chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Poor quality sleep, Sluggishness
Clinical narrative: She got her vaccine, was fine, just the sore arm.  Then on the 5th day later in the afternoon she started just feeling achy, mostly her legs, feets, arms and hands.  She tried to ignore it, and later that night her back was involved.  She went to bed, and was really painful.  She took 2 Ibuprofen and tossed and turned all night.  The next day it should of lingered through the night.  It came on again last night and then she took Tylenol, and it didn't really  help all that much either.  She tossed and turned and feels sluggish today, called the pharmacy and they me to report it to you.  She just feels low energy, just not right.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Fever, body aches, headache, chills, fatigue, don?t feel well, joint pain
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, body aches, headache, chills, fatigue, don?t feel well, joint pain
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Hypoaesthesia, Vomiting
Clinical narrative: 1 week later i took a short rd trip and on my way back my left arm and leg went numb so i pulled over to rest and i went to sleep when i woke up everthing  appeared normal so i got back on the road and i stopped at a friends house  and i went home i ate some watermelon then  i woke up at about 3:00 in the morning i was sick to my stomach threw up all over the place  at 11 am i called my friend to pick me up to take me to the hospital.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Delirium, Hallucination
Clinical narrative: Acute delirium, hallucinations, confusion.  Only at night.
Age: 63.0
Sex: F
Vaccine: COVID19, FLUA4, RSV
Symptoms: Blister, Bone pain, Decreased appetite, Dysphonia, Erythema
Clinical narrative: She got her vaccines, the next day she could not even get up . She was fatigued, her bones were hurting, the pain was excruciating, didn't do much that day.  She did not want to eat or do anything.  She then got into bed.  The next day she was a little bit better, a little hoarse.  She woke up with itching.  She went to her dermatologist who prescribed a cream, which he said that it looked like she had an AE reaction to the vaccine.  She was given prednisone for this, Triamcinolone cream for the itching as well.  She has been using it but it does not seem to be getting any better, and in fact feels like it's getting worse.  Her dermatologist.  She has an APT on 10/16/23 for a return FU.  She also likes swimming and wants to know if the chlorine would be good for her.  Her left side is the one that is affected with the blisters, redness.  On the right side she has just a few dots.  It went from her face, to her neck, her whole arm has blisters on the inside of the arm following where the injection was given.
Age: 63.0
Sex: F
Vaccine: COVID19, FLUA4, RSV
Symptoms: Fatigue, Mobility decreased, Pruritus
Clinical narrative: She got her vaccines, the next day she could not even get up . She was fatigued, her bones were hurting, the pain was excruciating, didn't do much that day.  She did not want to eat or do anything.  She then got into bed.  The next day she was a little bit better, a little hoarse.  She woke up with itching.  She went to her dermatologist who prescribed a cream, which he said that it looked like she had an AE reaction to the vaccine.  She was given prednisone for this, Triamcinolone cream for the itching as well.  She has been using it but it does not seem to be getting any better, and in fact feels like it's getting worse.  Her dermatologist.  She has an APT on 10/16/23 for a return FU.  She also likes swimming and wants to know if the chlorine would be good for her.  Her left side is the one that is affected with the blisters, redness.  On the right side she has just a few dots.  It went from her face, to her neck, her whole arm has blisters on the inside of the arm following where the injection was given.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: red rash, hives over body
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Myalgia, Nausea, Vomiting
Clinical narrative: Persistent fatigue, muscle aches and nausea/vomiting starting morning after vaccination and continuing x 4 weeks  Please note: Patient had a Covid booster and a flu shot earlier in the day at our facility but has had those before without these side effects.
Age: 45.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: About 5 minutes after receiving vaccine, patient felt very hot, faint, nauseated, and had to lie down to keep from passing out. Patient did not pass out. Patient felt better after about 10 minutes.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Patient symptoms of worsening erythema of left thigh at injection site 1 day after receiving vaccine. Patient came in 2 days to urgent care after vaccine was given at their PCP clinic because of worsening redness of skin, warmth, swelling, and  tenderness of injection site and blistering. Denies fever.  Treatment: Wound care to area in clinic and antibiotics prescribed Cephalexin TID x 7 days  Outcome: child followed up the next day in UC with improvement of symptoms and continued wound care
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Wound treatment
Clinical narrative: Patient symptoms of worsening erythema of left thigh at injection site 1 day after receiving vaccine. Patient came in 2 days to urgent care after vaccine was given at their PCP clinic because of worsening redness of skin, warmth, swelling, and  tenderness of injection site and blistering. Denies fever.  Treatment: Wound care to area in clinic and antibiotics prescribed Cephalexin TID x 7 days  Outcome: child followed up the next day in UC with improvement of symptoms and continued wound care
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Confusional state, Ear discomfort, Erythema, Hypoacusis
Clinical narrative: I had Spikevax. I had a really painful left arm that is swollen and red and puffy. I have been puffy on my legs, arms, and face. My ears feel like they are "gone", like when you're under water and your ears are plugged up. It feels like being waterlogged in your ears. Even at this moment. It has pressure to it, like when you pinch your nose to blow the pressure out. It makes things sound muffled and a vibrating sensation especially when I talk. I had ringing in my ears at the beginning after the vaccine. It was in both ears but now its in my right ear. It has lasted 1 week and 2 days. I also have extreme brain fog and confusion.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin swelling, Tinnitus, Vibratory sense increased
Clinical narrative: I had Spikevax. I had a really painful left arm that is swollen and red and puffy. I have been puffy on my legs, arms, and face. My ears feel like they are "gone", like when you're under water and your ears are plugged up. It feels like being waterlogged in your ears. Even at this moment. It has pressure to it, like when you pinch your nose to blow the pressure out. It makes things sound muffled and a vibrating sensation especially when I talk. I had ringing in my ears at the beginning after the vaccine. It was in both ears but now its in my right ear. It has lasted 1 week and 2 days. I also have extreme brain fog and confusion.
Age: 58.0
Sex: F
Vaccine: COVID19, FLUC4, VARZOS
Symptoms: Injection site erythema, Oral herpes
Clinical narrative: bilateral arm redness at injection site. cold sores (3) located on bottom lip. No opening eruptions on sores.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Headache, ,sore injection site, stiff neck/pain , sore quadricept muscles, chills, fever, tiredness all on Day 2 after injection. Day 3 is fine - like it never happened.  I took ALOT of Tylenol and it really helped.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pyrexia
Clinical narrative: Headache, ,sore injection site, stiff neck/pain , sore quadricept muscles, chills, fever, tiredness all on Day 2 after injection. Day 3 is fine - like it never happened.  I took ALOT of Tylenol and it really helped.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Injection site pain, Rash
Clinical narrative: Site of injection much more sore than any previous vaccine (was sore for 7 days, past vaccines sore for half a day). Back pain much worse than expected for given amount of physical activity (eccess back pain lasted for one day). Forehead broke out in red bumps, smaller red bumps on cheeks and chest.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches , nausea , cluster migraine ,
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Chills, Fatigue, Hypersomnia
Clinical narrative: Fatigue, joints ached, chills, slept 17 hours. Took 2 Tylenol PM and went to bed.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Muscle rigidity, Pruritus, Skin discolouration
Clinical narrative: Yesterday,: Started red, hot, itchy, then noticed a raised bump, more rigid than soft. Looked more like a bruise, color was purplish red.  About an hour later, bump was growing,, like a goose egg when you hit your head. I could feel my skin stretching, heat and itchy increased.  Took a single Benadryl, applied ice pack. Ice pack was effective in turning down the heat.  Today, more purple, still rigid bump about the shape of a goose egg. Raised level, maybe half an inch or so.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling
Clinical narrative: Yesterday,: Started red, hot, itchy, then noticed a raised bump, more rigid than soft. Looked more like a bruise, color was purplish red.  About an hour later, bump was growing,, like a goose egg when you hit your head. I could feel my skin stretching, heat and itchy increased.  Took a single Benadryl, applied ice pack. Ice pack was effective in turning down the heat.  Today, more purple, still rigid bump about the shape of a goose egg. Raised level, maybe half an inch or so.
Age: 4.0
Sex: M
Vaccine: FLUN4, MMRV
Symptoms: No adverse event
Clinical narrative: No adverse reaction at this time
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Pain, Pain in extremity
Clinical narrative: 2 days of mild Lightheadness on and off, 2 days of mild acheness, Arm is sore for 12 days
Age: 84.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash
Clinical narrative: rash on arm
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: No adverse effects
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest pain, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Started coughing heavily and couldn?t stop coughing. Throat started feeling like it was swelling. Shortness of breath and chest/throat pain .  I took Zyrtec and an old inhaler because that is all I had. Symptoms subsided within 30 minutes. Around 9:30pm of the same day, I started feeling short of breath, lightheaded, nauseous, had a bad headache,  and my whole body ached. I was at a sporting event so I powered through my match. When I got home, around  11pm, I took more inhaler and Flonase because I already took the maximum dose of Zyrtec.  I also took DayQuil  to help with body aches and throat pain (I assume the throat pain was from the initial coughing fit). I fell asleep  And only had fatigue, a small headache, and minor body aches the next day. Everything was fine the following day.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain, Pharyngeal swelling
Clinical narrative: Started coughing heavily and couldn?t stop coughing. Throat started feeling like it was swelling. Shortness of breath and chest/throat pain .  I took Zyrtec and an old inhaler because that is all I had. Symptoms subsided within 30 minutes. Around 9:30pm of the same day, I started feeling short of breath, lightheaded, nauseous, had a bad headache,  and my whole body ached. I was at a sporting event so I powered through my match. When I got home, around  11pm, I took more inhaler and Flonase because I already took the maximum dose of Zyrtec.  I also took DayQuil  to help with body aches and throat pain (I assume the throat pain was from the initial coughing fit). I fell asleep  And only had fatigue, a small headache, and minor body aches the next day. Everything was fine the following day.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis to the right arm
Age: 89.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Death, Neurological symptom
Clinical narrative: Death- Stroke like symptoms, ambulance called at 0745, ambulance showed at 0755, resident had already passed.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given Covid-19 Pfizer 12+ state vaccine but should have received Covid-19 Pfizer 5-11 state vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: FEVER, CHILLS, SORE ARM
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Blood culture negative, Candida infection, Chronic respiratory failure, Computerised tomogram head normal, Computerised tomogram normal
Clinical narrative: Nausea, fatigue, ptosis of the eyes, muscle weakness.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Eyelid ptosis, Fatigue, Flatulence, Gastroenteritis viral
Clinical narrative: Nausea, fatigue, ptosis of the eyes, muscle weakness.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Human rhinovirus test positive, Lumbar puncture, Magnetic resonance imaging head normal, Muscular weakness, Nausea
Clinical narrative: Nausea, fatigue, ptosis of the eyes, muscle weakness.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Scimitar syndrome, Tracheal stenosis, Ultrasound abdomen normal, Vomiting
Clinical narrative: Nausea, fatigue, ptosis of the eyes, muscle weakness.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Granuloma annulare, Rash
Clinical narrative: Developed rash on entire upper body covering upper chest and back and neck. Still present  Treated with steroid cream to no avail. Currently taking Hydroxichloriquin. So far no improvement
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Injection site pain
Clinical narrative: Gastrointestinal upset - diarrhea 3-4 times between 2:00-6:30PM on 10/10/23. Pain at injection site (left arm) began around 11:00PM on 10/10/23. Fever, chills, body aches, headache, stiff neck, extreme lethargy all began somewhere between 11:00 PM (10/10/23) and 1:00 AM (10/11/23) and continued through 11AM 10/11/23 despite taking Tylenol around 8:00 AM (10/11/23). Symptoms have gotten better since 11AM; however, I am still very lethargic, have a bit of a headache, and low-grade body aches. Injection site is still sore, but not nearly as bad as it was over night.
Age: 37.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Lethargy, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Gastrointestinal upset - diarrhea 3-4 times between 2:00-6:30PM on 10/10/23. Pain at injection site (left arm) began around 11:00PM on 10/10/23. Fever, chills, body aches, headache, stiff neck, extreme lethargy all began somewhere between 11:00 PM (10/10/23) and 1:00 AM (10/11/23) and continued through 11AM 10/11/23 despite taking Tylenol around 8:00 AM (10/11/23). Symptoms have gotten better since 11AM; however, I am still very lethargic, have a bit of a headache, and low-grade body aches. Injection site is still sore, but not nearly as bad as it was over night.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Pyrexia, Syncope, Tremor
Clinical narrative: Extreme chills and shaking of hands about 9pm. High fever all night-did not take Tylenol Temperature 102 in morning-Took 1 tablet of Tylenol Very weak.  Chills and fever.  Fainted about 9am. Chills throughout the day
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy Hx: initial positive UPT on the weekend of 10/7/23-10/8/23 EDD: tbd  Friday, October 6th, pt., came into the office for a travel consultation for a trip 12/5/23-01/08/24. When reviewing her health history that she filled out online, I mistakenly overlooked that she had noted possible pregnancy and no mention of it was made by pt. at the visit. After reviewing all of her vaccination records that she brought with her, pt. received Hep A dose #2, Polio, Tdap, and Varicella dose #2. She also prepaid and scheduled a cholera vaccine. Additionally, I dispensed an oral typhoid vaccine to her at the visit and eRx'd malarone and azithromycin to her pharmacy. I received a message on Tuesday Oct 11 that she had called to report that she had a positive pregnancy test over the weekend. I called pt. Tuesday morning to instruct her to not start the oral typhoid. She had told me that she wouldn't be taking it over the weekend and once she found out she was pregnant, she did not start it. Additionally, I informed her that the malarone and azithromycin Rxs had been cancelled and she will need to consult with and get Rxs from her OB for malaria and TD as malarone, doxy and azitromycin are CI in pregnancy and Larium is CI for her as well due to her psychiatric hx. Client told me that she does have an OB visit scheduled 4 weeks prior to trip to discuss options. Informed client we will cancel cholera and refund cost. Client informed that all other vaccines are fine in pregnancy with the exception of varicella which is CI due to it being a live vaccine. Reassured client that the risk to the fetus is theoretical and no complications of pregnancy have been reported in any studies. I did emphasize that all vaccines received on Oct 6th, particularly the varicella, need to be disclosed to her OB in case her doctor needs to follow up on anything. Client verbalized understanding. I spoke with pt. again on Wednesday, Oct 12 and asked her to return the oral typhoid to the clinic. I offered a Typhim Vi vaccine, per the suggestion, but pt. declined stating that she might be cancelling her trip due to her limited options for malaria medication. She agreed to return the oral typhoid to the clinic this week during our open hours which are between 9:30-5:30 M-F. She informed me that she spoke with a nurse at her OB's office and the OB is supposed to call her back to discuss options for malaria medications. I reiterated that she needs to inform her OB of the vaccines she received last Friday, especially the varicella since it is CI in pregnancy. Client verbalized understanding.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Immediately when the vaccine was injected I felt a sharp pain go down my arm a few inches from the injection site.  The injection was placed much higher than I've had previously.  My arm has been very painful in the time since (now 3 weeks).  It hurts in the shoulder joint, and in the biceps tendon.  It is very stiff and painful at night and in the morning, and even once I get it moving it is still very painful during the day.  Pain relievers don't work.  I have been applying heat per my primary care doctor's recommendation, but it is not getting  better.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site, Tendon pain
Clinical narrative: Immediately when the vaccine was injected I felt a sharp pain go down my arm a few inches from the injection site.  The injection was placed much higher than I've had previously.  My arm has been very painful in the time since (now 3 weeks).  It hurts in the shoulder joint, and in the biceps tendon.  It is very stiff and painful at night and in the morning, and even once I get it moving it is still very painful during the day.  Pain relievers don't work.  I have been applying heat per my primary care doctor's recommendation, but it is not getting  better.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Pain to Left arm injection site was immediate but was not unusual then on the next day patient with inability to raise, had to be supported with Right hand/arm, and inability to rotate arm (i.e.: patient is unable to clasp bra) to the extent of needing spousal assistance with dressing upper torso. To date, which is >2 weeks, the pain is more manageable, however, it still persists with movement and patient presented to hospital for assessment. Home remedies? - Tylenol 500 mg ER since 10.02.2023.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Child had received a Pfizer dose #1 on 08/12/2022 and therefore should have received a Pfizer product however not Pfizer product was available. / Notified Dr. Medical Director
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Rash
Clinical narrative: I felt achy and run down initially. I was getting in the shower and my husband noticed rashes on me. Under my right breast and it was teacup sized and it was on my chest and under my breasts. No pain or anything. It was like hives but no puss or liquid. From my collar bone to the bottom of my ribcage area.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Vaccines were given - mother noticed two dots where injections were given that never went away. Then noticed a bigger reddened area about a week later. Mother gave Tylenol.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given pfizer covid 19 omicron vaccine for ages 6 months - 4 years instead of pfizer covid 19 oricron vaccine for ages 5year - 11years.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient reported that after receiving the flu vaccine at the flu clinic she developed a large bruise, swelling, and pain in the location of the injection. She stated that she was told by flu clinic to use a cold compress on the area and that it happened because the injection was given too low. Patient reported this to the Patient Safety Officer on 10/11/23 and patient still has a large bruise
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: He has swollen red bumps the size of dimes  around where the vaccine was injected and it is itchy.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Patient's wife called this evening, stated her husband received his flu vaccine yesterday. He woke up this morning with cheeks, forehead, and nose red. It started to fade in early afternoon, but not has gotten redder again.  He has eczema, but this is different and she thinks it may be from the flu vaccine.  He has had the flu shot in the past, but never had a problem before.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site mass
Clinical narrative: about 30 minutes after shot was given, arm started itching a lot and started feeling sore and heavy. following day, the site where the vaccine was given was red swollen and had a big bump, felt hot to the touch and was still itching, swollen and redness lump lasted about 2 days. to this day it is still itching, bump in almost gone but still red.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: about 30 minutes after shot was given, arm started itching a lot and started feeling sore and heavy. following day, the site where the vaccine was given was red swollen and had a big bump, felt hot to the touch and was still itching, swollen and redness lump lasted about 2 days. to this day it is still itching, bump in almost gone but still red.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given pfizer covid 19 omicron vaccine for ages 6 months - 4 years instead of pfizer covid 19 omicron vaccine for ages 5year - 11years.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac telemetry, Chronic left ventricular failure, Fluid intake restriction, Haematuria
Clinical narrative: Length of Stay:          Hospital Day(s): 6      CURRENT MEDICAL STATUS AND PLAN OF CARE Level of Care  | Level of Service LEVEL OF CARE: Levelofcare: ICU CLASS: inpatient Diagnosis HEMATURIA COVID-19 DISEASE  SYSTOLIC HEART FAILURE, CHRONIC  Status Post  ()    Discussed with Chart Review/Dr/(caregiver) Current Treatment Plan/ Plan of Care   - Salt and fluid restriction - Daily weights, strict I&O - Continue to monitor on telemetry    MSW referral initiated No Palliative Care referral initiated No    Additional Comments 9/30/ spoke to caregiver; unable to take patient back today due to personal at facility; explained patient medically cleared for DC; appeal DC. Can take patient back tomorrow.    DISCHARGE PLAN IM Reissue 9/30/23 Preferences Discussed Yes back to facility Anticipated DC Dispo Board and Care with HH Transportation at DC BLS DME Needs for DC n/a Teaching/ Learning Needs TBD Risk for readmission HIGH     PCC to Follow Clinical prgress for emerging DC planning needs.  Arrange transportation Appealed DC   RN  9/30/2023 2:22 PM            Note Details  Author RN File Time 10/2/2023  8:00 AM Author Type REGISTERED NURSE Status Signed Last Editor RN Specialty GENERAL, OTHER Admit Date 9/25/2023  ED to Hosp-Admission (Discharged) on 9/25/2023  ED to Hosp-Admission (Discharged) on 9/25/2023   Detailed Report  Note shared with patient Care Timeline  09/26   Transferred to ICU 2145   Admitted from ED (Observation) 2145 09/27   Admitted 1158    Transferred out of ICU 2025 10/01   Discharged 1515
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Medical diet
Clinical narrative: Length of Stay:          Hospital Day(s): 6      CURRENT MEDICAL STATUS AND PLAN OF CARE Level of Care  | Level of Service LEVEL OF CARE: Levelofcare: ICU CLASS: inpatient Diagnosis HEMATURIA COVID-19 DISEASE  SYSTOLIC HEART FAILURE, CHRONIC  Status Post  ()    Discussed with Chart Review/Dr/(caregiver) Current Treatment Plan/ Plan of Care   - Salt and fluid restriction - Daily weights, strict I&O - Continue to monitor on telemetry    MSW referral initiated No Palliative Care referral initiated No    Additional Comments 9/30/ spoke to caregiver; unable to take patient back today due to personal at facility; explained patient medically cleared for DC; appeal DC. Can take patient back tomorrow.    DISCHARGE PLAN IM Reissue 9/30/23 Preferences Discussed Yes back to facility Anticipated DC Dispo Board and Care with HH Transportation at DC BLS DME Needs for DC n/a Teaching/ Learning Needs TBD Risk for readmission HIGH     PCC to Follow Clinical prgress for emerging DC planning needs.  Arrange transportation Appealed DC   RN  9/30/2023 2:22 PM            Note Details  Author RN File Time 10/2/2023  8:00 AM Author Type REGISTERED NURSE Status Signed Last Editor RN Specialty GENERAL, OTHER Admit Date 9/25/2023  ED to Hosp-Admission (Discharged) on 9/25/2023  ED to Hosp-Admission (Discharged) on 9/25/2023   Detailed Report  Note shared with patient Care Timeline  09/26   Transferred to ICU 2145   Admitted from ED (Observation) 2145 09/27   Admitted 1158    Transferred out of ICU 2025 10/01   Discharged 1515
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cytomegalovirus test, Full blood count, Rash, Rash papular, Treponema test
Clinical narrative: papular rash over palms and feet
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Complete loss of taste
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Moderate fatigue that prevented normal activity, for first 36 hours. Fatigue gone by 2nd day after injection. Pain, swelling, and immobility at site of right deltoid injection that prevented normal activity. No redness. Mild pain at injection site on night of injection. Next morning after injection (day 1): could not ABduct right arm, due to severe pain at injection site. Took 1 Aleve (NSAID) every 8 hours. Applied heating pad to right deltoid site for many hours. Confined to bed on day 1. Day 2 less pain but ABduct right arm less than 50%, due to moderate pain. Continuing Aleve and heating pad. Grade 3 reaction, according to published chart.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Moderate fatigue that prevented normal activity, for first 36 hours. Fatigue gone by 2nd day after injection. Pain, swelling, and immobility at site of right deltoid injection that prevented normal activity. No redness. Mild pain at injection site on night of injection. Next morning after injection (day 1): could not ABduct right arm, due to severe pain at injection site. Took 1 Aleve (NSAID) every 8 hours. Applied heating pad to right deltoid site for many hours. Confined to bed on day 1. Day 2 less pain but ABduct right arm less than 50%, due to moderate pain. Continuing Aleve and heating pad. Grade 3 reaction, according to published chart.
Age: 78.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administration error, Wrong product administered
Clinical narrative: Patient wanted to receive Fluzona HD, standard flu shot was administered in error. no adverse reactions besides patient wanted HD vaccine
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events reported at this time but patient received two rsv vaccines.  Abrysvo was given on 9/27/23 and Arexvy was given on 10/11/23.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypertonic bladder
Clinical narrative: Overactive bladder symptoms suddenly became very intense, and have continued for several weeks after vaccine.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: Unknown exact onset of symptoms believe it was on 10/10/23.  Have not spoken with patient, but her fellow coworkers report she has no pain at site, but can't lift her arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Contusion, Syncope
Clinical narrative: Patient experienced a faint and hit her head after receiving her 11 year old vaccines.  Sustained reddish bruise on L frontal area. No LOC or change in mental status. Felt better after receiving juice, snack and an ice pack.   Patient was observed over a 20 minute period sitting up then standing.  BP was checked and patient felt well at discharge and no longer experiencing any symptoms.  Discharged to home with mother. Follow up phone call that evening confirmed patient was doing well.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: Patient is in 2 weeks post vaccine in left deltoid. Complaint is a pain described as nerve pain radiating from from bottom of tricep muscle down through elbow and into mid forearm. Said is was not muscle pain, but more "under the muscle". He described this occuring shortly after his covid shot in his left arm. Said pain was not horrible at a 1-2 on pain scale, but noticable. He stated he did not think he needed any medication to help with pain as it was not signifigant. Told him to report back to us about pain to see if resolves.
Sex: F
Vaccine: HPV9
Symptoms: Vision blurred
Clinical narrative: the patient has been experiencing blurred vision since the administration of the GARDASIL 9 vaccine.; This spontaneous report was received from a Consumer and refers to a 42-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included bupropion hydrochloride (+) naltrexone hydrochloride (CONTRAVE).   On 25-SEP-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml/ 1st dose, lot #X004374, expiration date not provided but upon internal validation established  as 02-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 25-SEP-2023, reported as since the administration of GARDASIL 9 vaccine, the patient experienced blurred vision. It was reported that the blurred vision was improving. At the time of reporting, the patient was recovering from the event.   The causal relationship between blurred vision and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP calling to report AE for Supported TE for PROQUAD. Unknown Administered Date; This spontaneous report has been received from a nurse and refers to a 4-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a single dose of a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection that had suffered a temperature excursion. (lot number X007358 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 08-SEP-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). Temperature excursion happened in a timeframe of 18 minutes at a -13 degrees Celsius (C); previous excursion's timeframe was for 26 minutes at a temperature of -13.8 C.; Sender's Comments:  US-009507513-2310USA001447:Case # 02485007
Sex: M
Vaccine: HEP, HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: No additional AE or PQC; the patient received a dose of ENGERIX-B instead of RECOMBIVAX HB.; This spontaneous report has been received from a health care professional (HCP) (also reported as a pharmacist) concerning a male patient of unknown age.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 05-SEP-2023, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) of their three-dose series (dose, anatomical location, route of administration, lot#, expiration date were not reported) for prophylaxis. On 05-OCT-2023, the patient was vaccinated with hepatitis b vaccine rhbsag (yeast) (ENGERIX B) (dose, anatomical location, route of administration, lot#, expiration date, and indication were not reported) as the second dose instead of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (Interchange of vaccine products).  No additional adverse event was reported.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Autoimmune disorder, Autonomic nervous system imbalance, Disability, Dizziness
Clinical narrative: epilepsy: several seizures over several months; lethargy; joint pain; serious autoimmune, autonomic, and neurological dysfunctions, chronic fatigue, syncope/neurocardiogeniogenic syncope (dizziness); serious autoimmune, autonomic, and neurological dysfunctions,; serious autoimmune, autonomic, and neurological dysfunctions,; as well as a constellation of adverse symptoms, complications, injuries, and other adverse events; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning female patient (age not specified). Patient's current conditions, medical history and concomitant therapy was not reported. On 05-FEB-2019 (at 14 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, following her vaccination, pt suffered lethargy, joint pain, dizziness, syncope, pt also had several seizures over several months that required multiple emergency room visits. She was prescribed eslicarbazepine acetate (APTIOME) for her seizures, she also received a tilt table test and tested positive for neurocardiogeniogenic syncope. As a result of her symptoms, pt had been unable to engage in activities that a normal young person would enjoy. Based upon her chronic and severe post quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to epilepsy, chronic fatigue, neurocardiogeniogenic syncope. Pt contends that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection caused her to develop serious and debilitating autoimmune, autonomic nervous system imbalance, and neurological, injuries, including but not limited to epilepsy, chronic fatigue, and neurocardiogeniogenic syncope, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) induced autoimmune disorder. At the time of reporting, plaintiff had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All the events were considered as disabling by reporter.  Upon internal review, the event of epilepsy, and autoimmune disorder were determined to be medically significant.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Epilepsy, Fatigue, Lethargy, Loss of personal independence in daily activities, Seizure
Clinical narrative: epilepsy: several seizures over several months; lethargy; joint pain; serious autoimmune, autonomic, and neurological dysfunctions, chronic fatigue, syncope/neurocardiogeniogenic syncope (dizziness); serious autoimmune, autonomic, and neurological dysfunctions,; serious autoimmune, autonomic, and neurological dysfunctions,; as well as a constellation of adverse symptoms, complications, injuries, and other adverse events; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning female patient (age not specified). Patient's current conditions, medical history and concomitant therapy was not reported. On 05-FEB-2019 (at 14 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, following her vaccination, pt suffered lethargy, joint pain, dizziness, syncope, pt also had several seizures over several months that required multiple emergency room visits. She was prescribed eslicarbazepine acetate (APTIOME) for her seizures, she also received a tilt table test and tested positive for neurocardiogeniogenic syncope. As a result of her symptoms, pt had been unable to engage in activities that a normal young person would enjoy. Based upon her chronic and severe post quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to epilepsy, chronic fatigue, neurocardiogeniogenic syncope. Pt contends that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection caused her to develop serious and debilitating autoimmune, autonomic nervous system imbalance, and neurological, injuries, including but not limited to epilepsy, chronic fatigue, and neurocardiogeniogenic syncope, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) induced autoimmune disorder. At the time of reporting, plaintiff had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All the events were considered as disabling by reporter.  Upon internal review, the event of epilepsy, and autoimmune disorder were determined to be medically significant.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tilt table test positive
Clinical narrative: epilepsy: several seizures over several months; lethargy; joint pain; serious autoimmune, autonomic, and neurological dysfunctions, chronic fatigue, syncope/neurocardiogeniogenic syncope (dizziness); serious autoimmune, autonomic, and neurological dysfunctions,; serious autoimmune, autonomic, and neurological dysfunctions,; as well as a constellation of adverse symptoms, complications, injuries, and other adverse events; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning female patient (age not specified). Patient's current conditions, medical history and concomitant therapy was not reported. On 05-FEB-2019 (at 14 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, following her vaccination, pt suffered lethargy, joint pain, dizziness, syncope, pt also had several seizures over several months that required multiple emergency room visits. She was prescribed eslicarbazepine acetate (APTIOME) for her seizures, she also received a tilt table test and tested positive for neurocardiogeniogenic syncope. As a result of her symptoms, pt had been unable to engage in activities that a normal young person would enjoy. Based upon her chronic and severe post quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to epilepsy, chronic fatigue, neurocardiogeniogenic syncope. Pt contends that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection caused her to develop serious and debilitating autoimmune, autonomic nervous system imbalance, and neurological, injuries, including but not limited to epilepsy, chronic fatigue, and neurocardiogeniogenic syncope, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) induced autoimmune disorder. At the time of reporting, plaintiff had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All the events were considered as disabling by reporter.  Upon internal review, the event of epilepsy, and autoimmune disorder were determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reported VARIVAX  was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved VARIVAX X000532 1/4/2025        ?    Temperature 8.1°F        ?    Time frame 3 hours; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 21-SEP-2023 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # X000532 and expiration date 04-JAN-2025, for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion lasted for 3 hours 0 minutes 0 seconds in 8.1 Fahrenheit degrees (F).
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: developing shingles/suspected vaccination failure; covid infection; developing shingles post covid infection; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: developing shingles/suspected vaccination failure) (serious criteria GSK medically significant), covid-19 (Verbatim: covid infection) and shingles (Verbatim: developing shingles post covid infection).  The outcome of the vaccination failure was unknown and the outcome of the covid-19 and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, covid-19 and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure, covid-19 and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 5-Oct-2023 The patient self reported that developing shingles post covid infection. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.