chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Respiratory arrest, Vomiting
Clinical narrative: administered 3/6/19 930a, I was denied insert and instead handed CDC printout. symptoms beginning at 6pm and within 3 days: colic, pale, bruising and redness at site of injection, lost appetite, hair loss, continued difficulty sleeping, green stool, vomiting, signs of reflux, mucous cough, continued difficulty breathing, skin rash noticed in fold of foot 3/10/19 Cough peak 3/21/19 3/28/19 stopped breathing Cough peaked 3/31/19 Cough continued until mid 7/2019 and remains only at night  I was hung up on when asked for batch # and to report reactions on 4/1/19.  Doctor diagnosed as ?cold? 4/2019 sporadic skin rash in crease of foot and on legs continued and diagnosed as eczema 9/24/19 urgent care All testing rejected at 9 month well check with Dr. at Hospital Called PEDS again 10/1/19 at 8am spoke with nurse was denied vaccine specific information from chart, asked to speak with the nurse in charge of vaccines who provided lot# 90027 exp 11/30/2020 fax release form
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Blepharospasm
Clinical narrative: Patient complains of eye twitching since getting the shot. Told her never heard of this side effect but she should follow up with an optometrist
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea, Retching
Clinical narrative: Patient had nausea and vomiting X3, dry heaving and spitting up saliva after receiving flu Mist vaccine. Pt was sweaty, hot and dizzy. No SOB or fainting.  VSS, 5:55pm 120/78, 6:05pm 122/76, 6:14pm 120/74.  Cool towel applied to neck and forehead. sat with pt and advised deep breathing. Pt has history of this the last 2 out of 3 years when getting flu vaccine, shot or mist.  Pt felt better and sent home with mom at 6:30 pm to f/u with peds.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: Patient had nausea and vomiting X3, dry heaving and spitting up saliva after receiving flu Mist vaccine. Pt was sweaty, hot and dizzy. No SOB or fainting.  VSS, 5:55pm 120/78, 6:05pm 122/76, 6:14pm 120/74.  Cool towel applied to neck and forehead. sat with pt and advised deep breathing. Pt has history of this the last 2 out of 3 years when getting flu vaccine, shot or mist.  Pt felt better and sent home with mom at 6:30 pm to f/u with peds.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nodule, Pyrexia
Clinical narrative: Patient received vaccine on 10-10-2019. On 10-11-2019 patient reports that she had a fever above 101 F. As of 10-13-2019, patient states that her arm has a softball size knot. Advised patient to continue taking Tylenol, apply ice/cold packs to the area, and contact physician if no improvement tomorrow.
Age: 77.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Erythema, Joint swelling, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reported to the pharmacy morning of 10-12-19 stating right arm hurting and swollen. It woke her up in the night.   The right arm between the shoulder and an inch above the  elbow was swollen and warm.  The inside of the arm was slightly red.   She reported no other symptoms other than soreness.  I advised the patient to take ibuprofen over the counter and apply cool compress or ice pack for short time. I told her this was a sometimes expected adverse reaction for many vaccines but it was a large area.  I advised her to seek medical attention if worsened in color, swelling, pain, developed fever or other symptoms.  I tried to contact the patient @5:30pm 10-12-19 to check in with now answer. ( left a message for her to contact me).  The patient returned my call @11am 10-13-19.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Hyperhidrosis, Nausea, Pallor
Clinical narrative: pt became clammy, nauseous, sweaty and pale after receiving flu vaccine.  VSS 4:45pm BP 120/80, P 84. 5:20pm BP 110/80 P 84. student had not eaten since breakfast. Pt was observed and rested until she felt better.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Since receiving the vaccine, patient has had long lasting pain in her arm and has difficulty lifting her arm.
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Tongue swollen then throat started closed up. Patient experienced symptoms within 20 minutes after the shot.  Patient took 3 tablets of bendaryl before going to ER.  In ER patient was given epi pen shot, IV (patient does not know what in the IV). Patient states to contact ER for more details
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: extreme arm pain, very bad chills, severe body aches, head pain this occurred a couple of hours after the injection and completely resolved in 48 hours patient did not receive any treatment for these symptoms
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient has prolonged arm pain from receiving the shingles vaccination.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: extreme arm pain, very bad chills, severe body aches, head  and neck pain this occurred a couple of hours after the injection and completely resolved in 48 hours patient received no treatment
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Symptoms began about 4 hours after shot.  Vaccination site became sore and pink in color.  Started feeling warm. Began to cough. Nose started to run with a watery clear colored liquid. Eyes started oozing a thick whitish color substance like I had pink eye.  Cough was very wet. I'm not sure if my throat began to swell or if it was just clogged with mucus.  I started having difficulty breathing and began to panic somewhat.  I started drinking as much cold water as I could. I took 2 Aleve PMs and tried to calm myself down.  I put drops in my eyes to help clear the gunk. I had my phone ready to call 911 but breathing got easier.  I put Vicks vapor rub under my nose and went to bed.  I got up several times during the night to wipe my eyes with a warm wet washcloth as I was afraid my eyes would be glued together by the next morning if I did not.  The symptoms were gone by the next morning.  I was exhausted so I stayed in bed until 11am.   I was still a little foggy in the brain the next day and tired today.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Panic attack, Productive cough, Rhinorrhoea, Vaccination site discolouration, Vaccination site pain
Clinical narrative: Symptoms began about 4 hours after shot.  Vaccination site became sore and pink in color.  Started feeling warm. Began to cough. Nose started to run with a watery clear colored liquid. Eyes started oozing a thick whitish color substance like I had pink eye.  Cough was very wet. I'm not sure if my throat began to swell or if it was just clogged with mucus.  I started having difficulty breathing and began to panic somewhat.  I started drinking as much cold water as I could. I took 2 Aleve PMs and tried to calm myself down.  I put drops in my eyes to help clear the gunk. I had my phone ready to call 911 but breathing got easier.  I put Vicks vapor rub under my nose and went to bed.  I got up several times during the night to wipe my eyes with a warm wet washcloth as I was afraid my eyes would be glued together by the next morning if I did not.  The symptoms were gone by the next morning.  I was exhausted so I stayed in bed until 11am.   I was still a little foggy in the brain the next day and tired today.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Respiratory tract congestion, Throat irritation
Clinical narrative: 3 hours after getting the high dose injection I began coughing with  a tickle like cough that also felt  like there was congestion in my chest.  It was almost like an asthma cough although I wasn't wheezing but couldn't stop.  It lasted about 45 minutes and my throat was very sore after but I was able to have hot tea and a cough drop which seemed to help calm things down.  Spoke to a 24hr nurse at Insurance during this and we accessed that my  reaction was not a severe allergic reaction during that time (no other symptoms)and if it got any worse I should go to a nearby clinic.  These symptoms did not continue during the night. Just thought this reaction should be included on possible reactions.  I have gotten flu shots for many years and maybe the stronger dose caused this reaction.  I am not sick or fighting a cold or any type of illness at this time.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: patients arm got red, hot , and swollen 2 days after injection
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: pt reported rash and swelling of arm at and around injection site, advised pt to follow up with md
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: patient fainted while standing about 4-5 minutes after receiving Flucelvax vaccine. Patient sat up immediately after fainting. Paramedics were called onto the scene, where they took the patient's vitals. Patient and family declined being taken to hospital, and went home.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Fungal infection, Rash
Clinical narrative: rash after 4 days that comes and goes, doc said it was a fungus
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt. came in 10 days after receiving the vaccine and complained of severe arm and shoulder pain.  He has been putting ice on it, which has seemed to help.  We checked in with him at day 12, and he said the pain was improved, but still present.  He mentioned that it seemed to be worse after a period of inactivity.
Age: 16.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: patient was given Flucelvax vaccine. He was standing in our waiting area while he was waiting for the rest of the family to be vaccinated. patient fainted about 1 minute after receiving vaccine. he was conscious a few seconds after fainting. paramedics were called to the scene, where they took his vitals. patient and family declined being taken to the hospital, and went home afterwards
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Muscle tightness
Clinical narrative: VACCINE WAS ADMINISTERED.  AFTER APPROXIMATELY 5 MINUTES OF TALKING WITH THE PATIENT HE STATED HE FELT LIKE HIS MUSCLES WERE TIGHTENING AND HE WAS GOING TO FAINT.  PATIENT FAINTED.  EMS WAS CALLED AND ARRIVED IN APPROXIMATELY 4-5 MINUTES.  HE WAS CHECKED, AND DENIED AN EMERGENCY ROOM VISIT AND WAS RELEASED.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: Patient reports up to a half-dollar size area of skin at injection site that was swollen, red, itchy and radiated heat.    Over the next few days the swollen area traveled from outside her arm into the inside of her arm.  A couple days later the area dissipated.  She also experienced flu-like symptoms including headache, body ache, shivering and a slight fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Patient reports up to a half-dollar size area of skin at injection site that was swollen, red, itchy and radiated heat.    Over the next few days the swollen area traveled from outside her arm into the inside of her arm.  A couple days later the area dissipated.  She also experienced flu-like symptoms including headache, body ache, shivering and a slight fever.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills, nausea, headache  12 hours
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Burning sensation, Ear discomfort, Throat irritation
Clinical narrative: about 6 to 7 hours post immunization pt states that she felt a burning from her ears/face/throat, states that she never felt like she had any trouble breathing and then without any treatment the symptoms went away on their own after about 1 to 2 hours
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Sinus headache
Clinical narrative: Patient reported getting a sinus headache almost immediately after the vaccine was administered.  She said she continues to experience sinus headache and runny nose.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Skin irritation
Clinical narrative: put had an irritation on the skin.  wife is a nurse and is concerned it is due to the vaccine not being in the muscle and causing the irritation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Antinuclear antibody positive, Aspiration bone marrow, Ataxia, Blood creatine phosphokinase increased, Borrelia test
Clinical narrative: That evening - severe bloody nose - fever of 104 as measured by home thermometer.  Fever, nose bleeds, lethargic behavior for subsequent days.  June 17th (5th day) morning - unable to stand (bare weight) on legs.   In months following, recurrent inability to stand/walk.  Approximately six months following, neurological symptoms including chorea, head bobbing, dysphagia, ataxia.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Chorea, Dysphagia, Dysstasia, Electroencephalogram, Epistaxis
Clinical narrative: That evening - severe bloody nose - fever of 104 as measured by home thermometer.  Fever, nose bleeds, lethargic behavior for subsequent days.  June 17th (5th day) morning - unable to stand (bare weight) on legs.   In months following, recurrent inability to stand/walk.  Approximately six months following, neurological symptoms including chorea, head bobbing, dysphagia, ataxia.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Full blood count, Gait inability, Lethargy, Lumbar puncture, Magnetic resonance imaging brain
Clinical narrative: That evening - severe bloody nose - fever of 104 as measured by home thermometer.  Fever, nose bleeds, lethargic behavior for subsequent days.  June 17th (5th day) morning - unable to stand (bare weight) on legs.   In months following, recurrent inability to stand/walk.  Approximately six months following, neurological symptoms including chorea, head bobbing, dysphagia, ataxia.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Magnetic resonance imaging spinal, Posture abnormal, Pyrexia, Scan with contrast, Swallow study
Clinical narrative: That evening - severe bloody nose - fever of 104 as measured by home thermometer.  Fever, nose bleeds, lethargic behavior for subsequent days.  June 17th (5th day) morning - unable to stand (bare weight) on legs.   In months following, recurrent inability to stand/walk.  Approximately six months following, neurological symptoms including chorea, head bobbing, dysphagia, ataxia.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Ultrasound joint, Weight bearing difficulty, X-ray limb, X-ray of pelvis and hip
Clinical narrative: That evening - severe bloody nose - fever of 104 as measured by home thermometer.  Fever, nose bleeds, lethargic behavior for subsequent days.  June 17th (5th day) morning - unable to stand (bare weight) on legs.   In months following, recurrent inability to stand/walk.  Approximately six months following, neurological symptoms including chorea, head bobbing, dysphagia, ataxia.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Food intolerance, Heart rate increased, Pharyngeal swelling
Clinical narrative: Patient came in requesting a flublok vaccine. Questions were asked if she had any allergies. She stated she's had flu shots in the past without any issues, however, last year, after her flu shot she realized she was experiencing increase in heart rate but didn't think anything of it so she went home and used her albuterol inhaler. She then later realized some slight swelling in the throat, but nothing too severe to go to the emergency room and felt better in a couple of days. She also stated that lately, she has noticed that she cannot tolerate eggs. Even though she can have eggs when mixed in foods like cake, she just cannot eat eggs alone. Every time she had eggs by itself, she would experience increase in heart, slight swelling of throat. She also added that after careful review with her PCP, her doctor thinks she may have an egg allergy.  The choice was then made to give flublok instead because of the egg intolerance she had been experiencing. Patient was educated to wait in the pharmacy at least 30minutes and report any issues such as increase in rate, dizziness or etc. A couple of minutes after vaccine administration, patient stated feeling an increase in rate. Due to similar characteristics patient had described with her pervious flu shot, Permission was seeked on her behalf to call the ambulance and patient agreed. Ambulance arrived in less than 5 minutes after call was placed. Patient was alert and responded well to every question until paramedics arrived. Epinephrine was set in place in the place in the course should patient require it. Epinephrine was however never administered at any point throughout this incident. Paramedics transported patient to hospital upon request and monitored for a few and discharged the same day. Patient reported that she was given Benadryl and steroids  whiles at the hospital and upon discharge.  Patient husband stated, patient resumed work two days following this incident.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Laboratory test, Seizure
Clinical narrative: Seizures, patient was taken to Hospital where they performed test for Meningitis. Stayed at the hospital for  3 nights.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Ocular hyperaemia
Clinical narrative: bloodshot left the day after injection. bruising on left thigh
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Oedema, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Pt developed pain and itching in left arm about 2 hour after injection, then swelling from elbow to shoulder described as severe enough to be "pitting edema" by patient.  Fever then developed and lasted till about 4 am on 10/10/19.  Pt took acetaminophen, ibuprofen, and benadryl and had majority of symptoms resolve within 24 hours.  Pain and itching lasted about 48 hours.  Right arm (site of Fluzone HD vaccination) was not involved in reaction
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in the right arm and then it started getting red and swollen. Patient went to ER and received antihistamines and steroids. Patient will continue taking ER meds and use cold compress or motrin or tylenol as needed.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Pallor, Seizure, Unresponsive to stimuli
Clinical narrative: after giving the flu shot the boy complained about dizziness after 3-5 minutes and according to the mother he got seizure. he was pale and don't remember what happened. he started responding to the questions in about 1-2 minutes and he was pale. called 911 and they took him in the ambulance to the hospital.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient reported to the pharmacy on 10/13/2019 that she went to the emergency room of the local hospital  because her arm was red and in pain. Patient reported that she was given benadryl and a steroid injection at the hospital. Patient also filled a prescription for cephalexin.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness where the injection site happened. The redness was a large patch on patient's arm. I counseled the patient to inform her doctor as well and to take some benadryl to help with some of the adverse reaction symptoms.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: PT INDICATED HER ARM HAS A BIG BUMP ON IT, AS IT IT WAS SWOLLEN. IT IS VERY HOT TO THE TOUCH, AND HAS BEEN PUT ICE ON IT
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient reported to the pharmacy on 10/13/2019 that he went to the emergency room of the local hospital  because his arm was red and in pain. Patient reported that he was given benadryl and a steroid injection at the hospital.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever of 101.0 F. Controlling with ibuprofen.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria
Clinical narrative: Immediate hive, about 1cmx2cm on right thigh with small area of surrounding erythema at injection site of MMR on right thigh
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: patient returned to pharmacy tonight at 9:30 pm complaining of swollen , red and painful right upper arm.   no rash or fever present.  recommended 50 mg benadryl and 500 mg acetaminophen with  cold compress
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye pruritus, Joint stiffness, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: I did not seek medical assistance for these symptoms. Approximately 4 hours after receiving the injection I felt my throat get very sore, and it felt like it was closing up. However, it did not reach the point that  I felt my breathing was hampered.  My eyes became very itchy and began to emit a thick mucous that would coat my eyes within minutes so I had to wipe it away in order to open my eyes.  After about 1 hour I felt the throat closing stop and the soreness began to lessen after a few hours.  The mucus from the eyes continued until about 2 am and then nearly stopped.  Today is Sunday at 7:15 PM  and my eyes are still itchy and red but are improving.  There is very little mucus being emitted from my eyes. On Saturday, the day after the vaccination, my knees were stiff in a way I have never felt before and remain a little stiff on Sunday.  I am athletic and do not have any problem with my knees.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: I did not seek medical assistance for these symptoms. Approximately 4 hours after receiving the injection I felt my throat get very sore, and it felt like it was closing up. However, it did not reach the point that  I felt my breathing was hampered.  My eyes became very itchy and began to emit a thick mucous that would coat my eyes within minutes so I had to wipe it away in order to open my eyes.  After about 1 hour I felt the throat closing stop and the soreness began to lessen after a few hours.  The mucus from the eyes continued until about 2 am and then nearly stopped.  Today is Sunday at 7:15 PM  and my eyes are still itchy and red but are improving.  There is very little mucus being emitted from my eyes. On Saturday, the day after the vaccination, my knees were stiff in a way I have never felt before and remain a little stiff on Sunday.  I am athletic and do not have any problem with my knees.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had redness, swelling, heat and pain at the injection site
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Patient fainted after receiving the shot and he was unresponsive and then rouse slowly. Epipen was refused by father. 911 was contacted.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Patient began having severe arm pain the night of the immunization. Patient then began having trouble with lifting her arm and then had no range of motion in her arm the following days. The patient went to see an orthopedic Dr on 10/9 and then her primary physician on 10/10. Patient has been prescribed physical therapy for 2 weeks and then will have a follow up after that.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Nodule, Rash erythematous, Rash pruritic
Clinical narrative: Red rash that is itchy, feels like knots - dose was given subcut instead of IM on Mon 10/7. Rash developed 10/9
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Contusion
Clinical narrative: Patient presented to the pharmacy on Saturday, October 12 with a 5-6 inch bruise on the inside muscle on his arm. He had a spot on his bicep which is not where his shot was given. I told him to place a cold washcloth on his arm and take an anti-inflammatory and benadryl. He purchased the benadryl and told him we would call him Monday to see if it is any better.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Patient came into the store on 10/12/10, and reported minor soreness and redness. Patient came in on 10/13/19 at approximately 12:00Noon presenting with a red swollen right bicep muscle. Patient said there was no pain, soreness, or itching.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 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 about 05-SEP-2017, the pt was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result 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.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity, Tendonitis
Clinical narrative: The day after the immunization, I woke up with severe leg aches that took 4-6 weeks to resolve. My left arm also ached where the shot was given for 4-6 weeks. Within 2 weeks of receiving the shot, I developed bilateral Achilles tendonitis that has NOT resolved despite 2 months of physical therapy. At some point after the shot, I also started to experience sore knuckles in my hands that continues. I have now seen a rheumatologist who believes that all of this is related to the Shingrix.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody positive, Arthralgia, Injection site pain, Pain in extremity, Red blood cell sedimentation rate abnormal
Clinical narrative: The day after the immunization, I woke up with severe leg aches that took 4-6 weeks to resolve. My left arm also ached where the shot was given for 4-6 weeks. Within 2 weeks of receiving the shot, I developed bilateral Achilles tendonitis that has NOT resolved despite 2 months of physical therapy. At some point after the shot, I also started to experience sore knuckles in my hands that continues. I have now seen a rheumatologist who believes that all of this is related to the Shingrix.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tendonitis, Vaccination complication
Clinical narrative: The day after the immunization, I woke up with severe leg aches that took 4-6 weeks to resolve. My left arm also ached where the shot was given for 4-6 weeks. Within 2 weeks of receiving the shot, I developed bilateral Achilles tendonitis that has NOT resolved despite 2 months of physical therapy. At some point after the shot, I also started to experience sore knuckles in my hands that continues. I have now seen a rheumatologist who believes that all of this is related to the Shingrix.
Age: 0.42
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Was given at 5 months age, before recommended 6 months age. No side effects or adverse events.
Age: 0.42
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Was given at 5 months age, before recommended 6 months age. No side effects or adverse events.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cyanosis
Clinical narrative: "arm turned black"; This case was reported by a pharmacist via call center representative and described the occurrence of decoloration skin in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 14th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced decoloration skin. On an unknown date, the outcome of the decoloration skin was recovered/resolved.   It was unknown if the reporter considered the decoloration skin to be related to Shingrix.  Additional details were provided as follows: After receiving the dose of Shingrix, the patients arm turned black, it did not hurt or got hard. The event lasted for 6 weeks. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin discolouration
Clinical narrative: "arm turned black"; This case was reported by a pharmacist via call center representative and described the occurrence of decoloration skin in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 14th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced decoloration skin. On an unknown date, the outcome of the decoloration skin was recovered/resolved.   It was unknown if the reporter considered the decoloration skin to be related to Shingrix.  Additional details were provided as follows: After receiving the dose of Shingrix, the patients arm turned black, it did not hurt or got hard. The event lasted for 6 weeks. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Headache, Paraesthesia, Swelling face, Urticaria
Clinical narrative: Shortness of breath / Difficulty breathing; Hives all over her body; Headache; Tingling; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 5th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th October 2019, less than a day after receiving Shingrix, the patient experienced headache and tingling. On 6th October 2019, the patient experienced shortness of breath and hives. On an unknown date, the outcome of the headache, tingling, shortness of breath and hives were unknown.   It was unknown if the reporter considered the headache, tingling, shortness of breath and hives to be related to Shingrix.  Additional case details were reported as follows: The reporter calling on behalf of the patient. The patient received vaccine in left arm. On Saturday night of 5th October 2019, the patient developed a headache and tingling.  On Sunday morning, 1 day after vaccination, patient developed shortness of breath, difficulty breathing and hives all over her body.  The patient went to urgent care on Monday, 7th October 2019. The emergency room visit was required. The reporter did not provide any additional information. The reporter consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Headache, Paraesthesia, Urticaria
Clinical narrative: Shortness of breath / Difficulty breathing; Hives all over her body; Headache; Tingling; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 5th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th October 2019, less than a day after receiving Shingrix, the patient experienced headache and tingling. On 6th October 2019, the patient experienced shortness of breath and hives. On an unknown date, the outcome of the headache, tingling, shortness of breath and hives were unknown.   It was unknown if the reporter considered the headache, tingling, shortness of breath and hives to be related to Shingrix.  Additional case details were reported as follows: The reporter calling on behalf of the patient. The patient received vaccine in left arm. On Saturday night of 5th October 2019, the patient developed a headache and tingling.  On Sunday morning, 1 day after vaccination, patient developed shortness of breath, difficulty breathing and hives all over her body.  The patient went to urgent care on Monday, 7th October 2019. The emergency room visit was required. The reporter did not provide any additional information. The reporter consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; shivering; aching; neck warm; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 4th October 2019, the patient received the 1st dose of Shingrix. On 4th October 2019, less than a day after receiving Shingrix, the patient experienced fever, shivering, pain and skin warm. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the fever, shivering, pain and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the fever, shivering, pain and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. Within about 4 hours of the vaccination, the patient had fever, shivering, aching and neck warmth. The patient was treating the events with Motrin and was getting relief, however the events returned after the Motrin had warn off. The patient was still having the events 4 days out. The median duration of events from clinical trials was reviewed and encouraged consumer to discuss with physician. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the argus it was reported as not recovered/ not resolved.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain, Pyrexia, Skin warm
Clinical narrative: fever; shivering; aching; neck warm; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 4th October 2019, the patient received the 1st dose of Shingrix. On 4th October 2019, less than a day after receiving Shingrix, the patient experienced fever, shivering, pain and skin warm. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the fever, shivering, pain and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the fever, shivering, pain and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. Within about 4 hours of the vaccination, the patient had fever, shivering, aching and neck warmth. The patient was treating the events with Motrin and was getting relief, however the events returned after the Motrin had warn off. The patient was still having the events 4 days out. The median duration of events from clinical trials was reviewed and encouraged consumer to discuss with physician. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the argus it was reported as not recovered/ not resolved.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: chills; fever; malaise; This case was reported by a physician via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced chills, fever and malaise. On an unknown date, the outcome of the chills, fever and malaise were resolved with sequelae.   It was unknown if the reporter considered the chills, fever and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had chills, fever, malaise, after each dose of Shingrix. The patient thought that it was due to not having chickenpox. The reporter was seeing patient and did not wish to provide patient's information. The reporter did not consent to follow up. This case is link with US2019180012 having same reporter and same patient.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Red expanding area around injection dute spreading g from upper arm down towards elbow. Hot to the touch. Itchy and painful to young patient.  Attending  at walk in clinic gave  liquid ibuprofen and prescribed medicine.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site very hard, swollen, red and painful about 4 inches x 3 inches in size.  This reaction occurs every year and has slowly becomes larger year after year.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, Condition aggravated, Injection site swelling
Clinical narrative: Approx 5 hours after receiving the flu shot I developed a large swollen area only left deltoid area.  The swelling continued to worsen and progressed to what was diagnosed as a flare up of my autoimmune disease.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Reaction to flu shot-no treatment.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: c/o itching and hives up and down her arm
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: About 4 hours after getting my flu shot, my arm movement was restricted.  It has continually gotten worse over the last two days.  I cannot lift my arm higher than 45 degrees
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Cellulitis, Chills, Full blood count normal, Injection site erythema, Injection site streaking
Clinical narrative: Pt developed redness just inferior to injection site that was streaky in nature and spreading. She also had fever and chills and body aches.  She was started on oral Augmentin and the streaking progressed. She was diagnosed with cellulitis and possible lymphangitis and admitted to inpatient hospital for IV clindamycin. She had a 2 day stay and the infection was resolving. She was discharged on oral clindamycin to finish the course. She had complete resolution of the infection.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain, Pyrexia
Clinical narrative: Pt developed redness just inferior to injection site that was streaky in nature and spreading. She also had fever and chills and body aches.  She was started on oral Augmentin and the streaking progressed. She was diagnosed with cellulitis and possible lymphangitis and admitted to inpatient hospital for IV clindamycin. She had a 2 day stay and the infection was resolving. She was discharged on oral clindamycin to finish the course. She had complete resolution of the infection.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood culture negative, Cellulitis, Erythema, Laboratory test, Local reaction
Clinical narrative: Pt developed redness just inferior to injection site that was streaky in nature and spreading. She also had fever and chills and body aches.  She was started on oral Augmentin and the streaking progressed. She was diagnosed with cellulitis and possible lymphangitis and admitted to inpatient hospital for IV clindamycin. She had a 2 day stay and the infection was resolving. She was discharged on oral clindamycin to finish the course. She had complete resolution of the infection.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Pt developed redness just inferior to injection site that was streaky in nature and spreading. She also had fever and chills and body aches.  She was started on oral Augmentin and the streaking progressed. She was diagnosed with cellulitis and possible lymphangitis and admitted to inpatient hospital for IV clindamycin. She had a 2 day stay and the infection was resolving. She was discharged on oral clindamycin to finish the course. She had complete resolution of the infection.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Computerised tomogram normal, Deafness unilateral, Dizziness, Ear pruritus, Facial paralysis
Clinical narrative: swelling of mouth, face, lips. burning, numbness, tingling sensation, paralysis of facial muscles, trouble controlling movements, eyesight changes, loss of apetite, upset stomach
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Gait disturbance, Pain in extremity, Pruritus
Clinical narrative: swelling of mouth, face, lips. burning, numbness, tingling sensation, paralysis of facial muscles, trouble controlling movements, eyesight changes, loss of apetite, upset stomach
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Abdominal discomfort, Blood test, Burning sensation, Computerised tomogram, Decreased appetite
Clinical narrative: swelling of mouth, face, lips. burning, numbness, tingling sensation, paralysis of facial muscles, trouble controlling movements, eyesight changes, loss of apetite, upset stomach
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyskinesia, Facial paralysis, Hypoaesthesia, Lip swelling, Magnetic resonance imaging
Clinical narrative: swelling of mouth, face, lips. burning, numbness, tingling sensation, paralysis of facial muscles, trouble controlling movements, eyesight changes, loss of apetite, upset stomach
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mouth swelling, Paraesthesia, Swelling face, Visual impairment
Clinical narrative: swelling of mouth, face, lips. burning, numbness, tingling sensation, paralysis of facial muscles, trouble controlling movements, eyesight changes, loss of apetite, upset stomach
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; the patient received improperly stored PEDVAXHIB; This spontaneous report has been received from a medical assistant referring to a 4-month-old male patient. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 11-SEP-2019, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot # S000352, expiration date: 17-OCT-2021, dose and route of administration were not provided) for prophylaxis (product storage error). The vaccine was exposed to temperature above 9 degrees Celsius (8.93 degrees Celsius) for 30 minutes. Previous temperature excursion included temperature above 9 degrees Celsius (8.87 degrees Celsius) for 30 minutes and 2-8 degrees Celsius (8.07 degrees Celsius) for 30 minutes. Data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of GARDASIL 9 was administered; No adverse effects; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On an unknown date, the patient received improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N022952, expiration date 14-JUN-2020, dose and route of administration were not provided) for prophylaxis (product storage error). The vaccine was exposed to temperature of below 36 degrees Fahrenheit (32.1 degrees Fahrenheit) for 8 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects.
Sex: F
Vaccine: HPV9
Symptoms: Ataxia
Clinical narrative: ataxia; This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in September 2019 (reported as "about two weeks ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. It was unknown by reporter which dose in the series was given. On 01-SEP-2019 (reported as two weeks ago), the patient experienced ataxia and was treated by an unspecified Neurologist. The patient did sought medical attention. The outcome of ataxia was unknown. The causality assessment between the event and suspect therapy was not provided.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered an improperly stored ROTATEQ and RECOMBIVAX HB; no adverse events; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On an unknown date, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R021372, expiration date 25-MAY-2021 (dose and route of administration were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R030929, expiration date 23-JUL-2020 (dose and route of administration were not reported), both for prophylaxis. The vaccines had been stored improperly in temperature above 47 degrees Fahrenheit / 9 degrees Celsius (11.3 C) for 9 hours and 55 minutes. The temperature was measured with Digital Data Logger. There were no previous temperature excursions reported. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Office manager reported that improperly stored doses of VAQTA were administered to patient on an unspecified date.; No adverse affects reported.; This spontaneous report was received from an office manager referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent condition, concomitant medication and drug reaction/allergy was not provided.  On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) (lot# S009562, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019; strength, dose detail  and route were not reported) for prophylaxis (improper storage of product in use). The hepatitis a vaccine, inactivated(VAQTA) was exposed to temperature of 35.1 fahrenheit degree for 5 hours. No previous temperature excursion. No adverse effects were reported. Data logger was involved. The outcome of the event was unknown.