chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated orally with improperly stored doses of ROTATEQ oral liquid (lot# K019371, expiry date 16-JUL-2016 and lot# L004454, expiry date 07-AUG-2016; exact doses were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates staring on or after 22-APR-2016, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L030608, expiration date 15-APR-2017, lot # M003661, expiration date 15-SEP-2017) (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 32 F for 2 hours and 8 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger.  No adverse effect was reported. This is one of several reports received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions and medical history were unspecified by the reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, site of administration and lot# not reported). Concomitant medication was unspecified by reporter. They pharmacist reported that on an unknown date, the very next day of vaccination, the patient went to physician's office and he was diagnosed with shingles on that visit. It was unknown if the patient went to the physician for some type of shingles symptoms or if the visit was for some other reason. Pharmacist reported that this patient was not his regular patient and the patient goes to another pharmacy and therefore, pharmacist did not have more adverse event information. No additional information provided. VZVIP packet faxed. The outcome of herpes zoster was unknown. Causality statement was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: HIBV
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 regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection (lot# K008679, expiry date 05-MAR-2017 and lot# K015464, expiry date 09-JUL-2017; exact dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.12
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reports as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Diarrhoea, Dizziness, Full blood count normal, Hyperhidrosis
Clinical narrative: Sore throat, lightheaded, stuffy headed hours after receiving immunization went to ER, dx with reaction to vaccine. On 5/6/16 reports woke with low grade temp, nausea, diarrhea, generalized weakness, palms and feet sweaty.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Sinus congestion, Vaccination complication
Clinical narrative: Sore throat, lightheaded, stuffy headed hours after receiving immunization went to ER, dx with reaction to vaccine. On 5/6/16 reports woke with low grade temp, nausea, diarrhea, generalized weakness, palms and feet sweaty.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stored doses of ROTATEQ orally (lot # L027076, expiration date 25-MAY-2017; lot # L029934, expiration date 01-MAY-2017; lot # L029617, expiration date 19-MAY-2017; lot # M004890, expiration date 10-NOV-2017) (dose was not reported). The administered doses experienced a temperature excursion of 32 F for 2 hours and 8 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: 10.5 cm x 8 cm rash left arm. Received varicella vaccine on 5/3/16. Rash noted on 5/5/16. Hydrocortisone 1% applied with ice and ace wrap.
Age: 32.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Tenderness
Clinical narrative: Localized erythema and tenderness x's 2 days; cool compress/NSAIDS such as ibuprofen.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 5 patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as after excursion on 24-FEB-2016), the patients were vaccinated with the doses of improperly stored (Oka/Merck) VARIVAX (lot # K002914, expiration date 26-FEB-2016; dose and route were not reported). No adverse effects were reported. The vaccines were stored in cumulative maximum temperature of 14.1F for total of 3 hours and 20 minutes, reported on 24-FEB-2016 with Data Logger. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Lacrimation increased, Skin tightness, Throat irritation
Clinical narrative: After receiving PPSV vaccine client stated that his "cheeks felt tight and his throat felt scratchy". Eyes became watery. Client also had redness on his face, chest, back, and arms. Client was assessed by nursing staff and was seen by our on-site physician. Client was also given generic BENADRYL and was observed for 30 min after vaccination. Client's redness did begin to subside following administration of BENADRYL and client reported that his throat and checks "felt normal" prior to leaving the clinic.
Age: 1.92
Sex: M
Vaccine: FLUX
Symptoms: Decreased appetite, Ear infection, Mental disorder, Oral infection, Pyrexia
Clinical narrative: Mouth, ear, nose infection, loss of appetite. Fever and mental health damage.
Age: 1.92
Sex: M
Vaccine: FLUX
Symptoms: Rhinitis
Clinical narrative: Mouth, ear, nose infection, loss of appetite. Fever and mental health damage.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Poor quality sleep, Pyrexia, Rash
Clinical narrative: Patient developed a rash (possible hives) on her abdomen, legs, and arms. Patient also had a fever of 101.6F and did not sleep well that night.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Arm where shot was received, from shoulder to past elbow, was swollen, red, and hot to the touch.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Skin warm
Clinical narrative: Arm where shot was received, from shoulder to past elbow, was swollen, red, and hot to the touch.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMRV, PER
Symptoms: Dermatitis diaper, Urticaria
Clinical narrative: The child started with what initially appeared to be a diaper rash but quickly turned to welts and moved/spread all over her body and face throughout the day and the next several days. We took her to urgent care. They did not administer any medications or treatment. We gave her children's Benadryl at home, which helped reduce the welts swelling, but did not completely make them go away.
Age: 29.0
Sex: F
Vaccine: MEN
Symptoms: Fatigue, Lymphadenopathy, Muscle swelling, Tenderness
Clinical narrative: Fatigue, left neck muscle swelling, left cervical chain tender lymphadenopathy.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 2 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as after excursion on 24-FEB-2016), the patients were vaccinated with the doses of improperly stored PROQUAD (lot # L005295, expiration date 17-AUG-2016; dose and route were not reported). No adverse effects were reported. The vaccines were stored in cumulative maximum temperature of 14.1F for total of 3 hours and 20 minutes, reported on 24-FEB-2016 with Data Logger. Also PROQUAD with lot L031602 with expiration date 18-FEB-2017, with lot # L034930 with expiration date 03-MAR-2017 and with lot # L005295 with expiration date 17-AUG_2016 were improperly stored, but they were not administered to the patients at the time of this report. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Developed redness of left arm just below the deltoid. Dark red flat oblong non indurated area.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient received a dose of 0.5 FLUZONE vaccine instead of a 0.25 FLUZONE.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lethargy, Vomiting
Clinical narrative: Patient received Rota on 5-03-16 and started vomiting 5-09-16 x6 times, also patient was lethargic.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved.  There were no previous excursions reported. There was no adverse effect report. This is one of several reports received from the same reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified  number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, injection (lot # L017140, expiry date 13-NOV-2016; lot # L027634l, expiry date 21-JAN-2017; lot # L024497, expiry date 01-JAN-2017; exact dose and route of administration were not reported). No adverse effects were reported. There was no product quality complaint involved.  This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect 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: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. no information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (PNEUMOVAX23) injection (lot # K019386, expiry date 09-JUN-2016, lot # L001311, expiry date 06-JUN-2016, and lot # L022262, expiry date 05-NOV-2016; exact dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint 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 registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot # L022259, expiry date 06-APR-2017 and lot # K010579, expiry date 12-FEB-2017; exact dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported.  There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 7 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # L024256, expiration date 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved.  There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL, injection (lot # K016966, expiry date 10-MAY-2017 and lot # reported as L026034, expiry date 23-JUL-2017), exact dose and route of administration were not reported. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hypertension, Neurological examination normal, Pain in extremity, Tremor
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a 11-year old male patient. The patient's medical history included headache and body mass index increased. The patient's concurrent conditions were not provided. On 20-AUG-2015, the patient was vaccinated with the first dosed of GARDASIL 9 (lot # K026246, expiration date 28-JAN-2017), dose 1, intramuscular in the right arm (dose was not provided). Concomitant medications were not reported. On 11-NOV-2015, the patient experienced increased blood pressure and was diagnosed with pediatric hypertension. On 07-APR-2015, the patient was vaccinated with second dose of GARDASIL 9 (lot # L020015, expiration date: 16-AUG-2017), intramuscular in the left arm (dose was not provided). Later that same day, the patient experienced dizziness, tremor and pain in his left index finger (pain in extremity). On 08-APR-2016, the patient returned to the physician (by which time these symptoms had resolved) who performed a neurologic assessment which was normal. NO treatment was given for the adverse events and there was no intervention to prevent serious criteria. No product quality complaint (PQC) was involved. The outcome of hypertension, dizziness, tremor and pain in extremity was reported as resolved. The primary reporter did not provide the casual relationship between GARDASIL 9 and the events. 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. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # K008822, expiry date 19-JUN-2016; lot # L017142, expiry date 13-MAY-2017; lot # L013827, expiry date 21-APR-2017; exact dose and route of administration were not reported). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot# K014697, expiry date 04-FEB-2016, lot# L016417, expiry date 13-APR-2017, lot# L016959, expiry date 12-MAR-2018, and lot# L006231, expiry date 06-OCT-2016; exact dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 7 year old patient of unknown gender. There was no information about the patient's concurrent condition, concomitant therapies or medical history provided. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pt developed rash that was sore and itching at injection site - continued to grow in size to 2 inches x 1 inch. Advised BENADRYL, ice.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Vaccination 4/19/16. On 4/20 c/o pain/swelling rt. shoulder area, no SOB/sx. No numbness, weakness. 4/21 - unscheduled visit to Dr. - Increased rt. shoulder pain, swelling decreased ROM rt. shoulder - MEDROL DOSE PAK given 4/24/16 - Called, arm improved.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Oropharyngeal pain, Sneezing, Throat irritation
Clinical narrative: Reported scratchy sore throat a.m. of 03/22/16. Sneezing morning of 03/24/16. Erythema left upper arm injection site 6.5 cm x 7.5 cm. Follow up with PCP 3/24/16. Typical antihistamine and cold patch ordered.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU4, RV5
Symptoms: Bordetella test positive, Bronchitis, Polymerase chain reaction positive
Clinical narrative: Child with bronchitis. Tested by PCR positive for Bordetella pertussis.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Asthenia, Decreased appetite, Feeling abnormal, Feeling of body temperature change, Headache
Clinical narrative: 3/16/16 Soreness, swollen; 3/17, 3/18, 19, 20, 21, 22, 23, 24, 25, 26, and 27, sick; felt very strange internally; weakness; headache; no appetite; very sleepy; hot and cold internally; felt back to half normal 3/28/16. Will not take another.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Malaise, Pain, Somnolence, Swelling
Clinical narrative: 3/16/16 Soreness, swollen; 3/17, 3/18, 19, 20, 21, 22, 23, 24, 25, 26, and 27, sick; felt very strange internally; weakness; headache; no appetite; very sleepy; hot and cold internally; felt back to half normal 3/28/16. Will not take another.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Myalgia, Pyrexia, Rash
Clinical narrative: Low grade fever, polyarthralgias, polymyalgias, central rash, chest and thorax.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Dyskinesia, Electroencephalogram abnormal, Partial seizures, Unresponsive to stimuli
Clinical narrative: Patient would turn her head sharply to the right and be unresponsive for approximately 20 seconds. She also would turn in a circle to the right. This started the evening of 08/06/2015. She was taken to the Emergency Room and was admitted. After an EEG, she was diagnosed with having focal seizures.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 18 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 03-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # L034727, 09-DEC-2016 inadvertently reconstituted with expired sterile diluent (L005459, 18-FEB-2016). No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Date logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 2 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Fatigue, Flushing, Local swelling, Nasopharyngitis
Clinical narrative: Cold symptoms, swollen face and neck, periorbital edema, flushed skin, rash on chest, fatigue, weakness. Lasted for 2 + weeks. Prescribed BENADRYL. Symptoms started on 4/1/16. Reported to Emp Hlth on 5/4/16, not observed.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Periorbital oedema, Rash, Swelling face
Clinical narrative: Cold symptoms, swollen face and neck, periorbital edema, flushed skin, rash on chest, fatigue, weakness. Lasted for 2 + weeks. Prescribed BENADRYL. Symptoms started on 4/1/16. Reported to Emp Hlth on 5/4/16, not observed.
Sex: U
Vaccine: VARZOS
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-NOV-2015, the patient was vaccinated with first does of ZOSTAVAX (route and site of administration, lot # and expiry date were not reported). On 03-MAY-2016, the patient received second dose of ZOSTAVAX, (route and site of administration, lot # and expiry date were not reported, inadvertently. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9, lot # L016428, expiration date 30-JUL-2017 (dose and route unspecified), which was exposed to temperature excursion 48.5 Fahrenheit degree (F) for 2 hours. It was not because of a data logger. The vaccine previous temperature excursion was reported as 50.28 F for 7 hours. No adverse effect was reported. Additional information has been requested.
Age: 1.07
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 17 year old patient of unknown gender.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm redness and swelling, traveling down, towards elbow.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Vision blurred
Clinical narrative: This spontaneous report as received from a physician and a medical assistant via a company representative refers to a 15 year old female patient. The patient's concurrent conditions included amoxicillin allergy (it gave her hives on an unknown date) and allergy to SEPTRA. None concomitant medications were reported. The physician stated that the patient had no history of migraines, nor was there a family history of migraines. On 18-MAR-2016 at 11:15, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L045711, expiration date 08-MAY-2017; dose and route was not reported). The physician stated that the patient remained in the office for 20 minute post vaccination without any effects. The physician stated per the patient's mother who reported to the office at an unspecified time that when patient was driving home, about 30 to 35 minutes post vaccination (approximately on 18-MAR-2016 at 11:45) the patient started to experience a sharp head pain on right side and blurry vision. The physician stated per the mother that the headache and blurry vision persisted so upon further communication between the patient's mother and the physician, the physician advised parents to take the patient to the hospital's emergency room (the patient was seen in the emergency room approximately 12 hours post vaccination). The physician stated that the emergency room staff did not find anything except blurred vision. The physician also stated that the patient continued with blurred vision in right eye and was later assessed by an unspecified eye specialist that confirmed that blurred vision but also did not find anything else. The patient was not hospitalized and no treatment was given for the adverse events. The outcome of the adverse events was reported as recovered in 2016. It was also reported that the patient was doing fine now. The relatedness between the adverse events and GARDASIL 9 was not reported. 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 and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 28-APR-2016, the patient was vaccinated with the second dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (which had a lot # of L009213 and an expiration date of 17-MAR-2017; however, dose, route of administration and anatomical location were not reported). No concomitant medications were reported. The vaccine experienced temperature excursions of 10.3 degrees C and 1 degree C for time frames of 4 hours and 42 minutes, and 42 minutes, respectively. Previously, it had experienced a temperature excursion of 10.30 degrees C for a time frame of 4 hours. These excursions were called out because of a data logger. Despite these excursions, no adverse effects were reported. This is one of several cases from the same reporter. Additional information is not expected because the reporter did not allow further contact.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. Information regarding concurrent or medical conditions were not reported. On 22-APR-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection 40, lot number reported as L022261 with expiration date 01-APR-2016 (dose and route were not reported). No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Anaphylactic reaction, Dysphagia, Erythema, Pruritus, Swollen tongue
Clinical narrative: Anaphylaxis symptoms approx 10-15 mins after vaccine administration. Hives, itching, swollen tongue, reddened skin, difficulty swallowing 5 mins after onset. Epi 0.5 given IM Epi 0.5 give x2 over next 30 mins. Pt transferred to ER for further eval and treatment.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Tryptase, Urticaria
Clinical narrative: Anaphylaxis symptoms approx 10-15 mins after vaccine administration. Hives, itching, swollen tongue, reddened skin, difficulty swallowing 5 mins after onset. Epi 0.5 given IM Epi 0.5 give x2 over next 30 mins. Pt transferred to ER for further eval and treatment.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Acute inflammatory demyelinating polyneuropathy or possibly Guillain-Barre syndrome occurring 4+ months following his influenza immunization.
Sex: U
Vaccine: HPV4
Symptoms: Death, Syncope
Clinical narrative: This spontaneous report was received from a consumer referring to a young patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (anatomical route of vaccination, lot number and expiration date were not provided). The patient's concomitant medications were not reported. The reported stated, that after watching TV news, heard about a young child who collapsed and died after receiving GARDASIL. At the time of the report, the outcome was reported as fatal. Relatedness between the adverse event and vaccination with GARDASIL was not provided. This is one of several cases received from the same source. MARRS: 1605USA003026. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Deafness, Depressed level of consciousness, Dizziness, Seizure
Clinical narrative: Approx. 5 minutes after receiving MENVEO client began to feel light headed. She was then sat in a chair. Approx. 5 minutes after feeling light headed client began to convulse for 30 seconds. When she gained full consciousness, she said that she had experienced hearing loss. Her BP was 60/38 at 10:45 AM. We moved her to the bed and propped her feet up, at 10:55 we took her BP again and it was 118/83. She was picked up by her mother to be monitored.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Lip swelling, Peripheral swelling, Pruritus
Clinical narrative: Developed bilateral hand swelling with itching. Lip swelling. No oral or pharyngeal swelling.  No shortness of breath. No rash. Went to emergency room and was given methylprednisolone 125 mg IV; famotidine 20 mg IV and diphenhydramine 50 mg IV. Discharged from emergency room with prescriptions for prednisone 20 mg 3 tabs dly for 3 days, diphenhydramine 25 mg PRN, famotidine 40 mg 1 tab daily.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Local injection site erythema and swelling w/vesicular lesions overlying induration - Left lateral upper extremity (triceps area).
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Drug administered at inappropriate site, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upon waking on 10/17/16, patient noticed redness, warmth and swelling on her left arm where her flu shot was given.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Electrocardiogram, Seizure, Syncope
Clinical narrative: This spontaneous report concerning a 17 year old female patient was received from the patient's mother. Information on patient's concurrent conditions and medical pertinent history was not provided; however she was allergic to MOTRIN and AUGMENTIN. On an unknown date, the patient was vaccinated with a 1st dose of GARDASIL intramuscularly, (anatomical location, dose, lot # and expiration date not provided). On 29-SEP-2014, the patient was vaccinated with a second dose of GARDASIL. Subsequently, on the same date, the patient started fainted and started to have seizures, also reported as "seizure like spells". The patient sought medical attention and was seeing by a neurologist and a cardiologist; she received MIDRON as treatment and performed an electrocardiogram and a computed tomography scans (results not provided). On 25-NOV-2015, the patient received the third dose of GARDASIL 9. No product quality complaint was involved. The outcome of the events was unknown. No product quality complaint was involved. The relatedness between the vaccination with GARDASIL seizures and syncope was not reported. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest pain, Lip swelling, Urticaria
Clinical narrative: Chest pain, hives, and swelling of the lips a few minutes after leaving the physician's office.
Age: 69.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Pain in extremity
Clinical narrative: Immediately after administration patient states that her arm felt the pain from the shot. Pharmacist gave her an ice pack to put on arm. Patient then states that she felt like she is going to faint and throw up. Pharmacist asked if patient wants her to call 911. Patient said no. Took patient's blood pressure at 12:10pm was 93/62 and 12:38 pm was 113/73. Patient does not know normal blood pressure value. Patient states she feels good at 12:39 pm and asked to leave.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Large area of redness and pain to the injection site. Not improving. No tx administered d/t no s/s of fever, vomiting, or rash.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Burning sensation, Conversion disorder, Demyelination, Dyspnoea
Clinical narrative: Right arm pain at injection site, right arm numbness. on 2/8/16 rash, short of breath, tightness in throat, treated with oral steroid burst and taper. burning, numbness, pain in neck, upper back, and shoulders. headaches. bilateral leg and left arm weakness.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Injection site pain, Muscular weakness, Musculoskeletal pain
Clinical narrative: Right arm pain at injection site, right arm numbness. on 2/8/16 rash, short of breath, tightness in throat, treated with oral steroid burst and taper. burning, numbness, pain in neck, upper back, and shoulders. headaches. bilateral leg and left arm weakness.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Rash, Throat tightness
Clinical narrative: Right arm pain at injection site, right arm numbness. on 2/8/16 rash, short of breath, tightness in throat, treated with oral steroid burst and taper. burning, numbness, pain in neck, upper back, and shoulders. headaches. bilateral leg and left arm weakness.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chills, Cough, Hyperhidrosis, Pyrexia
Clinical narrative: Sweating, chills, fever, the month of march rash came on top of both my feet moving up legs to knees. Cough that does not seem to get any better.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, X-ray
Clinical narrative: Sweating, chills, fever, the month of march rash came on top of both my feet moving up legs to knees. Cough that does not seem to get any better.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Anxiety, Body temperature, Decreased activity, Hypophagia, Irritability
Clinical narrative: The baby is very fussy, has a temperature and is not eating. Not active and seems anxious.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Full blood count normal, Red blood cell sedimentation rate normal, Skin warm, Swelling
Clinical narrative: Two red streaks below injection site. Then next morning slight redness and swelling. Warm to touch. Labs normal. Started on BACTRIM and KEFLEX by NP. Could be skin infection.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Extensive swelling of vaccinated limb, Injected limb mobility decreased, Injection site cellulitis, Injection site pain
Clinical narrative: Two red streaks below injection site. Then next morning slight redness and swelling. Warm to touch. Labs normal. Started on BACTRIM and KEFLEX by NP. Could be skin infection.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Swelling, White blood cell count normal
Clinical narrative: Two red streaks below injection site. Then next morning slight redness and swelling. Warm to touch. Labs normal. Started on BACTRIM and KEFLEX by NP. Could be skin infection.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash with itching at injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Injection site erythema, Injection site swelling, Ultrasound scan
Clinical narrative: Right arm with swelling and erythema extending from the injection site down to mid arm.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Hot flush, Hyperhidrosis, Palpitations, Pruritus
Clinical narrative: Patient felt a hot flash, sweating, racing heart, itching of upper extremities.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Culture, Debridement, Eschar, Pyrexia
Clinical narrative: Chills and fever and swelling 5 inches with black center Eschar developed. Been to wound care for debriding and bandaging three times a week and still going. Wound is deep.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Chills and fever and swelling 5 inches with black center Eschar developed. Been to wound care for debriding and bandaging three times a week and still going. Wound is deep.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Extreme fatigue followed by chills, headache and fever to 101.5 F. Soreness at injection site.