chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: A HBP was transferred onto the line by a Merck account representative to report a temperature excursion. The caller stated doses of improperly stored VARIVAX were administered to patients.; no additional adverse events; This spontaneous report was received from a healthcare business professional (HBP) concerning an unknown age and gender patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On an unknown date, varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# W039294, expiry date: 11-DEC-2024) was stored at a temperature of 17.4 degree Fahrenheit (F) for 2 hours 0 minutes and 0 seconds. There was no previous temperature excursion. After temperature excursion, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (dose, route of administration, and anatomical location not provided) as prophylaxis (product storage error). There were no additional adverse events reported (no adverse event).  This is one of 9 reports received from the same reporter.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Audiogram, Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden unilateral hearing loss, rt. ear 4 days post vaccination. Diagnosed and treatment begun. 10/16/23
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Arthralgia, Brain fog, Chills, Depersonalisation/derealisation disorder
Clinical narrative: Achey joints, chills, nausea, vomiting, headache, brain fog, mood swings, difficulty with concentration,  de-personalization,  difficulty with recall, hair loss, depression
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Depression, Disturbance in attention, Headache, Memory impairment, Mood swings
Clinical narrative: Achey joints, chills, nausea, vomiting, headache, brain fog, mood swings, difficulty with concentration,  de-personalization,  difficulty with recall, hair loss, depression
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Vomiting
Clinical narrative: Achey joints, chills, nausea, vomiting, headache, brain fog, mood swings, difficulty with concentration,  de-personalization,  difficulty with recall, hair loss, depression
Age: 74.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Heart rate abnormal, Vomiting
Clinical narrative: Patient experienced elevated resting heart rate >100 BPM (his normal resting HR is ~50 BPM) and vomiting. Patient went to the emergency room.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received additional influenza vaccine when she has already received one for the 2023-24 year. Patient experienced no adverse effects and is aware of the mishap.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Abnormal dreams, Nightmare, Sleep disorder
Clinical narrative: Pt reports having vivid nightmares, which had disrupted her sleep.  This is not a normal occurance.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Inflammation, Pruritus, Tenderness
Clinical narrative: Inflamed, hard and red welt about 3" x 2".  Went from very tender to itchy. Have never had a reaction to any vaccination. This was the first Moderna vaccination. The rest have been Pfizer with no reaction.  I am on day three and it is finally starting to get better. It was nasty enough friends and family were encouraging me to report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Inflamed, hard and red welt about 3" x 2".  Went from very tender to itchy. Have never had a reaction to any vaccination. This was the first Moderna vaccination. The rest have been Pfizer with no reaction.  I am on day three and it is finally starting to get better. It was nasty enough friends and family were encouraging me to report.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site oedema, Injection site pain, Injection site swelling, Oedema peripheral, Peripheral swelling
Clinical narrative: The day after he got the influenza vaccine (10/18/23), he was sore in the muscle where it was given but didn't really have any major issues. Mom noticed last night it looked a little swollen. The following morning when he woke up the entire arm appeared swollen from the injection site down to his wrist. He has no pain, free range of motion and there was no redness really noted by mother.   Patients left arm from the deltoid to wrist is edematous generally. The musculature is less well defined compared to the right arm as well. Patient has no pain and has full range of motion at the left shoulder, left elbow and left wrist. There are good pulses in the ulnar and radial sides of the arm near the wrist. Good capillary refill of the fingertips.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT PRESENTED TO THE CLINIC FOR A HEP A VACCINE (PEDIATRIC DOSE).  CLINIC STAFF ADMINISTERED ADULT HEP A VACCINE INSTEAD.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Swelling
Clinical narrative: Swelling on right side of trunk on side of injection site. Redness on right side, headache. On Keflex.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Lymph node swelling and pain in left axilla (same side as injection arm). Pain, redness and swelling at injection site.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: patient reported tingling and spasms in left face , was referred to pcp or ER . pending outcome from medical expert.
Age: 76.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: right are was fine left arm (shingrix) - was red and swollen  elbow up to shoulder.  red and hot in appearance and touch.    patient stated really tired. some upset stomach and shoulder ached. no shortness of breath and no irregular heart rate. I recommended that patient contact doctor to see if he felt  medical treatment (meds) would be necessary and to see if doctor wanted to see him in the office.  patient had no taken any meds yet to treat this;
Age: 76.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Injection site warmth
Clinical narrative: right are was fine left arm (shingrix) - was red and swollen  elbow up to shoulder.  red and hot in appearance and touch.    patient stated really tired. some upset stomach and shoulder ached. no shortness of breath and no irregular heart rate. I recommended that patient contact doctor to see if he felt  medical treatment (meds) would be necessary and to see if doctor wanted to see him in the office.  patient had no taken any meds yet to treat this;
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: She got her vaccine, in the late afternoon about 5-6 hours she had itching, swelling and redness at the vaccine site.  After 2 days these symptoms disappeared.  She did not have to take as much BP medication as her #'s were lower than normal.   She may have taken a Tylenol for her symptoms.    She did not have any reactions with the previous COVID vaccines.    She got her flu vaccine yesterday in her left arm, and has a small bit of soreness and nothing like she had with the COVID vaccine.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Drug hypersensitivity
Clinical narrative: NONE
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: I woke up at 11pm or around midnight and had diarrhea and i woke every hour with diarrhea. I had a headache. This all lasted about 24 hours. I was pretty tired.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt was supposed to get a Moderna 12+ Adult dose (private). We are out of private stock and had to borrow from State stock. Pt was given Moderna (state) 6 months - 11 years 0.5ml. I spoke with dr and no treatment or additional vaccines are needed. Pt was notified with no concerns voiced. Advised him of state being notified with no other vaccine or treatment recommended.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on both outer forearms, from elbow to wrist, lasting 4+ days.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Epistaxis
Clinical narrative: The patient was vaccinated with both vaccines then she proceeded to sit down. Less than 3 minutes had passed when she tells me that she is bleeding. When I look at her, I see that she is bleeding from her nose and I give her a gauze. But I see that the bleeding was a lot and it didn't stop. We waited a few minutes and the nosebleed continued and it was heavy. Since it didn't even stop, the patient was told that she had to go to the hospital.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: PATIENT PRESENT TO  CLNINC TO RECEIVE HIGH DOSE FLU VACCINE DUE TO AGE INDICATION.  CLINIC STAFF ADMINISTERED FLU VACCINE INDICATED FOR AGES 65 AND  YOUNGER.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Monoplegia
Clinical narrative: Partial paralysis of right hand
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Pain in extremity, Sleep disorder
Clinical narrative: Pt called to say whole arm and left side was in extreme pain to the point she "did not sleep a minute during the night." She was calling to see if she can take IBU.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature increased, Chills, Headache, Hot flush
Clinical narrative: Temperature spiked, didn't measure but guessing around 102. Alternated between chills and hot flashes. Strong headache. Some balance issues. Basically, incapacitated me to the point where all I could do was lay in bed and wait it out. Headache persisted the next day, although not as strong. I had COVID last December (thankfully short--a couple of days) and these symptoms were almost identical. A year or so ago I got the original Moderna shot and did not have any issues.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Temperature spiked, didn't measure but guessing around 102. Alternated between chills and hot flashes. Strong headache. Some balance issues. Basically, incapacitated me to the point where all I could do was lay in bed and wait it out. Headache persisted the next day, although not as strong. I had COVID last December (thankfully short--a couple of days) and these symptoms were almost identical. A year or so ago I got the original Moderna shot and did not have any issues.
Age: 86.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Body temperature increased, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: 24 hours (about 3:30pm Wednesday, Sept 18) after receiving the injection, I started having a slight headache, stiffness and soreness in my neck and arms.  Later that same evening I had a high fever (100) and my body was very warm.  While my body was warm, I was freezing and cold.  I took two Tylenol. I retired around 9:00pm and during the night the fever broke and I produced a lot of sweat.  By the next morning, Thursday. I was weak and still a little stiff.  I took two more Tylenol and around noon on Thursday I was feeling normal.  Since that event I have had no more symptoms.
Age: 86.0
Sex: M
Vaccine: RSV
Symptoms: Musculoskeletal stiffness, Skin warm
Clinical narrative: 24 hours (about 3:30pm Wednesday, Sept 18) after receiving the injection, I started having a slight headache, stiffness and soreness in my neck and arms.  Later that same evening I had a high fever (100) and my body was very warm.  While my body was warm, I was freezing and cold.  I took two Tylenol. I retired around 9:00pm and during the night the fever broke and I produced a lot of sweat.  By the next morning, Thursday. I was weak and still a little stiff.  I took two more Tylenol and around noon on Thursday I was feeling normal.  Since that event I have had no more symptoms.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysphonia, Lip swelling, Nausea, Peripheral swelling, Vomiting
Clinical narrative: Employee received the Flucelvax Quadrivant vaccine on 10/17/23 around 10:30am, she reported developing nausea and vomiting around 3:00pm - 4:00pm that day.  The employee also said she developed lip and hand swelling the day after the vaccine and her voice was horse.  She did not seek medical treatment and the symptoms resolved with OTC allergy medicine.  The employee notified Employee Health on 10/20/23 of the occurrence, by this time all her symptoms had resolved.  She denies any redness or swelling at the injection site.  She reports having the flu vaccine in the past without issue.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: PATIENT PRESENTED TO CLINIC TO RECEIVE INFLUENZZA VACCINE HIGH DOSE AS INDICATED FOR AGE.  CLINIC STAFF ADMINSTERED THE FLU VACCINE FOR AGES 64 AND UNDER.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Redness, mild swelling, warmth at the injection site. Treatment: Ice pack to the area and Benadryl at night as needed for itching
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Stomatitis
Clinical narrative: Pt reported spiking a fever and mouth sores the following day after receiving the vaccine. She called us on Friday (3 days after the vaccine) and said the mouth sores were diminishing but still present. She was using oragel for the pain.
Age: 9.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered was for ages 12+ and patient is age 9.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: I immediately had shortness of breath and my chest felt tight. It lasted a little while. That night I felt weak and tired. I went to bed and felt rapid heart rate/beats. I feel like I kept seeing things like hallucinations. I only hallucinate when the medication I take is too high.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction
Clinical narrative: I immediately had shortness of breath and my chest felt tight. It lasted a little while. That night I felt weak and tired. I went to bed and felt rapid heart rate/beats. I feel like I kept seeing things like hallucinations. I only hallucinate when the medication I take is too high.
Age: 92.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: none
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pruritus, Pruritus
Clinical narrative: After getting the Afluria Flu vaccine, I experienced itching of hands, fingers, feet, legs, neck and back area over several days. I went back to the pharmacy and told the pharmacist and she told me to try an antihistamine. I had already taken Cetirizine Hydrochloride and purchased more on 10/19/2023 and it is helping the itching.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Injection site vesicles, Skin texture abnormal
Clinical narrative: Sixteen year old, female received a yellow fever shot on Friday afternoon (13 Oct 2023) as a precaution for travel in December. She developed a small, localized rash on the third day (15 Oct 2023) at the injection site that developed into a larger, 3"x3" localized rash with defined edges and a bright pink color by Tuesday (17 Oct 2023).  The rash did not  change size or shape from this point forward, but did change color and texture, taking on an orangish tint with visible small blisters developing by 19 October 2023.  Parent provided photos to vaccination clinic technician and on-call pediatrician to rule out concerns for larger issues.  Other than the rash, she has not had any fever, headaches, or respiratory issues commonly associated with yellow fever leading the doctor to determine that the rash was non-threatening.  Patient was advised to keep the rash clean and covered and monitor for any changes.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pain 2 inches below injection, rash around 2 1/2 inches in diameter. After several days became itchy, almost unbearable. Still persists 16 days later. Reported to my PCP on 10/06/2023.
Age: 73.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Blister, Contusion, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Pt. said 4-5 days after the vaccine,  some bruising started on her arm and became painful. She presented to pharmacy 10/18/23, her arm had an irregular shaped area that was slightly swollen, partly red/purple. After consultation with her PCP she went to Urgent Care and was prescribed cephalexin for 5 day course. Per pt, it then blistered. She showered last evening, forgot about the area, and washing it.  The skin came off the blister area.  She woke up today with the area very painful and black/bluish. She went to ER and was prescribed oxycodone for pain.
Age: 73.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Blister, Blister rupture, Injection site pain, Pain in extremity, Vaccination site bruising
Clinical narrative: Pt. said 4-5 days after the vaccine,  some bruising started on her arm and became painful. She presented to pharmacy 10/18/23, her arm had an irregular shaped area that was slightly swollen, partly red/purple. After consultation with her PCP she went to Urgent Care and was prescribed cephalexin for 5 day course. Per pt, it then blistered. She showered last evening, forgot about the area, and washing it.  The skin came off the blister area.  She woke up today with the area very painful and black/bluish. She went to ER and was prescribed oxycodone for pain.
Age: 73.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Vaccination site discolouration, Vaccination site necrosis
Clinical narrative: Pt. said 4-5 days after the vaccine,  some bruising started on her arm and became painful. She presented to pharmacy 10/18/23, her arm had an irregular shaped area that was slightly swollen, partly red/purple. After consultation with her PCP she went to Urgent Care and was prescribed cephalexin for 5 day course. Per pt, it then blistered. She showered last evening, forgot about the area, and washing it.  The skin came off the blister area.  She woke up today with the area very painful and black/bluish. She went to ER and was prescribed oxycodone for pain.
Age: 53.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Fluad 65+ High Dose instead of flu vaccine for appropriate age
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Catheterisation cardiac, Dialysis, Disability, Dizziness
Clinical narrative: He got his vaccine, he was sweaty, his heart was beating real fast to the point that he thought he was going to pass out.  The next week he passed out but could not get up, his wife called her brothers and they took  him to Hospital and they transferred him, did a catheter in his heart and told him that his kidneys failed and that he needed dialysis.  He then started dialysis at Hospital wheeled him to the basement, it took 4 hours to do dialysis.  He was then discharged from the hospital after dialysis.  He has been having dialysis about 7-8 months on M-W-F schedule and he has been going faithfully.  While he was in the ER they ran a lot of tests, did a Hep line and found out that he had blood clots in both his lungs and in his legs.  His pulmonologist said that his lungs are half open and half closed and is now on oxygen and will keep him on that until he is able to breath on his own.  He is also on a nebulizer that he does 3 times a day and is on Symbicort and Albuterol.  He also has an instant chamber in it.  His heart was skipping beats, sees Dr. and was given Amiodarone which fixed that and then his heart was beating too slow,  had a heart monitor on it for 30 days, and he is supposed to see him in November as he wants to do a heart ablation on him.    The hematologist said that the markers and his genes do not match up to having blood clots, and she believes it is due to the vaccines, and going to get more information.   He has to be in a wheelchair when they take out too much water during dialysis, but is able to walk right now.  He goes to Dialysis Unit.    He was perfectly health prior to the vaccine, nothing was wrong with him until he had the vaccine and a week later he has been disabled since then.    He is now sheduled to have a heart ablation, in 2/24 he is supposed to have prostate surgery and to have a biopsy on his kidney as he found cancer in one of his kidneys.  He is now mega sick since the vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Extrasystoles, Heart rate decreased, Heart rate increased, Hyperhidrosis
Clinical narrative: He got his vaccine, he was sweaty, his heart was beating real fast to the point that he thought he was going to pass out.  The next week he passed out but could not get up, his wife called her brothers and they took  him to Hospital and they transferred him, did a catheter in his heart and told him that his kidneys failed and that he needed dialysis.  He then started dialysis at Hospital wheeled him to the basement, it took 4 hours to do dialysis.  He was then discharged from the hospital after dialysis.  He has been having dialysis about 7-8 months on M-W-F schedule and he has been going faithfully.  While he was in the ER they ran a lot of tests, did a Hep line and found out that he had blood clots in both his lungs and in his legs.  His pulmonologist said that his lungs are half open and half closed and is now on oxygen and will keep him on that until he is able to breath on his own.  He is also on a nebulizer that he does 3 times a day and is on Symbicort and Albuterol.  He also has an instant chamber in it.  His heart was skipping beats, sees Dr. and was given Amiodarone which fixed that and then his heart was beating too slow,  had a heart monitor on it for 30 days, and he is supposed to see him in November as he wants to do a heart ablation on him.    The hematologist said that the markers and his genes do not match up to having blood clots, and she believes it is due to the vaccines, and going to get more information.   He has to be in a wheelchair when they take out too much water during dialysis, but is able to walk right now.  He goes to Dialysis Unit.    He was perfectly health prior to the vaccine, nothing was wrong with him until he had the vaccine and a week later he has been disabled since then.    He is now sheduled to have a heart ablation, in 2/24 he is supposed to have prostate surgery and to have a biopsy on his kidney as he found cancer in one of his kidneys.  He is now mega sick since the vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Loss of consciousness, Magnetic resonance imaging, Pulmonary embolism, Renal cancer
Clinical narrative: He got his vaccine, he was sweaty, his heart was beating real fast to the point that he thought he was going to pass out.  The next week he passed out but could not get up, his wife called her brothers and they took  him to Hospital and they transferred him, did a catheter in his heart and told him that his kidneys failed and that he needed dialysis.  He then started dialysis at Hospital wheeled him to the basement, it took 4 hours to do dialysis.  He was then discharged from the hospital after dialysis.  He has been having dialysis about 7-8 months on M-W-F schedule and he has been going faithfully.  While he was in the ER they ran a lot of tests, did a Hep line and found out that he had blood clots in both his lungs and in his legs.  His pulmonologist said that his lungs are half open and half closed and is now on oxygen and will keep him on that until he is able to breath on his own.  He is also on a nebulizer that he does 3 times a day and is on Symbicort and Albuterol.  He also has an instant chamber in it.  His heart was skipping beats, sees Dr. and was given Amiodarone which fixed that and then his heart was beating too slow,  had a heart monitor on it for 30 days, and he is supposed to see him in November as he wants to do a heart ablation on him.    The hematologist said that the markers and his genes do not match up to having blood clots, and she believes it is due to the vaccines, and going to get more information.   He has to be in a wheelchair when they take out too much water during dialysis, but is able to walk right now.  He goes to Dialysis Unit.    He was perfectly health prior to the vaccine, nothing was wrong with him until he had the vaccine and a week later he has been disabled since then.    He is now sheduled to have a heart ablation, in 2/24 he is supposed to have prostate surgery and to have a biopsy on his kidney as he found cancer in one of his kidneys.  He is now mega sick since the vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Renal failure, Thrombosis
Clinical narrative: He got his vaccine, he was sweaty, his heart was beating real fast to the point that he thought he was going to pass out.  The next week he passed out but could not get up, his wife called her brothers and they took  him to Hospital and they transferred him, did a catheter in his heart and told him that his kidneys failed and that he needed dialysis.  He then started dialysis at Hospital wheeled him to the basement, it took 4 hours to do dialysis.  He was then discharged from the hospital after dialysis.  He has been having dialysis about 7-8 months on M-W-F schedule and he has been going faithfully.  While he was in the ER they ran a lot of tests, did a Hep line and found out that he had blood clots in both his lungs and in his legs.  His pulmonologist said that his lungs are half open and half closed and is now on oxygen and will keep him on that until he is able to breath on his own.  He is also on a nebulizer that he does 3 times a day and is on Symbicort and Albuterol.  He also has an instant chamber in it.  His heart was skipping beats, sees Dr. and was given Amiodarone which fixed that and then his heart was beating too slow,  had a heart monitor on it for 30 days, and he is supposed to see him in November as he wants to do a heart ablation on him.    The hematologist said that the markers and his genes do not match up to having blood clots, and she believes it is due to the vaccines, and going to get more information.   He has to be in a wheelchair when they take out too much water during dialysis, but is able to walk right now.  He goes to Dialysis Unit.    He was perfectly health prior to the vaccine, nothing was wrong with him until he had the vaccine and a week later he has been disabled since then.    He is now sheduled to have a heart ablation, in 2/24 he is supposed to have prostate surgery and to have a biopsy on his kidney as he found cancer in one of his kidneys.  He is now mega sick since the vaccine.
Age: 26.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Patient is 36 weeks pregnant, has not had any adverse event so far. We are putting in a VEARS due to the fact AREXVY has not been studied to be safe in pregnant women, only the ABRYSVO. She spoke with her Obstetrician and apparently the biggest risk is preterm delivery but since she is 36 weeks, she is past that risk. There are no recommendations to revaccinate at this point, she was told they would vaccinate the baby after birth if needed.
Age: 26.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient is 36 weeks pregnant, has not had any adverse event so far. We are putting in a VEARS due to the fact AREXVY has not been studied to be safe in pregnant women, only the ABRYSVO. She spoke with her Obstetrician and apparently the biggest risk is preterm delivery but since she is 36 weeks, she is past that risk. There are no recommendations to revaccinate at this point, she was told they would vaccinate the baby after birth if needed.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash , redness and swelling aroundsite
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Brain fog, Chills, Fatigue, Influenza like illness
Clinical narrative: Flu-like symptoms began the night of the vaccine. Extreme cold, shivers, lymphadenopathy, joint pain, fogginess. Fogginess and extreme fatigue continues today.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nasopharyngitis
Clinical narrative: Flu-like symptoms began the night of the vaccine. Extreme cold, shivers, lymphadenopathy, joint pain, fogginess. Fogginess and extreme fatigue continues today.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient given expired vaccine. HIB vaccine . exp 2023SEP16
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given 12+ Pfizer Covid 19 Vaccine when they were supposed to get the 5-11 formulation..
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not have any adverse events.  Patient is 16 years old and this vaccine is indicated for patients 18 years of age and older.
Age: 63.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 63 y/o pt received high-dose flu vaccine. No noted adverse side effects.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Activated partial thromboplastin time, Epistaxis, Full blood count, International normalised ratio
Clinical narrative: epistaxis, pending specialist consultation
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came through drive thru flu POD, requested vaccination. When entering vaccine into patient record the following day, it was noted patient had two records which showed she had received HD flu vaccination August 26, 2023 from another facility. No adverse reaction known. Unable to reach by phone, left message. Records merged.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Pruritus, Rash, Rash macular, Rash pruritic
Clinical narrative: Received flu vaccine on 10/18/23 and on 10/19/23 developed a red, blotchy, non-elevated, mildly itchy rash on chest and neck, also experiencing mild itchiness to scalp and eyes; continues on 10/20/23 non-changed; has not taken any medications.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Severe abdominal cramping, explosive diarrheas for 1 hour, nausea, headache, tired.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: 10/7/23, WOKE UP WITH TENDERNESS TO BOTH AXILLA AND MULTIPLE, PALPABLE ENLARGED LYMPH NODES, BILATERAL
Age: 4.0
Sex: F
Vaccine: HEPA, HIBV, IPV, MMRV, PNC15
Symptoms: No adverse event, Product preparation error
Clinical narrative: 4yr old patient came in with mom requesting child immunizations. After reviewing. child vaccination record she was eligible to receive Hepatitis A, HIB, Polio, PCV15, MMR and Varicella. Mother agreed for patient to receive all the vaccines. I went ahead to dilute the HIB vaccine and administered to patient. Patient was observed for 15 minutes, and no adverse reaction was noted. At the end of the day while counting the vaccines it was discovered that the HIB diluent was still in the box and that's when I realized the vaccine was mixed with the wrong diluent, sterile water was used instead of sodium chloride 0.4%.  Provider was informed, and patient's mom was called. Mom mentioned that child was not having reaction.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child was 10 yrs of age on day vaccine was given. Received the 12+ formulation.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became warm, red, itchy and hard. Spot swelled to a size of 8cm X 8cm
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Computerised tomogram normal, Condition aggravated, Disability, Dysstasia
Clinical narrative: She got her vaccine, nothing at first, she didn't get sick and felt fine.  Then just over time her tremors started getting worse, they didn't get to the point that they are now.  The people at her job were concerned as she was a waitress and she could not pour coffee without spilling it, could not bring drinks without spelling it, and they decided to help her out and make it work.  In March she got in a car accident, but a minor accident, wasn't hurt at all, then a couple of days later the tremors went from 0-100 and it wasn't because of the accident, got checked out and everything was fine.  So she thought the tremors were going to go away, which is usually how they go, but they have stayed, and are getting worse a and worse.  Then she had to take medical leave off of work as she could not stand for 5 seconds.  She is seeing many doctors, has had numerous tests run and everything comes back normal, but you can visibly see there is a problem.     Her entire life she has had a slight tremor disorder.  She could write, walk and has had a job all these years.  After the vaccine something exploded in her to the point that she is crippled.  She cannot carry a cup of water that is halfway full as she will spill it.  Something changed in her dramatically after she got the vaccine.  MRI, CAT scan, EEG, everything is normal, but anybody can see how disabled she is.   Her movement specialist is Dr.    She did have a PCP but had not been sick and had not seen her for 2 years and she dropped her as a patient.  She sees many specialists and other doctors and does not feel that she needs a PCP due to her multiple doctors.    She now takes Alprazalam, Propranalol, Topurimac, Ambien, Gabapentin, Hydroxyzine for her current symptoms.  These medicines are for her tremors, anxiety, seizure medicine and a tremor control medicine which are not really working, they do help some.  She was to the point that she was crawling as she could not walk, but she can now.  She cannot work, cannot text or anything like she used to.    She has had episodes/seizures and did not show up on the EEG, and it showed that she has tremors, but no finds of seizures.  She has probably had about 30 seizures since this has happened, and had never had a seizure in her entire life prior to the vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram normal, Gait inability, Impaired work ability, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: She got her vaccine, nothing at first, she didn't get sick and felt fine.  Then just over time her tremors started getting worse, they didn't get to the point that they are now.  The people at her job were concerned as she was a waitress and she could not pour coffee without spilling it, could not bring drinks without spelling it, and they decided to help her out and make it work.  In March she got in a car accident, but a minor accident, wasn't hurt at all, then a couple of days later the tremors went from 0-100 and it wasn't because of the accident, got checked out and everything was fine.  So she thought the tremors were going to go away, which is usually how they go, but they have stayed, and are getting worse a and worse.  Then she had to take medical leave off of work as she could not stand for 5 seconds.  She is seeing many doctors, has had numerous tests run and everything comes back normal, but you can visibly see there is a problem.     Her entire life she has had a slight tremor disorder.  She could write, walk and has had a job all these years.  After the vaccine something exploded in her to the point that she is crippled.  She cannot carry a cup of water that is halfway full as she will spill it.  Something changed in her dramatically after she got the vaccine.  MRI, CAT scan, EEG, everything is normal, but anybody can see how disabled she is.   Her movement specialist is Dr.    She did have a PCP but had not been sick and had not seen her for 2 years and she dropped her as a patient.  She sees many specialists and other doctors and does not feel that she needs a PCP due to her multiple doctors.    She now takes Alprazalam, Propranalol, Topurimac, Ambien, Gabapentin, Hydroxyzine for her current symptoms.  These medicines are for her tremors, anxiety, seizure medicine and a tremor control medicine which are not really working, they do help some.  She was to the point that she was crawling as she could not walk, but she can now.  She cannot work, cannot text or anything like she used to.    She has had episodes/seizures and did not show up on the EEG, and it showed that she has tremors, but no finds of seizures.  She has probably had about 30 seizures since this has happened, and had never had a seizure in her entire life prior to the vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Road traffic accident, Seizure, Tremor
Clinical narrative: She got her vaccine, nothing at first, she didn't get sick and felt fine.  Then just over time her tremors started getting worse, they didn't get to the point that they are now.  The people at her job were concerned as she was a waitress and she could not pour coffee without spilling it, could not bring drinks without spelling it, and they decided to help her out and make it work.  In March she got in a car accident, but a minor accident, wasn't hurt at all, then a couple of days later the tremors went from 0-100 and it wasn't because of the accident, got checked out and everything was fine.  So she thought the tremors were going to go away, which is usually how they go, but they have stayed, and are getting worse a and worse.  Then she had to take medical leave off of work as she could not stand for 5 seconds.  She is seeing many doctors, has had numerous tests run and everything comes back normal, but you can visibly see there is a problem.     Her entire life she has had a slight tremor disorder.  She could write, walk and has had a job all these years.  After the vaccine something exploded in her to the point that she is crippled.  She cannot carry a cup of water that is halfway full as she will spill it.  Something changed in her dramatically after she got the vaccine.  MRI, CAT scan, EEG, everything is normal, but anybody can see how disabled she is.   Her movement specialist is Dr.    She did have a PCP but had not been sick and had not seen her for 2 years and she dropped her as a patient.  She sees many specialists and other doctors and does not feel that she needs a PCP due to her multiple doctors.    She now takes Alprazalam, Propranalol, Topurimac, Ambien, Gabapentin, Hydroxyzine for her current symptoms.  These medicines are for her tremors, anxiety, seizure medicine and a tremor control medicine which are not really working, they do help some.  She was to the point that she was crawling as she could not walk, but she can now.  She cannot work, cannot text or anything like she used to.    She has had episodes/seizures and did not show up on the EEG, and it showed that she has tremors, but no finds of seizures.  She has probably had about 30 seizures since this has happened, and had never had a seizure in her entire life prior to the vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Haemorrhage, Pain
Clinical narrative: Blood spurted Large bruise and pain
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Swelling face
Clinical narrative: Patient called 10.20.2023 saying her face was swelling from the covid vaccine. She noted since yesterday afternoon. Vaccine was administered 10/18/2023 at 5:45. She said she had allergy. I informed her about seeing doctor and she has visit today. She called for name of vaccine and I gave her name of vaccine. Using this information she will go to doctor and get treated for her swelling.
Sex: M
Vaccine: RVX
Symptoms: Diarrhoea, Nausea, Respiratory tract congestion
Clinical narrative: Nausea; Head congestion; Diarrhea; This non-serious case was reported by a consumer and described the occurrence of nausea in a 68-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number 2450472-09827) for prophylaxis.   Concomitant products included dutasteride (Avodart (Dutasteride)) and duloxetine hydrochloride (Cymbalta (Duloxetine)).   On 19-SEP-2023, the patient received RSV vaccine. On 21-SEP-2023, 2 days after receiving RSV vaccine, the patient experienced nausea (Verbatim: Nausea), head discomfort (Verbatim: Head congestion) and diarrhea (Verbatim: Diarrhea).  The outcome of the nausea, head discomfort and diarrhea were not resolved.   It was unknown if the reporter considered the nausea, head discomfort and diarrhea to be related to RSV vaccine.     It was unknown if the company considered the nausea, head discomfort and diarrhea to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 12-OCT-2023 It was reported that patient suffered from nausea, head discomfort and diarrhea after receiving RSV vaccine.
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This non-serious case was reported by a consumer and described the occurrence of shortness of breath in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included hypertension, cholesterol and gastritis. Concomitant products included clonidine, atorvastatin (Atorvastatine), esomeprazole magnesium (Nexium) and dobutamine hydrochloride (Butamine).   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, less than a day after receiving Arexvy, the patient experienced shortness of breath (Verbatim: shortness of breath).  The outcome of the shortness of breath was not resolved.   It was unknown if the reporter considered the shortness of breath to be related to Arexvy.     It was unknown if the company considered the shortness of breath to be related to Arexvy.   Additional Information: GSK receipt date: 13-OCT-2023 The patient had shortness of breath. The patient had Cardividol and hydroclorathizide as concomitant. The reporter was requested for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis acneiform, Rash
Clinical narrative: redness developed from pubic area to below my neck/body turned red like a sun burn; I might have had a fever; This non-serious case was reported by a other health professional via call center representative and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced localized erythema (Verbatim: redness developed from pubic area to below my neck/body turned red like a sun burn) and fever (Verbatim: I might have had a fever). The outcome of the localized erythema was not reported and the outcome of the fever was unknown.   It was unknown if the reporter considered the localized erythema and fever to be related to Shingrix.     It was unknown if the company considered the localized erythema and fever to be related to Shingrix.   Additional Information: GSK Receipt date: 10-OCT-2023 The patient was healthcare profession who reported a day after receiving the Shingrix he/she developed redness from pubic area to belowneck. The patients body turned red like a sunburn. The patient front body part did not had bumps and was not itchy. The patient stated he/she might have had a fever similar reaction to other unspecified vaccine. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injection site pain, Malaise, Pyrexia
Clinical narrative: injection site pain; experienced a fever of 102; Felt terrible; felt sick; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-SEP-2023, the patient received Arexvy. On 08-SEP-2023, immediately after receiving Arexvy, the patient experienced feeling unwell (Verbatim: felt sick). On an unknown date, the patient experienced injection site pain (Verbatim: injection site pain), fever (Verbatim: experienced a fever of 102) and feels awful (Verbatim: Felt terrible).The outcome of the injection site pain, fever, feeling unwell and feels awful were not reported.   It was unknown if the reporter considered the injection site pain, fever, feeling unwell and feels awful to be related to Arexvy.  It was unknown if the company considered the injection site pain, fever, feeling unwell and feels awful to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-Oct-2023 The patient received a dose of Arexvy and reported that she immediately felt sick.  She had bad injection site pain but also experienced a fever of 102.  She felt so terrible that she did. The reporter did not think it was within the normal expectations.  She was going to report it herself but spoke to her so she told her she would start the process. She would be happy to speak to you about her experience in detail. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired dose administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) for prophylaxis.   On 11-OCT-2023, the patient received Infanrix. On 11-OCT-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose administration).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 11 Oct 2023: Nurse reported a patient inadvertently received an expired dose of Infanrix, which led to expired vaccine used. Nurse did not report any patient demographics. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Accidental underdose, Vomiting
Clinical narrative: Vomitted dose; Vomitted dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of vomiting in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, immediately after receiving Rotarix lyophilized formulation, the patient experienced vomiting (Verbatim: Vomitted dose) and accidental underdose (Verbatim: Vomitted dose). The outcome of the vomiting was not reported and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-OCT-2023 The reporter stated that they had a patient who was given a private Rota but immediately vomited the dose. The provider requested not to repeat the dose until 6 months but that was not a valid dose. The provider asked if that should be documented on the immunization record, as if they did, it would mess up the validity of the next dose in health maintenance or should they cancel the order and consider it as a wasted dose. The patient immediately vomited the dose which led to accidental under dose.