chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Abdominal discomfort, Asthenia, Chills, Dissociation, Dizziness
Clinical narrative: Dizzy, vomiting, upset stomach, fever, chills, weak- can't walk, some dissociation- difficult articulating what he's feeling, hands felt large, vision got tunneled.
Age: 13.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Gait inability, Pyrexia, Sensory disturbance, Tunnel vision, Vomiting
Clinical narrative: Dizzy, vomiting, upset stomach, fever, chills, weak- can't walk, some dissociation- difficult articulating what he's feeling, hands felt large, vision got tunneled.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Disorganised speech, Sensory disturbance, Swollen tongue
Clinical narrative: Patient received a flu vaccine during a community based vaccination clinic. Approximately 5-10 minutes after receiving the vaccine, the patient complained that her tongue was swollen and she felt like she had a rash on her trunk. No rash was observed, but patient's tongue was visibly swollen and speech was garbled. BP 160/90, HR 90. 911 was called. While assessing the patient, the tongue swelling and garbled speech resolved on its own. Patient stated she felt better. EMS arrived and assessed patient who remained asymptomatic. Patient was transported to ER for further evaluation. Patient did report a past history of GI symptoms after her first flu vaccination, but stated she had received other flu vaccines without any side effects or adverse reactions.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Oropharyngeal discomfort, Urticaria
Clinical narrative: Throat fullness/epigastric pain x 24 hours Urticaria - 3+days
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles, I also had the shingles shots already.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Skin warm
Clinical narrative: PATIENT HAD AN ALLERGIC REACTION TO FLUZONE HD. HER ARM WAS HOT TO THE TOUCH, RED AND SWOLLEN. PATIENT WAS ADVISED TO TAKE IBUPROFEN AND CALL DOCTOR IF SWELLING DOES NOT RESOLVE WITH 3 TO 5 DAYS
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Death, Feeding disorder, Metastases to liver, Metastases to lung
Clinical narrative: He started experiencing pain all over his body. He could not eat. He said his bones were hurting. This was in February 2022 and in March of 2022 he finally went to the hospital. After some testing they informed him that he had metastasized cancer all over his chest, liver, lungs, spleen, practically all over his body. They could not do anything and suggested hospice. He was in hospice there in the hospital and was given morphine for the pain and he died within a day.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Metastases to spleen, Pain
Clinical narrative: He started experiencing pain all over his body. He could not eat. He said his bones were hurting. This was in February 2022 and in March of 2022 he finally went to the hospital. After some testing they informed him that he had metastasized cancer all over his chest, liver, lungs, spleen, practically all over his body. They could not do anything and suggested hospice. He was in hospice there in the hospital and was given morphine for the pain and he died within a day.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: 10/07/23: Mother reports patient noted with redness on left thigh after vaccines.  Patient received Pentacel yesterday, site noted with redness and swelling,  no difficulty breathing, warmth, hives or severe swelling noted. Patient able to bear weight on left lower extremity. Explained to parent common vaccine SE usually lasting from 24-72 hrs, advised to apply cold compress, may give Ibuprofen if necessary and scheduled appointment on Monday 10/09/23. 10/09/23: Per provider's note, redness around site has increased and has some bluish discoloration noted to left thigh,  able to ambulate. Return to clinic in 2 days,  appointment scheduled on 10/11/23 for f/u.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Throat irritation
Clinical narrative: Patient stated she felt lightheaded and scratchy throat after receiving flu immunization. Patient stated she has never received flu vaccine in the past.  Nurse checked vital signs, vital signs were stable. Patient continued to complain of feeling of itchy throat. Nurse  administered epinephrine 1 x and called 911. patient was transported via ambulance to hospital.  Patient remained awake, alert and oriented through entire event.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: PATIENT GOT RED AROUND INJECTION SITE AND LUMPS THAT TRAVELED DOWN THE ARM. RED SPOTS TRAVELED DOWN THE ARM AS WELL AS TRACKS THAT LOOKED LIKE SHE HAD BEEN SCRATCHED OR GOT A MILD CASE OF SHINGLES FROM THE VACCINE.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Mother reported labile fever commencing one week after vaccination, rash noted to upper torso (chest and back); lasted one week. Physical completed today, exactly two weeks after vaccination - rash is mostly resolved, noted to abdomen only.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproed storage unit
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cold urticaria, Delivery, Exposure during pregnancy, Food craving, Graves' disease
Clinical narrative: In May 2022, my 6-year-old child and I both received a  Pfizer covid shot (my 3rd, his 1st), while I was 7 months pregnant. I delivered a healthy baby, 8 lbs 9 oz.  In September, about 3-4 months after vaccine, I started getting cold urticaria (hives in cold weather). About 6-12 months after that, I started getting hyperthyroid symptoms (insomnia, tingling in arms, sugar cravings, irritability, etc.) and was diagnosed with Graves disease in August of 2023. In June 2023, my child was diagnosed with juvenile arthritis. Both are autoimmune conditions that developed around the same time as each other.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Irritability, Paraesthesia, Thyroid stimulating immunoglobulin, Thyroxine free
Clinical narrative: In May 2022, my 6-year-old child and I both received a  Pfizer covid shot (my 3rd, his 1st), while I was 7 months pregnant. I delivered a healthy baby, 8 lbs 9 oz.  In September, about 3-4 months after vaccine, I started getting cold urticaria (hives in cold weather). About 6-12 months after that, I started getting hyperthyroid symptoms (insomnia, tingling in arms, sugar cravings, irritability, etc.) and was diagnosed with Graves disease in August of 2023. In June 2023, my child was diagnosed with juvenile arthritis. Both are autoimmune conditions that developed around the same time as each other.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine free
Clinical narrative: In May 2022, my 6-year-old child and I both received a  Pfizer covid shot (my 3rd, his 1st), while I was 7 months pregnant. I delivered a healthy baby, 8 lbs 9 oz.  In September, about 3-4 months after vaccine, I started getting cold urticaria (hives in cold weather). About 6-12 months after that, I started getting hyperthyroid symptoms (insomnia, tingling in arms, sugar cravings, irritability, etc.) and was diagnosed with Graves disease in August of 2023. In June 2023, my child was diagnosed with juvenile arthritis. Both are autoimmune conditions that developed around the same time as each other.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome, Movement disorder
Clinical narrative: Guillain Barre Syndrome,    could not move legs
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 62.0
Sex: F
Vaccine: FLUR4, RSV
Symptoms: Arthralgia, Back pain, Dyspnoea, Immunisation reaction, Pulmonary thrombosis
Clinical narrative: Patient states no arm pain immediately, also thought she was breathing better.  Her RA MD told her not to resume MTX for 1 week.  She took next dose of MTX on 10/7/23.  She said that day she started to get back pain under her shoulders and shoulder pain that became more severe as the day went on.  She went to the Emergency Dept on 10/8/23 and they found a blood clot in her lung.  They told her they thought it was a result of the RSC vaccine and that she should not get any further new vaccines.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 95.0
Sex: M
Vaccine: FLUA4
Symptoms: Incorrect dose administered
Clinical narrative: Gave 2 fluAd vaccines
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: rash all over body started on evening of 10/05/2023, no treatment was necessary as rash did get better
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Feeling hot, Rash macular
Clinical narrative: Patient received the RSV vaccine (Abrysvo) in her right deltoid (IM) About a half hour after she got home (vaccine was administered at 12:30pm)  patient noticed diffuse red blotches on her right arm, right cheek, and her right ear was warm and red. Pt called me at 2:50pm to report her symptoms and stated she did not have any breathing issues or any swelling of face/tongue/lips etc. Pt is a nurse so she is very aware of what to do in case of anaphylactic shock. Pt has not had this type of reaction to a vaccine in the past. Pt applied topical Benadryl to any red blotchy areas and is planning to take Benadryl after she returns home from going out to dinner.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported. However, patient received two flu shots
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stores in an unapproved storage unit
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody negative, Arthralgia, C-reactive protein normal, Gait disturbance
Clinical narrative: In May 2022, my 6-year-old child and I both received a  Pfizer covid shot (my 3rd, his 1st). About 5-11 months later, he started complaining of knee pain. By June he was limping and his knee was swollen. In June 2023, my child was diagnosed with juvenile arthritis. It was found in both knees and both ankles by ultrasound in July 2023. I was diagnosed with Graves disease in August 2023. Both are autoimmune conditions that developed around the same time as each other.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Juvenile idiopathic arthritis, Platelet count increased, Ultrasound joint abnormal
Clinical narrative: In May 2022, my 6-year-old child and I both received a  Pfizer covid shot (my 3rd, his 1st). About 5-11 months later, he started complaining of knee pain. By June he was limping and his knee was swollen. In June 2023, my child was diagnosed with juvenile arthritis. It was found in both knees and both ankles by ultrasound in July 2023. I was diagnosed with Graves disease in August 2023. Both are autoimmune conditions that developed around the same time as each other.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diabetes mellitus, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Alopecia areata, Alopecia universalis, Biopsy skin abnormal, Exposure during pregnancy
Clinical narrative: Discovered a bald spot (Alopecia Areata) in December 2022, 1 month after vaccine while 5 months pregnant which got larger over course of pregnancy. After giving birth, within 1 month, I had lost all of the hair and have been diagnosed with Alopecia Universalis.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated with booster
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Dizziness, Magnetic resonance imaging normal, Nausea, Parosmia
Clinical narrative: Lightheadedness, vertigo, nausea . Sense of smell has changed. Have a strong metallic smell that smells like garbage that never goes away.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urine analysis normal, Vertigo
Clinical narrative: Lightheadedness, vertigo, nausea . Sense of smell has changed. Have a strong metallic smell that smells like garbage that never goes away.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Tinnitus, Headache for over 3 days
Age: 74.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Dizziness, Hypoaesthesia, Limb discomfort, Paraesthesia, Pyrexia
Clinical narrative: PATIENT CALLED PHARMACY 10/9/23 STATING SHE HAD A FEVER THE NIGHT OF THE VACCINE 10/4/23 FOR FLUAD AND COMIRNATY.  FEVER WENT AWAY THE SAME NIGHT.  NEXT DAY 10/5/23, PATIENT STATED SHE FELT DIZZY, PINS/NEEDLES SENSATION ON LEFT ARM/LEG, AND HEAVY/NUMBNESS FEELING IN LEFT ARM/LEGS.  MOST OF THE SYMPTOMS SUBSIDED BY 10/8/23.  CURRENTLY ONLY EXPERIENCING HEAVY/NUMBNESS FEELING IN LEFT LEG.  PATIENT STATES DID NOT CONTACT PCP OR WENT TO THE ER EITHER.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient, aged 17, received FluBok. No adverse events.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Erythema
Clinical narrative: Large area bright red skin
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt observed for 15 minutes, no immeidate reaction, notified parent of error. Mother states she was at the gym working out with pt and he was acting fine. Discussed side effects to monitor for and when seek medical attention.
Age: 22.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Syncope
Clinical narrative: Patient received flu vaccine with no issue, upon receiving Covid vaccine around 3:52PM, patient fainted for roughly 30 to 45 seconds. After regaining consciousness, patient attempted to stand up, and was told to remain seated by the pharmacist while the EMTs arrived.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy Rash on leg
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia, Syncope
Clinical narrative: Extreme fatigue, collapse, low grade fever
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pain
Clinical narrative: Patient reported large amount of bruising day after injection was given that has lasted over one week. Patient also experienced pain for one day.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient started to develop itching all through the bottle, little red spots all over the body, warm spots where the welts started to form.  Has not done anything for it yet but called the physician and was told to report to the pharmacy. Started getting better on its own 1 week after vaccination, but still not completely reversed
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: Lip swelling and numbness 20-25 minutes post injection
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19, Dyspnoea, Feeling abnormal, Feeling of despair, Hypersensitivity
Clinical narrative: I had Covid before being vaccinated, it was mild, felt like a small cold or allergic reaction. After getting both doses of the vaccine, I later got Covid and was sicker than I had ever been in my life, to the point where I literally thought I was going to die. At this time is when the allergy and sinus problem came into play in a severe manner. Allergy pills, Dayquil, pseudoephedrine, Mucinex, vitamins, nothing helps anymore. It seems to get worse; I suffer daily and half the time I lose sleep because I either cannot breathe, or I have to lay in the weirdest positions just to be able to breathe or not have not run down my face and soak my pillow. Half of my days consist of toilet paper up my nostrils just so I can get through my day without stopping to blow my nose. I was working remotely, and now laid off and desperately looking for work, and this has affected my life so badly I do not think I can find an On-site job due to the fact I will not be able to blow my nose every 2 minutes or walk around appropriately with toilet paper shoved up my nose. I am miserable daily and have no hope for my future. This is no way to live life.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Insurance issue, Loss of employment, Loss of personal independence in daily activities, Malaise
Clinical narrative: I had Covid before being vaccinated, it was mild, felt like a small cold or allergic reaction. After getting both doses of the vaccine, I later got Covid and was sicker than I had ever been in my life, to the point where I literally thought I was going to die. At this time is when the allergy and sinus problem came into play in a severe manner. Allergy pills, Dayquil, pseudoephedrine, Mucinex, vitamins, nothing helps anymore. It seems to get worse; I suffer daily and half the time I lose sleep because I either cannot breathe, or I have to lay in the weirdest positions just to be able to breathe or not have not run down my face and soak my pillow. Half of my days consist of toilet paper up my nostrils just so I can get through my day without stopping to blow my nose. I was working remotely, and now laid off and desperately looking for work, and this has affected my life so badly I do not think I can find an On-site job due to the fact I will not be able to blow my nose every 2 minutes or walk around appropriately with toilet paper shoved up my nose. I am miserable daily and have no hope for my future. This is no way to live life.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paranasal sinus inflammation, Rhinorrhoea, Sinus disorder, Sleep disorder
Clinical narrative: I had Covid before being vaccinated, it was mild, felt like a small cold or allergic reaction. After getting both doses of the vaccine, I later got Covid and was sicker than I had ever been in my life, to the point where I literally thought I was going to die. At this time is when the allergy and sinus problem came into play in a severe manner. Allergy pills, Dayquil, pseudoephedrine, Mucinex, vitamins, nothing helps anymore. It seems to get worse; I suffer daily and half the time I lose sleep because I either cannot breathe, or I have to lay in the weirdest positions just to be able to breathe or not have not run down my face and soak my pillow. Half of my days consist of toilet paper up my nostrils just so I can get through my day without stopping to blow my nose. I was working remotely, and now laid off and desperately looking for work, and this has affected my life so badly I do not think I can find an On-site job due to the fact I will not be able to blow my nose every 2 minutes or walk around appropriately with toilet paper shoved up my nose. I am miserable daily and have no hope for my future. This is no way to live life.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Syncope
Clinical narrative: The student received both his vaccines (covid-19 & influenza), and promptly fainted. His head relaxed backwards, yet he remained upright in the chair. He did not fall out of the chair, and remained seated upright the entire time.  I noted no skin color change, but a loss of consciousness for 15 seconds.  He regained consciousness and was verbal. I checked his pulse and felt a radial pulse, while he regained consciousness. He continued breathing and I noted his chest rising and falling.  I had RN take vital signs and that is what was charted on this consent.   He was verbal and sat to the side and drank some water. He was alert and verbal and oriented to himself and where he was and what was going on.   We contacted the vice principal, who notified the parents and let them know what had happened, but that he was fine. He returned to class with no further incidents while we were on site.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine recipient is a hospital volunteer who came to employee health to receive 2023-2024 seasonal influenza vaccine. Volunteer received a flu vaccine then went to another vaccine station, did not inform the vaccinator just received flu vaccine, and received another dose of flu vaccine. Volunteer was monitored for 30 minutes after receiving second flu vaccine, denied SOB or other symptoms, no s/sx of distress or adverse reactions observed when volunteer left employee health office.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Malaise
Clinical narrative: She got her vaccine, she did have some soreness, but that has been normal from shots.  During the night she felt chills.  Then she got up and had a headache, took her temperature and it was elevated to 101.  She took Tylenol and that alleviated the fever, and the fevers start going down but she hs been waking up with a fever almost every day since.  They are in the range of 100 to 100.6 range, and are still continuing today as well.  After the first day when she took the Tylenol she felt OK for a couple of days, and then she woke up and she was nauseous which she is hardly ever that way.  When she got up to use the bathroom and got back in the bed she was feeling shortness of breath.  The shortness of breath is main mainly when she wakes up, uses the restroom and goes back to bed.  She is having some problems with her breathing which she previously did not have.  It catches her breath, which she cannot describe as she has never had this reaction before.  She is still continuing to have that as well.  For a couple of days she was sweaty, but hasn't been consistent.  Yesterday at 5:00 AM it was 99.8, when she woke up at 8:30 it 100.6, at 9:30 it was 100.2, 11:00 it 99.6 and it continued to go down.  This morning it was above 100.3.  She has continued to take the tylenol with her fevers, and as soon as she takes it it starts to go down.  She called her pharmacist when she had the throat symptoms a week ago and she past Thursday called her PCP because she felt that it was not going away.  Yesterday she spoke with a different pharmacist to see when it would be out of her body, and he said that it takes around 2 weeks.  Her PCP told her to continue to take the Tylenol and was concerned if she had any respiratory issues.  She called the doctor back on Friday and was told to go to the ER/UC as it was the weekend.  She decided not to go to the ER as it was 30 minutes away, and she wasn't feeling well so she decided not to do that.  She is still suspecting that it is the Spike protein and is waiting for a CB from her rheumatologist to see if the rheumatoid medication that she is on could be one of the causes of her symptoms.  She feels that the Spike protein may be the issue.    She has had 5 previous vaccines and did not have any AE from those.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: She got her vaccine, she did have some soreness, but that has been normal from shots.  During the night she felt chills.  Then she got up and had a headache, took her temperature and it was elevated to 101.  She took Tylenol and that alleviated the fever, and the fevers start going down but she hs been waking up with a fever almost every day since.  They are in the range of 100 to 100.6 range, and are still continuing today as well.  After the first day when she took the Tylenol she felt OK for a couple of days, and then she woke up and she was nauseous which she is hardly ever that way.  When she got up to use the bathroom and got back in the bed she was feeling shortness of breath.  The shortness of breath is main mainly when she wakes up, uses the restroom and goes back to bed.  She is having some problems with her breathing which she previously did not have.  It catches her breath, which she cannot describe as she has never had this reaction before.  She is still continuing to have that as well.  For a couple of days she was sweaty, but hasn't been consistent.  Yesterday at 5:00 AM it was 99.8, when she woke up at 8:30 it 100.6, at 9:30 it was 100.2, 11:00 it 99.6 and it continued to go down.  This morning it was above 100.3.  She has continued to take the tylenol with her fevers, and as soon as she takes it it starts to go down.  She called her pharmacist when she had the throat symptoms a week ago and she past Thursday called her PCP because she felt that it was not going away.  Yesterday she spoke with a different pharmacist to see when it would be out of her body, and he said that it takes around 2 weeks.  Her PCP told her to continue to take the Tylenol and was concerned if she had any respiratory issues.  She called the doctor back on Friday and was told to go to the ER/UC as it was the weekend.  She decided not to go to the ER as it was 30 minutes away, and she wasn't feeling well so she decided not to do that.  She is still suspecting that it is the Spike protein and is waiting for a CB from her rheumatologist to see if the rheumatoid medication that she is on could be one of the causes of her symptoms.  She feels that the Spike protein may be the issue.    She has had 5 previous vaccines and did not have any AE from those.
Age: 8.0
Sex: F
Vaccine: FLU4, HEPA, IPV
Symptoms: Fatigue, Hypoaesthesia, Lethargy, Loss of consciousness
Clinical narrative: Client lost consciousness about 5-8minutes after vaccines given around 3:15pm.   Code assist paged.  Dr. at bedside.  Patient lethargic but alert and talking to mom. Staff from present.  Pt stated she can't feel her legs. Bp 65/36.  She could feel Dr. touching legs.  Patient is moving arms and legs/holding mom's hand.  Pt had breakfast but no lunch.  Dr. with patient.  Pat eating some juice and crackers.  At 1547 patient propped up on wall eating crackers and drinking juice with mom.  1556-sitting up "feeling better but too tired to talk" per client (8 yo child).  BP 92/64 and pulse 73 at 1550.  Client discharged at 4pm with a bp of 99/69 and pulse of 78. RN
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Swelling of eyelid
Clinical narrative: My vaccine was listed as "2023 monovalent Covid-19 Booster targeting the XBB 1.5 strain of COVID-19". I don't have other info about which vaccine I received.  I have received all recommended COvid vaccines, including 2 initial doses, one booster in Nov 2022 and this booster yesterday  I was vaccinated on 10/8 at 2:30pm.  That night, approx 10pm I was very fatigued.  By midnight I had significant aches and chills and took tylenol for that.  I use tylenol normally for pain and do not have issues with it.  The following day, (today) my aches were still present, but not as severe as overnight.  I took a second dose (2 tablets ) of tylenol.  By noon, my eyelid had swollen noticably, but not so much that I couldn't open it.  I had the same reaction to my last Covid Booster in Nov 2022 which was Pfizer.   In November, I had continued swelling for a couple of days.  I presume the eyelid edema will self resolve again.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye disorder, Eye pain, Eye swelling, Sleep disorder, Vision blurred
Clinical narrative: vaccine was administered on 9/29/23 and on 10/3/23 approximately about 11 pm I was awaken with pain in my left eye that felt like something was in it, and did continue to get worth I kept looking into and saw nothing and by Friday it felt I had a gash on my eye, the last time I felt that was when I had the COVID vaccine. That is when I knew it was the vaccine I had, I did have some hives which I treated with a corticoid steroid cream I tried to call my doctor on Friday but haven't been able to read him yet. My vision is extremely blurry and my eyes are swollen and now the other eye feels the same. I am treating it with erythromycin ointment  I had from so many eye infections I kept getting from the COVID vaccine. I went on 9/28/23 and just got a clean bill of health  with the ophthalmologist.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Electric shock sensation, Pain, Pain in extremity
Clinical narrative: Patient got a flu shot. At the time of injection, she stated she had an electrifying shock/shooting pain that ran down her left side of the body. She did not mention this at the time of her vaccine appointment; she mentioned it today on 10-9-2023. She states she does not have that shooting pain or shock anymore;however, her arm still hurts when she lifts her arm up to 45 degree. She will check in with her provider.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium, Full blood count, Metabolic function test, Syncope
Clinical narrative: patient received moderna covid booster 10/7/23 without any signs of immediate allergic reaction. On 10/8/2023, she has a syncopal event while sitting at a table the following afternoon. Similarly, she experienced this within 24h after receiving first modern booster and two-series moderna vaccination approximately one year ago.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Echocardiogram normal, Eye movement disorder, Feeling hot, Hyperhidrosis
Clinical narrative: patient received moderna covid booster 10/7/23 without any signs of immediate allergic reaction. On 10/8/2023, she has a syncopal event while sitting at a table the following afternoon. Similarly, she experienced this within 24h after receiving first modern booster and two-series moderna vaccination approximately one year ago.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Malaise, Nausea, Pallor, Poor quality sleep
Clinical narrative: patient received moderna covid booster 10/7/23 without any signs of immediate allergic reaction. On 10/8/2023, she has a syncopal event while sitting at a table the following afternoon. Similarly, she experienced this within 24h after receiving first modern booster and two-series moderna vaccination approximately one year ago.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Posture abnormal, Presyncope, Vomiting
Clinical narrative: patient received moderna covid booster 10/7/23 without any signs of immediate allergic reaction. On 10/8/2023, she has a syncopal event while sitting at a table the following afternoon. Similarly, she experienced this within 24h after receiving first modern booster and two-series moderna vaccination approximately one year ago.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Skin irritation, Urticaria, Wound
Clinical narrative: Patient states that he noticed hives on the same arm as the vaccination site 2 days after the vaccine was administered. On 10/9/23, patient stated that there is still a small amount of irritation/itchines, but they hives that were scratched opened have started to heal. Patient has no primary care physician at this time so he was unable to consult with a physician.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: Patient fainted
Age: 36.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vision blurred, Vitreous floaters, Vitreous opacities
Clinical narrative: blurred vision starting the night of vaccination, then developed floaters bilaterally and "vitreous opacity" over the next week, lasting >2 weeks now.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Immunizing technician was administering the flu vaccine to patient. The technician prepared to give the vaccine and administered the stick. However, after the stick the plunger would not move and would not allow administration of the vaccine.  This was most likely a result of the stick occurring to high on the arm based on the placement of band aid and where the actual stick occurred.  When this happened, the technician notified the pharmacist through the window. The pharmacist immediately came out and observed the situation. The pharmacist observed that the placement was too high and removed the needle. In addition, it is believed that no amount was administered during the process.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Cardiac stress test, Chest X-ray, Chest pain, Electrocardiogram, Pain in extremity
Clinical narrative: sore arm, chest pain, pluracy
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Pleurisy
Clinical narrative: sore arm, chest pain, pluracy
Age: 23.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: RN accidentally gave a 23-year-old patient the senior dose (Fluad) of flu vaccine instead of Flucelvax.  She did not realize it until after the clinic had ended. Patient was contacted on 10/9/2023 at 2:33 PM and notified of the error. He reports that he has had no adverse symptoms and "no problems." He expressed appreciation for being notified. He said, "I appreciate your letting me know. I haven't had any issues."
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Infant irritability, Wrong product administered
Clinical narrative: Quadracel inadvertently given rather than Vaxelis at 2 month old wellness visit.  Follow up with parents today (10/9/2023) 72 hours after administration. No fever at any point. No redness or swelling around injection site. Infant has been a little more fussy and not eating as well.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Rash
Clinical narrative: Employee stated having rash on various parts of his body, weakness, some numbness to arms. The symptoms resolved 2 days  after vaccine administration. Employee has not had previous reactions to multiple flu vaccines in the past.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Soreness at injection site for one day, nausea four days so far, dizziness four days, headache one day
Age: 1.17
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This was a vaccine administration error. Patient received first Fluzone injection on 9/26/23 and parents brought patient into a Flu Clinic on 10/7/23 where he received dose #2 too early. Received 11 days apart instead of 28 days. No adverse side effects occurred.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back injury, Cognitive disorder, Confusional state, Dizziness
Clinical narrative: 12 hours post immunization, I got to go to toilet and felt dizziness, I started talking loudly to people who were not present.iI got up x3 to use toilet and around 0430 fell against night stand and twisted my back. My husband took me to toilet. I had a headache and felt very confused. Around 0545, I got up and fell  down near toilet.  I became anxious and stayed in bed unless I had him to walk me. I fell asleep and had dreams I didn't understand and heard people talking to me.  Husband found a  walker in our attic and I used it all day. I was less cognitively impaired but still felt dizzy.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hallucination, Headache, Nightmare
Clinical narrative: 12 hours post immunization, I got to go to toilet and felt dizziness, I started talking loudly to people who were not present.iI got up x3 to use toilet and around 0430 fell against night stand and twisted my back. My husband took me to toilet. I had a headache and felt very confused. Around 0545, I got up and fell  down near toilet.  I became anxious and stayed in bed unless I had him to walk me. I fell asleep and had dreams I didn't understand and heard people talking to me.  Husband found a  walker in our attic and I used it all day. I was less cognitively impaired but still felt dizzy.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Aches, fatigue, headache, low grade fever still ongoing
Age: 31.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Immediate post-injection reaction, Swelling
Clinical narrative: LOCALIZED SWELLING. PATIENT TOOK 2 IBUPROFEN THAT SHE HAD. WE PROVIDED WATER. PATIENT SAT IN IMMUNIZATION ROOM FOR 10 MINUTES. SWELLING BEGAN TO REDUCE. PATIENT SAT IN LOBBY FOR AN ADDITIONAL 10 MINUTES. I PROVIDED HER WITH A 25MG BENADTYL TO TAKE ONCE SHE GOT HOME. PATIENT WAS CONTACTED BY PHONE AT 4:30PM AND SHE STATED THAT SHE IS OKAY. SWELLING OCCURRED WITH THE FLUCELVAX VACCINATIONATION INSTANTLY
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient was given a dose of expired ActHIB. Dose expired 10/7/23 and was administered 10/09/23
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: DAY AFTER VACCINE PATIENT EXPERIENCED RASH ALL OVER THE BODY. PATIENT SAW DR. THE FOLLOWING DAY AND WAS PRESCRIBED PREDNISONE TO CONTROL RASH
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain, Swelling
Clinical narrative: The patient reported that the nurse, administered the vaccine "really high on my arm but I didn't give it another thought. The next day and every day since I have such severe pain that I'm not able to raise my arm above my shoulder without shooting pain. Today (9/27/2023) the pain is so bad that even moving my arm backwards is not possible."
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional ae; Caller reported AE on behalf of a patient who was administered PROQUAD that was improperly stored. No symptoms reported. Obtained consent to contact HCP. Additional AE Filed (Case #02470635). No additional AE/PQC.  Product:; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 24-AUG-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml/dose, lot #X009730, expiration date: 30-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided)(incorrect product storage).   The vaccine was stored in temperature of 6 degrees up to 14 degrees Farenheit  for 1 hour 10 minutes. There was no previous temperature excursions. There was no additional adverse events reported.
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a patient turned 46 years old before receiving her 3rd dose; No additional AEs; This spontaneous report was received from a pharmacist, referring to female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On unknown days, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, lot# expiration date, route of administration and anatomical location were not provided) for prophylaxis. The patient turned 46 years old before receiving third dose (Inappropriate age at vaccine administration). Pharmacist stated she did not administer third vaccine. No additional adverse event (AE) (No adverse event) and product quality complaint (PQC) reported (No adverse event).
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No signs/symptoms of adverse reactions; HCP reported expired dose of PNEUMOVAX23 was administered. Expiration date of 09/30/2023 administered 10/04/2023. No signs/symptoms of adverse reactions.; This spontaneous report was received from an other health professional and referred to a 68-year-old male patient. Information of the patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-OCT-2023, the patient vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection(lot # was not reported, but expiration date was reported as 30-SEP-2023, strength, dose, frequency, and route of administration were not provided) for prophylaxis (Expired vaccine used). No other adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant reported VAQTA was administered after temperature excursion.; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 14-AUG-2023, the patient was vaccinated with a improperly stored hepatitis a vaccine, inactivated (VAQTA), intramuscular injection, 1 dose, lot # Y3ME2, expiration date: 23-FEB-2025, (strength, exact dose, dose#, and route of administration were not provided) for prophylaxis (product storage error). Lot Number Y3ME2 is not valid for a hepatitis a vaccine, inactivated (VAQTA), and does not match any Company product The operator of the device was a healthcare provider. No additional adverse event (no adverse event). For the suspect vaccine, temperature excursion was reported as 8.9 Celsius (C) degrees for 12 hours and 20 minutes on 14-AUG-2023, and 9.4 Celsius (C) degrees for 8 hours and 20 minutes on 28-SEP-2023. There was no previous temperature excursion reported.
Age: 0.92
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP calling to report PROQUAD was administered 3 days prior to the patient's 1st birthday. No side effects were reported. No additional AE/no PQC.; This spontaneous report was received from a physician and refers to a 11-month-old patient. No information on patient's medical history and current conditions was provided. Concomitant therapies included sterile diluent (STERILE DILUENT).      On 14-SEP-2023, the patient was vaccinated, at inappropriate age with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X007087 and expiration date 04-SEP-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: elevated body temperatures; severe local reaction of the injected arm  that was red; severe local reaction of the injected arm  that was hurt; severe local reaction of the injected arm  that was swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox twice, once as a child and again at the age of 51). Previously administered products included Zostavax (had Zostavax at age 60) and Shingrix with an associated reaction of erythema (On an unknown date, received first dose, for tolerance refer US2023AMR136194).   On 25-SEP-2023, the patient received the 2nd dose of Shingrix (left arm). In SEP-2023, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: severe local reaction of the injected arm that was red), pain in arm (Verbatim: severe local reaction of the injected arm that was hurt) and swelling arm (Verbatim: severe local reaction of the injected arm that was swollen). On 26-SEP-2023, the patient experienced fever (Verbatim: elevated body temperatures). The patient was treated with non-drug therapy (Ice Pack (No Medication)) and benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. The outcome of the fever was not resolved and the outcome of the erythema of extremities, pain in arm and swelling arm were resolving.   It was unknown if the reporter considered the fever, erythema of extremities, pain in arm and swelling arm to be related to Shingrix.   It was unknown if the company considered the fever, erythema of extremities, pain in arm and swelling arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR136194   Additional Information: GSK Receipt Date: 29-SEP-2023 The reporter stated that she received the second dose of Shingrix and since Tuesday, she had been experiencing elevated body temperatures between 99.6 to 99.8 degrees Fahrenheit and sometimes 100 degrees Fahrenheit. The patient also stated she had a severe local reaction of the injected arm that was red, swollen and hurt. The patient iced the arm and took Benadryl to alleviate symptoms. As of the day of reporting, the events with the arm had improved. The patient stated that she had a similar local reaction to the first dose of Shingrix (injected arm that was red, swollen and hurt), but was not as severe as the second dose. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR136194:Same patient, second dose
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Erythema, Fatigue, Injection site mass, Pain
Clinical narrative: lump at infection site; Redness; swelling; fatigue; full body aches/pain; joint pain; This non-serious case was reported by a consumer and described the occurrence of injection site lump in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 579F4, expiry date 23-JAN-2025) for prophylaxis.   On 23-SEP-2023, the patient received Arexvy. On 24-SEP-2023, 1 days after receiving Arexvy, the patient experienced injection site lump (Verbatim: lump at infection site), erythema (Verbatim: Redness), swelling (Verbatim: swelling), fatigue (Verbatim: fatigue), general body pain (Verbatim: full body aches/pain) and joint pain (Verbatim: joint pain).  On 29-SEP-2023, the outcome of the injection site lump, swelling, fatigue, general body pain and joint pain were resolved (duration 5 days) and the outcome of the erythema was resolving (duration 5 days).   It was unknown if the reporter considered the injection site lump, erythema, swelling, fatigue, general body pain and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site lump, erythema, swelling, fatigue, general body pain and joint pain to be related to Arexvy.   Additional Information: GSK Receipt date: 14-SEP-2023 The patient self-reported this case. The patient experienced redness, swelling, pain, lump at infection site; fatigue, full body aches, joint pain. The symptoms were not treated. The reporter agreed to follow up.
Sex: F
Vaccine: RSV
Symptoms: Swelling
Clinical narrative: lump at infection site; Redness; swelling; fatigue; full body aches/pain; joint pain; This non-serious case was reported by a consumer and described the occurrence of injection site lump in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 579F4, expiry date 23-JAN-2025) for prophylaxis.   On 23-SEP-2023, the patient received Arexvy. On 24-SEP-2023, 1 days after receiving Arexvy, the patient experienced injection site lump (Verbatim: lump at infection site), erythema (Verbatim: Redness), swelling (Verbatim: swelling), fatigue (Verbatim: fatigue), general body pain (Verbatim: full body aches/pain) and joint pain (Verbatim: joint pain).  On 29-SEP-2023, the outcome of the injection site lump, swelling, fatigue, general body pain and joint pain were resolved (duration 5 days) and the outcome of the erythema was resolving (duration 5 days).   It was unknown if the reporter considered the injection site lump, erythema, swelling, fatigue, general body pain and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site lump, erythema, swelling, fatigue, general body pain and joint pain to be related to Arexvy.   Additional Information: GSK Receipt date: 14-SEP-2023 The patient self-reported this case. The patient experienced redness, swelling, pain, lump at infection site; fatigue, full body aches, joint pain. The symptoms were not treated. The reporter agreed to follow up.