chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Erythema of eyelid, Eyelid oedema, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Mom called regarding high fever of 105F (rectal).  Fever started at 1600 on 1/7/2020.  Patient without other symtoms besides fever.  Patient was evaluated in our office on 1/8/2020, flu testing performed and was negative.  Patient looking well without other symptoms.  High fever continued and peaked at 105.9F on 1/10/2020. Patient was rechecked in our office on 1/10/2020 and had mild upper left eyelid erythema and edema, however no other symtoms and was looking well, no other testing was performed.  Patients fever resolved and no fever noted since morning of 1/11/20.  Patient subsequently has been well since.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Mom called regarding high fever of 105F (rectal).  Fever started at 1600 on 1/7/2020.  Patient without other symtoms besides fever.  Patient was evaluated in our office on 1/8/2020, flu testing performed and was negative.  Patient looking well without other symptoms.  High fever continued and peaked at 105.9F on 1/10/2020. Patient was rechecked in our office on 1/10/2020 and had mild upper left eyelid erythema and edema, however no other symtoms and was looking well, no other testing was performed.  Patients fever resolved and no fever noted since morning of 1/11/20.  Patient subsequently has been well since.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Neck pain, Pain, Swelling
Clinical narrative: Redness, swelling, pain radiating to axilla and neck
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient was treated for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX), the patient 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 included 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 not recovered. The event was considered related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Chills, Dizziness, Syncope
Clinical narrative: The patient experienced dizziness, shivers, and syncope following vaccination with VAQTA, GARDASIL9, and TRUMEBA.; The patient experienced dizziness, shivers, and syncope following vaccination with VAQTA, GARDASIL9, and TRUMEBA.; The patient experienced dizziness, shivers, and syncope following vaccination with VAQTA, GARDASIL9, and TRUMEBA.; This spontaneous report was received from a nurse referring to a 13-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were unknown by the reporter. The patient's historical vaccines included meningococcal b rfhbp vaccine (e. coli) (TRUMENBA).  On 04-JAN-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not reported), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) (dosage schedule, route, anatomical location, lot number, and expiration date of the three vaccines were unknown by the reporter) for vaccination prophylaxis..  On the same day during an office visit following vaccination, the patient experienced syncope, shivers (chills) and dizziness. After 2 minutes, the patient recovered consciousness. The patient also mentioned that she had not had breakfast before going to the doctor's office. No treatment was provided for the adverse events. It was reported that the patient sought medical attention since she was in the physician's office at the time. The outcome of syncope, chills, and dizziness was reported as recovered.   The causality assessment between the adverse events and the suspect therapy was not provided.  Upon internal review, the event syncope was considered to be medically significant.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Borrelia test negative, Joint stiffness, Malaise, Middle insomnia
Clinical narrative: "significant pain in my joints for the past 2 months. It started in my neck where I could not find a pillow to support my neck for about 10 days. I would wake up during the night needing to manually turn my head. After settling on a feather pillow that has helped some. Then it spread down thru both shoulders, upper back, hips & knees. I have been trying to do some back stretches, leg lifts, neck exercises on most days without relief. It takes considerable effort to turn in bed, get out of bed, squatting low is near impossible. Prior to all the joints aching, my left leg was super tight with pain around the knee joint. My L knee doesnt appear to be swollen but is tender. I have not done anything traumatizing & have greatly reduced my ability to move items. I am not aware of any bug bites. I had the Shingrix vaccine #1 in late October with one day of malaise. My hip pain has mostly resolved since 12/24. I got a upper back/neck massage on 12/10 which eased some tightness."
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Neck pain, Red blood cell sedimentation rate increased
Clinical narrative: "significant pain in my joints for the past 2 months. It started in my neck where I could not find a pillow to support my neck for about 10 days. I would wake up during the night needing to manually turn my head. After settling on a feather pillow that has helped some. Then it spread down thru both shoulders, upper back, hips & knees. I have been trying to do some back stretches, leg lifts, neck exercises on most days without relief. It takes considerable effort to turn in bed, get out of bed, squatting low is near impossible. Prior to all the joints aching, my left leg was super tight with pain around the knee joint. My L knee doesnt appear to be swollen but is tender. I have not done anything traumatizing & have greatly reduced my ability to move items. I am not aware of any bug bites. I had the Shingrix vaccine #1 in late October with one day of malaise. My hip pain has mostly resolved since 12/24. I got a upper back/neck massage on 12/10 which eased some tightness."
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Blood test normal, Bronchitis, Dyspnoea, Malaise
Clinical narrative: After 3 days patient had low energy and did not feel well.  Three days after the high fever started and had problems breathing.   The progression was slow.  After 4 days took went to doctor for fever. Doctor noticed red spots in mouth and specified it might be virus related. Blood results were negative.   Symptoms continued and school kept calling specifying patient was sick.  Patient went to doctor again with same symptoms; the chest X-rays were negative. Patient had problems breathing again so went to the doctor and diagnosed with bronchitis. Patient prescribed antibiotics and nebulizer to help with breathing. Patient's symptoms improved a little with medicine.   In December patient had one doctor visit and directed to continue with nebulizer.  The last doctor visit was 3 days ago and per doctor, it might be asthma.  Patient has problems breathing every time he runs.  Patient is not sure if patient continues to have bronchitis or asthma.  Patient was healthy before vaccine.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Oral mucosal eruption, Rash erythematous
Clinical narrative: After 3 days patient had low energy and did not feel well.  Three days after the high fever started and had problems breathing.   The progression was slow.  After 4 days took went to doctor for fever. Doctor noticed red spots in mouth and specified it might be virus related. Blood results were negative.   Symptoms continued and school kept calling specifying patient was sick.  Patient went to doctor again with same symptoms; the chest X-rays were negative. Patient had problems breathing again so went to the doctor and diagnosed with bronchitis. Patient prescribed antibiotics and nebulizer to help with breathing. Patient's symptoms improved a little with medicine.   In December patient had one doctor visit and directed to continue with nebulizer.  The last doctor visit was 3 days ago and per doctor, it might be asthma.  Patient has problems breathing every time he runs.  Patient is not sure if patient continues to have bronchitis or asthma.  Patient was healthy before vaccine.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Hep A vaccine given before approved age. No reported adverse events
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: Patient reporting pain in left arm 1 month after the injection.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Bronchiolitis, C-reactive protein increased, CSF red blood cell count, CSF white blood cell count negative
Clinical narrative: Status epilepticus with generalized seizure for 45-60 minutes, with intermittent seizures even after versed administration by EMS. Required intubation due to respiratory distress and worsening mental status, possibly secondary to versed. Also possible aspiration pneumonia due to seizure. Observed on continuous EEG overnight without clinical or subclinical seizures. Urinalysis was not concerning for UTI. Given 1 dose of Keppra and then discontinued due to lack of seizures on EEG. Was extubated the next day 01/14/2020 and transferred to the floor. However on 01/15/2020 developed respiratory distress likely secondary to bronchiolitis and/or pneumonia and was transferred back to ICU for increased respiratory support. Still hospitalized in ICU at this time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray abnormal, Computerised tomogram head normal, Culture urine negative, Electroencephalogram normal, Endotracheal intubation
Clinical narrative: Status epilepticus with generalized seizure for 45-60 minutes, with intermittent seizures even after versed administration by EMS. Required intubation due to respiratory distress and worsening mental status, possibly secondary to versed. Also possible aspiration pneumonia due to seizure. Observed on continuous EEG overnight without clinical or subclinical seizures. Urinalysis was not concerning for UTI. Given 1 dose of Keppra and then discontinued due to lack of seizures on EEG. Was extubated the next day 01/14/2020 and transferred to the floor. However on 01/15/2020 developed respiratory distress likely secondary to bronchiolitis and/or pneumonia and was transferred back to ICU for increased respiratory support. Still hospitalized in ICU at this time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enterovirus test negative, Full blood count normal, Herpes simplex test negative, Intensive care, Liver function test increased
Clinical narrative: Status epilepticus with generalized seizure for 45-60 minutes, with intermittent seizures even after versed administration by EMS. Required intubation due to respiratory distress and worsening mental status, possibly secondary to versed. Also possible aspiration pneumonia due to seizure. Observed on continuous EEG overnight without clinical or subclinical seizures. Urinalysis was not concerning for UTI. Given 1 dose of Keppra and then discontinued due to lack of seizures on EEG. Was extubated the next day 01/14/2020 and transferred to the floor. However on 01/15/2020 developed respiratory distress likely secondary to bronchiolitis and/or pneumonia and was transferred back to ICU for increased respiratory support. Still hospitalized in ICU at this time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain normal, Mental status changes, Metabolic function test normal, Pneumonia
Clinical narrative: Status epilepticus with generalized seizure for 45-60 minutes, with intermittent seizures even after versed administration by EMS. Required intubation due to respiratory distress and worsening mental status, possibly secondary to versed. Also possible aspiration pneumonia due to seizure. Observed on continuous EEG overnight without clinical or subclinical seizures. Urinalysis was not concerning for UTI. Given 1 dose of Keppra and then discontinued due to lack of seizures on EEG. Was extubated the next day 01/14/2020 and transferred to the floor. However on 01/15/2020 developed respiratory distress likely secondary to bronchiolitis and/or pneumonia and was transferred back to ICU for increased respiratory support. Still hospitalized in ICU at this time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Polymerase chain reaction, Procalcitonin increased, Respiratory distress, Respiratory syncytial virus test positive, Respiratory viral panel
Clinical narrative: Status epilepticus with generalized seizure for 45-60 minutes, with intermittent seizures even after versed administration by EMS. Required intubation due to respiratory distress and worsening mental status, possibly secondary to versed. Also possible aspiration pneumonia due to seizure. Observed on continuous EEG overnight without clinical or subclinical seizures. Urinalysis was not concerning for UTI. Given 1 dose of Keppra and then discontinued due to lack of seizures on EEG. Was extubated the next day 01/14/2020 and transferred to the floor. However on 01/15/2020 developed respiratory distress likely secondary to bronchiolitis and/or pneumonia and was transferred back to ICU for increased respiratory support. Still hospitalized in ICU at this time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure, Status epilepticus, Urine analysis normal
Clinical narrative: Status epilepticus with generalized seizure for 45-60 minutes, with intermittent seizures even after versed administration by EMS. Required intubation due to respiratory distress and worsening mental status, possibly secondary to versed. Also possible aspiration pneumonia due to seizure. Observed on continuous EEG overnight without clinical or subclinical seizures. Urinalysis was not concerning for UTI. Given 1 dose of Keppra and then discontinued due to lack of seizures on EEG. Was extubated the next day 01/14/2020 and transferred to the floor. However on 01/15/2020 developed respiratory distress likely secondary to bronchiolitis and/or pneumonia and was transferred back to ICU for increased respiratory support. Still hospitalized in ICU at this time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure
Clinical narrative: Status epilepticus with generalized seizure for 45-60 minutes, with intermittent seizures even after versed administration by EMS. Required intubation due to respiratory distress and worsening mental status, possibly secondary to versed. Also possible aspiration pneumonia due to seizure. Observed on continuous EEG overnight without clinical or subclinical seizures. Urinalysis was not concerning for UTI. Given 1 dose of Keppra and then discontinued due to lack of seizures on EEG. Was extubated the next day 01/14/2020 and transferred to the floor. However on 01/15/2020 developed respiratory distress likely secondary to bronchiolitis and/or pneumonia and was transferred back to ICU for increased respiratory support. Still hospitalized in ICU at this time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash
Clinical narrative: deltoid cellulitis and rash 1 day after vaccine
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Mom did not want him to receive pertussis vaccine. Pentacel was given in error. Vaers is being filled out due to administration error. Patient had no side effects of pentacel while at our office.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: flu-like symptoms, (aches and chills)
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site discolouration, Injection site indentation, Ultrasound scan, X-ray
Clinical narrative: Client's mom reports that approximately 1 week after vaccines were given on 11/25/19 that she noticed a discoloration on child's left thigh. Mom stated that child did not run a fever and had no signs of discomfort and no redness to area. Reports that after "a few days" she noticed an "indentation" on discolored area "especially when she stand up". Mom reported no other notable problems. Mom brought child back into clinic on 12-26-19 for evaluation. child was active and alert, standing and bouncing on mom's lap. Area on left leg noted to be slightly darker than surrounding skin. Approximately the size of a quarter, in an hour glass shape with notable indentation. Area is more in the middle of the front thigh area, not the vastus lateralus.  No redness or bruising present.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Somnolence, Urine output decreased, Vomiting
Clinical narrative: Ate lunch  and vomited shortly after, decreased wet diapers since morning, sleepiness
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain upper, Asthenia, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: On December 12, 2019 My body was very weak and sick, I was Nausea, stomach pain, dizziness and stiffness in trying to walk. A weird  feeling in my head along with a severe headache, my eyes hurt in the light.  It is the worst feeling ever.  Today is January 15, 2020, and I still feel very sick on different days, I feel weak and tired  with headaches. It is hard to get around and trying to work on those days is very difficult.
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Headache, Impaired work ability
Clinical narrative: On December 12, 2019 My body was very weak and sick, I was Nausea, stomach pain, dizziness and stiffness in trying to walk. A weird  feeling in my head along with a severe headache, my eyes hurt in the light.  It is the worst feeling ever.  Today is January 15, 2020, and I still feel very sick on different days, I feel weak and tired  with headaches. It is hard to get around and trying to work on those days is very difficult.
Sex: F
Vaccine: RAB
Symptoms: Malaise, Musculoskeletal stiffness, Nausea, Photophobia
Clinical narrative: On December 12, 2019 My body was very weak and sick, I was Nausea, stomach pain, dizziness and stiffness in trying to walk. A weird  feeling in my head along with a severe headache, my eyes hurt in the light.  It is the worst feeling ever.  Today is January 15, 2020, and I still feel very sick on different days, I feel weak and tired  with headaches. It is hard to get around and trying to work on those days is very difficult.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Diarrhoea, Dyspepsia, Eructation, Vomiting
Clinical narrative: I woke up at 0230 6 hours after the vaccine was administered with indigestion, sulfur burps, vomiting and liquid stool. These symptoms continued for about 2 hours. I still had liquid stool when I woke up at 0800, but I felt better. I did not seek treatment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Pain
Clinical narrative: Extreme soreness and tenderness at injection site. Headache, body aches, joint aches, chills. Only treatment to far is Ibuprofen.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Magnetic resonance imaging, Mobility decreased, Pain
Clinical narrative: Sharp Pain, pain running down arm, throbbing. worsened over time. Can no longer lift arm, or do much of anything anymore. numbness in fingers. relentless pain
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, X-ray
Clinical narrative: Sharp Pain, pain running down arm, throbbing. worsened over time. Can no longer lift arm, or do much of anything anymore. numbness in fingers. relentless pain
Age: 32.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Tenderness
Clinical narrative: Patient experienced a shingles outbreak after receiving the first dose of the shingrix vaccine. Patient reports " I have a new patchy erythematous rash on my neck, tender, not pruritic. Worried I have shingles again" and reports "That it?s acute in onset, tender, and not spreading beyond the dermatome."  Patient has no history of psoriasis or eczema.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Soreness at vaccination site and diarrhea
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Erythema, Fatigue, Pain, Pain in extremity
Clinical narrative: After receiving PCV13 on 11/11/19, patient reports feeling dizzy and tired that night. This self-resolved but on 11/12/19, she started getting Left arm pain with redness, swelling. No fever, chills, nausea, or vomiting.  Might have had similar vaccine reaction in past (not sure) but never this significant.   Slight pain, 3/10.  Rash is not spreading, no where else on body.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Rash
Clinical narrative: After receiving PCV13 on 11/11/19, patient reports feeling dizzy and tired that night. This self-resolved but on 11/12/19, she started getting Left arm pain with redness, swelling. No fever, chills, nausea, or vomiting.  Might have had similar vaccine reaction in past (not sure) but never this significant.   Slight pain, 3/10.  Rash is not spreading, no where else on body.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Epicondylitis, Rash
Clinical narrative: patient experienced tennis elbow the next day and said it spread to her other arm within a month and a half. rash on inject site arm appeared within a week
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Chills, Diarrhoea, Joint stiffness, Nausea
Clinical narrative: Chest pain, pain in arms, fever, chills, nausea and diarrhea, stiffness in jaw that ceased after waking up.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chest pain, pain in arms, fever, chills, nausea and diarrhea, stiffness in jaw that ceased after waking up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Seen back in office 2 days after vaccine with 2-3 cm of very warm, red, indurated skin in sharply demarcated area at the MMR injection site, treated for cellulitis with Keflex x 5 days.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Rash erythematous
Clinical narrative: Allergic reacción. Manny big and red spots.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Chills, Crying, Vomiting
Clinical narrative: After vaccine patient is crying all the time.  Patient went to school and complained stomach hurt, crying and vomiting.  Patient did not have fever so parent's have not called the doctor yet or provide any medication/treatment. Today, patient has chills and is throwing up severely--might take her to the ER
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Pt only relieved half a dose. Diluent used was Sterile water and not the supplied Diluent. Parents notified Jan 15, 2020 when error was discovered, and are returning to clinic for correct dose on Jan 17, 2020.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain, Periarthritis, X-ray limb
Clinical narrative: Patient alleges the vaccine caused her to have a frozen shoulder. Pain and decrease mobility happened with the next 24 hours. It has continued the last two months, however is starting to improve.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Weakness and nerve pain in left arm (injection arm), shoulder, top of back and chest.  Pain would be acute at times and lasted for approximately one month.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Neuralgia
Clinical narrative: Weakness and nerve pain in left arm (injection arm), shoulder, top of back and chest.  Pain would be acute at times and lasted for approximately one month.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Rash pruritic
Clinical narrative: The patient came in today for her medication and she was due to her second shingles vaccine.  She stated she had a rash after the first vaccine that only appeared on her back.  She could not identify the exact date it started; however, she did state that it appeared after vaccination and progressively worsened.  She finally went to see the doctor on 10/7/19 after the rash kept getting worse.  She stated the rash was incredibly itchy and uncomfortable.  She stated the doctor didn't think it was shingles; however, the patient took at 7 day course of Valtrex 1000mg TID for 7 days and it made the rash less itchy and more manageable.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Malaise
Clinical narrative: Patient is very weak and sick feeling.  no temperature reported
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Tendonitis
Clinical narrative: Pt states that a few weeks after receiving the vaccination, her arm began to hurt and she had difficulty lifting it.  She did see an urgent care doctor in January 2020 and she states that he informed her that she has Tendonitis caused by the flu shot given in September
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Decreased appetite, Dizziness, Headache
Clinical narrative: First day: sore arm, Second day: 4 inches of swelling and firm skin, soreness from shoulder to fingers, fever, flu like symptoms, fever, chills, lack of appetite, nausea, dizziness, headache, confusion. Third day: felt normal other than arm soreness
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain in extremity, Pyrexia, Skin induration
Clinical narrative: First day: sore arm, Second day: 4 inches of swelling and firm skin, soreness from shoulder to fingers, fever, flu like symptoms, fever, chills, lack of appetite, nausea, dizziness, headache, confusion. Third day: felt normal other than arm soreness
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: First day: sore arm, Second day: 4 inches of swelling and firm skin, soreness from shoulder to fingers, fever, flu like symptoms, fever, chills, lack of appetite, nausea, dizziness, headache, confusion. Third day: felt normal other than arm soreness
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: At 2:45 woke up and started to have severe shivers like shuttering. Patient was shaking severely so used deep breathing technique to control them and go back to sleep. These episodes repeated throughout the night. At about 5:30am shivering stopped, and finally got to sleep until 11:30am.  Patient had severe headache in temples; it started at night but severe by the time he woke up. Patient was very tired and fatigued--it felt like a sinus headache.   Around noon, patient called doctor who recommended Advil instead of aspirin.  Medicine helped but he still felt fatigued, sore and did not eat until 5-6pm because woke up with nausea.  Patient took Advil again by 5pm to prevent the headache. At night patient had to wake up every 4 hours to urinate but was able to get a good rest.  After first dose of shingles did not have any problems to cause trepidation about getting the next dose. Patient has received several vaccines overtime with no problems because he traveled overseas and has military background. In addition, patient is relatively active. Today felt most like himself but still fatigued.  Arm still is sore at vaccine site.  Recovery is at 95%.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Sinus headache, Tremor
Clinical narrative: At 2:45 woke up and started to have severe shivers like shuttering. Patient was shaking severely so used deep breathing technique to control them and go back to sleep. These episodes repeated throughout the night. At about 5:30am shivering stopped, and finally got to sleep until 11:30am.  Patient had severe headache in temples; it started at night but severe by the time he woke up. Patient was very tired and fatigued--it felt like a sinus headache.   Around noon, patient called doctor who recommended Advil instead of aspirin.  Medicine helped but he still felt fatigued, sore and did not eat until 5-6pm because woke up with nausea.  Patient took Advil again by 5pm to prevent the headache. At night patient had to wake up every 4 hours to urinate but was able to get a good rest.  After first dose of shingles did not have any problems to cause trepidation about getting the next dose. Patient has received several vaccines overtime with no problems because he traveled overseas and has military background. In addition, patient is relatively active. Today felt most like himself but still fatigued.  Arm still is sore at vaccine site.  Recovery is at 95%.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site inflammation, Injection site pain, Pain, Pain in extremity
Clinical narrative: Adverse reaction to flu shot: Pt stated that she has had pain in deltoid area from September after getting her flu shot until now (Jan. 14th). When she rolls over onto her arm, it's painful, it's painful to lift her arm, and she sometimes feels it in her back. She said the whole area feels inflamed. I suggested she talk with her doctor about the adverse reaction.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction to flu shot: Pt stated that she has had pain in deltoid area from September after getting her flu shot until now (Jan. 14th). When she rolls over onto her arm, it's painful, it's painful to lift her arm, and she sometimes feels it in her back. She said the whole area feels inflamed. I suggested she talk with her doctor about the adverse reaction.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: THERE WAS TOMATO REDNESS ON THE SITE OF INJECTION SPREADING ALMOST THE ENTIRE UPPER ARM ON THE FRONT AND BACK SIDE AND PAIN TO THE TOUCH. WHEN ASKED, PATIENT SAID THERE IS NO FEVER. SHE FELT SLIGHTLY NAUSEOUS BUT NOT SERIOUSLY SICK. I ADVISED HER TO USE APPLY COLDNESS ON TO SEE IF THAT WOULD ALLEVIATE THE WARM REDNESS BUT DO NOT APPLY DIRECTLY ONTO THE AFFECTED AREA BUT ON TOP OF A TOWEL.  IF NO IMPROVEMENT BY THE END OF TODAY, EITHER GO TO ER OR CALL DOCTOR.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb immobilisation, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Second night it felt like my shoulder dislocated when lifting arm. Had to support my arm as if it were in a sling. It took almost an hour before it returned to normal. The pain was excruciating.  One week later, the same event happened. Now I have intermittent pain shooting down left arm. The pain is bad.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Poor quality sleep
Clinical narrative: Immediate pain, constant burning in arm from shoulder to elbow. Cannot raise my arm above my head, cannot put arm all the way behind my back. Not sleeping well due to the pain & the burning.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Chills, Pyrexia, Tremor
Clinical narrative: Approximately one half hour of receiving  the vaccine I felt very unsteady. Within minutes, I began to have horrendous chills to the point of near continuous  shaking for nearly two hours. I tried to stay warm every way I could. These affects finally subsided into a low grade fever.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Cystoscopy normal, Pollakiuria, Urine analysis
Clinical narrative: 6 months of urinary frequency
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complained that the site of injections remain painful months after the event.  Pain is on and off , usually during cold weather.   No other symptoms reported.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Audiogram abnormal, Deafness unilateral, Dysacusis, Nerve injury, Sudden hearing loss
Clinical narrative: ON 12/10/2019 I had the 2nd of 2 shingrix vaccines. On 12/16/19 I noticed a sudden and obvious hearing loss, overnight. I also started hearing sounds echo. I visited a care facility on 12/28/19 and they were unable to diagnose, they prescribed a 10 day regiment of Amoxicillin, with no change in hearing after treatment. On 1/13/2020 I went to an ENT and had a hearing and ear pressure test. They identified significant hearing loss in the L ear and attribute it to nerve damage. Shingrix is a treatment for shingles, a nerve disease and it's predecessor, Zostavax, has caused hearing issues. Please feel free to contact my ENT
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pain, Pyrexia, Swelling
Clinical narrative: Had swelling and redness occ I was given the Shingrix vaccine in the above date. Within an hour it was red, swollen, hot. Over the weekend I had fever and flu like symptoms. It continued to swell and get red to the under side of my left arm. I stayed in contact with my PCP. It started fading by weeks end. Still sore and slightly swollen as if today 1/13/20.
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Abnormal sensation in eye, Ear pain, Eyelid function disorder, Facial paralysis, Sinus pain
Clinical narrative: My son got the HPV vaccine on 1/2 and started having sinus pain on his right side about a day later. I took him to the doctor and they thought it was possible sinus pressure and slight fluid in his ear. He then had tooth pain on his right side, then in his right ear. By 1/10 he had extreme pain in his right ear. By 1/11 he had complaints of his eye feeling weird. By 1/12 we started noticing his Right eye wasn't closing all of the way and his mouth on was drooping on the right side. By 1/13 he didn't have any movement on the right side of his face. We took him to the dr and they believe it is Bell's palsy. He is now one antiviral and steroids. Hopefully he will get full function back in his right side of his face.
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Toothache
Clinical narrative: My son got the HPV vaccine on 1/2 and started having sinus pain on his right side about a day later. I took him to the doctor and they thought it was possible sinus pressure and slight fluid in his ear. He then had tooth pain on his right side, then in his right ear. By 1/10 he had extreme pain in his right ear. By 1/11 he had complaints of his eye feeling weird. By 1/12 we started noticing his Right eye wasn't closing all of the way and his mouth on was drooping on the right side. By 1/13 he didn't have any movement on the right side of his face. We took him to the dr and they believe it is Bell's palsy. He is now one antiviral and steroids. Hopefully he will get full function back in his right side of his face.
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Cough, Ear pain, Epistaxis, Eye pain, Eyelid function disorder
Clinical narrative: My son got the HPV vaccine on 1/2 and started having sinus pain on his right side about a day later. I took him to the doctor and they thought it was possible sinus pressure and slight fluid in his ear. He then had tooth pain on his right side, then in his right ear. By 1/10 he had extreme pain in his right ear. By 1/11 he had complaints of his eye feeling weird. By 1/12 we started noticing his Right eye wasn't closing all of the way and his mouth on was drooping on the right side. By 1/13 he didn't have any movement on the right side of his face. We took him to the dr and they believe it is Bell's palsy. He is now one antiviral and steroids. Hopefully he will get full function back in his right side of his face.
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Facial pain, Facial paralysis, Ocular discomfort, Oral pain, Respiratory tract congestion
Clinical narrative: My son got the HPV vaccine on 1/2 and started having sinus pain on his right side about a day later. I took him to the doctor and they thought it was possible sinus pressure and slight fluid in his ear. He then had tooth pain on his right side, then in his right ear. By 1/10 he had extreme pain in his right ear. By 1/11 he had complaints of his eye feeling weird. By 1/12 we started noticing his Right eye wasn't closing all of the way and his mouth on was drooping on the right side. By 1/13 he didn't have any movement on the right side of his face. We took him to the dr and they believe it is Bell's palsy. He is now one antiviral and steroids. Hopefully he will get full function back in his right side of his face.
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Sinus congestion
Clinical narrative: My son got the HPV vaccine on 1/2 and started having sinus pain on his right side about a day later. I took him to the doctor and they thought it was possible sinus pressure and slight fluid in his ear. He then had tooth pain on his right side, then in his right ear. By 1/10 he had extreme pain in his right ear. By 1/11 he had complaints of his eye feeling weird. By 1/12 we started noticing his Right eye wasn't closing all of the way and his mouth on was drooping on the right side. By 1/13 he didn't have any movement on the right side of his face. We took him to the dr and they believe it is Bell's palsy. He is now one antiviral and steroids. Hopefully he will get full function back in his right side of his face.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: My husband received the Pneumonia vaccine 23 on Friday January 3, 2020 at Pharmacy. Shortly after he said it was painful. Took an extra strength Tylenol. Sat. am was tired slept almost all afternoon. Said his arm hurt. Took 2 extra strength Tylenol total that day. Sunday morning went to church. Came home his arm hurt and I looked at it and it was beet red, hot to touch, swollen and went several inches across and about 12 inches long it went from above the Elbow to down close to his wrist. He looked like he was carrying a loaf of bread on his arm. We called the pharmacy and I explained the problem. He said no I never heard of that before. If it was still bad on Mon. See the family doctor. Well I was concerned. We went to Clinic and he was seen and the PA said it was Cellulitis and gave him a strong dose of antibiotics. About 2 days later it improved. Now it's almost clear. I am telling you this so you can help educate pharmacists who give the vaccine. Thank you.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: My husband received the Pneumonia vaccine 23 on Friday January 3, 2020 at Pharmacy. Shortly after he said it was painful. Took an extra strength Tylenol. Sat. am was tired slept almost all afternoon. Said his arm hurt. Took 2 extra strength Tylenol total that day. Sunday morning went to church. Came home his arm hurt and I looked at it and it was beet red, hot to touch, swollen and went several inches across and about 12 inches long it went from above the Elbow to down close to his wrist. He looked like he was carrying a loaf of bread on his arm. We called the pharmacy and I explained the problem. He said no I never heard of that before. If it was still bad on Mon. See the family doctor. Well I was concerned. We went to Clinic and he was seen and the PA said it was Cellulitis and gave him a strong dose of antibiotics. About 2 days later it improved. Now it's almost clear. I am telling you this so you can help educate pharmacists who give the vaccine. Thank you.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Joint swelling, Rheumatoid factor increased
Clinical narrative: Pt has osteoarthritis in L wrist. Had surgery and regained 90% range of motion for years. About 2 weeks after dose 1 of Shingrix (in L deltoid) , his L wrist swelled some and remained swollen. After 2nd dose of Shingrix (in L deltoid), L wrist swelled much more, and now has about 10% range of motion. It has persisted for 3 weeks, and was seen by his physician. His Rheumatoid Factor is now 162.7 (range of 1-13.0), and he was referred to a rheumatologist.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuritis
Clinical narrative: she developed occipital neuritis with the shingles vaccination
Age: 30.0
Sex: M
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: VASOVAGAL Event within minute of vaccine SYMPTOMS resolved quickly with treatment
Age: 31.0
Sex: M
Vaccine: DTP
Symptoms: Swelling
Clinical narrative: & Swelling
Age: 18.0
Sex: M
Vaccine: FLU4, HEP, HPV9, MENB
Symptoms: Epistaxis
Clinical narrative: nose bleeds 2 wks after IZ administration; occurred in Jan of 2019 also See attached IZ record re: Vaccines given 1/25/19 and 10/16/19
Age: 79.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Pain at injection site, red Streak running from site to inside of arm. Ice, Benadryl given-for 48 hours. Redness & pain started to diminish after 48 hours of ice & Benadryl q 8 hrs.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Contusion, Erythema, Induration, Pain, Swelling
Clinical narrative: Pain, bump, redness and bruising, induration. swollen, treated with steroid area affected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient developed progressively worsening redness + swelling that encompassed entire (R) upper extremity + shortness of breath treated w/ oral steroids + Albuterol
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: 1.15.20 Child came with swelling Left arm Pain Redness aFter vaccination x 2 days.
Age: 15.0
Sex: M
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: RMA brought prepared Prevnar 13 vaccine into the exam room to administer to patient. Vaccine was prepped and she had attached the needle to the prefilled syringe. When she was taking the protective cover off the needle, the syringe snapped at the top of the syringe where the needle is attached. They syringe itself broke. The vaccine was not administered and another vaccine was obtained to complete the immunization without any difficulties. We have never encountered this type of syringe malfunction in the past at our clinic.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: I had my second Shingrix shot and had many of the side effects. Muscle pain, feeling tired or weak, headache; shivering, upset stomach for two full days after the shot and two more days to get back to myself.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: I had my second Shingrix shot and had many of the side effects. Muscle pain, feeling tired or weak, headache; shivering, upset stomach for two full days after the shot and two more days to get back to myself.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blister, Injection site erythema, Injection site macule, Injection site reaction, Skin lesion
Clinical narrative: Multiple small erythematous target like spots on legs with one larger macular spot on (L) leg. 2 tiny blister like lesions on (R) hand. Close monitoring, resolution with 1 week expected outcome.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: The night vaccine was given, the arm was throbbing, had some redness and he developed headache. The next day the arm was more red, hot and swollen. He also reported subjective fever.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: The night vaccine was given, the arm was throbbing, had some redness and he developed headache. The next day the arm was more red, hot and swollen. He also reported subjective fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test, Magnetic resonance imaging, Rheumatoid arthritis
Clinical narrative: Autoimmune rheumatoid arthritis - acute onset.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Bladder catheterisation, Blood test, Computerised tomogram, Constipation
Clinical narrative: inability to stand; myelitis; Pain; Urinary retention; constipation; This case was reported by a consumer via call center representative and described the occurrence of myelitis in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 72L29, expiry date 30th June 2020) for prophylaxis.   On 29th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st November 2019, 3 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced myelitis (serious criteria hospitalization and GSK medically significant), pain (serious criteria hospitalization), urinary retention (serious criteria hospitalization and GSK medically significant) and constipation (serious criteria hospitalization). On an unknown date, the patient experienced difficulty in standing (serious criteria hospitalization). On an unknown date, the outcome of the myelitis, pain, urinary retention, constipation and difficulty in standing were not recovered/not resolved.   It was unknown if the reporter considered the myelitis, pain, urinary retention, constipation and difficulty in standing to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter was patient's son. The patient received vaccine in left deltoid. The patient the patient developed pain and became bedridden. The patient also developed urinary retention and constipation. The patient could not stand on her own and had magnetic resonance imaging that showed myelitis in T2 of her spine. As a result, the patient was hospitalized for 32 days and was currently in rehabilitation center. The emergency room visit was required. The reporter consented to follow up.