chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Eosinophil percentage, Fatigue, Full blood count, Haematocrit normal
Clinical narrative: Fatigue, weakness, dizziness, headache, pains down left side of body, stomach pains, and lips turned blue.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin normal, Headache, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Fatigue, weakness, dizziness, headache, pains down left side of body, stomach pains, and lips turned blue.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Mean cell volume normal, Monocyte percentage increased, Neutrophil percentage, Pain, Platelet count normal
Clinical narrative: Fatigue, weakness, dizziness, headache, pains down left side of body, stomach pains, and lips turned blue.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell count normal, White blood cell count normal
Clinical narrative: Fatigue, weakness, dizziness, headache, pains down left side of body, stomach pains, and lips turned blue.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Sex: F
Vaccine: HEP
Symptoms: Photosensitivity reaction
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (reported as hepatitis vaccine) (dose, lot#, expiry date were not reported) one shot in an unknown location. The patient could not recall what "hepatitis" vaccine this was or who manufactured the vaccine. The patient reported that after receiving the vaccine she could not go out into the sunlight. If she went into the sunlight, she would have a "bad reaction". The outcome of the event was recovered. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 24-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017) (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies 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.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 27-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical location and route of administration were not reported)). Concomitant therapies 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.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions, concomitant therapies or allergies were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of ZOSTAVAX, (route of administration, dose and anatomical location were not provided) lot # L026415, expiration date 15-OCT-2016. No adverse event was reported. Product quality complaint was not 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: Information has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patient were vaccinated with improperly stored doses of GARDASIL 9 lot # L026602, expiry date: 19-OCT-2017. The temperature of exposure was reported as 29 degree Celsius for 3 hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 27-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017) (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies 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.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L026410, expiration date 15-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 4 degrees Celsius for 75 hours. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions, concomitant therapies or allergies were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of M-M-R II (route of administration, dose, albumin status, and anatomical location were not provided) lot# K024825, expiration date 02-DEC-2016. No adverse event was reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. Information regarding patient's medical history, concurrent conditions or concomitant therapies were not provided. On unspecified dates, unspecified number of patients were vaccinated with five doses of ROTATEQ were administered lot # L033549 expiry date 05-JUN-2017, lot # L027726 expiry date 10-MAY-2017, lot # L033545 expiry date 30-MAY-2017 (dose number, dose units, route and anatomical location were not reported). Concomitant medication were not reported. No symptoms were reported. The reporting nurse was not sure which lot numbers were administered but the lot numbers mentioned were the ones possibly involved. It was reported that the administered vaccines were exposed to temperatures of 46.9 Fahrenheit degrees for 15 minutes and 34.9 Fahrenheit degrees for 2 hours. This is one of the several reports from the same reporter. Follow up information has been received from Registered Nurse on 09-AUG-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 27-JUL-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies 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.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored VAQTA (lot #M021124, expiry date: 02-FEB-2018, lot #L043209, expiry date: 17-SEP-2017, lot# L032749, expiry date: 04-NOV-2016) (route: intramuscular). The vaccine was stored at a temperature of 53.3 F for a time frame of 3 hours and 23 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse (clinic coordinator) concerning unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients received doses of improperly stored ROTATEQ (lot #L044476 with expiration date 07-SEP-2017, dose and route were not reported). The doses of ROTATEQ underwent temperature excursions at 34.8 F for 6 hour 25 minutes and 14.6 F for 5 hours 45 minutes respectively. Previous temperature excursion was as followings: 47 F for 45 min, 48 F for 45 min, 49 F for 30 min, 50 F for 45 min and 50 F for 3 hour 15 min. Data logger was involved. Product quality complaint (PQC) was not involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant referring to multiple unknown patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD (lot# M012985, expired date 12-SEP-2017, human serum albumin (HSA); lot# M012986, expired date 12-SEP-2017, human serum albumin (HSA); lot# M007960, expired date 15-AUG-2017, recombinant human albumin; lot# M011662, expired date 08-SEP-2017, recombinant human albumin (dose and route unknown). The vaccines were exposed under 8.8 Fahrenheit degree (F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were inadvertently vaccinated with doses of improperly stored VAQTA (lot # was reported as M006708 (invalid) with expiration date 02-JUN-2018, dose and route were not reported). The vaccine was improperly stored at 34.7 Fahrenheit for 2 hours 30 minutes. It was reported that there was previous temperature excursion. Data logger was involved. No adverse effect was reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-AUG-2016, the patient was vaccinated with improperly stored ZOSTAVAX (lot# L031721 and expiry date: 19-NOV-2016), subcutaneously. No adverse effects were reported. The temperature and time frame of ZOSTAVAX exposure was 7 Fahrenheit (F) for 15 minutes, 6F for 1 hour and 7F for 2 hours. There was no previous temperature excursion and data logger was reported as yes. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown ages and genders. On unknown dates, the patients received improperly stored dose of (Oka/Merck) VARIVAX (Lot # L035128, Expiry date: 14-SEP-2017 (Lot# L043619, Expiry date: 02-NOV-2017) (route of administration: subcutaneous) (incorrect product storage). No adverse effect reported. The outcome of the events was unknown. Additional information has been received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L042266 with expiration date 27-OCT-2017 or lot # L048462 with expiration date 02-DEC-2017 or lot #L048465 with expiration date 02-DEC-2017 or lot # M009765 with expiration date 23-FEB-2018 or lot # reported as M010485 with expiration date 01-MAR-2018 or lot # reported as M019643 with expiration date 20-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 11.5 degrees Fahrenheit for 3 hours and 54 minutes. Data logger was involved. The temperature was back in range. The previous excursions were the following:  15 degrees Fahrenheit during one hour and 20 minutes, 7 degrees Fahrenheit during two hours and 24.1 unspecified degrees during five hours and 41 minutes. 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 as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients received doses of improperly stored VARIVAX lot# M000756 with expiration date: 06-JAN-2018 (dose, route of administration and injection site were not reported). Administered doses of VARIVAX underwent temperature excursions at 12 Fahrenheit degrees, for 720 minutes. Previous temperature excursion was at 32 Fahrenheit degrees, for 750 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L036823 with expiration date 24-DEC-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 11.5 degrees Fahrenheit for 3 hours and 54 minutes. Data logger was involved. The temperature was back in range. The previous excursions were the following: 15 degrees Fahrenheit during one hour and 20 minutes, 7 degrees Fahrenheit during two hours and 24.1 unspecified degrees during five hours and 41 minutes. 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: Information was received from a medical assistant referring to multiple unknown patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered doses of improperly stored (Oka/Merck) VARIVAX (lot# M002061, expired date 12-JAN-2018; lot# M004330, expired date 26-JAN-2018; lot# M006724, expired date 28-FEB-2018; lot# reported as M009764, expired date 23-FEB-2018) (dose and route unknown). The vaccines were exposed under 8.8 Fahrenheit degree (F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect 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 as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were subcutaneously vaccinated with improperly stored doses of VARIVAX (dose was not reported, lot # L011085 with expiry date of 01-APR-2017, lot# L012036 with expiry date of 07-APR-2017 and lot # reported as M012990 with expiry date of 14-MAR-2018). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 73 year old female patient. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 21-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU) vial (lot # M015925, expiration date, exact dose and route of administration were not reported) in the pharmacy. On an unspecified date in July 2016, the patient developed a shingles rash on the back of the arm and chest and she returned back to the reporter's pharmacy on 29-JUL-2016 due to the event. The patient was seen at urgent care clinic for the rash and she was prescribed an unspecified antiviral medication. The patient's rash recovered after completion of the antiviral treatment on an unspecified date in 2016. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram thorax, Decreased appetite, Dyspnoea, Exposure during pregnancy, Fatigue
Clinical narrative: In the early morning I had fatigue and achiness. Late morning body soreness, sore throat, no appetite, headache, blurry vision, extreme fatigue. By the afternoon fell asleep and awoke gasping for air/difficulty breathing and fast heart rate. All these symptoms persisted until the next day.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Heart rate increased, Oropharyngeal pain, Pain, Vision blurred
Clinical narrative: In the early morning I had fatigue and achiness. Late morning body soreness, sore throat, no appetite, headache, blurry vision, extreme fatigue. By the afternoon fell asleep and awoke gasping for air/difficulty breathing and fast heart rate. All these symptoms persisted until the next day.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. The pharmacist reported that multiple unknown patients were vaccinated on multiple unknown dates with improperly stored VARIVAX lot number M006157, expiration date 05-FEB-2018, lot number M003439, expiration date 19-JAN-2018 and lot number M010483, expiration date 01-FEB-2018, (dose, route and frequency not reported). No adverse effects were reported. The pharmacist reported that the temperature of the excursion was -14.4 C, and that the time frame was 12 hours and 15 minutes. There were no previous temperature excursions and the report was because of a data logger. No product quality complaint was reported. Lot numbers M006157, M003439 and M010483 have been verified to be valid lot numbers for VARIVAX. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 22-AUG-2016, the patient received and expired dose of (Oka/Merck) VARIVAX lot # K011082, expiration date 16-AUG-2016,  0.5 ml, subcutaneous. No adverse event was reported. No product quality complaint was involved. Additional information is not expected as the reporter did not authorize to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions, concomitant therapies or allergies were not provided. On an unknown date, the patient were vaccinated with an improperly stored dose of VARIVAX, (route of administration, dose, and anatomical location were not provided) lot # L011082, expiration date 01-APR-2017. No adverse event was reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant referring to multiple unknown patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered doses of improperly stored ZOSTAVAX (lot# reported as M003488, expired date 27-MAR-2017) (dose and route unknown). The vaccines were exposed under 8.8 Fahrenheit degree (F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect 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 physician refers to multiple unspecified patients of unknown ages and gender. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored ROTATEQ (lot# L027070, expiry date: 30-APR-2017; lot # L033694, expiry date: 16-JUN-2017) (route: oral) (incorrect product storage). The vaccine was stored at a temperature of 53.3 F for a time frame of 3 hours and 23 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to two unspecified siblings. On 30-NOV-2015, both the patients were vaccinated with first dose of GARDASIL 9 (lot # L016429 and expiry date: 09-AUG-2016). Both the patients received second dose of GARDASIL 9 (lot# L026602 and expiry date: 19-OCT-2017) on 04-APR-2016 and third dose (lot# M003659 and expiry date: 20-SEP-2017) on 14-JUN-2016. No adverse effects were reported. Both the siblings received doses of GARDASIL 9 outside the recommended dosing schedule. No product quality complaint (PQC) was reported for GARDASIL 9. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In August 2016, reported as dates starting on or after 04-AUG-2016, the patients were vaccinated with improperly stored dose of ROTATEQ, orally, lot # L028645, expiry date 25-MAY-2017 (strength and dose were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours and 25 minutes and 47 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of several cases 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 as received from a physician refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (lot #L044694, expiry date: 04-FEB-2018, lot #L044707, expiry date: 06-OCT-2018) (route: intramuscular) (incorrect product storage). The vaccine was stored at a temperature of 53.3 F for a time frame of 3 hours and 23 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 5-year-old male patient who received KINRIX (batch number GM7X3, expiry date 13th November 2017). Concomitant products included MMRV. On 9th August 2016, the patient received KINRIX .5 ml. On 10th August 2016, 1 days after receiving KINRIX, the patient experienced fever (serious criteria other: serious as per reporter), injection site redness, injection site swelling and injection site warmth. On an unknown date, the outcome of the fever, injection site redness, injection site swelling and injection site warmth were unknown. The reporter considered the fever, injection site redness, injection site swelling and injection site warmth to be almost certainly related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by an administrator. The patient received KINRIX vaccine in his right thigh. On the same day, the patient received MMRV vaccine concomitantly. The patient experienced fever (101.4 degrees F) as well as injection site redness, swelling and warmth after receiving KINRIX vaccination. The patient had visited the emergency room. This case has been linked to case US2016117316, reported by the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL which had lot # K016966, expiry date: 10-MAY-2017 (route, dose not reported). The vaccine was exposed to temperature of 53 degree Fahrenheit for 50 minutes. No previous temperature excursion and no adverse effects were reported. The vaccine was brought back in range. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medications, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #, expiration date, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4, MMR
Symptoms: No adverse event, Product name confusion, Product preparation error
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. It was reported that a medication error occurred on an unspecified date due to product confusion described as "GARDASIL (lot # L035105, expiration date 14-MAY-2017) was used to reconstitute an M-M-R II (lot # L039551, expiration date 07-OCT-2017), 1 vial each and 0.5 ml was intramuscularly administered to the patient once". No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 13-AUG-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K012424, expiration date 05-JUN-2016, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates between 06-AUG-2016 and 09-AUG-2106, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L048854, expiration date: 31-AUG-2017, (exact dose was not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 48 degrees Fahrenheit for 1 hour 6 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effect were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same 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 medical assistant refers to multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot# M019708, 25-OCT-2017, lot # L033549, 05-JUN-2017. No adverse effects were reported. Data logger was yes, Vaccines went to 35F for 30 hours. Vaccines were back in range. This is one of the 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 as received from a Registered Nurse (R.N.) refers to a patient of unknown age and unknown gender. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L048854, Expiration Date: 31-AUG-2017), oral. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection, once, lot # L030162, expiration date: 11-AUG-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursions of 30 degrees Fahrenheit for 73 hours and 49 degrees Fahrenheit for 25 hours, respectively, that were captured using digital data logger. No adverse effects were reported. No product complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been received.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding 2 patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal
Clinical narrative: This solicited report was received from a patient's family member and refers to a female patient of unknown age, enrolled in a market research. There was no information regarding the patient's medical history, concurrent conditions or concomitant therapies provided. In approximately 2007 (reported as about 9 years ago), the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date, the patient felt lousy from the shot. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as there was no consent to follow-up.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored (1.7 Centigrade for 19 minutes) GARDASIL 9 (lot # L020015 with expiration date: 16-AUG-2017, lot# L026602 with expiration date: 19-OCT-2017 and lot# L043214 with expiration date: 30-AUG-2017, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse via company representative regarding a patient of unknown demographics. There was no information about concurrent condition and  historical medication. On an unknown date the patient was vaccinated with (wistar ra 27-3) M-M-R II. No concomitant medication was reported. On an unknown date the patient's titers were drawn which were negative. No PQC(Product quality complaint) was involved. The outcome of the event was unknown. Causality was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II which had lot # L000458, expiry date: 06-JAN-2017 (route, dose not reported). The vaccine was exposed to temperature of 53 degree Fahrenheit for 50 minutes. No previous temperature excursion and no adverse effects were reported. The vaccine was brought back in range. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product physical consistency issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The pharmacist reported that she has two cartons (x 10 vials) of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) that had "crystals" forming inside the vial (PQC was filed for this defect, onset date unknown). She stated that because of this issue, on an unknown date, she had to "turn a patient down when they wanted to have ZOSTAVAX administered", because she had no more vials in stock. No adverse effects were reported. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of (ROTATEQ), once orally, lot # L033543, expiration date: 30-MAY-2017 (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursions of 30 degrees Fahrenheit for 73 hours and 49 degrees Fahrenheit for 25 hours, respectively, that were captured using digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Swelling to the area (swollen from shoulder down arm), redness, hot to touch, skin tight.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dyskinesia, Hyperhidrosis, Loss of consciousness
Clinical narrative: 30 seconds after administering the shot, patient said i think i am going to pass out and he had few light jerks and he passed out on the chair that he was sitting. RPh called out to call 911..within 30 seconds patient said I am ok. He was dizzy. Tech went to get lemonade for him. Gave him paper towel to wipeout the sweat. After few minutes he felt better.  He walked to the bench in front of the pharmacy and sat their for about 20 minutes then he said he was feeling good and he wanted to walk . After about 10 minutes he came back said he is feeling good and wanted to leave. I talked to him and checked if he was ok  then he left.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Decreased appetite, Diarrhoea, Dyspepsia
Clinical narrative: Patient states she started feeling unwell on Friday, 8/12/16. She noted small, flat red marks on her body - legs, stomach, chest, back. They did not start itching until a few days later. Pt started a fever a few days later as well as diarrhea, indigestion, no appetite, severe headache, cough, and severe pain and swelling in her joints. She kept track of her fevers, which occurred on and off since the vaccination was administered, ranging up to 102'F. She still has fevers up to the current date (8/24/16), last time she checked. The red spots have since grown and developed into welts that itch. She went to the ER as well as her family physician. According to her report, they state she has a UTI and gave her Augmentin, which she started yesterday.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Joint swelling, Malaise, Pruritus
Clinical narrative: Patient states she started feeling unwell on Friday, 8/12/16. She noted small, flat red marks on her body - legs, stomach, chest, back. They did not start itching until a few days later. Pt started a fever a few days later as well as diarrhea, indigestion, no appetite, severe headache, cough, and severe pain and swelling in her joints. She kept track of her fevers, which occurred on and off since the vaccination was administered, ranging up to 102'F. She still has fevers up to the current date (8/24/16), last time she checked. The red spots have since grown and developed into welts that itch. She went to the ER as well as her family physician. According to her report, they state she has a UTI and gave her Augmentin, which she started yesterday.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urinary tract infection, Urticaria
Clinical narrative: Patient states she started feeling unwell on Friday, 8/12/16. She noted small, flat red marks on her body - legs, stomach, chest, back. They did not start itching until a few days later. Pt started a fever a few days later as well as diarrhea, indigestion, no appetite, severe headache, cough, and severe pain and swelling in her joints. She kept track of her fevers, which occurred on and off since the vaccination was administered, ranging up to 102'F. She still has fevers up to the current date (8/24/16), last time she checked. The red spots have since grown and developed into welts that itch. She went to the ER as well as her family physician. According to her report, they state she has a UTI and gave her Augmentin, which she started yesterday.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient noted swelling, pain, and redness near injection site and continuing approx. from her elbow to her shoulder.
Age: 17.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Back pain, Headache, Pain in extremity
Clinical narrative: Soreness of the right arm last night then woke up this morning with headache and back pain followed by pain radiating down the right thigh.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Feeling hot, Heart rate increased, Pallor, Skin abrasion
Clinical narrative: Pt did well with immunizations initially but as he stood with mom at scheduling desk he became light-headed and fainted. He sustained mild abrasion to the chin and both knees but mom was able to partially catch him as he went down. Legs were elevated and he was immediately aware of his surroundings. Felt faint and hot but resolved quickly. Looked pale, HR up to 100s but slowed to 80s within a couple of minutes as color also returned. He sat up on floor and had no pain to head, neck or elsewhere. He was able to get up into chair and sat for 5 minutes and drank some water. Denied any further dizziness.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt did well with immunizations initially but as he stood with mom at scheduling desk he became light-headed and fainted. He sustained mild abrasion to the chin and both knees but mom was able to partially catch him as he went down. Legs were elevated and he was immediately aware of his surroundings. Felt faint and hot but resolved quickly. Looked pale, HR up to 100s but slowed to 80s within a couple of minutes as color also returned. He sat up on floor and had no pain to head, neck or elsewhere. He was able to get up into chair and sat for 5 minutes and drank some water. Denied any further dizziness.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient given DTaP and IPV combination (Kinrix) at just shy of 4 years of age.  Vaccine not approved for under 4 years of age.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Erythematous pruritic papular rash x 1 week.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Accidentally gave pt 3 pneumovax injections over the course of 3 years. Pt was supposed to receive Prevnar 13.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: Immediately after injection patient started seizing. I sat with patient until it passed as he advised it had happened previously and just had to "get through it".
Age: 69.0
Sex: M
Vaccine: YF
Symptoms: Malaise, Rash generalised
Clinical narrative: Rash covering entire body, general feeling of malaise.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient stated he had a mild fever the same night for about 3-4 hours, but it resolved after he took some tylenol.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling
Clinical narrative: Patient stated she developed extremely swelling in the arm that she received the flu shot. Upon inspection, the arm looked completely normal, no swelling after 1 week.  We recorded the flu administered on the Right arm and pneumo on the Left, but patient insisted that we got it wrong. She said she remembered flu was administered on the right, and pneumo on the left.
Age: 9.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Abdominal discomfort, Dizziness, Vomiting
Clinical narrative: Child was given 1st dose of Hepatitis A and HPV with dad present.  Dad and child remained in waiting area for 15 mins prior to leaving.  Child was eating ice cream and vomited one time and had lightheaded and dizziness.  Dad brought child back to LHD.  After lying down child felt that his stomach felt "a little better" and less lightheaded/dizziness.  BP 128/79 and then 118/68.  Dad declined to stay any longer at the LHD.  Child was assisted into the sitting position and then into the standing position.  Child felt that his stomach was feeling a little better and again less lightheadedness/dizziness.  Dad felt that his child would feel better if he ate something and took child home.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, once, lot # M004116, expiration date: 12-OCT-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursions of 30 degrees Fahrenheit for 73 hours and 49 degrees Fahrenheit for 25 hours, respectively, that were captured using digital data logger. 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.