chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to a currently 65 years old female patient with milk, sugar and wheat allergy. It was reported that the patient presented shingles on an unknown date (Pertinent medical history also reported as none). In July 2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, lot NO., lot expiration date, route and anatomical location of administration were not reported). The patient had no concomitant therapies. On an unknown date, the patient "got shingles, but had shingles prior to vaccination, and still has outbreaks". The patient sought medical attention and went to a clinic, nevertheless no laboratories were performed. The pharmacist stated that the patient received a prescription for Lidocaine on 17-JUN-2016. No Product Quality Complain (PQC) was involved. The outcome of the event was reported as not recovered. The causal relationship between the event and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact.
Age: 70.0
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Went for yearly exam. To a booster Pneumonia shot. I asked what was in it or side effect. I mention my Wegner's granulomatosis. Shot was itchy, swollen, red, hard, hot, grew to 5" x 7". 6 day later saw doctor. Next week went away.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with their second dose of GARDASIL 9 (lot #, expiration date, exact doses and route of administration were not reported) as late as 6 months after the scheduled due date for second dose. No adverse effects were reported. 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 nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L048465, expiration date 02-DEC-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Infection, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Copied and pasted from Dr's report to me via e-mail: She was seen on 6/27/16 for a checkup.  She was given an ADACEL vaccine.  She called on 6/29/16 because the site was raised, hot, and about the size of a silver dollar.  We advised ice, Benadryl, ibuprofen. It got worse over the long weekend.  She called Dr. on Saturday 7/2 and he advised the same treatment.  On 7/3 it was worse still, and she went to the ER.  The ER doctor told her that the vaccine was administered incorrectly and that she had an infection.  He started her on Keflex 500 mg.  I saw her on 7/5.  She told me that the MA who administered the vaccine swiped her arm once with alcohol, pinched her triceps, and immediately gave her the injection in the triceps.  She had a red area over her triceps where the vaccine was given.  The redness had come down considerably with antibiotics.  She has a firm area in the fatty area near the triceps which represents where the shot was given. Patient is in the process of recovering.
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Cerebral palsy, Mobility decreased, Muscle tightness, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: 5 episodes of apnea 1) 1:19 PM 2) 3:32 PM 3) 4:08 PM 4) 4:19 PM baby slow to respond with stimulation, oxygen given, pulse below 60. 5) 6:36 PM pulse below 80. Baby born at 36 3/7 weeks. Diagnosed with cerebral palsy due to lack of oxygen to brain during apnea episodes. Unable to use right hand/fingers. Walks on tip toe right foot. Extreme muscle tightness. Scar found during MRI on brain. Permanently disabled. Chiropractor/physical therapy/occupational therapy weekly.
Sex: F
Vaccine: HEP
Symptoms: Scar, Slow response to stimuli, Toe walking
Clinical narrative: 5 episodes of apnea 1) 1:19 PM 2) 3:32 PM 3) 4:08 PM 4) 4:19 PM baby slow to respond with stimulation, oxygen given, pulse below 60. 5) 6:36 PM pulse below 80. Baby born at 36 3/7 weeks. Diagnosed with cerebral palsy due to lack of oxygen to brain during apnea episodes. Unable to use right hand/fingers. Walks on tip toe right foot. Extreme muscle tightness. Scar found during MRI on brain. Permanently disabled. Chiropractor/physical therapy/occupational therapy weekly.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site discomfort, Muscle contracture, Pain
Clinical narrative: Right upper arm is uncomfortable to move back or extend in any direction.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Dysstasia, Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 20-year-old female patient of an unspecified ethnicity received her first dose of TRUMENBA, via an unspecified route of administration on an unspecified date in Jun2016 at single dose. Medical history and concomitant medications were not reported. The patient experienced dizziness, fainting, chills, and had to sit down on an unspecified date in Jun2016. No treatment was required and no visit to emergency room needed. The outcome of the events was resolved.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abasia, Asthenia, Blood pressure abnormal, Chills, Headache
Clinical narrative: This is a spontaneous report from a contactable Pfizer colleague reported for his/her daughter. A 17-year-old female patient received first dose of TRUMENBA, intramuscular on 24Jun2016 at 0.5ml, single dose. The patient medical history was not reported. There were no concomitant medications. On 24Jun2016 the patient experienced severe headache, severe chills, numbness (for limbs) over hand and foot, could not walk, trembling, blood pressure abnormal and weak. The patient was hospitalized for the events. The outcome for all events was reported as recovering except for weakness reported as not recovered.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Tremor
Clinical narrative: This is a spontaneous report from a contactable Pfizer colleague reported for his/her daughter. A 17-year-old female patient received first dose of TRUMENBA, intramuscular on 24Jun2016 at 0.5ml, single dose. The patient medical history was not reported. There were no concomitant medications. On 24Jun2016 the patient experienced severe headache, severe chills, numbness (for limbs) over hand and foot, could not walk, trembling, blood pressure abnormal and weak. The patient was hospitalized for the events. The outcome for all events was reported as recovering except for weakness reported as not recovered.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This solicited report was received from a pharmacist who is also the patient's father, concerning his 16-year-old daughter. The patient was enrolled in a Market Research program . The patient did not have any concurrent conditions, medical history or concomitant therapies. On an unknown date, the subject was vaccinated with GARDASIL, injection (dose, route and anatomical site of injection were not reported). On an unknown date the subject experienced pain when she received the injection of GARDASIL, injection., It was reported that the information regarding the vaccination's responsible physician was unknown. Also, there were no diagnostic test performed. At the time of reporting, the outcome of injection site pain was reported as recovered on an unknown date. The investigator considered injection site pain to be related to GARDASIL. Additional information is not expected as the reporter refused additional contact.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. The patient's medical history included Shingles on an unspecified date before vaccination with ZOSTAVAX. The patient has none drug reactions. On an unspecified date in 2015 (reported as a "year ago"), the patient was vaccinated with ZOSTAVAX (dosage, dose number, route of administration, lot number and expiration date were not provided). Concomitant therapies included lisinopril (manufacturer unknown), estradiol (manufacturer unknown) and cyanocobalamin (manufacturer unknown). On 05-JUN-2016 (reported as a day or two before 07-JUN-2016), the patient developed shingles again. It was also reported that the patient sought for medical attention by visiting the physician. The treatment given for shingles included valacyclovir. Additionally, it was reported that no intervention to prevent a serious criteria was necessary, that shingles was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of Shingles was reported as not recovered. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 09-JUN-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB (injection strength: 2.5 mcg/0.5 ml, lot # K019502, expiration date: 04-FEB-2016) (exact dose and route of administration were not provided). No concomitant therapy was reported. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report concerning a patient of unknown gender and age was received from a registered nurse. Concurrent conditions and medical history were not reported. On 25-MAY-2016, the patient was vaccinated with VARIVAX lot # K006131, expiration date: 29-APR-2016 (strength, dose, route and frequency were not provided). There were no concomitant medications and adverse events reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M010486, expiration date 25-MAY-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as on or after 11-APR-2016), the patients were vaccinated with improperly stored doses of VARIVAX injection , lot # L025210, expiration date 07-JUL-2017, lot # L046887, expiration date 23-NOV-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of VARIVAX experienced the temperature excursion at 10 degrees Fahrenheit for 68 days. Data logger was involved. There were no previous temperature excursions reported. Product quality complaint was not involved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction. Large red circular area at site, swelling, aching. No treatment yet.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Dizziness, Nausea
Clinical narrative: 7/2/16 12 am patient states started feeling, nausea, dizzy, diarrhea, weakness.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling, Sleep disorder, Sunburn
Clinical narrative: Pt got home from work and noticed her left arm appeared to be sunburned and swollen, and painful to the touch. Pt was unable to sleep on left side that night. Pt took ibuprofen for pain.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Rapidly progressing hive like rash. Given BENADRYL 25 mg PO with nominal alleviation. No facial swelling. No respiratory involvement.
Age: 70.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient presented to pharmacy with a red rash from 1" below shoulder to elbow. Rash was warm to the touch. patient also has chills. Patient came to pharmacy 6/25/16. Noticed rash on 6/25/16. Follow up on 6/28/16 SX improvement but still present.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Erythema, Eye pain, Pain in extremity, Pain in jaw
Clinical narrative: Redness, swelling, pain in right arm, jaw, ear, eye.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Redness, swelling, pain in right arm, jaw, ear, eye.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Muscular weakness, Pain
Clinical narrative: PT REPORTS THAT LEFT DELTOID TURNED RED AND GOT SWOLLEN. LOCAL PAIN, WEAKNESS IN THE LEFT ARM - DIZZINESS - LOW FEVER.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: PT REPORTS THAT LEFT DELTOID TURNED RED AND GOT SWOLLEN. LOCAL PAIN, WEAKNESS IN THE LEFT ARM - DIZZINESS - LOW FEVER.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient complains vaccinated arm is sore and swollen at and around injection site.  Advised him to take naproxen or ibuprofen and I would follow up this afternoon to inquire about condition of arm.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt. had a shingle vaccine 6/16/2016. Pt. was seen at clinic today for rash noted left side dermatome- bra line. Pt. states began hurting 10 days ago and broke out in the past few days. Pt. diagnosed today with shingles and treated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Orbital apex syndrome
Clinical narrative: Herpes Zoster Ophthalmicus with Orbital Apex Syndrome/involvement of cranial nerves II, III, VI.
Age: 10.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Rash pruritic
Clinical narrative: Patient is brought on 6/30/2016 in by mom complaining of rash on left arm times 1 day. Patient received BEXSERO vaccine on left deltoid 7 days ago and was  fine until 6/29/2016. The rash is itchy and confluent on 6/30/2016. No other exposure, no fever, cough, runny nose, trauma. Diphenhydramine HCl (BENADRYL Allergy) 25 MG Oral Tablet Sig: 1 - 1 1/2 tab po Q 6 hours prn.
Age: 10.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Pruritus
Clinical narrative: Patient is brought on 6/30/2016 in by mom complaining of rash on left arm times 1 day. Patient received BEXSERO vaccine on left deltoid 7 days ago and was  fine until 6/29/2016. The rash is itchy and confluent on 6/30/2016. No other exposure, no fever, cough, runny nose, trauma. Diphenhydramine HCl (BENADRYL Allergy) 25 MG Oral Tablet Sig: 1 - 1 1/2 tab po Q 6 hours prn.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Presyncope
Clinical narrative: GAVE HEP A AND HPV 9 VALENT - VASOVAGAL REACTION.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Mild Rash.
Age: 53.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Neck pain
Clinical narrative: Redness, swelling of the injection site 5*2.5 inch. muscle pain. Neck pain.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 1.5 inch and growing raised, hot, red bump on child's arm where shot was administered.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Seizures/seizure like activity.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure, Seizure like phenomena
Clinical narrative: Seizures/seizure like activity.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: ERYTHEMA, DIAMETER APPROX. 3INCHES, WARM TO TOUCH, NO PAIN, SOME ITCHING, NO FEVER. MAINTAINED SAME SIZE FOR 24 HOURS.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Death
Clinical narrative: Undetermined cause of death within 24 hours of vaccines.
Age: 49.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Anti-aquaporin-4 antibody positive, Myelitis transverse, Neuromyelitis optica spectrum disorder
Clinical narrative: The patient received the HBV (adult) 3rd dose on 4/24/16 and developed severe cervicothoracic transverse myelitis on 5/8/16 and was subsequently diagnosed with neuromyelitis optica.
Age: 49.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Back pain, Nerve compression, Neuromyelitis optica spectrum disorder, Pain, Plasmapheresis
Clinical narrative: The patient received the HBV (adult) 3rd dose on 4/24/16 and developed severe cervicothoracic transverse myelitis on 5/8/16 and was subsequently diagnosed with neuromyelitis optica.
Age: 49.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Tenderness
Clinical narrative: The patient received the HBV (adult) 3rd dose on 4/24/16 and developed severe cervicothoracic transverse myelitis on 5/8/16 and was subsequently diagnosed with neuromyelitis optica.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Medical Assistant (R.M.A) concerning an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # K010224; expiration date: 11-DEC-2016) orally (dose and anatomical location of administration were not reported). The temperature excursions reported were: 34.7F for 2 hours 23 minutes; and 53.2F for 1 hour 27 minutes. There was no previous temperature excursion. Digital data logger and product quality complaint were not involved. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Dyskinesia, Fatigue, Musculoskeletal stiffness, Seizure like phenomena, Staring
Clinical narrative: Patient had seizure like activity 5 days after vaccines. Has had these same vaccine in the past with fever to 100.  Patient is a 6 m.o. male. History provided by father and mother. He is a very active baby. Mom feels like he has been advanced compared to his sibs. When he was 3 months old, mom noted that he moved his hand and feet more than any other kids she know. Sometimes he will stiffen his feet for no reason. Over the past few weeks he has been moving his hands (twisting, shaking) and a week ago he had some shaking along with it. Mom was holding him and he had some arm shaking and hand movement. On Tuesday he had an episode while he was in the car seat, mom noted that he was staring in to space and he had arm shaking. (He had recently had his 6 month vaccines and he has had a fever with previous shots although he did not note fever that day). On Wed he looked more tired than expected then he tilted to one side and mom could not get his attention. His mouth was open and his feet were pointed.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Patient had seizure like activity 5 days after vaccines. Has had these same vaccine in the past with fever to 100.  Patient is a 6 m.o. male. History provided by father and mother. He is a very active baby. Mom feels like he has been advanced compared to his sibs. When he was 3 months old, mom noted that he moved his hand and feet more than any other kids she know. Sometimes he will stiffen his feet for no reason. Over the past few weeks he has been moving his hands (twisting, shaking) and a week ago he had some shaking along with it. Mom was holding him and he had some arm shaking and hand movement. On Tuesday he had an episode while he was in the car seat, mom noted that he was staring in to space and he had arm shaking. (He had recently had his 6 month vaccines and he has had a fever with previous shots although he did not note fever that day). On Wed he looked more tired than expected then he tilted to one side and mom could not get his attention. His mouth was open and his feet were pointed.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Blood glucose increased, Hyperhidrosis, Pallor
Clinical narrative: Diaphoresis, significant pallor, sitting upright in waiting room also pt coherent at all times alert and oriented x 2, HR 48, Accu-Chek-293, cold compress applied.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of M-M-R II injection, (dose and route of administration were not reported) (lot # L026551, expiration date 16-JUL-2017; lot # L035674, expiration date 17-SEP-2017; and lot # L030162, expiration date 11-AUG-2017), which were improperly stored at 53.4 for 3.25 hours. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers that on an unknown date, unspecified doses PEDVAXHIB lot # L042258 (expiration date: 18-AUG-2018) and ROTATEQ lot # L028645 (expiration date: 25-MAY-2017)were exposed to a temperature excursion of 30.2 F for a time frame of 7.18 hours. However, no doses of these vaccines were administered to any patients. The vaccines experienced a temperature excursion of 30.2 F for a time frame of 7.18 hours. There were, reportedly, no previous temperature excursions and the call for the aforementioned ones was because of a data logger. Moreover, despite this temperature excursion, no adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hive on each thigh distal to immunization site. Size equal or smaller by 40 minutes after admin. No respiratory distress, cough, wheeze, site edema, emesis.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: Patient called and states she is unable to move her arm very well. Pt advised to ice area and try to move her arm a few times a day.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Back pain, Dyspnoea, Fall, Fatigue
Clinical narrative: Tingly, pain starting in toes/feet progressing to lower limbs, upper limbs, and lower back within 24 hours of vaccine administration. Weakness/inability to walk without taking effort, SOB after walking short distance or stairways. Exhaustion. Lower back pain. Unsteady gait/falling/stumbling.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Gait disturbance, Guillain-Barre syndrome, Inflammatory marker increased, Pain in extremity, Paraesthesia
Clinical narrative: Tingly, pain starting in toes/feet progressing to lower limbs, upper limbs, and lower back within 24 hours of vaccine administration. Weakness/inability to walk without taking effort, SOB after walking short distance or stairways. Exhaustion. Lower back pain. Unsteady gait/falling/stumbling.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Localized redness, swelling, and heat within 24 hrs. - this grew to space of 3 inches circumferentially in 7 days and pt. started on KEFLEX to rule out infection.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Defaecation urgency, Diarrhoea
Clinical narrative: E-mailed clinician 5/27/16 at 6AM with c/o GI urgency, loose BM's, joint pain. No problem at inj. site. No hx of any prob. w/prior IZs in lifetime (rec'd meningococcal vaccine elsewhere, 7/9/10).
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received MMRV at age 13 when it is only indicated for 12 and below. No adverse event noted.
Age: 21.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Abdominal pain, Paraesthesia
Clinical narrative: Patient was bit/scratch by feral cat. She received HRIG/Dose # 1 vaccine on 6/14/16, and remaining doses at emergency department. On 6/29/16 she call DOH service to complain of tingling/prickly feelings in both arms. By 6/30 930 patient felt better. At 1300 on 6/30 patient called DOH again c/p tingling, and abd pain. Patient was referred to her primary MD.
Age: 21.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Abdominal pain, Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient was bit/scratch by feral cat. She received HRIG/Dose # 1 vaccine on 6/14/16, and remaining doses at emergency department. On 6/29/16 she call DOH service to complain of tingling/prickly feelings in both arms. By 6/30 930 patient felt better. At 1300 on 6/30 patient called DOH again c/p tingling, and abd pain. Patient was referred to her primary MD.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rubella antibody positive, Urticaria
Clinical narrative: Urticaria (L) arm and face (L) eye (R) eye - 15 days later arrived c/o increased rash from 6-15-16 - 6-30-16.
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash morbilliform, Vaccination complication, Viral rash
Clinical narrative: Morbilliform rash, diarrhea, fever starting approximately 7/2/16. Appears to be viral exanthema likely secondary MMR vaccine.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV
Symptoms: Apnoea, Syncope
Clinical narrative: Syncope post vaccination, brief episode of apnea.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV
Symptoms: Apnoea, Crying, Cyanosis, Syncope
Clinical narrative: Syncope post vaccination, brief episode of apnea.
Age: 42.0
Sex: F
Vaccine: YF
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Pt. had the shot on Sunday on Wednesday (6/29) she called and complained of tiredness, weak, dizziness she wants to know if it was the yellow fever vaccine that was causing it. She stated that she is anemic.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: VARIVAX was given 06-21-16. Patient's Mom called 7-05-16 for an appointment. Pt. had rash all over body indicating adverse reaction.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Patient had to go to ER for cellulitis.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local erythema, pain and swelling to left deltoid pain. 7/10 offered urgent care appointment, patient refused. Given ER/Urgent care precautions and advised.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Daughter called to report that patient has been experiencing mild fever (not measured w/thermometer), diarrhea and significant fatigue and weakness.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dyspnoea, Fatigue, Myalgia, Urticaria
Clinical narrative: 6/3/16 pm c/o shortness of breath upon standing. 6/4/16 c/o fatigue and muscle hurting. 6/5/16 woke up with urticarial lesions trunk and extremities. Seen at urgent care - given SOLU-MEDROL injection and oral steroids x 5 days.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache
Clinical narrative: Patient received Men B shot and MENACTRA had headache for four days.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 15 year old female patient. The patient's concurrent conditions included asthma. The patient did not have any concomitant medications, known drug reactions or allergies. On 14-JUN-2016, the patient was vaccinated with a dose of GARDASIL 9, one dose (route of administration, lot # and expiration date were not reported). After the administration, a urine pregnancy test was conducted in the office, which resulted positive. The patient noted that the conception took place on 23-MAY-2016 (reported as "about three weeks ago"). The patient became pregnant with last menstrual period (LMP) of 09-MAY-2016 (based on the date of conception) and estimated date of delivery (EDD) of 13-FEB-2017. Initial exposure to GARDASIL 9 was at 3 weeks. The pregnancy outcome was pending. The patient was provided with the website for the pregnancy registry. The outcome of exposure during pregnancy was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 15 year old female patient. The patient's concurrent conditions included asthma. The patient did not have any concomitant medications, known drug reactions or allergies. On 14-JUN-2016, the patient was vaccinated with a dose of GARDASIL 9, one dose (route of administration, lot # and expiration date were not reported). After the administration, a urine pregnancy test was conducted in the office, which resulted positive. The patient noted that the conception took place on 23-MAY-2016 (reported as "about three weeks ago"). The patient became pregnant with last menstrual period (LMP) of 09-MAY-2016 (based on the date of conception) and estimated date of delivery (EDD) of 13-FEB-2017. Initial exposure to GARDASIL 9 was at 3 weeks. The pregnancy outcome was pending. The patient was provided with the website for the pregnancy registry. The outcome of exposure during pregnancy was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Initial unsolicited report received from a healthcare professional on 17 Jun 2016. This case involves a 18 years old male patient who was vaccinated with a first dose of MENACTRA (Batch number- U5410AA, expiration date: 21 Sep 2017, route of administration was not reported) on left deltoid on 16 Jun 2016 at 3:30 P.M. Illness at time of vaccination was reported as none, pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergies (NKA). Concomitant medications were not reported. On 16 Jun 2016, at 3:30 P.M., within a few second following the vaccination, the patient passed out. The patient came back to within few second. EMT (Emergency Medical Technician) came out and checked everything and he signed a form not go to hospital. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. On 16 Jun 2016 patient recovered from the event. Upon internal review, the company decided to consider the case serious because of important medical event passed out. List of documents held by sender: none. Sender's Comments: Loss of consciousness is listed with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset is compatible with the role of the vaccine. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Initial unsolicited report received from a healthcare professional on 17 Jun 2016. This case involves a 18 years old male patient who was vaccinated with a first dose of MENACTRA (Batch number- U5410AA, expiration date: 21 Sep 2017, route of administration was not reported) on left deltoid on 16 Jun 2016 at 3:30 P.M. Illness at time of vaccination was reported as none, pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergies (NKA). Concomitant medications were not reported. On 16 Jun 2016, at 3:30 P.M., within a few second following the vaccination, the patient passed out. The patient came back to within few second. EMT (Emergency Medical Technician) came out and checked everything and he signed a form not go to hospital. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. On 16 Jun 2016 patient recovered from the event. Upon internal review, the company decided to consider the case serious because of important medical event passed out. List of documents held by sender: none. Sender's Comments: Loss of consciousness is listed with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset is compatible with the role of the vaccine. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No symptoms- pt. given adult hep A.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Pain, Peripheral swelling, Pyrexia
Clinical narrative: 103 fever; severe chills; severe pain all over body; injection site arm swollen and immobile.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. In approximately 2004 (reported as 10 to 12 years ago), the patient was in an unspecified clinical trial for ZOSTAVAX (study site, investigator name, protocol number, patient number all unknown), and was vaccinated with ZOSTAVAX (dose, route and lot# unknown). On approximately 09-JUN-2016 (reported as two weeks ago), the patient developed shingles on his torso. The shingles was painful. The patient visited the physician. The outcome of the event was unknown at this time of reporting. The causal relationship between the event and ZOSTAVAX was not provided. Additional information is not expected because there is no consent to contact the physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-MAY-2016, the patient was vaccinated with GARDASIL 9 (lot # L043213, expiry date: 23-AUG-2017) that was improperly stored. The vaccine was stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours and 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-MAY-2016, the patient was vaccinated with GARDASIL 9 (lot # L043213, expiry date: 23-AUG-2017) that was improperly stored. The vaccine was stored in refrigerator at a temperature of 14.2UC for 8 hours 30 minutes and at 1.5 UC for 26 hours 30 minutes and in freezer at a temperature of -12UC for 8 hours 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with one dose of PROQUAD (lot # M007965, therapy type rHA, expiration date 15-AUG-2017, strength and route were not reported) which was improperly stored. The vaccine has been stored under temperature of -9.6 degree for 18 minutes. Digital data logger had been involved. No adverse effects reported. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Abdominal pain, Fatigue, Lethargy, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: Based on additional information received on 14 September 2015, this case became medically confirmed. Initial unsolicited report received from a consumer (patient parent) on 17-Aug-2015. A nine years old male patient, had received a first dose of IPOL (dose details, batch number: K1513-1, expiry date: 19-Sep-2016, route and site of administration were not reported) on 11-Aug-2015. There was no illness at the time of vaccination and there were no known allergies. Concomitant medications were not provided. It was reported that it was the first polio vaccine he ever had. On 11-Aug-2015, same day post-vaccination, the patient developed fever to 105 degree F; sore, red, swollen throat that was negative for strep throat test. He also experienced abdominal pain and lethargy and was sleeping more (like a nap in the afternoon) and felt tired. He was vaccinated at his own primary care physician's office. Corrective treatments were not provided. The patient required ER/doctor visit. At the time of this report, the patient improved and his symptoms had resolved. He recovered from the above mentioned events on an unknown date. Documents held by sender: none. Follow-up information received from a physician on 14 September 2015. The patient received first dose of IPOL in right deltoid. A patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions, illness at the time of vaccination were none reported.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Pharyngeal oedema, Pyrexia, Somnolence, Streptococcus test negative
Clinical narrative: Based on additional information received on 14 September 2015, this case became medically confirmed. Initial unsolicited report received from a consumer (patient parent) on 17-Aug-2015. A nine years old male patient, had received a first dose of IPOL (dose details, batch number: K1513-1, expiry date: 19-Sep-2016, route and site of administration were not reported) on 11-Aug-2015. There was no illness at the time of vaccination and there were no known allergies. Concomitant medications were not provided. It was reported that it was the first polio vaccine he ever had. On 11-Aug-2015, same day post-vaccination, the patient developed fever to 105 degree F; sore, red, swollen throat that was negative for strep throat test. He also experienced abdominal pain and lethargy and was sleeping more (like a nap in the afternoon) and felt tired. He was vaccinated at his own primary care physician's office. Corrective treatments were not provided. The patient required ER/doctor visit. At the time of this report, the patient improved and his symptoms had resolved. He recovered from the above mentioned events on an unknown date. Documents held by sender: none. Follow-up information received from a physician on 14 September 2015. The patient received first dose of IPOL in right deltoid. A patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions, illness at the time of vaccination were none reported.
Age: 68.0
Sex: M
Vaccine: IPV
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional on 17 September 2015. This case involves a 68-years-old male patient who was vaccinated with 0.1 ml of IPOL (batch number: K1330-1, expiry date: 20 June 2016, dose in series, route of administration were not reported) in left forearm on 14 September 2015 instead of TUBERCULIN PPD (TB Test) in error. The patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as none. Concomitant medications were not reported. On 15 September 2015, one day following the vaccination, the patient had developed slightly less than a dime size raised red area where the vaccine was administered. The patient required ER/doctor visit. It was a wrong vaccine administered and vaccine administered at inappropriate site. Relevant diagnostic tests/laboratory data was reported as none. Corrective treatment was not reported. The patient was not recovered from the event. Follow-up information received from a physician on 13 November 2015. It was reported that Tuberculin TB was given in right forearm (batch number: 725986, expiry date: June 2016) which was to be read in 72 hours. The patient had recieved IPOL intradermally. It was reported that the patient had developed 6cm area or redness, slightly red and minimally warm at medial forearm (no evidence of ulceration, vesicles or skin sloughing) and had minimal discomfort with no ithching. The outcome of minimal discomfort was not reported. List of documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: IPV
Symptoms: Vaccination site swelling, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional on 17 September 2015. This case involves a 68-years-old male patient who was vaccinated with 0.1 ml of IPOL (batch number: K1330-1, expiry date: 20 June 2016, dose in series, route of administration were not reported) in left forearm on 14 September 2015 instead of TUBERCULIN PPD (TB Test) in error. The patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as none. Concomitant medications were not reported. On 15 September 2015, one day following the vaccination, the patient had developed slightly less than a dime size raised red area where the vaccine was administered. The patient required ER/doctor visit. It was a wrong vaccine administered and vaccine administered at inappropriate site. Relevant diagnostic tests/laboratory data was reported as none. Corrective treatment was not reported. The patient was not recovered from the event. Follow-up information received from a physician on 13 November 2015. It was reported that Tuberculin TB was given in right forearm (batch number: 725986, expiry date: June 2016) which was to be read in 72 hours. The patient had recieved IPOL intradermally. It was reported that the patient had developed 6cm area or redness, slightly red and minimally warm at medial forearm (no evidence of ulceration, vesicles or skin sloughing) and had minimal discomfort with no ithching. The outcome of minimal discomfort was not reported. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Eye discharge, Injection site erythema, Injection site swelling, Injection site warmth, Ocular hyperaemia
Clinical narrative: Initial unsolicited report received from a nurse on 2 June 2016. This case involves a four-year-old male patient who was vaccinated with fifth dose of DAPTACEL (batch number: C4756AA, expiration date: 11 June 2017, dose and route not reported) in the right arm, fourth dose of (IPOL) (batch number: L1442-1, expiration date: 15 September 2017, dose and route not reported) in the right arm and second dose of PROQUAD (Manufacturer: Merck, batch number: M002053, expiration date, dose and route not reported) in the left arm on 31 May 2016. Patients Illness at time of vaccination was reported as Sick for 3 days before well check up, temperature of 100 with red eyes and nasal congestion. Pre-existing physician diagnosed allergies, birth defects, medical conditions was not provided. Any other vaccinations within 4 weeks of vaccinations was reported as none. Concomitant medication was not reported. On 31 May 2016 in the night, same day post vaccination, the patient had fever (104 degree Celsius). On 01 June 2016, one day post vaccination, the patient had right eye redness with discharge. On an unspecified date, post vaccination, the patient experienced right arm swollen and red, warm to touch, measured 6X8mm. It was reported that patient was not tested for cellulitis. The patient required ER or doctor visit. Laboratory data was not reported. The patient received corrective treatment with Augmentin preventatively for both arm. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 2 June 2016. This case involves a four-year-old male patient who was vaccinated with fifth dose of DAPTACEL (batch number: C4756AA, expiration date: 11 June 2017, dose and route not reported) in the right arm, fourth dose of (IPOL) (batch number: L1442-1, expiration date: 15 September 2017, dose and route not reported) in the right arm and second dose of PROQUAD (Manufacturer: Merck, batch number: M002053, expiration date, dose and route not reported) in the left arm on 31 May 2016. Patients Illness at time of vaccination was reported as Sick for 3 days before well check up, temperature of 100 with red eyes and nasal congestion. Pre-existing physician diagnosed allergies, birth defects, medical conditions was not provided. Any other vaccinations within 4 weeks of vaccinations was reported as none. Concomitant medication was not reported. On 31 May 2016 in the night, same day post vaccination, the patient had fever (104 degree Celsius). On 01 June 2016, one day post vaccination, the patient had right eye redness with discharge. On an unspecified date, post vaccination, the patient experienced right arm swollen and red, warm to touch, measured 6X8mm. It was reported that patient was not tested for cellulitis. The patient required ER or doctor visit. Laboratory data was not reported. The patient received corrective treatment with Augmentin preventatively for both arm. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.