pm the following day she had large bruise with red and yellow along site of vaccinations. We called on call doctor and were told to go to urgent care. On 2/23/17 patient was seen at Urgent Care. The doctor just prescribed allergy medicine and topical ointment and follow up with primary. On 2/24/17 patient was seen at primary care. The site where shot was given was hot to touch and she was in pain while moving leg. Her leg was infected at vaccination site. She was prescribed antibiotic. She still has large discolored area and pending follow up appointment at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination site bruising, Vaccination site discolouration, Vaccination site infection
Clinical narrative: Patient got a fever and a red mark from vaccine. We monitored and by 6pm the following day she had large bruise with red and yellow along site of vaccinations. We called on call doctor and were told to go to urgent care. On 2/23/17 patient was seen at Urgent Care. The doctor just prescribed allergy medicine and topical ointment and follow up with primary. On 2/24/17 patient was seen at primary care. The site where shot was given was hot to touch and she was in pain while moving leg. Her leg was infected at vaccination site. She was prescribed antibiotic. She still has large discolored area and pending follow up appointment at this time.
Age: 13.0
Sex: F
Vaccine: FLUX, HEPAB
Symptoms: Asthenia, Blood test, Hepatitis B, Malaise, Vomiting
Clinical narrative: Hep b,throwing up not being able to eat food without throwing it up was very weak had IVs in my head.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Conjunctival haemorrhage, Fatigue, Influenza like illness, Injection site swelling, Pain
Clinical narrative: Flu like symptoms, achiness, fatigue, swelling at site of injection and subconjuctival hemorrhage one eye.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. The pharmacist reported that on 06-MAR-2017, the patient was administered an expired PNEUMOVAX23 (strength, frequency and lot number were not provided) at a dose of 0.5 ml, intramuscularly for prophylaxis, with expiration date of 16-FEB-2017. No adverse effects reported. The Physician called to inquire about potency of expired dose of PNEUMOVAX23 which was administered. No further information provided. There was no product quality complaint (PQC) involved. Additional information has been requested.