chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Dizziness, Fatigue, Feeling abnormal, Hypersensitivity
Clinical narrative: Employee works for daycare which requires her to receive certain vaccines to include hepatitis B vaccine. She received her first hep B vaccine on 6/1/2016 experiencing a sore arm otherwise no issues. She received her second hepatitis B vaccine on 7/7/2016. She advised she had had a slight cough the week or so before being vaccinated as she just stopped taking ZYRTEC (mid June). She had been using ZYRTEC from May-June for new environmental like allergies (cough, congestion, runny nose) per her HCP. She recalls day of 2nd vaccination, her left arm was again sore and she worked thru the pain not taking any medication. The next day, Friday, her arm was still sore but she could work. That evening, she began to feel more fatigued than usual stating she was weak. She described this weakness as a strong ure to sleep and no energy. She stated this fatigue persisted over the next 2 days with her sleeping most of the weekend, onset of chills/fever (100F) and her body ached. She stated she could only walk on bent knees Saturday due to discomfort. She again did not take any meds for pain/fever and had limited food intake (did not check blood sugars, did take daily medications). By Sunday she was dizzy, walked normally, and was feeling better so she ate/drank fluids and felt much better that evening. Monday she went to work feeling better; however that evening she had a fever of 100.5F, was coughing and overall felt bad. She stayed home Tuesday due to dizziness and went to clinic where physician did CXR and labs and diagnosed with pneumonia in her left lung. She was treated with Z-pak and ROBITUSSIN PM. She returned to work Thursday and was re-evaluated by Dr and again sent home to see her CIV HCP. By Sunday she was better and cleared to work on Monday 7/18/2016.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Pain, Pain in extremity, Pneumonia, Pyrexia
Clinical narrative: Employee works for daycare which requires her to receive certain vaccines to include hepatitis B vaccine. She received her first hep B vaccine on 6/1/2016 experiencing a sore arm otherwise no issues. She received her second hepatitis B vaccine on 7/7/2016. She advised she had had a slight cough the week or so before being vaccinated as she just stopped taking ZYRTEC (mid June). She had been using ZYRTEC from May-June for new environmental like allergies (cough, congestion, runny nose) per her HCP. She recalls day of 2nd vaccination, her left arm was again sore and she worked thru the pain not taking any medication. The next day, Friday, her arm was still sore but she could work. That evening, she began to feel more fatigued than usual stating she was weak. She described this weakness as a strong ure to sleep and no energy. She stated this fatigue persisted over the next 2 days with her sleeping most of the weekend, onset of chills/fever (100F) and her body ached. She stated she could only walk on bent knees Saturday due to discomfort. She again did not take any meds for pain/fever and had limited food intake (did not check blood sugars, did take daily medications). By Sunday she was dizzy, walked normally, and was feeling better so she ate/drank fluids and felt much better that evening. Monday she went to work feeling better; however that evening she had a fever of 100.5F, was coughing and overall felt bad. She stayed home Tuesday due to dizziness and went to clinic where physician did CXR and labs and diagnosed with pneumonia in her left lung. She was treated with Z-pak and ROBITUSSIN PM. She returned to work Thursday and was re-evaluated by Dr and again sent home to see her CIV HCP. By Sunday she was better and cleared to work on Monday 7/18/2016.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Respiratory tract congestion, Rhinorrhoea, Somnolence
Clinical narrative: Employee works for daycare which requires her to receive certain vaccines to include hepatitis B vaccine. She received her first hep B vaccine on 6/1/2016 experiencing a sore arm otherwise no issues. She received her second hepatitis B vaccine on 7/7/2016. She advised she had had a slight cough the week or so before being vaccinated as she just stopped taking ZYRTEC (mid June). She had been using ZYRTEC from May-June for new environmental like allergies (cough, congestion, runny nose) per her HCP. She recalls day of 2nd vaccination, her left arm was again sore and she worked thru the pain not taking any medication. The next day, Friday, her arm was still sore but she could work. That evening, she began to feel more fatigued than usual stating she was weak. She described this weakness as a strong ure to sleep and no energy. She stated this fatigue persisted over the next 2 days with her sleeping most of the weekend, onset of chills/fever (100F) and her body ached. She stated she could only walk on bent knees Saturday due to discomfort. She again did not take any meds for pain/fever and had limited food intake (did not check blood sugars, did take daily medications). By Sunday she was dizzy, walked normally, and was feeling better so she ate/drank fluids and felt much better that evening. Monday she went to work feeling better; however that evening she had a fever of 100.5F, was coughing and overall felt bad. She stayed home Tuesday due to dizziness and went to clinic where physician did CXR and labs and diagnosed with pneumonia in her left lung. She was treated with Z-pak and ROBITUSSIN PM. She returned to work Thursday and was re-evaluated by Dr and again sent home to see her CIV HCP. By Sunday she was better and cleared to work on Monday 7/18/2016.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a Vaccine Account Representative and refers to two patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route and site of administration, lot # and expiration date were not reported). On an unknown dates, the patients experienced the same side effects which was: injection site redness, injection site swelling and injection site soreness. The outcome of the events was reported as recovered. The pharmacist mentioned that both patients was doing "fine" at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2015, the patient was vaccinated with the dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017, dose and route were not reported) that  has experienced an excursion. On 14_DEC-2015, the patient was vaccinated with another dose of GARDASIL (lot # L010596; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 17 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with a dose of GARDASIL 9 (lot # L007560, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 14-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 13 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-AUG-2015 and on 09-MAY-2016, the patient was vaccinated with doses of GARDASIL 9 (lot # L007560, lot # L048237, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Food allergy
Clinical narrative: Information has been received from a physician concerning a 5 year old female patient. The patient's medical history and concurrent condition were not provided. In approximately 2012 (reported as "at one year of age"), the patient was vaccinated with VARIVAX (lot number, expiration date, route and dose unknown). The concomitant therapy was not provided. On an unspecified date, the patient experienced peanut allergy. On 21-JUL-2016, the patient was exposed to peanuts and experienced a mild anaphylactic reaction, on the same day, the patient received DECADRON 4mg and would begin prednisolone (manufacture unknown) 25mg, twice a day, for two days and then prednisolone 12.5mg, twice a day, for two days. The outcome of peanut allergy and anaphylactic reaction was unknown. The physician considered the events was not related to VARIVAX. Upon internal review, anaphylactic reaction was considered as medically significant. Additional information is not expected as the physician did not want to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies, or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L045711, expiration date 08-MAY-2017; exact doses and route of administration were not provided). It was reported that the vaccines was exposed to temperature of 1.1 Celsius (C) degrees for 1 hour and 45 minutes and then for 1 hour and 17 minutes (cumulative 3 hours and 2 minutes at lowest 1.1 C) before administration to the patients. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Dosage, dose number, route of administration, lot # and expiration date were not reported). No concomitant therapies were reported. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K005083 and expiration date 04-NOV-2016, lot # K010215 and expiration date 05-MAY-2017; exact doses and route of administration were not provided). It was reported that the vaccines was exposed to temperature of 1.1 Celsius (C) degrees for 1 hour and 45 minutes and then for 1 hour and 17 minutes (cumulative 3 hours and 2 minutes at lowest 1.1 C) before administration to the patients. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2016, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral ROTATEQ (lot # L029618 and expiration date 20-MAY-2017, lot # L035511 and expiration date 21-MAY-2017, orally; except doses were not provided). It was reported that the vaccines was exposed to temperature of 1.1 Celsius (C) degrees for 1 hour and 45 minutes and then for 1 hour and 17 minutes (cumulative 3 hours and 2 minutes at lowest 1.1 C) before administration to the patients. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 05-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact dose was not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature at 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator referring to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not applicable. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L046887, expiration date 23-NOV-2017, and lot # reported as M006107, expiration date 01-AUG-2017, 0.5 ml, subcutaneously). The vaccines were stored at minus 13.21 degree C for 12 hours. No adverse effects were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse refers to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with the dose of GARDASIL  (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 05-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact dose was not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 45 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported.  This is one of the several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of oral ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact doses were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 80 year old female patient with allergy to sulfa drugs and penicillin (unspecified). On 10-JUL-2016, the patient was inadvertently vaccinated with ZOSTAVAX (lot # L046897, expiration date 20-FEB-2017, dose was not reported0 via the intramuscular route rather than the recommended subcutaneous route. Concomitant therapies included lovastatin (manufacturer unknown), spironolactone, valsartan and VESICARE). On an unspecified date in  July 2016, the patient had an area about 1-1.5 inches that was red, hard, swollen, burised and itchy at the injection site. The patient sought medical attention so visited the pharmacy and reported the events. The patient received unspecified treatment for the events. None labs were performed. There was no product quality complaint. The outcome of the events was reported as not recovered, at the time of the report. the relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 30-JUN-2016, the patient was vaccinated with an improperly stored dose of oral ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact dose was not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, 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 regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. In January 2010, the patient was vaccinated with the first dose of ZOSTAVAX (0.65 ml, subcutaneous , lot # and expiration date were not provided). In January 2012, the patient received a second dose of ZOSTAVAX (0.65 ml, subcutaneous, lot # and expiration date were not provided). No adverse reactions were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2015, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 29-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L037924, expiration date 22-JUN-2017, orally; exact dose were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effects were reported. This is one the several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Abasia, Injection site pain
Clinical narrative: Shot was given on left thigh, pain on site and can't walk.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Considerable swelling, pain, erythema at injection site.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Arms and legs began to itch.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2 month old patient of unknown gender. No information about the patients pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 26-JUL-2016, the patient was vaccinated with an expired dose ROTATEQ 2 ml, orally, lot # K022993 and expiration date 20-JUL-2016. No adverse effects reported. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 2 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-OCT-2015, the patient was vaccinated with a dose of GARDASIL 9 (lot # L007560, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an 18 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAY-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot # L048237, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2015, the patient was vaccinated with the dose of GARDASIL (lot # K014191; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 13 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-AUG-2015, 09-NOV-2015 and on 09-MAY-2016, the patient was vaccinated with doses of GARDASIL 9 (lot # L007560, lot # L048237, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX 1 dose (lot # L050561, expiration date: 14-DEC-2017; route was not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 10-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # reported as K004204. No adverse reaction was reported at the time of the report. It was verified that lot # K004204 is not valid for GARDASIL 9, however it is valid for GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 11 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JAN-2016 and on 14-MAR-2016, the patient was vaccinated with doses of GARDASIL 9 (lot # L007560, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2015, the patient was vaccinated with the dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, 1 dose (lot # M001578, expiration date: 21-NOV-2018; route was not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 30-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, (lot # L037924, expiration date 22-JUN-2017, orally; exact dose was not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effect were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M006708 and expiration date 02-JUN-2018, lot # L033343 and expiration date 13-SEP-2017, exact doses and route of administration were not reported. It was reported that the vaccines were exposed to temperature of 1.1 Celsius (C) degrees for 1 hour and 45 minutes and then for 1 hour and 17 minutes (cumulative 3 hours and 2 minutes at lowest 1.1 C) before administration to the patients. No adverse effects were reported.  This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # K008333 and expiration date 10-MAR-2017, lot # M01116 and expiration date 17-JUN-2017, lot # reported as M015773 and expiration date 26-MAY-2017; exact doses and route of administration were not provided). It was reported that the vaccines were exposed to temperature of 1.1 Celsius (C) degrees for 1 hour and 45 minutes and then for 1 hour and 17 minutes (cumulative 3 hours and 2 minutes at lowest 1.1 C) before administration to the patients. No adverse effects were reported.  This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 20 patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot number L048237, expiry date 08-MAY-2017 (doses, route and anatomical sites of injection were not reported). Concomitant therapies were not provided. Information regarding the temperature storage, duration of excursion and previous excursions were not reported. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, who was also the patient's mother, refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-JUL-2016, the patient was vaccinated orally with the first dose of ROTATEQ oral liquid (dose, lot# and expiry date were not reported). Then, on 21-JUL-2016, the patient was inadvertently vaccinated orally with the second dose of ROTATEQ oral liquid (dose, lot# and expiry date were not reported) by an unspecified healthcare provider. There were no concomitant therapies reported. No adverse effect were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 13 patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot number L016429, expiry date 09-AUG-2017 (doses, route and anatomical sites of injection were not reported). Concomitant therapies were not provided. Information regarding the temperature storage, duration of excursion and previous excursions were not reported. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of unspecified patients. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 60 patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot number L024993, expiry date 17-OCT-2017 (doses, route and anatomical sites of injection were not reported). Concomitant therapies were not provided. Information regarding the temperature storage, duration of excursion and previous excursions were not reported. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of unspecified patients. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiration date, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified amount of unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot numbers, expiry dates, doses, route and anatomical sites of injection were not reported). Concomitant therapies were not provided. Information regarding the temperature storage, duration of excursion and previous excursions were not reported. No averse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 20 patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot number L018351, expiry date 11-AUG-2017 (doses, route and anatomical sites of injection were not reported). Concomitant therapies were not provided. Information regarding the temperature storage, duration of excursion and previous excursions were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with the dose of GARDASIL (lot # K014191; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 21-JUL-2016, the patient was vaccinated with improperly stored ROTATEQ lot # L035510 with expiry date: 13-MAY-2017 (dosing details were not reported). It was reported that the vaccines were exposed to the temperature of 0.0 C during a time frame of 13 hours and 45 minutes. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Hyperhidrosis, Pain
Clinical narrative: Body aches,  headaches, sweats x 2 weeks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash
Clinical narrative: Reports that the child has a rash on her arms and is itching. Instructed to use BENADRYL and Calamine lotion for itching. Instructed to seek medical attention if condition becomes worse.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fatigue, Headache, Lethargy, Nausea, Pain
Clinical narrative: Pain down left side of body, (side of injection) Lethargy, nausea, headache, fatigue.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Discomfort, Feeling abnormal, Limb discomfort, Muscle tightness
Clinical narrative: Pt received Tdap and MENACTRA. She felt "funny" after 15 minutes (described as head and legs feeling heavy and jaw felt tight) symptoms lasted for about 45 minutes (drank fluids but no other Tx rendered).
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Eye pruritus, Headache, Nausea, Pruritus generalised
Clinical narrative: Patient stated an hour or 2 after receiving the vaccine she developed chills, itch eyes, headache, nausea and itching all over the body. She stated she did not have anything to eat or drink after the vaccine. No rash on body but she is constantly itching.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Severe (L) arm/shoulder pain 6 days after vaccine. Decreased ROM. No relief with warm compresses, anti-inflammatories. Treated w/T#3, percocet, steroid injection at clinic. Then given DILANDID and TORADOL at ER. Now 90% improved 1 month after.
Age: 37.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Erythema, Headache, Pallor
Clinical narrative: Client received first dose of TWINRIX. After 5-10 minutes post injection she said she began having a headache and some dizziness. (Before the injection, she told me that she had developed, the day before at work, a rash around her neck after crawling out of a crawlspace under a house. She wasn't sure why she had developed it, other than that was the only area not covered by her has-mat uniform. At the time of vaccination she still has a slight amount of pale redness on the front of her neck. She was advised to stay seated and drink fluids (She did not want to lie down). She continued to have a headache after a duration of one hour. She was advised that she should notify her medical provider and advise them of her current symptoms. (She said she would do it TUES when she took her child to his doctor appt. It was advised that she should not go to work and go home and rest. She went to work and her boss sent home after receiving our recommendations. She was advised to talk to her medical provider regarding receiving further vaccine for Hepatitis A and B.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Dizziness, Erythema, Heart rate increased, Nausea, Ocular hyperaemia
Clinical narrative: At 2030 last night (7/26/16) he felt dizzy, nausea, fever 103, increased heart rate, face was red, and she had bloodshot eyes and pain in her arm. Today (7/27/16) temp is 99, but she is still having pain in her left arm.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: At 2030 last night (7/26/16) he felt dizzy, nausea, fever 103, increased heart rate, face was red, and she had bloodshot eyes and pain in her arm. Today (7/27/16) temp is 99, but she is still having pain in her left arm.