chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV2, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Listless, Pallor
Clinical narrative: Approximately 7 min after giving MENVEO, GARDASIL and TDaP, mom informed RN that patient was sweaty, dizzy and felt weak. Patient was extremely diaphoretic, pale and listless. Taken to lie down with feet elevation 3 sets of VS were taken in 10 min intervals sips of H2O given. Pt went to sitting, standing answering appropriately instructed to drink fluids and not to go to soccer at 3PM. 2:11 84/, 216 90/60, 227 94/60, 240 90/64 P74, RN
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site induration, Pain, Peripheral swelling
Clinical narrative: Upper arm became red, swollen, warm itchy and sore progressively over 2 days redness and induration 10x16 Left upper arm treated with oral prednisone.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Skin warm
Clinical narrative: Upper arm became red, swollen, warm itchy and sore progressively over 2 days redness and induration 10x16 Left upper arm treated with oral prednisone.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: First experienced swelling and redness at injection site. Also was hot. Now swelling has gone away and is only lightly warm. She did not feel she needed to see MD.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Decreased appetite, Flushing, Headache, Nausea
Clinical narrative: 8/16 approximately 2 PM 3 hours post vaccine fever of 103 degrees , flushing, arm soreness, aches, chills, rash, headache. TYLENOL at 5 PM temp same 2x500 mg to 102 degrees, 8/17 next morning 2x500 mg x 6 hrs 101 degrees, back to 100 degrees then 8/18 100 degrees 48 hours post vaccine. Loss of appetite - only water, juice. Nausea/not vomit.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: 8/16 approximately 2 PM 3 hours post vaccine fever of 103 degrees , flushing, arm soreness, aches, chills, rash, headache. TYLENOL at 5 PM temp same 2x500 mg to 102 degrees, 8/17 next morning 2x500 mg x 6 hrs 101 degrees, back to 100 degrees then 8/18 100 degrees 48 hours post vaccine. Loss of appetite - only water, juice. Nausea/not vomit.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stated that flu shot hurt when administered and was placed high on deltoid muscle. She thinks the vaccination may have inflamed the bursa or maybe entered the bursa of shoulder. She is having pain in shoulder area and limited movement to the side without significant pain. Pain has continued for 12 days with no relief from Ibuprofen. About to see urgent care for possible steroid or treatment.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Back pain, C-reactive protein normal, Erythema, Full blood count normal, Gait disturbance
Clinical narrative: Pt given MENACTRA and Tdap-30 mins after face got very red-next AM c/o back pain. 2 days post (Rt) leg pain with difficulty walking.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Spinal X-ray normal
Clinical narrative: Pt given MENACTRA and Tdap-30 mins after face got very red-next AM c/o back pain. 2 days post (Rt) leg pain with difficulty walking.
Age: 0.58
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection sight after giving HIBERIX.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Injection site pain, Neck pain, Pain
Clinical narrative: Right arm pain deltoid runs to neck, aching constant. Headache last two day from when form was completed.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: A black mark as left at injection site after giving HIBERIX.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site induration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 82.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Rash around injection site, hot to touch, redness, painful. Abx given by ER (KEFLEX 500mg QID). Rash is on Right upper arm.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Hives 2 days after vaccines administered.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Communication disorder, Lethargy, Pyrexia, Rash, Seizure
Clinical narrative: Within hours high fever and rash. Within 48 hours seizure, lethargic. Within few days stopped talking. Seizures lasted over 1 year after vaccine.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Erythema, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Approx. 6hrs after receiving injection, I began having swelling and redness distal to injection site. The area became indurated and hot, and I experienced slight dizziness. I took certrizine, applied ice pack. Later took warm shower. In the AM the arm remained reddened and swollen but not indurated and had progressed further distally on left arm. The dizziness persisted when bending over or twisting head. Third day, seems like dizziness has subsided, but the redness and swelling have further progressed to forearm area.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Peripheral swelling
Clinical narrative: Approx. 6hrs after receiving injection, I began having swelling and redness distal to injection site. The area became indurated and hot, and I experienced slight dizziness. I took certrizine, applied ice pack. Later took warm shower. In the AM the arm remained reddened and swollen but not indurated and had progressed further distally on left arm. The dizziness persisted when bending over or twisting head. Third day, seems like dizziness has subsided, but the redness and swelling have further progressed to forearm area.
Age: 60.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Dry skin, Hair disorder, Hypersensitivity, Scab, Skin discolouration
Clinical narrative: Pt came to clinic C/O raised, irritated hair follicles on both arms from shoulder to elbow, rt leg, and rt chest. Pt reports this started "1 week after the shots for travel." Pt denies itching, but reports over time, "spots got dry and felt rough like a cheese grater." Pt reports her PCP diagnosed it as an allergic reaction to the vaccines and told her to come back to office. Pt reports she has been "taking BENADRYL every night for 5 nights" and that this has provided some relief. On examination, hair follicles in affected areas appear darker than surrounding skin, raised, dry, and in some cases crusted at apex. Pt denies any difficulty breathing or fever. Advised pt to continue with BENADRYL and use a non-fragranced moisturizing lotion on affected areas. Discussed w/pt concerns about second Hep A vaccine and advised she is not required to have second Hep A if she does not wish to. Advised of pt visit and concerns. Occurrence Date: 08/30/2017; Created on 08/30/2017 at 09:16.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # N005274, expiration date 03-APR-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.4 degrees Fahrenheit) and 32 degrees Fahrenheit to 35 degrees Fahrenheit (35 degrees Fahrenheit) for unknown duration. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA012210: US-009507513-1708USA012211: US-009507513-1708USA012212: US-009507513-1708USA012213: US-009507513-1708USA012214.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: Information has been received from a nurse concerning a 9 week old female patient. There was no concomitant therapy, relevant medical history or drug reactions/allergies. On 11-AUG-2017, the patient was administered first dose in vaccination series of ROTATEQ (lot # M012495, expiration date 09-OCT-2017; dose and frequency were unknown) orally for prevention of rotavirus. On 11-AUG-2017, the patient spit up the dose a few minutes later. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was recovered. The causality between the event and ROTATEQ was not provided.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. On 11-AUG-2017, the patient was vaccinated with an improperly stored dose of VARIVAX 0.5 ml, subcutaneous, lot # N002204, exp.19-JAN-2019, for prophylaxis. Concomitant therapies included sterile diluent (lot# N015631, exp. 18-MAR-2019). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unknown age. The patients' medical history, concomitant medication and concurrent conditions were not reported. Since 09-MAR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ from lot# 27-JUN-2018 and lot# M005080, expiry: 03-OCT-2018, for prophylaxis. No adverse effect reported. The vaccine was exposed to -4.4 degree Celsius for 1,057 hours (44 days) and 9 degree Celsius to 25 degree Celsius for 2 hours. The call was due to data logger. This is one of four reports received from same reporter. Sender's Comments: US-009507513-1708USA007831.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. In 2017, the patient was vaccinated with PEDVAXHIB lot # reported as N003968 with expiry date 31-OCT-2019, lot # N003700 with expiry date 01-NOV-2019 for prophylaxis. In 2017, the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB. Additional information has been requested. Sender's Comments: US-009507513-1708USA013258: US-009507513-1708USA013259: US-009507513-1708USA013257.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M028798 for prophylaxis. Concomitant therapies included sterile diluent. On 21-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 year old patient with prophylaxis. On 23-AUG-2017 the patient was vaccinated with PEDVAXHIB for prophylaxis. Other suspect therapies included GARDASIL 9. On 23-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event and product label confusion. Additional information has been requested. Sender's Comments: US-009507513-1708USA013207.
Sex: M
Vaccine: RV5
Symptoms: Headache, Pyrexia, Secondary transmission
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 3 year old male patient. On 22-AUG-2017, the patient's brother was vaccinated with ROTATEQ, orally for prevention of rotavirus gastroenteritis. On 22-AUG-2017, the patient experienced secondary transmission. On 23-AUG-2017, the patient experienced pyrexia and headache. The outcome of headache, pyrexia and secondary transmission was reported as not recovered/not resolved. The relatedness between the adverse events and ROTATEQ was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Immunosuppression
Clinical narrative: Information has been received from a registered nurse referring to a 30 year old patient of unknown gender. The patient's concurrent condition, historical condition and concomitant therapy were not reported. On unspecified dates, the patient was "vaccinated in childhood" with an unknown number of doses of PEDVAXHIB (strength, dosage, frequency, lot#, route and expiration date were not provided). The reporter reported that the patient was currently "immunosuppressed". It was unknown by reporter if patient was "immunosuppressed" prior to being "vaccinated in childhood" with of PEDVAXHIB. The outcome of the event was unknown.  The causality between the event and the vaccine was not reported. Upon internal review, "immunosuppressed" was considered to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included a properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of VAQTA from lot numbers N005605 and N008823; with expiration dates on 08-APR-2018 and 26-MAY-2018, respectively. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA012976: US-009507513-1708USA012974: US-009507513-1708USA012975: US-009507513-1708USA012972: US-009507513-1708USA012973.
Sex: U
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010106, intramuscular for prophylaxis. On 24-AUG-2017, 5 days after onset of therapy the patient experienced chills, hyperhidrosis and injection site pain. The outcome of hyperhidrosis, injection site pain and chills is unknown. Sender's Comments: US-009507513-1708USA011999.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117/expiration date 06-NOV-2018, lot # M032649/expiration date 11-NOV-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.4 degrees Fahrenheit) and 32 degrees Fahrenheit to 35 degrees Fahrenheit for unknown duration. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003262: US-009507513-1708USA012211: US-009507513-1708USA012212: US-009507513-1708USA012213: US-009507513-1708USA012214.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit and 32 degrees Fahrenheit to 35 degrees Fahrenheit for unknown duration. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003262: US-009507513-1708USA012210: US-009507513-1708USA012212: US-009507513-1708USA012213: US-009507513-1708USA012214.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M037770 / expiration date 01-JUN-2019, lot # M044717 / expiration date 19-JUL-2019, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.4 degrees Fahrenheit) and 32 degrees Fahrenheit to 35 degrees Fahrenheit (35 degrees Fahrenheit) for unknown duration. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA003262: US-009507513-1708USA012210: US-009507513-1708USA012211: US-009507513-1708USA012213: US-009507513-1708USA012214:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # M044020 / expiration date 01-MAY-2018, lot # N013268 / expiration date 25-NOV-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 6 degrees Fahrenheit for 2.5 hours and 6.2 degrees Fahrenheit for 1 hour. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003262: US-009507513-1708USA012210: US-009507513-1708USA012211: US-009507513-1708USA012212: US-009507513-1708USA012214:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # M009764/expiration date 23-FEB-2018, lot # M033212/expiration date 13-JUL-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 6 degrees Fahrenheit for 2.5 hours and 6.2 degrees Fahrenheit for 1 hour. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003262: US-009507513-1708USA012210: US-009507513-1708USA012211: US-009507513-1708USA012212: US-009507513-1708USA012213.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. In August 2017, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB for prophylaxis. No adverse effects reported. Sender's Comments: US-009507513-1708USA012500: US-009507513-1708USA012501.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to unspecified number of patients unknown age and gender. On unknown dates, the patients were vaccinated with VAQTA lot # M036458 with expiration date 02-MAR-2018 and lot # M006458 (determined to be not valid) with expiration date 18-AUG-2017. On an unknown date, the patient experienced incorrect product storage and no adverse event. Additional information has been requested. Sender's Comments: US-009507513-1708USA012331: US-009507513-1708USA012441
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to unspecified number of patients unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL 9 lot # N000326 with expiration date 14-OCT-2019 and lot # M036458 (determined to be not valid) with expiration date 18-AUG-2017. On an unknown date, the patient experienced incorrect product storage and no adverse event. Additional information has been requested.; Sender's Comments: US-009507513-1708USA012440: US-009507513-1708USA012331:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. In August 2017, the patients were vaccinated with a improperly stored doses of M-M-R II which were reconstituted with improperly storage sterile diluent for prophylaxis. No adverse effects reported. Sender's Comments: US-009507513-1708USA012500: US-009507513-1708USA012428.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a multiple patients of unknown age. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse event.; Sender's Comments: US-009507513-1708USA012451: Original Case : 1708USA012451.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient experienced rash. The outcome of rash is unknown.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Amnesia, Electroencephalogram abnormal, Impaired driving ability, Loss of consciousness, Road traffic accident
Clinical narrative: This spontaneous report was received from a consumer referring to a friend's son, a 18 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 10-APR-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, Lot # M035486 expired on 05-JUN-2019 for prophylaxis (strength and route of administration were not reported). On an unknown day in April 2017, reported as "toward the end of April", the patient started to have incidents resembling fainting. His mother took him to a couple of doctors and they did not get an initial diagnosis. On an unknown day in June 2017, reported as "early June", the patient was driving his car and apparently lost consciousness at the wheel in a parking lot and drove the car up an embankment. The patient had not recollection of the incident. Subsequently, the patient saw a neurologist and an electroencephalogram (EEG) was performed on an unknown date in 2017, showing seizure activity. He was unable to operate a vehicle until seizure free for 6 months. At the reporting time, the patient was taking unspecified anti-seizure medication. At the time of reporting, the outcome of seizure, memory impairment, syncope and loss of consciousness was unknown. The causality assessment between the vaccination with GARDASIL 9 and the aforementioned events was not provided, however it was mentioned that the full situation was reported to the pediatrician but they dismissed a connection to GARDASIL 9. Upon internal review, loss of consciousness and seizure were considered to be medically significant events.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure, Syncope
Clinical narrative: This spontaneous report was received from a consumer referring to a friend's son, a 18 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 10-APR-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, Lot # M035486 expired on 05-JUN-2019 for prophylaxis (strength and route of administration were not reported). On an unknown day in April 2017, reported as "toward the end of April", the patient started to have incidents resembling fainting. His mother took him to a couple of doctors and they did not get an initial diagnosis. On an unknown day in June 2017, reported as "early June", the patient was driving his car and apparently lost consciousness at the wheel in a parking lot and drove the car up an embankment. The patient had not recollection of the incident. Subsequently, the patient saw a neurologist and an electroencephalogram (EEG) was performed on an unknown date in 2017, showing seizure activity. He was unable to operate a vehicle until seizure free for 6 months. At the reporting time, the patient was taking unspecified anti-seizure medication. At the time of reporting, the outcome of seizure, memory impairment, syncope and loss of consciousness was unknown. The causality assessment between the vaccination with GARDASIL 9 and the aforementioned events was not provided, however it was mentioned that the full situation was reported to the pediatrician but they dismissed a connection to GARDASIL 9. Upon internal review, loss of consciousness and seizure were considered to be medically significant events.
Age: 65.0
Sex: F
Vaccine: VARZOS, FLU3
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a 68 year old female patient with drug hypersensitivity to codeine. Concomitant therapies included sterile diluent(manufacturer unknown). On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not reported) for prophylaxis. On 23-AUG-2016, 3 years 6 months 12 days after onset of therapy the patient experienced herpes zoster and rash (reported as "shingles like rash"). The outcome of herpes zoster and rash was reported as recovered/resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS, FLU3
Symptoms: Asthenia, Decreased appetite, Discomfort, Fatigue, Feeling abnormal
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a 68 year old female patient with drug hypersensitivity to codeine. Concomitant therapies included sterile diluent(manufacturer unknown). On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not reported) for prophylaxis. On 23-AUG-2016, 3 years 6 months 12 days after onset of therapy the patient experienced herpes zoster and rash (reported as "shingles like rash"). The outcome of herpes zoster and rash was reported as recovered/resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS, FLU3
Symptoms: Headache, Influenza like illness, Injection site pain, Lymphadenopathy, Neck pain
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a 68 year old female patient with drug hypersensitivity to codeine. Concomitant therapies included sterile diluent(manufacturer unknown). On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not reported) for prophylaxis. On 23-AUG-2016, 3 years 6 months 12 days after onset of therapy the patient experienced herpes zoster and rash (reported as "shingles like rash"). The outcome of herpes zoster and rash was reported as recovered/resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS, FLU3
Symptoms: Pain, Somnolence
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a 68 year old female patient with drug hypersensitivity to codeine. Concomitant therapies included sterile diluent(manufacturer unknown). On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not reported) for prophylaxis. On 23-AUG-2016, 3 years 6 months 12 days after onset of therapy the patient experienced herpes zoster and rash (reported as "shingles like rash"). The outcome of herpes zoster and rash was reported as recovered/resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 28-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M042503, .65 ml, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent. On 28-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a other health professional refers to a 72 year old male patient. On 18-AUG-2009 the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent. On 21-AUG-2009, 4 days after onset of therapy the patient experienced rash vesicular. The outcome of rash vesicular was reported as recovered/resolved.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB from lot numbers N002920 and N002202; with expiration dates on 30-SEP-2018 and 04-NOV-2019, respectively. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA012976: US-009507513-1708USA012974: US-009507513-1708USA012975: US-009507513-1708USA011949: US-009507513-1708USA012973.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 from lot numbers N013695 and N000326; with expiration dates on 21-MAR-2019 and 14-OCT-2019, respectively. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1708USA012976: US-009507513-1708USA012974: US-009507513-1708USA012975: US-009507513-1708USA012972: US-009507513-1708USA011949:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of M-M-R II with lot number N002337 and expiration date on 20-JAN-2019. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA012976: US-009507513-1708USA011949: US-009507513-1708USA012975: US-009507513-1708USA012972: US-009507513-1708USA012973.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 with lot number N010109 and expiration date on 20-NOV-2018. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA012976: US-009507513-1708USA012974: US-009507513-1708USA011949: US-009507513-1708USA012972: US-009507513-1708USA012973.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included a properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of ROTATEQ from lot numbers M031804 and M044397; with expiration dates on 02-MAR-2018 and 20-JUN-2018, respectively. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA011949: US-009507513-1708USA012974: US-009507513-1708USA012975: US-009507513-1708USA012972: US-009507513-1708USA012973.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M009378, M017983, and M043731, for prophylaxis.; Sender's Comments:  US-009507513-1708USA012995: US-009507513-1708USA012863:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M036056 and lot # M036057, for prophylaxis. Sender's Comments: US-009507513-1708USA012994: US-009507513-1708USA012863.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On 28-AUG-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # L000877 and expiry date: 22-JUN-2017. No adverse effects were reported and no temperature excursion was reported prior to administration. There was no product quality complaint.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date in March 2017, the patients were administered improperly stored doses of RECOMBIVAX HB lot # M035487, expiration date 23-FEB-2019 for prophylaxis. The doses were stored at temperatures in the range of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a time frame of 4 hours; 36 degrees Fahrenheit to 46 degrees Fahrenheit for a time frame of 12 hours. There were no previous temperature excursions. The call was not because of a data logger. No adverse effects were reported. No further information was provided. This is one of the several reports from the same reporter. Follow up information was received from nurse on 25-AUG-2017. The nurse stated that it was determined that they did not have a temperature excursion and the state was looking at wrong records. Sender's Comments: US-009507513-1707USA002699.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date in March 2017, the patients were administered improperly stored doses of ROTATEQ lot # M040270, expiration date 29-APR-2018 for prophylaxis. The doses were stored at temperatures in the range of 32 degrees Fahrenheit to 35  degrees Fahrenheit for a time frame of 4 hours; 36 degrees Fahrenheit to 46 degrees Fahrenheit for a time frame of 12 hours. There were no previous temperature excursions. The call was not because of a data logger. No adverse effects were reported. No further information was provided. This is one of the several reports from the same reporter. Follow up information was received from nurse on 25-AUG-2017. The nurse stated that it was determined that they did not have a temperature excursion and the state was looking at wrong records. Sender's Comments: US-009507513-1707USA002699.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date in March 2017, the patients were administered improperly stored doses of GARDASIL 9 lot # M041212, expiration date 21-JUN-2019 for prophylaxis. The doses were stored at temperatures in the range of 32 degrees Fahrenheit to 35 degrees Fahrenheit (34 Fahrenheit) for a time frame of 4 hours; 36 degrees Fahrenheit to 46 degrees Fahrenheit (35.8 Fahrenheit) for a time frame of 12 hours. There were no previous temperature excursions. The call was not because of a data logger. No adverse effects were reported. No further information was provided. This is one of the several reports from the same reporter. Follow up information was received from nurse on 25-AUG-2017. The nurse stated that it was determined that they did not have a temperature excursion and the state was looking at wrong records. Sender's Comments: US-009507513-1707USA002699.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 year old patient with prophylaxis. On 23-AUG-2017 the patient was vaccinated with PEDVAXHIB for prophylaxis. Other suspect therapies included GARDASIL 9. On 23-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event and product label confusion. Additional information has been requested. Sender's Comments: US-009507513-1708USA010483.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 10 week old patient. On 21-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 21-AUG-2017, the patient experienced incorrect product storage.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient. On 23-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 3 month old patient. On 23-AUG-2017 the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient. On 28-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 28-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 9 week old patient. On 28-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 28-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 5 month old patient. On 21-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 21-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 16 month old patient. On 29-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 29-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old patient. On 30-AUG-2017, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 30-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 1.67
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 20 month old patient. On 21-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 21-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old patient. On 21-AUG-2017 the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 21-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old patient. On 23-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old patient. On 23-AUG-2017, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.