chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Cerebrovascular accident, Dysphagia, Facial asymmetry, Muscular weakness
Clinical narrative: acute left ACA/MCA ischemia cerebrovascular accident; acute left ACA/MCA ischemia cerebrovascular accident; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided.  On or around 03-OCT-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), pt suffered right upper extremity weakness and dysphagia. Pt was hospitalized and diagnosed with acute left anterior cerebral artery (ACA)/middle cerebral artery(MCA) ischemia cerebrovascular accident with resultant right sided facial asymmetry, distal right upper extremity weakness and aphasia. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Upon internal review, acute left anterior cerebral artery (ACA)/middle cerebral artery(MCA) ischemia cerebrovascular accident  was determined to be medically significant. Acute left anterior cerebral artery (ACA)/middle cerebral artery(MCA) ischemia cerebrovascular accident was considered as disability by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Deafness neurosensory, Dizziness, Herpes zoster, Hypoaesthesia
Clinical narrative: cerebrovascular accident; sensorineural hearing loss; vertigo; shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 14-AUG-2017, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), pt suffered numbness in her extremities, vertigo, and dizziness. Pt was diagnosed with a cerebrovascular accident, vertigo, and sensorineural hearing loss. Pt also suffered a painful rash on her arms and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Upon internal review, cerebrovascular accident and sensorineural hearing loss were determined to be medically significant. All events were considered as disability by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vertigo
Clinical narrative: cerebrovascular accident; sensorineural hearing loss; vertigo; shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 14-AUG-2017, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), pt suffered numbness in her extremities, vertigo, and dizziness. Pt was diagnosed with a cerebrovascular accident, vertigo, and sensorineural hearing loss. Pt also suffered a painful rash on her arms and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Upon internal review, cerebrovascular accident and sensorineural hearing loss were determined to be medically significant. All events were considered as disability by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: fever of 101-102 onset on the evening he recieved shots.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Severe headache, chills, low-grade fever (but increasing slightly), muscle soreness at injection site.  Plan to rest and take Tylenol and monitor temperature.   I have notified my PCP.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Nervousness, Syncope
Clinical narrative: Mother of client mentioned that client was nervous.  Mother talked about friends telling them about adverse event after vaccination.  Discussed possibility of fainting and need to have Mother hold client on way to car.  Client stood in hall while nurse conversed with Mother.  Client was interacting and then stopped responding and stared and then fainted with nurse holding him gently down into squatting position.  Client regained consciousness quickly.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Twitching of right arm and hand, muscle spasms in neck and right shoulder causing flexion of the neck and back and shoulder. Started 2 days after vaccine and having more painful muscle spasms in next and shoulder today 8-11-2020.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: developed hives on face, neck, and belly
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: My son was awakened the morning following his vaccination with excrutiating pain in his left foot. No swelling, no redness, no injury, and no bug bite.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Nausea
Clinical narrative: After client received last vaccine (HPV) he began to lose consciousness, this lasted for less than one minute. When client loss consciousness his body went forward, with his head hitting the desk. No injury to forehead sustained. His body was supported to prevent him from falling onto the floor. Client gained consciousness without assistance, within a minute. He appeared flushed and slightly disoriented.  In less than five minutes he was fully aware of the situation. He was given water and an ice pack. He complained of feeling nauseous and hot. Client was monitored for 30minutes. Before leaving client denied any pain to his head and generalized. He was able to stand and walk without assistance or c/o dizziness. Client?s mother was present. She was advised to monitor patient and contact healthcare provider for further guidance. Prior to leaving clinic BP 134/56 HR 62 RESP 18
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever of 102.2 lasted for about 4 hours on 8/9/2020. Patient rested and the fever went away. Patient also felt fatigue.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient describes pain, swelling and redness at injection site 3 days post-vaccination. Range of motion reported normal.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Lethargy, Nausea, Pain
Clinical narrative: headache - 8-11 beginning about 1:00 pm body aches - 8-10  beginning about 10:00 pm fever - 8-11  beginning at 11:30 am until 4:00 pm - Took Tylenol at 11:30  (highest temp was 100.5 then dropped to 99.5 about 4:00) lethargic - 8-11 beginning about 11:00 am until about 4:00 (I took a nap for 2 hours - unusual for me to nap more than 30 minutes.) arm pain at injection site - 8:10 beginning about 3:00 pm - Tylenol at 2:00 am - pain continues in arm - It is now 4:40 pm 8-11. nausea - 8-10 beginning about 10 pm and continuing to now - 4:40 pm 8-11
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: headache - 8-11 beginning about 1:00 pm body aches - 8-10  beginning about 10:00 pm fever - 8-11  beginning at 11:30 am until 4:00 pm - Took Tylenol at 11:30  (highest temp was 100.5 then dropped to 99.5 about 4:00) lethargic - 8-11 beginning about 11:00 am until about 4:00 (I took a nap for 2 hours - unusual for me to nap more than 30 minutes.) arm pain at injection site - 8:10 beginning about 3:00 pm - Tylenol at 2:00 am - pain continues in arm - It is now 4:40 pm 8-11. nausea - 8-10 beginning about 10 pm and continuing to now - 4:40 pm 8-11
Age: 1.83
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Bacterial test positive, Body temperature increased, Chest X-ray normal, Culture urine, Full blood count
Clinical narrative: Fri, 8/7/2020 @ 6 pm, patient had seizure activity & was transported to Medical Center by ambulance. Temp 103.4. She was released from the hospital but returned several hours later with parents. Temp 104.9. She was admitted to the hospital to monitor and treat with antibiotics. Discharged home with parents on Monday, 8/10/2020.
Age: 1.83
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Lumbar puncture, SARS-CoV-2 test negative, Seizure, White blood cells urine positive
Clinical narrative: Fri, 8/7/2020 @ 6 pm, patient had seizure activity & was transported to Medical Center by ambulance. Temp 103.4. She was released from the hospital but returned several hours later with parents. Temp 104.9. She was admitted to the hospital to monitor and treat with antibiotics. Discharged home with parents on Monday, 8/10/2020.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Discomfort, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient states she woke up this morning and noticed that her left subclavicular lymph nodes were swollen. She states that they are painful to the touch and rates the pain a 3/10 on the pain scale. She reports no other adverse events at this time. Advised to take OTC pain reliever and continue to watch the area, if discomfort or swelling gets worse to seek medical care.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fall, Urticaria
Clinical narrative: Patient had left the office without complications. Patient was light headed and dizzy and fell to the floor in the elevator. Rest for about 5 minutes and drank some water.  Transferred to wheelchair and regained strength. Ambulance was called. Patient was transferred to ER due to  welts developing on arms. In ER, benadryl was given.  Was released home.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt has redness, swelling warmth around the iinjection site towards the entire dorsal left upper arm just above the elbow
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pain in extremity
Clinical narrative: Arm pain x3 day; low grade fever x3 day; generalized muscle pain x2 day; nausea x2 day; fatigue x3 day; shivering x2 day.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Arm pain x3 day; low grade fever x3 day; generalized muscle pain x2 day; nausea x2 day; fatigue x3 day; shivering x2 day.
Age: 52.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Muscle twitching, Oedema, Pain, Sensitive skin, Skin warm
Clinical narrative: symptoms began in late evening of 08/09 with chief complaint of pain, edema/swelling, warm to the tough, sensitive. pt also states he felt nauseous and had some form of twitching
Age: 52.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Swelling
Clinical narrative: symptoms began in late evening of 08/09 with chief complaint of pain, edema/swelling, warm to the tough, sensitive. pt also states he felt nauseous and had some form of twitching
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Hypoaesthesia oral, Injection site paraesthesia, Neck pain
Clinical narrative: patient states she had multiple adverse reactions after receiving her immunization.  She states her side of her mouth went numb approx. an 1/2  hour after leaving the pharmacy on the left side and injection was tingly  but went away after 15 minutes.  She was dizzy when she got up the next morning and had patches of red bumps  near her knees and on her arms that were itchy. Would describe more as bumps and not hives.  She also reported some soreness in her neck and back.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: patient states she had multiple adverse reactions after receiving her immunization.  She states her side of her mouth went numb approx. an 1/2  hour after leaving the pharmacy on the left side and injection was tingly  but went away after 15 minutes.  She was dizzy when she got up the next morning and had patches of red bumps  near her knees and on her arms that were itchy. Would describe more as bumps and not hives.  She also reported some soreness in her neck and back.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Itchiness and tingling in the left arm
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9, PPV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Pain
Clinical narrative: Chart review indicates that HPV and Pneumovax were given in the right arm. Hep A in the Left arm. Injections were given around 9:15AM  Patient called into Triage around 1:30 indicating that her arm was in pain and thought that vaccine was given to High. After Triage talked with patient around 5:30 was instructed to go to Urgent Care or the ER. Patient presented to the ER that day 7/20/20 ER Documented, Patient is a 19 y.o. female with past medical history of anxiety who presents to the emergency department for evaluation of shoulder pain. Started today after receiving 2 immunizations. Located throughout the shoulder, not present with touch but worse with movement. No numbness or tingling. No fall or injury. She received 2 immunizations of the right shoulder and 1 in the left. She also started to have left shoulder pain but is not nearly as severe. She took ibuprofen earlier. No fevers. No skin redness or swelling? Patient had Follow up with PCP 7/29/20 which documented, ?Right shoulder pain, unspecified chronicity  Patient recently in the ED for Right shoulder pain and stiffness She had 2 vaccines in that arm (HPV and Hep A) just prior to pain and stiffness Slight swelling and bruising.  No redness She says that she now doing much better Symptoms lasted about 5 days. Towards the end of her course pain went in to left shoulder as well.  Later she was evaluated by Ortho. Both ED and Ortho evals were benign?
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9, PPV
Symptoms: Pain in extremity
Clinical narrative: Chart review indicates that HPV and Pneumovax were given in the right arm. Hep A in the Left arm. Injections were given around 9:15AM  Patient called into Triage around 1:30 indicating that her arm was in pain and thought that vaccine was given to High. After Triage talked with patient around 5:30 was instructed to go to Urgent Care or the ER. Patient presented to the ER that day 7/20/20 ER Documented, Patient is a 19 y.o. female with past medical history of anxiety who presents to the emergency department for evaluation of shoulder pain. Started today after receiving 2 immunizations. Located throughout the shoulder, not present with touch but worse with movement. No numbness or tingling. No fall or injury. She received 2 immunizations of the right shoulder and 1 in the left. She also started to have left shoulder pain but is not nearly as severe. She took ibuprofen earlier. No fevers. No skin redness or swelling? Patient had Follow up with PCP 7/29/20 which documented, ?Right shoulder pain, unspecified chronicity  Patient recently in the ED for Right shoulder pain and stiffness She had 2 vaccines in that arm (HPV and Hep A) just prior to pain and stiffness Slight swelling and bruising.  No redness She says that she now doing much better Symptoms lasted about 5 days. Towards the end of her course pain went in to left shoulder as well.  Later she was evaluated by Ortho. Both ED and Ortho evals were benign?
Age: 14.0
Sex: M
Vaccine: HPV9, PNC13
Symptoms: Activated partial thromboplastin time normal, Angiogram normal, Aphasia, Confusional state, Electrocardiogram normal
Clinical narrative: Acute onset of severe headache, confusion, aphasia, muscular weakness, nausea, and vomiting
Age: 14.0
Sex: M
Vaccine: HPV9, PNC13
Symptoms: Full blood count normal, Headache, Laboratory test normal, Magnetic resonance imaging brain normal, Metabolic function test normal
Clinical narrative: Acute onset of severe headache, confusion, aphasia, muscular weakness, nausea, and vomiting
Age: 14.0
Sex: M
Vaccine: HPV9, PNC13
Symptoms: Muscular weakness, Nausea, Troponin normal, Vomiting
Clinical narrative: Acute onset of severe headache, confusion, aphasia, muscular weakness, nausea, and vomiting
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Alopecia, Altered state of consciousness, Asthenia, Blood test normal, Crying
Clinical narrative: A few days after I received my Fall 2019 flu shot, I had awful side effects. I was going to class full-time and I all of a sudden had weak knees, I couldn't even make it back to my car after class. I was suddenly very lightheaded, I was crying uncontrollably for no reason, my hair was falling out, I couldn't even drive a mile down the road without feeling like I was going to pass out at any minute. These side effects lasted for about a month. To this day, I suffer every single day of lightheadedness/dizziness. It all came down after I received my flu shot. I've taken flu shots every single year and I have never had side effects. I take therapy for it and I have what they call "sensory mismatch." It is very common to have after a live virus enters your system. My life has been a living hell after last year's flu shot, unfortunately.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Impaired driving ability
Clinical narrative: A few days after I received my Fall 2019 flu shot, I had awful side effects. I was going to class full-time and I all of a sudden had weak knees, I couldn't even make it back to my car after class. I was suddenly very lightheaded, I was crying uncontrollably for no reason, my hair was falling out, I couldn't even drive a mile down the road without feeling like I was going to pass out at any minute. These side effects lasted for about a month. To this day, I suffer every single day of lightheadedness/dizziness. It all came down after I received my flu shot. I've taken flu shots every single year and I have never had side effects. I take therapy for it and I have what they call "sensory mismatch." It is very common to have after a live virus enters your system. My life has been a living hell after last year's flu shot, unfortunately.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Presyncope
Clinical narrative: DIZZINESS AND PRESYNCOPE
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Patient experienced a warm rash outbreak from her neck all the way to the bottom of her torso. This included her arms.
Age: 72.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: cellulitis, red & swollen at and surrounding the injection site
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Skin discolouration, Swelling
Clinical narrative: Patient said she developed black tiny spots on her arm, bruising and swelling
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Seizure, Somnolence
Clinical narrative: Shortly after receiving the 3 vaccines (order: Trumenba, Gardisil, Menactra), the patient experience what appeared to be a seizure episode lasting for around half a minute. The patient's mother was present at the time. The patient's informed consent and mother indicated that patient has not had history of seizure. When the episode ended, the patient stated that he thought he fell asleep.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Massive headache Nausea Diarrhea Body ache Fatigue For 3 days Extreme lightheadedness/dizzy
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Massive headache Nausea Diarrhea Body ache Fatigue For 3 days Extreme lightheadedness/dizzy
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site nodule, Injection site pain, Injection site reaction, Muscle spasms, Muscle tightness
Clinical narrative: Patient came back about 1 week after vaccine administration and described a 'knot' feeling at the administration site. Arm was sore and hurt for 6 days. 8/11/20 was the first day that her arm felt ok and more normal. Left deltoid muscle was tight, sore, and knotted up for 6 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient came back about 1 week after vaccine administration and described a 'knot' feeling at the administration site. Arm was sore and hurt for 6 days. 8/11/20 was the first day that her arm felt ok and more normal. Left deltoid muscle was tight, sore, and knotted up for 6 days.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash morbilliform
Clinical narrative: rash (measles like rash) adenopathy
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pallor, Seizure, Tremor
Clinical narrative: Pt came in with mom for a flu. She was checked in with normal temp of 98. Potential SE from Flu shot was explained to pt and her mom, including injection site irritation and fever. Also informed what to do in event of these SE occurring. Prior to immunization given, pt seems nervous and anxious. Flu shot was given around 1pm. I, Rph, gave her the shot following the normal protocol and proper injection technique. Immediately following the shot she said it stung at the injection site. Notified her that it was normal and to ice it if it gets swollen or irritated more. Also informed pt's party to let us know if anything else. Pt was snapping at her mom stating that she really needed to eat. She was quite inpatient about getting something to eat. After confirming all questions answered and I walked away from the pt and into the pharmacy. Within a few seconds, I heard a loud yelling, but didn't hear what was said. Initially, I was under the impression that mom and daughter were fighting since pt, the daughter, had been rude to her mom before and after the injection. Then I started to hear "HELP, HELP, she's having a seizure." I ran outside immediately with an epinephrine pen to assess pt. Upon getting to her, she came back to be awake and alert, but seemed very pale. I did not witness what has happened since it was over by the time I got there. Mom and I agree that it probably only lasted for 10-15 seconds. Mom described event to be where she started shaking with her arms crossed in a locked position. Her body was stiff and went into seizure. Again, by the time I came back out, pt was awake and alert already, but didn't remember what had happened. I measure her temperature again and it measured 95 degrees. Gave her some water and chocolate per pt's request as she continued to complain that she wanted to get out to go eat. She also stated that she felt hot and sweaty. In the meantime, as soon as my tech saw me run to pt, he called 911 and they got to us within about 5 minutes. They assessed her and took her to ER. We were informed that her BP and HR was low. In my opinion, this event is unlikely to be a direct consequence of flu shot side effect or injection technique error. I believe that pt may have had other conditions, physical or mental, pre-existing prior to the shot given and her getting the shot escalated the condition to lead to her having a possible syncope or seizure episode. The mom was here during the whole event. She has been communicated as stated above of potential SE from Flu shot and what is to be expected. Took necessary actions following event to make sure pt was taken care of and assisted EMT in providing them with all necessary information. Pt was taken to ER with mom. Mom was informed of my name and asked mom to give us a call if needing anything else and to let us know what happens. Mom was also informed that we are filing a report. Called Risk Management team and opened up a case.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lymphocyte count decreased, Nausea, Swelling face, White blood cell count
Clinical narrative: (L) sided facial swelling, chills nausea
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Patient's mother reports patient was covered head to toe in hives approximately 36 hours after receiving the vaccine, states resolved with Benadryl use. Denies coming in contact with any new foods, detergents, or environmental items
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, UNK
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: syncope episode/she thought he was having a seizure becuase his body jerked one time when he was having syncope episode; This report was identified from a line listing obtained on request by the Company from the FDA (VAERS ID: 826197) under the Freedom of Information Act. This spontaneous report was received from a licensed practical nurse and refers to a 16-year-old male patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient historical condition included faint (several times). On 30-JUL-2019 at 09:20, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, in left arm, lot # 1602283, expiration date was not provided, but upon internal validation it was established as 18-AUG-2021 (strength and dose were not reported), for prophylaxis. Other suspected vaccines administered at the same time included a second dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) intramuscularly, in left arm, lot # U6208AB and a first dose meningococcal b rfhbp vaccine (e. coli)(TRUMENBA) intramuscularly, in right arm, lot # X46476 (strength, dose and indication were not reported).  The patient was sitting upright on exam table and meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) was administered in right deltoid. Then proceeded to left arm and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered. The patient immediately had a syncope episode (30-JUL-2019 at 09:20). The patient was placed on the table. His mom thought he was having a seizure because his body jerked one time when he was having syncope episode. He was "out" for 10-15 seconds. The patient's legs were elevated above heart level. He was talking and responding to surroundings. The patient was observed for few minutes before leaving the office. The outcome was reported as recovered (the patient said he was fine). The causality assessment was not provided. The agency considered the report to be non-serious.  Follow-up information has been received from the reporting licensed practical nurse on 05-AUG-2020. The reporter was unable to fill out a vaccine letter which she was sent via mail due to lack of patient identifiers. No further information was available. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: 1602283; expirationdate: 18-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 11.0
Sex: U
Vaccine: HPV9, MNQ, TDAP, MNQ, HPV9, MNQ, TDAP
Symptoms: Bradycardia, Hypotension, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: syncope; This spontaneous report as received from a registered nurse refers to a 11 year old patient.    On 03-AUG-2020 the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # S028737 expiration date 03-APR-2022, for prophylaxis); diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid(BOOSTRIX) (Lot # C5JL7) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (Lot # U6596AB).  On te same date, the patient experienced syncope after receiving the vaccines.    At the reporting time, the patient was sent home in stable condition.   The causal relationship between the suspect therapies and the event was not provided.  Upon internal review, syncope was considered a medically significant event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 11.0
Sex: U
Vaccine: HPV9, MNQ, TDAP, MNQ, HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: syncope; This spontaneous report as received from a registered nurse refers to a 11 year old patient.    On 03-AUG-2020 the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # S028737 expiration date 03-APR-2022, for prophylaxis); diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid(BOOSTRIX) (Lot # C5JL7) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (Lot # U6596AB).  On te same date, the patient experienced syncope after receiving the vaccines.    At the reporting time, the patient was sent home in stable condition.   The causal relationship between the suspect therapies and the event was not provided.  Upon internal review, syncope was considered a medically significant event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 11.0
Sex: U
Vaccine: HPV9, MNQ, TDAP, MNQ, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report as received from a registered nurse refers to a 11 year old patient.    On 03-AUG-2020 the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # S028737 expiration date 03-APR-2022, for prophylaxis); diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid(BOOSTRIX) (Lot # C5JL7) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (Lot # U6596AB).  On te same date, the patient experienced syncope after receiving the vaccines.    At the reporting time, the patient was sent home in stable condition.   The causal relationship between the suspect therapies and the event was not provided.  Upon internal review, syncope was considered a medically significant event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Soreness at sight of injection Mild headache
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: GARDASIL 9 was out of the refrigerator; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 11-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R030453, expiration, date 23-JUL-2020 for prophylaxis (exact dose, vaccine schedule, anatomical location and route of administration were not provided) that might have been improperly stored.  On 13-MAY-2020, the reporter stated that the reporter's facility was made aware that the box of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was out of the refrigerator. It was unknown what date it was taken out of the refrigerator. At the time of this report, product was still out of temperature range. It was unknown whether there were previous temperature excursions or if digital data logger was involved.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA008545:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; GARDASIL 9 was stored improperly and administered; This spontaneous report was received from a licensed practical nurse and refers a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, concomitant medications and drug reactions or allergies.  On 29-JUL-2020, the patient was vaccinated with an improperly stored dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# 1637651 and expiration date 09-JUN-2022 for prophylaxis (exact dose, route and site of administration were not reported). Administered dose of vaccine was exposed to the temperature of 50 degrees Fahrenheit (F) for 1 hour and 46 minutes. There was no previous temperature excursion. The call was because of a digital data logger. There were no additional adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000326: US-009507513-2008USA000372: US-009507513-2008USA000367: US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2007USA012124: US-009507513-2007USA012061: US-009507513-2007USA012060: US-009507513-2007USA012054: US-009507513-2007USA012014: US-009507513-2008USA000266: US-009507513-2008USA000307: US-009507513-2008USA000370:
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: herpes zoster eye disease; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 08-JUN-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by the healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: herpes zoster and herpes zoster eye disease. The outcomes of the events were not provided. The reporter assessed that the events were related to the zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of herpes zoster eye disease was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster oticus
Clinical narrative: zoster related hearing loss; zoster related hearing loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a hospital for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician at a vision center for zoster related hearing loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), hte pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered the events of zoster related hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness bilateral, Deafness neurosensory
Clinical narrative: Bilateral sensorineural hearing loss; This initial spontaneous report was received from a lawyer on 03-AUG-2020, regarding a case in litigation and refers to a female patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 13-APR-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a decline in hearing and was diagnosed with bilateral sensorineural hearing loss. As a direct and proximate result of vaccination, the patient's symptoms resulted in physical limitations not present prior to the use of the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Neuropathy peripheral, Pain
Clinical narrative: Neuropathy; Vision loss; Trigeminal neuropathy; This initial spontaneous report was received from a lawyer on 03-AUG-2020, regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 31-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered burning pain on the left side of his face. The patient was diagnosed with neuropathy, trigeminal neuropathy and vision loss. As a direct and proximate result of vaccination, the patient's symptoms resulted in physical limitations not present prior to the use of the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmic herpes zoster
Clinical narrative: zoster related vision loss; zoster related vision loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at an eye center for zoster related vision loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered the events of zoster related vision loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was determined to be medically significant.