chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: MMRV, MMRV
Symptoms: General physical condition abnormal, Infection, Irregular breathing, Laboratory test, Lethargy
Clinical narrative: He got his vaccine (reported by dad), he starting having vomiting but nothing major, but then it got worse.  He started having fever up to 101, used Tylenol form, did the cold thought trick.  When he was going to dialysis around 5-6 PM, his breathing was really fast, he was very warm, temp showing 101, and seemed very tired.   His mother took him to the hospital, did x-rays, cultures, urinalysis, but he said based on his white cells being elevated, red cells being down, fever, breathing and discomfort that he had some form of infection and started him on antibiotics.  He's awake and his condition wavers up and down and he becomes more lethargic, but is breathing irregular still.  He is immunocompromised due to his kidney issues.  There is no cough, no mucus or any discharge.  He had 2 days of antibiotics and he was still having the fever, having breathing issues and stopped that.  They were trying to collect a urine specimen and said that something grew after 2 days, but they did not feel it was accurate as they did the specimen through cotton balls.  They did a blood transfusions as his red blood cells are down, but they gave him some fluids and has been put on dialysis twice, but he still keeps bringing on his fever.  The hospital is still telling them there are viral colds out there, and father is asking what cold is there with no drainage.  He tells them that he had the vaccine, and they don't believe it is related to the vaccine, but he was at his usual status prior to the vaccine.  He has even told them what the AE are to MMRV which he has those reactions and they are still saying there is a cold, but they cannot find evidence of a cold.  He is on oxygen at the hospital and if they take it off his sats drop down to the 80s, still without mucous.  He does not have oxygen on a regular basis at home.
Age: 1.5
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Oxygen saturation decreased, Pyrexia, Red blood cell count decreased, Respiratory rate increased, Skin warm
Clinical narrative: He got his vaccine (reported by dad), he starting having vomiting but nothing major, but then it got worse.  He started having fever up to 101, used Tylenol form, did the cold thought trick.  When he was going to dialysis around 5-6 PM, his breathing was really fast, he was very warm, temp showing 101, and seemed very tired.   His mother took him to the hospital, did x-rays, cultures, urinalysis, but he said based on his white cells being elevated, red cells being down, fever, breathing and discomfort that he had some form of infection and started him on antibiotics.  He's awake and his condition wavers up and down and he becomes more lethargic, but is breathing irregular still.  He is immunocompromised due to his kidney issues.  There is no cough, no mucus or any discharge.  He had 2 days of antibiotics and he was still having the fever, having breathing issues and stopped that.  They were trying to collect a urine specimen and said that something grew after 2 days, but they did not feel it was accurate as they did the specimen through cotton balls.  They did a blood transfusions as his red blood cells are down, but they gave him some fluids and has been put on dialysis twice, but he still keeps bringing on his fever.  The hospital is still telling them there are viral colds out there, and father is asking what cold is there with no drainage.  He tells them that he had the vaccine, and they don't believe it is related to the vaccine, but he was at his usual status prior to the vaccine.  He has even told them what the AE are to MMRV which he has those reactions and they are still saying there is a cold, but they cannot find evidence of a cold.  He is on oxygen at the hospital and if they take it off his sats drop down to the 80s, still without mucous.  He does not have oxygen on a regular basis at home.
Age: 1.5
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Transfusion, Urine analysis, Vomiting, White blood cell count increased, X-ray
Clinical narrative: He got his vaccine (reported by dad), he starting having vomiting but nothing major, but then it got worse.  He started having fever up to 101, used Tylenol form, did the cold thought trick.  When he was going to dialysis around 5-6 PM, his breathing was really fast, he was very warm, temp showing 101, and seemed very tired.   His mother took him to the hospital, did x-rays, cultures, urinalysis, but he said based on his white cells being elevated, red cells being down, fever, breathing and discomfort that he had some form of infection and started him on antibiotics.  He's awake and his condition wavers up and down and he becomes more lethargic, but is breathing irregular still.  He is immunocompromised due to his kidney issues.  There is no cough, no mucus or any discharge.  He had 2 days of antibiotics and he was still having the fever, having breathing issues and stopped that.  They were trying to collect a urine specimen and said that something grew after 2 days, but they did not feel it was accurate as they did the specimen through cotton balls.  They did a blood transfusions as his red blood cells are down, but they gave him some fluids and has been put on dialysis twice, but he still keeps bringing on his fever.  The hospital is still telling them there are viral colds out there, and father is asking what cold is there with no drainage.  He tells them that he had the vaccine, and they don't believe it is related to the vaccine, but he was at his usual status prior to the vaccine.  He has even told them what the AE are to MMRV which he has those reactions and they are still saying there is a cold, but they cannot find evidence of a cold.  He is on oxygen at the hospital and if they take it off his sats drop down to the 80s, still without mucous.  He does not have oxygen on a regular basis at home.
Age: 1.5
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Pyrexia
Clinical narrative: He got his vaccine (reported by dad), he starting having vomiting but nothing major, but then it got worse.  He started having fever up to 101, used Tylenol form, did the cold thought trick.  When he was going to dialysis around 5-6 PM, his breathing was really fast, he was very warm, temp showing 101, and seemed very tired.   His mother took him to the hospital, did x-rays, cultures, urinalysis, but he said based on his white cells being elevated, red cells being down, fever, breathing and discomfort that he had some form of infection and started him on antibiotics.  He's awake and his condition wavers up and down and he becomes more lethargic, but is breathing irregular still.  He is immunocompromised due to his kidney issues.  There is no cough, no mucus or any discharge.  He had 2 days of antibiotics and he was still having the fever, having breathing issues and stopped that.  They were trying to collect a urine specimen and said that something grew after 2 days, but they did not feel it was accurate as they did the specimen through cotton balls.  They did a blood transfusions as his red blood cells are down, but they gave him some fluids and has been put on dialysis twice, but he still keeps bringing on his fever.  The hospital is still telling them there are viral colds out there, and father is asking what cold is there with no drainage.  He tells them that he had the vaccine, and they don't believe it is related to the vaccine, but he was at his usual status prior to the vaccine.  He has even told them what the AE are to MMRV which he has those reactions and they are still saying there is a cold, but they cannot find evidence of a cold.  He is on oxygen at the hospital and if they take it off his sats drop down to the 80s, still without mucous.  He does not have oxygen on a regular basis at home.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Vaccination site erythema
Clinical narrative: Redness where vaccine was given. 10cm
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient arrived at pharmacy 9/29/23 2:12 PM, one day after her immunization. Her left arm had swelling around the injection site around a foot circumference. Patient stated that it felt hot, swollen, and itchy. There was a hard line around the reaction area. No spread towards torso or neck. No complaints of breathing.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Biopsy lymph gland, Hodgkin's disease, Positron emission tomogram
Clinical narrative: Classic Hodgkins Lymphoma
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Flu vaccine--I don't know which one. Received 9/27.  Starting 9/28 the area was very warm to the touch, almost felt round like the vaccine didn't start absorbing or something. 9/29- the skin over the area that felt round is now red and tight. it hurts if any pressure is applied. the upper arm area is a little achy too.  I have not treated it with anything. Just letting it run. The achy-ness isn't uncomfortable enough that I'll take anything and it only hurts when its actively pushed on so I've just been careful about leaning up against things with that arm. I don't expect it to get much worse just reporting to keep y'all in the loop.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Skin tightness
Clinical narrative: Flu vaccine--I don't know which one. Received 9/27.  Starting 9/28 the area was very warm to the touch, almost felt round like the vaccine didn't start absorbing or something. 9/29- the skin over the area that felt round is now red and tight. it hurts if any pressure is applied. the upper arm area is a little achy too.  I have not treated it with anything. Just letting it run. The achy-ness isn't uncomfortable enough that I'll take anything and it only hurts when its actively pushed on so I've just been careful about leaning up against things with that arm. I don't expect it to get much worse just reporting to keep y'all in the loop.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Livedo reticularis, Peripheral swelling, Skin warm
Clinical narrative: On 9/28/23023 parent reported that both of patient's legs were swollen ,mottled and hot to touch after receiving 6m set on 3/16/23. Parent denied  any other symptoms. Parents took infant to ER. Mom stated they were no help.  Mother provided photo of patient's legs. Left leg appeared more swollen and mottled.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: This patient was given Men B instead of Men A
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Injury associated with device, No adverse event
Clinical narrative: Employee got a finger stick after giving a vaccine to patient.  Patient and employee are both okay.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Flushing, Pruritus, Rash erythematous
Clinical narrative: Early facial flushing, then neck and chest itching, follow by burning, inflamed skin. Immediately took OTC extra-strength Benadryl. Two does before bed.  Woke up my entire core was covered, front and back with prickly, itchy, sun-burn type rash. Paged my PCP Sunday morning @ 8am.  PCP called in prescription for Prednisone 20mg (2x daily) for 5 days, along with Hydroxyzine 25mg (3x daily).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Decreased appetite, Headache, Injection site pain
Clinical narrative: Headache, chills, no appetite, sore at shot site
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Product administration error
Clinical narrative: HEP B SHOT WAS ADMINISTERED IM IN THE PATIENTS LEFT ARM. AFTERWARDS IT WAS RECOGNIZED THE PATIENT HAD AN OBSERVATION NOTED FOR IMMUNITY TO HEP B AND THAT THE SHOT WAS UNNECESSARY.
Age: 50.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: patient can not lift her left arm  (where she got shingles vaccine ) since day of vaccination.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest pain, Dry mouth, Fatigue, Hypoaesthesia
Clinical narrative: First day within 24 hours numbness and tingling in vaccinated arm and hand, few days later fatigue, weakness, chest pain, now today 9/29 numbness tingling on entire left side of body, dry mouth extreme fatigue
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: First day within 24 hours numbness and tingling in vaccinated arm and hand, few days later fatigue, weakness, chest pain, now today 9/29 numbness tingling on entire left side of body, dry mouth extreme fatigue
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Breast pain, Discomfort, Fear, Sensory disturbance
Clinical narrative: I went to bed the night of the vaccine I felt a sensation that was from the left side of my breast and i couldnt sleep. the next night I felt that sensation in the right side. Research said it might be my lymph nodes. It went on for 3 weeks and i waited to see if it would go away. I read something of a lady with this. Now its been almost 6 months and I still have this sensation. It feels heavy, like there is something not right with a dull pain. It wakes me up and I am very scared. I can't sleep on my stomach anymore. Nothing else was wrong, I was fine. It has caused me a lot of anxiety and I am so scared that something is wrong with me now.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: I went to bed the night of the vaccine I felt a sensation that was from the left side of my breast and i couldnt sleep. the next night I felt that sensation in the right side. Research said it might be my lymph nodes. It went on for 3 weeks and i waited to see if it would go away. I read something of a lady with this. Now its been almost 6 months and I still have this sensation. It feels heavy, like there is something not right with a dull pain. It wakes me up and I am very scared. I can't sleep on my stomach anymore. Nothing else was wrong, I was fine. It has caused me a lot of anxiety and I am so scared that something is wrong with me now.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: off balance feeling
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fall, Fatigue, Head injury, Hypersomnia, Incontinence
Clinical narrative: Received vaccine in the early afternoon, was fine during the day, after supper was vomiting. Vomiting continued throughout the night. Had to use the bathroom and had incontinence episode which then caused her to slip and fall hitting her arm on bathtup.  Overnight continued to feel tired, worn out. The following day slept most of the day. Ate some Wednesday and went to bed around 9-10 then slept like normal.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Vomiting
Clinical narrative: Received vaccine in the early afternoon, was fine during the day, after supper was vomiting. Vomiting continued throughout the night. Had to use the bathroom and had incontinence episode which then caused her to slip and fall hitting her arm on bathtup.  Overnight continued to feel tired, worn out. The following day slept most of the day. Ate some Wednesday and went to bed around 9-10 then slept like normal.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis. She did not disclose to pharmacist what treatment was given. Cellulitis cleared up after time.
Age: 71.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Chills, Dizziness
Clinical narrative: patient states that he was dizzy and had chills for 4 hours after administration of the vaccines
Age: 1.83
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Provider wrote order for COVID-Moderna  0.25 ml 6mo-11yrs. Medical Assistant administered COVID-Moderna Spikevax  0.5 ml for ages 12 and up No adverse reactions at time of report. Contacted manufacture (Case Number) and was instructed to report case to VAERS. RN and MA notified patient's father at 99/28/230 3:48 p.m. via interpreter. (Patient and father's IDs were verified.) Per patient's father, the patient is normal.  MA called patient's father again (09 29/23) at 2:30 p.m. No interpreter. (Patient and father's IDs were verified.) Per patient's father, "she (patient) is doing really good."
Age: 72.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Brain fog, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: She got her vaccine, her arm was sore which is typical.  Then she started feelign totally exhausted and had brain fog.  She had pains, and still has pains all over.  Her stomach is nauseated, she is not able to eat much due to this.  She is having very bad headaches, which is not something she has on a regular basis, and taking a lot of Tylenol.  Her throat is feeling finey, sore, like the muscles are sore, they hurt.  She has a slight cough, lots of congestion every day.  She was having low grade fevers, but is not having those.  The hardest part of this is the fatigue as she is not able to get out and do it.  She's barely able to get out of bed in the morning.  She called her doctor this morning for results of blood work that was done on her kidney, liver, thyroid and some other blood work was done, and everything seemed to be alright.  She is borderline diabetic and was given some information on what she needed to do to get that under control.
Age: 72.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: She got her vaccine, her arm was sore which is typical.  Then she started feelign totally exhausted and had brain fog.  She had pains, and still has pains all over.  Her stomach is nauseated, she is not able to eat much due to this.  She is having very bad headaches, which is not something she has on a regular basis, and taking a lot of Tylenol.  Her throat is feeling finey, sore, like the muscles are sore, they hurt.  She has a slight cough, lots of congestion every day.  She was having low grade fevers, but is not having those.  The hardest part of this is the fatigue as she is not able to get out and do it.  She's barely able to get out of bed in the morning.  She called her doctor this morning for results of blood work that was done on her kidney, liver, thyroid and some other blood work was done, and everything seemed to be alright.  She is borderline diabetic and was given some information on what she needed to do to get that under control.
Age: 72.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Respiratory tract congestion
Clinical narrative: She got her vaccine, her arm was sore which is typical.  Then she started feelign totally exhausted and had brain fog.  She had pains, and still has pains all over.  Her stomach is nauseated, she is not able to eat much due to this.  She is having very bad headaches, which is not something she has on a regular basis, and taking a lot of Tylenol.  Her throat is feeling finey, sore, like the muscles are sore, they hurt.  She has a slight cough, lots of congestion every day.  She was having low grade fevers, but is not having those.  The hardest part of this is the fatigue as she is not able to get out and do it.  She's barely able to get out of bed in the morning.  She called her doctor this morning for results of blood work that was done on her kidney, liver, thyroid and some other blood work was done, and everything seemed to be alright.  She is borderline diabetic and was given some information on what she needed to do to get that under control.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear congestion, Ear pain, Fatigue, Injection site pain
Clinical narrative: As with all previous covid related vaccinces, I was immobilized -- unable to get up and move around due to:  extreme exhaustion, sore throat, ear congestion/ache, body aches and pains (entire body), rash about the size of two hands at/and/around injection site (at it's peak) and pain; shifting to intense itching - similar to my skin allergic reactions; intermittent chills; night sweats;  this took place over the course of 3 days, now, today 9-29-23 I'm feeling nearly back to normal.  I believe I have recovered.  However, this happening each time I have a Covid vaccine injection is concerning, and I'd like some response from someone about all this.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Mobility decreased, Night sweats, Oropharyngeal pain
Clinical narrative: As with all previous covid related vaccinces, I was immobilized -- unable to get up and move around due to:  extreme exhaustion, sore throat, ear congestion/ache, body aches and pains (entire body), rash about the size of two hands at/and/around injection site (at it's peak) and pain; shifting to intense itching - similar to my skin allergic reactions; intermittent chills; night sweats;  this took place over the course of 3 days, now, today 9-29-23 I'm feeling nearly back to normal.  I believe I have recovered.  However, this happening each time I have a Covid vaccine injection is concerning, and I'd like some response from someone about all this.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: As with all previous covid related vaccinces, I was immobilized -- unable to get up and move around due to:  extreme exhaustion, sore throat, ear congestion/ache, body aches and pains (entire body), rash about the size of two hands at/and/around injection site (at it's peak) and pain; shifting to intense itching - similar to my skin allergic reactions; intermittent chills; night sweats;  this took place over the course of 3 days, now, today 9-29-23 I'm feeling nearly back to normal.  I believe I have recovered.  However, this happening each time I have a Covid vaccine injection is concerning, and I'd like some response from someone about all this.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Headache
Clinical narrative: At 4 pm on August 22, 2023 a headache underneath my occipital bone began.  I used tylenol low dose about every 4 hours.  These headaches were with me for 2 weeks most of the day and night.  When I would wake up in the middle of the night to urinate, I took another tylenol.  After the first 2 weeks the headaches under my occipital bone became less frequent.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Headache, Hyperhidrosis, Pain
Clinical narrative: Temp 101.7° Head ache Body aches  Sweating
Age: 70.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Feeling abnormal, Hyperhidrosis, Loss of consciousness
Clinical narrative: AFTER THE PATIENT WAS VACCINATED WITH THE COVID-19 SPIKEVAX AND FLUZONE SHE WAS SITTING DOWN AND SHE SPASED OUT AND PASSED OUT. WE CALLED 911 BUT THE PATIENT REGAINED CONSIOUSNESS AND SAID SHE FELT NAUSEOUS. PATIENT WAS SEATED AND WE ASKED HER TO STAY SEATED IN HER CHAIR WHILE WE CALLED 911, THE TECNNICIAN CALLED 911 AND INFORMED THEM ABOUT THE SITUATION. THE PARAMEDICS TOLD US NOT TO GIVE HER ANYTHING BY MOUTH. PATIENT SAID SHE FELT SWEATY AND WE THE HUSBAND IF SHE ATE ANYTHING BEFORE COMING AND HE SAID YES. I ASKED HAS THIS HAPPENED BEFORE AND THE HUSBAND REPLIED NO SHE HAS GOTTEN 4 VACCINES BEFORE NO PROBLEM. THE PATIENT STATED THAT SHE TAKES BLOOD PRESSURE AND THYROID MEDICATIONS, DOESN'T KNOW THE STRENGTHS. I ASKED THE PATIENT TO TAKE DEEP BREATHS AND RELAX WHILE THE PARAMEDICS CAME IN. THE PATIENT THREW UP AND THE PARAMEDICS GOT THERE AND ASKED US WHAT HAPPENED AND THEY TOOK OVER FROM THERE.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Periorbital swelling, Pyrexia, Rash, Rash erythematous
Clinical narrative: Red rash over body, swelling around eyes. Fever 101-102
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Gait disturbance, Mobility decreased, Tenderness
Clinical narrative: Covid Morderna Spikevax 2023-24 (12YUP) SYRG Lot 3030068 was administered in my RIGHT arm (Pharmacy emailed my shot record to me and it indicated the vaccine was given in my left deltoid but that is not correct) by RPh.  I was feeling perfectly well before the shot and felt fine after the shot.  Two and a half hours after getting the shot, however, I suddenly noticed a pain in my left hip as I was walking in my kitchen.  I had not injured or bumped my hip.  The pain came on rather suddenly and increased to the extent that it made me limp (I never have had that place on my hip hurt before).  The pain was pinpointed on the side of the top front point of my left ilium (pelvic bone).  It caused me so much discomfort that I had to lie down with a heating pad, and sleep with the heating pad the next 2 nights.   It is now one week post vaccine and the place on my hip is still tender an occasionally causes me to want to  limp slightly as I walk (I am an extremely active person for 70 -- I usually walk 20+ miles per week).  The only other side effect I experienced was tiredness
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Spinevat Moderna Vaccine received on Sunday September 17th. On Monday, September 18th, a small rash spot appeared on my right neck. The size was a 50 cent piece. Later on Monday the 18th, a fine rash started along my left jawline. Tuesday morning a fine rash began to surface along my left clavicle bone to my shoulder and by Wednesday the rash extend down my left arm.  I took Benadryl, Advil and Zyrtec. By Friday I applied OTC topical ointment, cortisone 10. By Monday the arm was hot and red like a cellulitis, so I went to Dermatology where Doxycycline and a topical prescription steroid was prescribed. I was covid negative on Tuesday the 26th as I tested after flying home from my son's wedding.  On Wednesday, September 27th, I tested Covid +.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I had a rash on my torso with each vaccine, progressively worse each time.  All were 24 to 30 hours after the vaccine.  All were all on my torso front, a little towards my back, and a little under my armpits.  Took either Benadryl or Zyrtec each time and they faded overnight and disappeared within a couple of days.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthritis bacterial
Clinical narrative: Patient claims they developed Septic Arthritis after receiving vaccinations..
Age: 68.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site warmth, Pain, Swelling
Clinical narrative: Swelling going on 11 days, fever at site 3 days, sore going on 11 days   iced, tylenol
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reports having bothersome muscle pain in the same deltoid in which she received the first dose of the Shingrix vaccine. The pain has bothered her off and on since getting the vaccine. The arm did not appear swollen, red, or warm. She was advised to seek medical attention with her primary care provider and hold off on getting the 2nd dose in the series until cleared by her provider.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema of eyelid, Periorbital swelling
Clinical narrative: patient received the vaccine on Friday 9/1/2023. Monday 9/4/2023 patient started noticing red circles around her both eyes, but one eye was worse than the other. Red circle around her eye and her eye was very puffy.  The symptoms lasted for 2 days and subsided after that. In a few days the patient started having the same symptoms again. Patient visited her primary care physician and was prescribed some prednisone and Valtrex, also she took Benadryl. The same cycle of symptoms occurred to the patient multiple times. According to the patient she's in the fifth cycle of the same symptoms, which lasts for 2 days and disappears and then reappear in few days.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Administration site erythema, Administration site pain, Administration site swelling
Clinical narrative: Patient refers pain, redness and swelling in site of administration, 5 days after vaccination.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal discomfort, Shoulder injury related to vaccine administration
Clinical narrative: The vaccine was given into right arm and at the time of administration, she reports she felt severe pain, winced and told the administering nurse that it was very painful. She reports immediate pain and worsening discomfort and limited range of motion of the right shoulder.  Demonstrates symptoms consistent with SIRVA.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Nausea, Neck pain, Neuropathy peripheral, Pain
Clinical narrative: I think this was my fifth shot.  I have strong pain in my right arm.  The biggest issue has been severe, sharp shooting pains in my neck and head that lasted the whole first night after the shot and less frequently the next day (it lessened after Tylenol).  Now on the third day I have body aching all over, neuropathy and nausea, and I've had a headache since the first night.  I have had similar reactions every time I have gotten the vaccine, but this has been one of the worst.  It's so bad I'm not sure I can get another one in the future and I'm also scared now of getting the flu shot.  (I am in no way anti-vax, just having a really hard time with this).  I haven't spoken with doctor yet but am planning to on next appointment.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: I think this was my fifth shot.  I have strong pain in my right arm.  The biggest issue has been severe, sharp shooting pains in my neck and head that lasted the whole first night after the shot and less frequently the next day (it lessened after Tylenol).  Now on the third day I have body aching all over, neuropathy and nausea, and I've had a headache since the first night.  I have had similar reactions every time I have gotten the vaccine, but this has been one of the worst.  It's so bad I'm not sure I can get another one in the future and I'm also scared now of getting the flu shot.  (I am in no way anti-vax, just having a really hard time with this).  I haven't spoken with doctor yet but am planning to on next appointment.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenocortical insufficiency acute, Chills, Condition aggravated, Dyspnoea, Feeling cold
Clinical narrative: I began having symptoms of Adrenal/Addisonian crisis approximately 12 hours after vaccination (extreme cold, violent shivering, shortness of breath, nausea, mental status changes, low blood pressure and rapid heart rate.)  I had to take an immediate dose of steroids  (hydrocortisone) at the time and then increase my usual dose for the following day as well (as I have been instructed by my physicians to do in case of crisis.) No further medical treatment was necessary since I am familiar with "sick-day" self-treatment for adrenal crisis.  This has happened to me once before following COVID-19 vaccination (Pfizer booster) but never from any other routine vaccinations (influenza, pneumococcal, tetanus etc)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypotension, Mental status changes, Nausea
Clinical narrative: I began having symptoms of Adrenal/Addisonian crisis approximately 12 hours after vaccination (extreme cold, violent shivering, shortness of breath, nausea, mental status changes, low blood pressure and rapid heart rate.)  I had to take an immediate dose of steroids  (hydrocortisone) at the time and then increase my usual dose for the following day as well (as I have been instructed by my physicians to do in case of crisis.) No further medical treatment was necessary since I am familiar with "sick-day" self-treatment for adrenal crisis.  This has happened to me once before following COVID-19 vaccination (Pfizer booster) but never from any other routine vaccinations (influenza, pneumococcal, tetanus etc)
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccines were stored in an unapproved storage unit
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Autoimmune disorder, Biopsy skin abnormal, Inflammation, Lichen planopilaris
Clinical narrative: Patient began losing hair in January of 2022. It was late 2022 before a scalp biopsy confirmed lichen planopilaris, an autoimmune scalp condition. Patient being treated by dermatologist who did the biopsy.  Scalp still actively inflamed in patches. Hair still falling out somewhat. Much of hair loss may be irreversible. Patient also using a functional medicine MD using diet , exercise, stress management and supplements to try and turn off the autoimmune reaction.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury, Syncope
Clinical narrative: Patient received the HPV vaccine . Tolerated well. Stood up from the examination table and went by the sink in the room to look at stickers. Within 2-3  minutes of standing up, Patient felt lightheaded and fainted, hitting her head on the edge of the counter during her fall to the ground. Patient's mom and Dr. were present in the room during this event. Patient was assisted to the examination table by Dr. and mom. RN was called to assist. Patient was awake and alert when RN arrived . Was responding appropriately to all questions. Ice pack was applied to back of Patient's head and Patient was inspected for any bleeding, bruising, swelling or abrasion. None noted. Vital signs were checked and documented. Apple juice was offered . Patient drank the contents of the entire bottle. Denied any symptoms of headache, dizziness, blurred vision, nausea or vomiting. Patient remained in the room and was observed directly by Dr. for the next 15 minutes. Once cleared to leave to go home, Patient's mom was given home care instructions  by DR..  All questions were answered to mom's satisfaction. Patient ambulated independently out of the clinic with her mother and younger sister. Was observed smiling and laughing while exiting the clinic.
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: syncope 30 minutes after Fluzone HD. guided to the ground. 911 called
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Caller stated the patient has not reported any symptoms; Nurse called to report that a 6 year old patient received a dose of PEDVAXHIB on 8/25/2023. Caller stated the patient had received previous doses of PEDVAXHIB on 9/8/2017, 11/8/2017, 1/9/2018, and 10/15/2018.; Nurse called to report that a 6 year old patient received a dose of PEDVAXHIB on 8/25/2023; Previous dose on 10/15/2018; Previous dose on 1/9/2018; This spontaneous report was received from a registered nurse and refers to a 6-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-SEP-2017, the patient was vaccinated with Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (dose, frequency, strength, lot #, expiry date, and route of administration were not provided). Later, on 08-NOV-2017, 09-JAN-2018 (Inappropriate schedule of product administration), and 15-OCT-2018 (Extra dose administered), he received additional doses of the vaccine. Then, on 25-AUG-2023, when patient had 6 years, a dose of Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was given (Product administered to patient of inappropriate age) (Extra dose administered). The patient had no reported any symptoms (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administration error, Wrong product administered
Clinical narrative: No additional AE; Nurse calling to report adverse event for a dose of PROQUAD that was given in error.  Nurse reported that the patient received the PROQUAD dose in error when they were supposed to be administered the MenACWY meningococcal vaccine.  Nurse stated that; Nurse calling to report adverse event for a dose of PROQUAD that was given in error.  Nurse reported that the patient received the PROQUAD dose in error when they were supposed to be administered the MenACWY meningococcal vaccine.  Nurse stated that; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient received a third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). However, this third dose was administered in error as they were supposed to be administered meningococcal vaccine a/c/y/w conj (tet tox) (MENACWY TT).  The nurse stated that the patient involved did not report any adverse reaction or symptoms related to this vaccine administration error. The reporter reported that the patient involved had previously completed their series of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administration and this dose was the third the patient had received.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event reported; Inadvertently gave VARIVAX with PROQUAD/the patient was supposed to get only PROQUAD.; This spontaneous report was received from other health professional and referred to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, first dose, (lot number W026319 has been verified to be a valid lot number, expiration date reported as 28-FEB-2024 and validated as 18-FEB-2024) (strength, vaccination scheme, anatomical location and route of administration were not provided); and was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, first dose, (lot number X010534 has been verified to be a valid lot number, expiration date reported and validated as 11-APR-2025) (strength, vaccination scheme, anatomical location and route of administration were not provided), administered for prophylaxis. The patient was supposed to get only measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (extra dose administered). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed no side effects or symptoms/No additional AE/no PQC; Pharmacist called to report an expired dose of PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a pharmacist and refers to an unknown age patient.  The patient's concurrent conditions, medical history, drug allergies or reactions and concomitant therapies were not reported.  On 21-SEP-2023, the patient received an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot #U032086 (which was confirmed to be a valid lot # for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)), expiration date reported and confirmed to be 29-AUG-2023 (route and site of administration, strength and indication not provided) (expired product administered). It was confirmed that there were no side effects or symptoms, no additional adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; Improperly stored vaccine was administered.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 21-JUN-2023, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # U025789 (expiration date reported and upon internal validation established as 19-AUG-2023) for prophylaxis (dose, anatomical location, and route of administration were not reported). The vaccine was stored at a temperature of 6 Celsius (C) degrees for 7 hours. It did not have previous temperature excursions.  No side effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details/ No PQC; Dose was administered on 9/9/2023, excursion occurred on 9/7/2023.; This spontaneous report was received from a Health Professional and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-SEP-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection,  lot #W039293, expiration date: 11-DEC-2024, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) following a temperature excursion for 0 hours 30 minutes from minus 14 degrees Celsius (C) up to 10C  and then for 0 hours 30 minutes from minus 10C up to 8C (Improper storage of product in use), it was stated that no previous temperature excursion occurred. No additional adverse event was reported.  This is one of 3 cases from the same reporter.; Sender's Comments:  US-009507513-2309USA009166:
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product name confusion, Wrong product administered
Clinical narrative: Was confused by the 'VAX' at the beginning of both products; No additional AEs or PQC reported; Caller reported VARIVAX inadvertently administered to a 9 month old.; Caller reports child should have received VAXELIS and VARIVAX was administered/was confused by the 'VAX' at the beginning of both products; This spontaneous report was received from other health professional and referred to a 9-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-SEP-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered intramuscularly for prophylaxis (lot number X006982 has been verified to be a valid lot number, expiration date reported and validated as 07-MAR-2025) (anatomical location was not provided) instead of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) (VAXELIS) injection for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age) (wrong product administered). The health care provider (HCP) was confused by the "VAX" at the beginning of both products (product name confusion). No additional adverse events were reported.