chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal, Hyperhidrosis, Loss of consciousness, Nausea, Tearfulness
Clinical narrative: Approximately 9:45 am employer of patient came to our medical window reporting patient had returned back to work after immunization and reported he had blacked out and woke up in the field across the street from here. Employer bought patient back here and this nurse along with another RN went to parking lot to assess patient. Patient noted to be in passenger seat of truck with head reclined. Patient alert and oriented. Color good. Skin/lips pink. C/O nausea. Patient tearful. Patient states he felt fine after immunization was given. Had reported that he has history of passing out when giving blood with last episode 2-3 years ago. Patient reports he never had any episodes with immunizations. Patient declined going to private room with a bed for immi. Patient given Tdap in left deltoid with no issues noted/reported. Patient stayed in facility after immunization approx. 5-6 minutes with no complaints. Stated that that "was the easiest shot I have had." Patient left denying issues/complaints. Patient reported to this RN that after he walked out of here, he jogged to his truck, got inside and became nauseated and sweaty. He said he sat in truck and drank a pop. Patient states he thought he was in park, but the next thing he remembers is "coming to with his head bumping left drivers window and he was in field across the street from us, behind the radio station. Patient states, "I should have come back into the office when I started feeling bad." Patient states he drove back to work (close to here), but doesn't remember doing so. Employer states he saw patient lying back in truck and patient told him what happened. No injuries noted or reported by patient. No injury to head noted/reported. Patient states he ate prior to immunization. Patient instructed to go to ER/Urgent Care for evaluation. Patient states he wasn't going to go. Told patient this RN would call tomorrow for follow up. Patient verbalized understanding. No damage to vehicle noted/reported. Employer to drive patient back to work site and wife meeting patient there.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Culture stool, Full blood count, Haematochezia, Occult blood, Stool analysis
Clinical narrative: Hematochezia after 2 mo ROTA multiple formula changes to formula until resolution of heme (+) stools hematochezia 9d. after 2nd dose admin at 7mo.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Full blood count, Heart rate increased, Hyperhidrosis, Paraesthesia
Clinical narrative: 11/02/2015 rapid heart beating, sweating called advice nurse. 11/03/2015 Red itchy rash all over body. Notice rash burning, whelps under skin little red itchy bumps that still exist now today. Skin feel like it burning and something biting me.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Skin burning sensation, Skin test negative
Clinical narrative: 11/02/2015 rapid heart beating, sweating called advice nurse. 11/03/2015 Red itchy rash all over body. Notice rash burning, whelps under skin little red itchy bumps that still exist now today. Skin feel like it burning and something biting me.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 11/02/2015 rapid heart beating, sweating called advice nurse. 11/03/2015 Red itchy rash all over body. Notice rash burning, whelps under skin little red itchy bumps that still exist now today. Skin feel like it burning and something biting me.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm extremely red, swollen, and warm to touch.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 2 patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose VARIVAX 0,5 ml, subcutaneously, lot # M023379 with an expiration date: 11-MAY-2018. Administered dose of VARIVAX experienced temperature excursion of 11.1 Celsius degree for 1 hour 40 minutes, on an unknown date. No adverse effects were reported. This is one of two 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 pharmacist refers to an unspecified patient of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On an unspecified date the patient was vaccinated with improperly stored vaccine of ZOSTAVAX (lot # M018593 and expiry date 28-JUN-2017) (dosing regimen and frequency were not reported). No concomitant medications were reported. On 28-JUN-2016, the vaccine was exposed to temperature excursion of 24.5 Fahrenheit for 7 hours. No adverse effects were reported. No product quality complain (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L035511, expiration date 21-MAY-2017; dose and route were unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. 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 nurse, refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. In 2015 (about a year ago), the patient was vaccinated with first dose of GARDASIL 9, (lot/expiry date, dose, frequency and route of administration were unspecified). Patient was in the office to receive a second dose of GARDASIL 9 (unspecified lot/unspecified expiration). No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information available. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II lot # L020189, expiration date 03-JUN-2017; lot # L026551, expiration date 16-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Follow up has been received on 14-SEP-2016, reporting the administered vaccine doses that have experienced multiple temperature excursions. It was reported that the patients were vaccinated with M-M-R II (lot # L027591, expiration date: 23-JUL-2017) on 12-APR-2016, 18-APR-2016, 19-APR-2016, 22-APR-2016, 26-APR-2016 and 27-APR-2016. The longest duration of temperature excursion with M-M-R II was 18 hours at 33.2 Fahrenheit degrees. The temperature excursions were detected by a data logger. Additional information has been requested. General, product, event information and narrative were updated.
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. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot # M009766, expiration date: 23-FEB-2018 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 19.6 degrees Fahrenheit for 5 hours and 15 minutes. The temperature excursion was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen, red, warm to touch.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left upper arm extremely red, swollen, and warm to touch.
Sex: U
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Feeling cold
Clinical narrative: Felt faint and had chills. No unconsciousness. Given water, BENADRYL syrup 2 tsp PO once, nasal O2. O2 sat and BP normal.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain, swelling, redness at site of injection. Fever, flu like symptoms.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: Numbness and tingling at bottom of toes starting 12/30/13 and continuing. Neurologist diagnosis "Symmetric (small and large fibre; length-dependent, sensory axonal) polyneuropathy".
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Peripheral sensory neuropathy
Clinical narrative: Numbness and tingling at bottom of toes starting 12/30/13 and continuing. Neurologist diagnosis "Symmetric (small and large fibre; length-dependent, sensory axonal) polyneuropathy".
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored doses of GARDASIL 9 lot # L037554 with expiration date 25-DEC-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of 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 registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017; dose and route were not provided). No adverse symptoms were reported. 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: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route unknown, lot # L035686, expiration date: 16-FEB-2017; lot # M020521, expiration date: 17-NOV-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 63 years old female patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 13-SEP-2016, the patient was vaccinated with ZOSTAVAX injection, 1 DF, subcutaneously (dose, lot number and expiration date were not provided). There were no concomitant medications provided. On 13-SEP-2016, reported as immediately after vaccination with ZOSTAVAX the patient developed 1  hive. The patient sought medical attention for evaluation of the hive and no product quality complain was involved. The outcome of urticaria was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patients were vaccinated with improperly stored GARDASIL (dose and route unknown, lot # K011325, expiration date: 08-APR-2017). No adverse effects were 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: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L015460 with expiration date 20-JUL-2017, lot # M002268 with expiration date 20-SEP-2017 and lot # reported as M022924 with expiration date 24-JAN-2018; dose and route were not reported). The vaccines were stored in 50.3F for 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a 13 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unknown. Approximately in 2006 (reported as 10 years ago), the patient was vaccinated with all the three doses of GARDASIL via intramuscular route. Nurse reported that after receiving the third dose, patient began having plantar warts on her feet; 9 on 1 foot, 13 on the other. The patient required medical attention. Nurse reported that they burned off the plantar warts. Outcome of the event was unknown. Reporting nurse had not assessed the causality of the event with respect to therapy with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were unknown. On unspecified dates, the patients were vaccinated several doses of improperly stored PROQUAD (dose and frequency unknown, lot # L041627, expiration date: 20-APR-2017). The vaccines were stored at 8.1 Fahrenheit degree for 17 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as the physician would not be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (dose and route unknown, lot # L013824, expiration date: 21-APR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II lot # L020189, expiration date 03-JUN-2016; lot # L026551, expiration date 16-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Follow up has been received on 14-SEP-2016, reporting the administered vaccine doses that have experienced multiple temperature excursions. It was reported that the patients were vaccinated with M-M-R II (lot # L030162, expiration date: 11-AUG-2016) on 27-MAY-2016, 28-MAY-2016, 06-JUN-2016, 08-JUN-2016, 09-JUN-2016, 14-JUN-2016, 16-JUN-2016, 20-JUN-2016, 22-JUN-2016, 30-JUN-2016, 07-JUL-2016, 09-JUL-2016, 13-JUL-2016 and 14-JUL-2016. The longest duration of temperature excursion with M-M-R II was 18 hours and the range of the temperature excursion was between 30 and 34.5 Fahrenheit degrees. The temperature excursions were detected by a data logger. Additional information has been requested. General, product, event information and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II lot # L020189, expiration date 03-JUN-2017; lot # L026551, expiration date 16-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Follow up has been received on 14-SEP-2016, reporting the administered vaccine doses that have experienced multiple temperature excursions. It was reported that the patients were vaccinated with M-M-R II (lot # L020189, expiration date:03-JUN-2017) on 23-FEB-2016, 25-FEB-2016, 08-MAR-2016, 17-MAR-2016 and 18-MAR-2016. The longest duration of temperature excursion with M-M-R II was 18 hours at the range of temperature excursion was between 0.4  to 1. 8 Celsius degrees. The temperature excursions were detected by a data logger. Additional information has been requested. General, product, event information and narrative were updated.
Sex: M
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a 13 year old male patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unknown. Approximately in 2008 (reported as about 8 years ago), the patient was vaccinated with the second dose of GARDASIL via intramuscular route. Nurse reported that following the second dose and before the third dose of vaccine, the patient developed planter warts around every finger and on his right elbow. The patient required medical attention. Nurse stated that they burned off the warts and the patient did not received third vaccine dose. Outcome of the event was unknown. Reporting nurse had not assessed the causality of the event with respect to therapy with GARDASIL. 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 healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored doses of RECOMBIVAX HB lot # M001578 with expiration date 21-NOV-2018 (dose and route of administration were not reported). No adverse effects reported. This is one several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a physician and refers to 2 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with first dose of GARDASIL 9 (lot #, expiry date, dose, strength, vaccination site, route unspecified). On an unknown date, the patients experienced intractable seizure disorder after vaccination. The reporter stated that, the patients never had seizures until they received GARDASIL 9. The outcome of the event was unknown. Causality assessment was not provided. No further information was provided. Upon internal review, the event seizure was considered to be medically significant. 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 registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ orally (lot # M014318, expiration date: 30-SEP-2017; dose was not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a female consumer referring to herself. There were no concomitant medication, pertinent medical history and drug reactions/allergies. At unspecified times, the patient was vaccinated with doses one and two of GARDASIL 9 injection (dosage, route, lot# and expire date unknown). The patient had a blood test to determine pregnancy at an unspecified healthcare provider's office on 22-AUG-2016 because she was due for her third dose in GARDASIL 9 series. The blood test came back negative for pregnancy. The patient received her third dose in the GARDASIL 9 series on 23-AUG-2016. On 24-AUG-2016, she administered an unspecified home pregnancy test to herself. This home pregnancy test came back positive for pregnancy. The patient had a second blood test to determine pregnancy at her unspecified healthcare provider's office on 25-AUG-2016. This test confirmed her pregnancy. The last menstrual period and estimated date of delivery were unknown. No adverse events reported. The patient did not see medical attention and no treatment was given for the event. There was no lab diagnostics studies performed. 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 medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # M006708 with expiration date 02-JUN-2018, lot # L048848 with expiration date 09-AUG-2018 and lot # reported as M020926 with expiration date 11-AUG-2018; dose and route were not reported). The vaccines were stored in 50.3F for 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patients were vaccinated with improperly stored PEDVAXHIB (dose and route unknown, lot # K011078, expiration date: 31-MAR-2017). No adverse effects were 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: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patients were vaccinated with improperly stored ROTATEQ (dose and route unknown, lot # L039141, expiration date: 16-AUG-2017). No adverse effects were reported. This is one of several reports received from the same reporter. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II lot # L020189, expiration date 03-JUN-2017; lot # L026551, expiration date 16-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours. Data logger was involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Follow up has been received on 14-SEP-2016, reporting the administered vaccine doses that have experienced temperature excursions. It was reported that the patients were vaccinated with M-M-R II (lot # L026551, expiration date: 16-JUL-2017) on 22-MAR-2016, 25-MAR-2016, 04-APR-2016, 10-APR-2016, 11-APR-2016, 28-APR-2016, 29-APR-2016, 03-MAY-2016, 05-MAY-2016, 18-MAY-2016, 23-MAY-2016, 02-JUN-2016, 08-JUN-2016. The longest duration of temperature excursion with M-M-R II was 18 hours and the range of temperature excursion was between 0.5 and 1.7 Celsius degrees. The temperature excursions were detected by a data logger. Additional information has been requested. General, product, event information and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX 0.5 ml, subcutaneously, lot # M023379 with an expiration date: 11-MAY-2018. Administered dose of VARIVAX experienced temperature excursion of 11.1 Celsius degree for 1 hour 40 minutes, on an unknown date. 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 as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016, (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of ROTATEQ lot # L026067, expiration date 06-APR-2017; lot # L029617, expiration date 19-MAY-2017; lot # L027076, expiration date 25-MAY-2017; lot # L033545, expiration date 30-MAY-2017; lot # M004508, expiration date 29-JUN-2017; lot # M014318, expiration date 30-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours, 0.3 degrees Celsius for 837 hours and 30 degrees Fahrenheit for 542 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Follow up has been received on 14-SEP-2016, reporting the administered vaccine doses that have experienced multiple temperature excursions. It was reported that the patients were vaccinated with ROTATEQ (lot# L029617, expiration date: 19-MAY-2017) on 02-MAR-2016, 04-MAR-2016, 07-MAR-2016, 09-MAR-2016, 14-MAR-2016, 15-MAR-2016, 16-MAR-2016, 18-MAR-2016, 21-MAR-2016, 22-MAR-2016, 23-MAR-2016, 26-MAR-2016, 29-MAR-2016 and 05-APR-2016. The longest duration of temperature excursion with ROTATEQ was 18 hours and the inappropriate temperature range was between 0.3 and 1.7 Celsius degrees. The temperature excursions were detected by a data logger. Additional information has been requested. General, product information and narrative were updated.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Information was received from a nurse practitioner via company representative concerning a female patient of unknown age. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, in approximately September 2014, reported as one or two years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, anatomical location, lot number, expiration date were not reported). Concomitant therapy was not reported. On an unspecified date after receiving the vaccination, the patient experienced swelling from the elbow to the shoulder. The outcome of the event was not reported. The causality between the event and ZOSTAVAX was not reported. 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 healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored doses of VAQTA lot # M003011 with expiration date 15-NOV-2017 and lot # L015460 with expiration date 20-JUL-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of 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 an unspecified number of patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017, lot # L026602, expiration date: 19-OCT-2017 and lot # L043214, expiration date: 30-AUG-2017; dose and route were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Pruritus
Clinical narrative: Pt developed large area of swelling and redness on back/side of (R) arm that was very itchy and minimally uncomfortable. No fever. No respiratory sxs. Given BENADRYL at time of report.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Left arm pain persistent for greater than 7 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site pruritus, Pain in extremity, Peripheral swelling
Clinical narrative: ZOSTAVAX shot was administered Friday (9/23/16) after 5 pm. Patient complained of injection site redness, tingling and itching. Area is very warm, swollen and sore to the touch. Recommended cold compress with ice and Hydrocortisone cream for itch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: ZOSTAVAX shot was administered Friday (9/23/16) after 5 pm. Patient complained of injection site redness, tingling and itching. Area is very warm, swollen and sore to the touch. Recommended cold compress with ice and Hydrocortisone cream for itch.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: 3 x 4 cm area of erythema and induration about 1 cm below injection site in left arm.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Hives. Within 20 minutes of receiving vaccines at 4 month well child visit developed hives.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Chest X-ray, Hand-foot-and-mouth disease, Measles antibody, Rash
Clinical narrative: Child was seen in ER on 9-2-16. Diagnosed with hand, foot and mouth. Child was taken by mom to ER on 9-4-16 because no better. Temp 102.4 and rash that started on abdomen and back. CXR showed possible right lower lobe infiltrate suggestive of Pneumonia. Given Prednisolone and Augmentin by ER.
Age: 1.33
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Differential white blood cell count, Full blood count, Petechiae
Clinical narrative: Petechiae on face after vaccines.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Measles
Clinical narrative: Post MMR rash.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Deltoid swelling and erythema 14.5 cm x 15.5 cm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: 9-13-16. Noted to have pink vesicular rash on erythematous base (approximately 30 lesions). Believed to be mild case of varicella in vaccinated 6 year old.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reddened, slightly raised, area baseball size, warm to touch, caused itching to area. Injection site back to normal w/in 24-48 hrs.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Abnormal behaviour, Decreased eye contact, Musculoskeletal stiffness
Clinical narrative: Few hours after HIB/PVC #1 Baby had 10 sec episode of stiffening and 2 weeks "out of it" - poor eye contact, not happy.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme starting 1 wk post vaccine and persisting over 4 weeks.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Approximately 24 hrs after receiving a shingles shot pt. called us complaining of rash/swelling at injection site. When rash had not improved by the second day the pt. saw her physician and was given several prescription to treat the rash (topical/oral steroids and antibiotic cream).
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Gait disturbance, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Thurs 09/15/16: Pain at injection site; (left thigh) and would not move left LE at night. Fri 09/16/16: Fever to 102: reluctant to walk. Sat 09/17/2016: Exam by MD; back to normal; mom agreed.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse symptoms reported. Patient was given an additional dose of Ped. Hep B, instead of HIB.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MENB, MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received Tdap 8/25/2010 (historical in MCIR). Patient inadvertently received another dose 8/24/2016 6 yrs after 1st dose. Td/Tdap not needed at this time.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Was given shots when not required and up to date. Received extra dose of MMR-V, Dtap, HIB, PCV. No illness event post immunizations.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
Clinical narrative: Numbing of jaw and arm along the vaccinated arm w/aggravated pain (joint). Elevated w/BENADRYL and ALEVE after 24 hours. Pain has decreased and almost gone; however, the arm still does not feel normal.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Foreign record. Missed #4 dose of IPV 7/6/09 which was admin age 9. IPV given 8/31/16 dose not needed. No adverse symptoms.
Age: 41.0
Sex: F
Vaccine: FLUN4, TTOX, FLUN4, TTOX
Symptoms: Abasia, Condition aggravated, Dysstasia, Mobility decreased, Multiple sclerosis
Clinical narrative: Initial unsolicited report received from a consumer via other company (Teva pharmaceuticals) on 19 Sep 2016. (Manufacturer report number: 616596USA). This case involves a 41-year-old (reported as 42 years) female patient who was vaccinated with a dose of TETANUS VACCINE (route and site of administration: not reported) and a dose of FLU-NASAL MIST VACCINE by nasal route (manufacturer: unknown, batch number, expiry date: not reported for both vaccine) on 24-Dec-2014. Patient was also given 40 mg COPAXONE subcutaneously on an unspecified date (reported as same day of the event). Patient had medical history of Multiple Sclerosis (still continuing) and concomitant medication was not reported. On an unspecified date, in the middle of the night, post vaccination, the patient "couldn't get up, couldn't walk, couldn't hardly move", patient had to use the bathroom but couldn't get up on her own. Patient was taken to hospital in ambulance. The emergency room doctor told that patient had MS attack and wanted to admit her but the patient did not want to be admitted. It was reported that patient was on shared solution at the time of event. The patient's laboratory data was not reported. Patient was treated with oral steroids. The patient was released once her daughter was able to help her get out of the bed in hospital. The patient went home and on an unspecified date recovered well from the event. Upon internal review, the company decided to consider the event serious due to important medical event: MS attack, couldn't walk, couldn't hardly move and couldn't get up. List of documents held by sender: none. Sender's Comments: The patient was diagnosed case of Multiple sclerosis was on treatment with COPAXONE currently with no symptoms. Patient had attack of Multiple sclerosis following TETANUS VACCINE and FLU-NASAL MIST VACCINE. Time to onset is compatible, addition information regarding the type of multiple sclerosis and the drug compliance by the patient, past vaccination history which trigger similar event are needed to further assess the case. Based on available information and considering the temporal relationship the role of vaccine cannot be rule out.
Age: 41.0
Sex: F
Vaccine: FLUN4, TTOX, FLUN4, TTOX
Symptoms: Abasia, Condition aggravated, Mobility decreased, Multiple sclerosis
Clinical narrative: Initial unsolicited report received from a consumer via other company (Teva pharmaceuticals) on 19 Sep 2016. (Manufacturer report number: 616596USA). This case involves a 41-year-old (reported as 42 years) female patient who was vaccinated with a dose of TETANUS VACCINE (route and site of administration: not reported) and a dose of FLU-NASAL MIST VACCINE by nasal route (manufacturer: unknown, batch number, expiry date: not reported for both vaccine) on 24-Dec-2014. Patient was also given 40 mg COPAXONE subcutaneously on an unspecified date (reported as same day of the event). Patient had medical history of Multiple Sclerosis (still continuing) and concomitant medication was not reported. On an unspecified date, in the middle of the night, post vaccination, the patient "couldn't get up, couldn't walk, couldn't hardly move", patient had to use the bathroom but couldn't get up on her own. Patient was taken to hospital in ambulance. The emergency room doctor told that patient had MS attack and wanted to admit her but the patient did not want to be admitted. It was reported that patient was on shared solution at the time of event. The patient's laboratory data was not reported. Patient was treated with oral steroids. The patient was released once her daughter was able to help her get out of the bed in hospital. The patient went home and on an unspecified date recovered well from the event. Upon internal review, the company decided to consider the event serious due to important medical event: MS attack, couldn't walk, couldn't hardly move and couldn't get up. List of documents held by sender: none. Sender's Comments: The patient was diagnosed case of Multiple sclerosis was on treatment with COPAXONE currently with no symptoms. Patient had attack of Multiple sclerosis following TETANUS VACCINE and FLU-NASAL MIST VACCINE. Time to onset is compatible, addition information regarding the type of multiple sclerosis and the drug compliance by the patient, past vaccination history which trigger similar event are needed to further assess the case. Based on available information and considering the temporal relationship the role of vaccine cannot be rule out.
Age: 75.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Cough, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself.  This 75-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single in the left arm on 24Jun2016 for immunisation. Medical history included ongoing diabetes (diagnosed in the late 1980's to early 1990's), blood potassium abnormal, pancreatitis in Mar2015 (hospitalized). Concomitant medication included insulin human, insulin human injection, isophane (NOVOLIN) subcutaneous 15 units injection twice daily for diabetes, losartan oral 1 DF daily for potassium, metformin oral 1000 mg, 2x/day for diabetes, atorvastatin oral 10 mg, 1x/day, all since 2015 and ongoing. The patient previously took influenza vaccine in 1966 and as a result had the worst case of the flu, pneumococcal vaccine for immunisation. The patient experienced vomiting on Jun2016 with outcome of recovered, coughing on 26Jun2016 with outcome of recovered. The patient reported that PREVNAR 13 had a strange looking syringe. She went back to the pharmacy because of the bad reaction to find out what it was they gave her. They said they sent the pharmacist to another store. It was a short syringe and it looked like a horses saddle.  It was covered and brown in color. She had never seen a syringe like it before, like it had a saddle over it. She thinks she may have been given a Flu Vaccine. The patient underwent lab tests and procedures which included blood glucose: 445 on an unspecified date, blood glucose: 175 on 24Jun2016, chest x-ray: negative on 17Aug2016, influenza virus test: negative on Jun2016.  Therapeutic measures were taken as a result of coughing included Amoxicillin and Benzonatate but they did not work for her cough. She was given an inhaler, Asmanex, one puff as needed on 17Aug2016 for coughing and she started feeling funny. The Asmanex inhaler sent her blood sugar crazy. Then her blood sugar went up to 445. She does not remember having a blood sugar like that.  She was told that it has a steroid in it that was causing her blood sugar to go up, so she stopped using the product on 19Aug2016. The consumer subsequently confirmed that no new events occurred and stated a product complaint was filed. She received a prepaid package with a jar to send product back. Consumer stated she does not have the product to send back.  Follow-up (08Sep2016): New information reported form a contactable Consumer includes: no new event confirmed; product complaint filed.
Age: 75.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Blood glucose increased, Chest X-ray normal, Cough, Influenza virus test negative, Product quality issue
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself.  This 75-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single in the left arm on 24Jun2016 for immunisation. Medical history included ongoing diabetes (diagnosed in the late 1980's to early 1990's), blood potassium abnormal, pancreatitis in Mar2015 (hospitalized). Concomitant medication included insulin human, insulin human injection, isophane (NOVOLIN) subcutaneous 15 units injection twice daily for diabetes, losartan oral 1 DF daily for potassium, metformin oral 1000 mg, 2x/day for diabetes, atorvastatin oral 10 mg, 1x/day, all since 2015 and ongoing. The patient previously took influenza vaccine in 1966 and as a result had the worst case of the flu, pneumococcal vaccine for immunisation. The patient experienced vomiting on Jun2016 with outcome of recovered, coughing on 26Jun2016 with outcome of recovered. The patient reported that PREVNAR 13 had a strange looking syringe. She went back to the pharmacy because of the bad reaction to find out what it was they gave her. They said they sent the pharmacist to another store. It was a short syringe and it looked like a horses saddle.  It was covered and brown in color. She had never seen a syringe like it before, like it had a saddle over it. She thinks she may have been given a Flu Vaccine. The patient underwent lab tests and procedures which included blood glucose: 445 on an unspecified date, blood glucose: 175 on 24Jun2016, chest x-ray: negative on 17Aug2016, influenza virus test: negative on Jun2016.  Therapeutic measures were taken as a result of coughing included Amoxicillin and Benzonatate but they did not work for her cough. She was given an inhaler, Asmanex, one puff as needed on 17Aug2016 for coughing and she started feeling funny. The Asmanex inhaler sent her blood sugar crazy. Then her blood sugar went up to 445. She does not remember having a blood sugar like that.  She was told that it has a steroid in it that was causing her blood sugar to go up, so she stopped using the product on 19Aug2016. The consumer subsequently confirmed that no new events occurred and stated a product complaint was filed. She received a prepaid package with a jar to send product back. Consumer stated she does not have the product to send back.  Follow-up (08Sep2016): New information reported form a contactable Consumer includes: no new event confirmed; product complaint filed.