chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Fall, Gait disturbance, Hemiparesis, Muscular weakness
Clinical narrative: Woke up 10/13/23 feeling light headed and weak on entire left side from shoulder to foot. Left hand was swollen. Had difficulty walking, fell twice. Dropped coffee because no strength in left hand. Soaked in hot water and swelling in hand went down. All side effects completely resolved by 10/14/23
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: Woke up 10/13/23 feeling light headed and weak on entire left side from shoulder to foot. Left hand was swollen. Had difficulty walking, fell twice. Dropped coffee because no strength in left hand. Soaked in hot water and swelling in hand went down. All side effects completely resolved by 10/14/23
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: Within hours of receiving the vaccine, the injection site broke out into hives followed by a headache.  By the next morning, I had a severe headache, fever above 100F, body aches and nausea, and my upper arm was covered in huge red welts.  The welts merged to form a large itchy swelling covering my upper arm that was painful to the touch.  I had difficulty lifting my arm above shoulder level.  The severe headache did not dissipate until two days after the injection, and the swelling lasted for several more days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Tenderness, Urticaria
Clinical narrative: Within hours of receiving the vaccine, the injection site broke out into hives followed by a headache.  By the next morning, I had a severe headache, fever above 100F, body aches and nausea, and my upper arm was covered in huge red welts.  The welts merged to form a large itchy swelling covering my upper arm that was painful to the touch.  I had difficulty lifting my arm above shoulder level.  The severe headache did not dissipate until two days after the injection, and the swelling lasted for several more days.
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient was administered a ProQuad and should have been administered the individual vaccines.  No adverse reaction occurred.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Dyspnoea, Dyspnoea exertional, SARS-CoV-2 test positive
Clinical narrative: The patient was brought into the ED via EMS on 9/24/23 for evaluation of shortness of breath that started the day prior. EMS reports initial O2 sat at 90%, which improved to 92-93% after 2 L of O2, and was sitting at 97% with 16L of O2 en route. EMS also reports dyspnea on exertion. A COVID PCR test performed in the ED resulted positive. Ultimately, the patient was admitted 9/24/23 - 9/27/23 with discharge diagnoses including acute hypoxic respiratory failure secondary to COVID-19 infection, among other diagnoses. The patient did not require additional oxygen after he was admitted. Of note, the patient has received the primary COVID vaccine series and one booster.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Loss of personal independence in daily activities, Migraine, Nausea, Therapeutic product ineffective
Clinical narrative: Migraine that will not go away. NOT a headache. Migraine with nausea that has lasted so far 4 days and counting. Treated with numerous doses of ibuprofen, Aleve, acetaminophen, and Dayquil. Drank lots of water and ate healthy. No relief of pain whatsoever. At the very least if I ever have a naturally occurring migraine one of the drugs will work to alleviate a little bit. Nothing has worked. Migraine has been moving from left side to right side numerous times throughout the day. I cannot function because it is very debilitating.
Age: 1.67
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was administered Kinrix vaccine.  No adverse reactions to the vaccine noted.  The dose is valid per system.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Autonomic nervous system imbalance, Dizziness, Fatigue, Headache
Clinical narrative: Chronic severe nausea, digestive upset, dizziness, headaches, fatigue, abrupt loss of 20lbs. Symptoms continuing and chronic since administration of the vaccine.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Weight decreased
Clinical narrative: Chronic severe nausea, digestive upset, dizziness, headaches, fatigue, abrupt loss of 20lbs. Symptoms continuing and chronic since administration of the vaccine.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, COVID-19, Cough, Dizziness, Feeling abnormal
Clinical narrative: She got her vaccine, had a very very painful arm, swelling and redness around the site.  No fever, nothing like that and was fine othewise until Tuesday.  On Tuesday she woke up with a cough just feeling really bad, sore throat.  She took Dayquill for cough and cold, which did not help her.  She called the doctor and was given Prednisone and an antibiotic and felt that it was viral and she did not take the antibiotic.  The prednisone did help her.  She is still very very weak, dizzy and just does not feel good at all.  They started getting better after the Tuesday outbreak and the next Saturday came up and she was just weak all day and she tested her husband and herself and they were both positive for COVID.  This is the first time she has had COVID.  She is a go getter for her age and cannot do anything at this time.  She called her doctor today to see if she could do blood work and is waiting for them to call back.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Oropharyngeal pain, Pain in extremity
Clinical narrative: She got her vaccine, had a very very painful arm, swelling and redness around the site.  No fever, nothing like that and was fine othewise until Tuesday.  On Tuesday she woke up with a cough just feeling really bad, sore throat.  She took Dayquill for cough and cold, which did not help her.  She called the doctor and was given Prednisone and an antibiotic and felt that it was viral and she did not take the antibiotic.  The prednisone did help her.  She is still very very weak, dizzy and just does not feel good at all.  They started getting better after the Tuesday outbreak and the next Saturday came up and she was just weak all day and she tested her husband and herself and they were both positive for COVID.  This is the first time she has had COVID.  She is a go getter for her age and cannot do anything at this time.  She called her doctor today to see if she could do blood work and is waiting for them to call back.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: SARS-CoV-2 test positive
Clinical narrative: She got her vaccine, had a very very painful arm, swelling and redness around the site.  No fever, nothing like that and was fine othewise until Tuesday.  On Tuesday she woke up with a cough just feeling really bad, sore throat.  She took Dayquill for cough and cold, which did not help her.  She called the doctor and was given Prednisone and an antibiotic and felt that it was viral and she did not take the antibiotic.  The prednisone did help her.  She is still very very weak, dizzy and just does not feel good at all.  They started getting better after the Tuesday outbreak and the next Saturday came up and she was just weak all day and she tested her husband and herself and they were both positive for COVID.  This is the first time she has had COVID.  She is a go getter for her age and cannot do anything at this time.  She called her doctor today to see if she could do blood work and is waiting for them to call back.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Hypophagia, Ileal stenosis, Ileocaecal resection, Imaging procedure, Intestinal dilatation
Clinical narrative: Patient presented on 10/10 with persistent emesis/inability to tolerate PO intake. Discharged home after reassuring UGI and PO trial in ED. Represented on 10/13 in extremis. Found to have an acute surgical abdomen with ileocolic intussusception and narrowing at the terminal ileum noted on exploratory laparotomy.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Intussusception, Laparotomy, Vomiting, X-ray gastrointestinal tract abnormal
Clinical narrative: Patient presented on 10/10 with persistent emesis/inability to tolerate PO intake. Discharged home after reassuring UGI and PO trial in ED. Represented on 10/13 in extremis. Found to have an acute surgical abdomen with ileocolic intussusception and narrowing at the terminal ileum noted on exploratory laparotomy.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush
Clinical narrative: Patient is reporting tension like headache, hot flashes, after she eats.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: This bivalent covid 19 vaccine was given after the FDA ended the EUA on 9/11/2023. Our clinic was not notified of the FDA ending the EUA until 9/13/2023. The vaccine was discarded upon receiving the email notification of the EUA ending.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: April 7th, 2023. Vaccine administered at incorrect time. No adverse events. Notified patient and patient has no side effects.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Redness, warmth, swelling of L shoulder area extending to neck and forearm
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: This bivalent covid 19 vaccine was given after the FDA ended the EUA on 9/11/2023. Our clinic was not notified of the FDA ending the EUA until 9/13/2023. The vaccine was discarded upon receiving the email notification of the EUA ending.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chest pain, Pain in extremity, Thrombosis
Clinical narrative: Substantial and painful blood clots in my left arm and left upper chest and shoulder. These are persisting and getting worse, not better, over time. I also had blood clots from the J&J vaccine, in my left leg especially, but that problem didn't last as long. I am uninsured due to medical disability and living where the disability awarding system is disfunctional and the governors reject government money for insurance expansion, so I found a new free clinic online. I will see them on Friday afternoon hopefully and ask for blood thinners. Until then I am taking naproxen sodium and turmeric to manage pain / improve circulation.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Inflammatory marker test, Injection site bruising, Injection site reaction
Clinical narrative: red/bruise mark @ 3" in diameter beginning PM 9/18/2023;  by end of day 9/19/2023, I was having difficulty using my arm - PT appointment was cancelled; 9/19/2023 - site was @ 4" in diameter. unable to sleep on affected side. by 9/24 the site had grown to the top of my shoulder blade and was approximately 5" in diameter with bruising descending down arm; 9/25: deep red/black bruising w "regular" bruising @ 2/3 of way down arm; 9/27: original round mark extends above should; rash has developed; woke me up at 4:00 AM with a pain level of @ 8-9 9/30: round mark is approximately 1" over shoulder; bruising is solid 2/3 of way down arm
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Rash, Sleep disorder
Clinical narrative: red/bruise mark @ 3" in diameter beginning PM 9/18/2023;  by end of day 9/19/2023, I was having difficulty using my arm - PT appointment was cancelled; 9/19/2023 - site was @ 4" in diameter. unable to sleep on affected side. by 9/24 the site had grown to the top of my shoulder blade and was approximately 5" in diameter with bruising descending down arm; 9/25: deep red/black bruising w "regular" bruising @ 2/3 of way down arm; 9/27: original round mark extends above should; rash has developed; woke me up at 4:00 AM with a pain level of @ 8-9 9/30: round mark is approximately 1" over shoulder; bruising is solid 2/3 of way down arm
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient started complaining of itching.  Noted to have hives across the top of her chest approximately 15 minutes after her shot.  No shortness of breath.   She was reassessed before health staff left the facility.   She still had itching, now on arms, but no shortness of breath.  Patient was last assessed 1 1/2 hours after receiving the injection.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: generalized hives starting in the legs, spreading up the trunk and arms, and then the scalp and face
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: This bivalent covid 19 vaccine was given after the FDA ended the EUA on 9/11/2023. Our clinic was not notified of the FDA ending the EUA until 9/13/2023. The vaccine was discarded upon receiving the email notification of the EUA ending.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects noted. The incorrect flu shot (Fluzone HD) was removed from the fridge and administered to the patient instead of the correct flu shot (flucelvax)
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given FluAD instead of Fluarix for their age by staff. Patient had no adverse events and patient is also aware of the incident and comprehended well. RPh has reach out to the doctor as well.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Product administration error
Clinical narrative: administered flu mist without realizing pt had coclear implant
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue at the end of the day I received the flu shot and headaches until 10/13/23. Headaches were ongoing in the evenings and I experienced unusual fatigue throughout the day.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was administered Quadracel and is only 2 years old.  Patient should have re two separate vaccines. 1 DTap and 1 IPV.  Patient have no adverse reaction to the Quadracil vaccine. Patient tolerated the injection well. Patient and parent was informed by the provider of medication error.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pain, Pyrexia, X-ray limb
Clinical narrative: Fever, nausea, aches still existing today, on Oct 16, 2023. I received the Shingrix vaccine at the same time. No problems with severe aches before the vaccinations.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Hyperhidrosis, Injection site pain, Syncope, Tremor
Clinical narrative: Shot was more painful towards the end of the injection, Syncopy: sweating, light headed within 1 min  of completed shot and lasting about a total of 10 minutes, then my hands & fingers started to shake for about 2 more minutes.  Tech stayed with me. Once symptoms subsided he brought me water.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Patient reported headache, fever, and chills starting the day of the vaccine (10/11/23). She did not feel better until 10/16/23. She asks that I report her adverse reaction in case other patients experience the same side effects.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Head discomfort, Headache, Hunger, Nausea
Clinical narrative: Had morning SAM-e and one coffee.  Symptoms began ~ hour later.  Chills came on quick and strong. Then nausea with a feeling of hunger. Then bad headache that felt similar to sinus headache (pressure in the head) that seemed to move around in my head depending how I laid or held my head. Felt like my head wanted to explode.  Had a fever but did not take temp. Chills slacked off by evening (12 hours after starting). No vomiting. Finally could eat piece of dry bread and take one Advil and one Tylenol ~ midnight
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had morning SAM-e and one coffee.  Symptoms began ~ hour later.  Chills came on quick and strong. Then nausea with a feeling of hunger. Then bad headache that felt similar to sinus headache (pressure in the head) that seemed to move around in my head depending how I laid or held my head. Felt like my head wanted to explode.  Had a fever but did not take temp. Chills slacked off by evening (12 hours after starting). No vomiting. Finally could eat piece of dry bread and take one Advil and one Tylenol ~ midnight
Age: 67.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Patient describes a soreness and a lump in upper arm forming after vaccination lasting until current date (10/16/23). Patient reports redness on same arm lower than vaccination location for approximately 2 weeks after vaccination that has cleared. Patient self-managed symptoms with acetaminophen. Reports the same events for vaccinations in the left arm that occurred in the previous week.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Dyspnoea, Headache, Oxygen saturation decreased, Pyrexia
Clinical narrative: Non-stop runny nose, headache, fever, cough, shortness of breath
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Rhinorrhoea
Clinical narrative: Non-stop runny nose, headache, fever, cough, shortness of breath
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Chest discomfort, Hypoaesthesia, Musculoskeletal discomfort, Paraesthesia, Peripheral swelling
Clinical narrative: arm swelling, tingling and numbness ipsalateral arm and face, chest and back tightness for 10 days, sx much more mild but still persistent
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: deceased 10-6-23 at Health Care Center
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Cold sweat, Feeling abnormal, Nausea, Road traffic accident, Vomiting
Clinical narrative: After shots or blood withdrawals, I frequently feel light headed.  So after the shot I sat in my car for about 10 minutes.  I headed home about 10-15 minutes later while on a divided highway I began to feel weird & I drifted off the road & scraped up against a guardrail., I attempted to right the car but scraped the guardrail a 2nd time. I could see things but nothing seemed to register. And then I was fully conscious.  I continued on home but about 5 minutes later I began to  feel nauseous.  On the exit ramp waiting for a green light I threw up everywhere.  I continued home but not before entering into our subdivision when the police pulled me over for suspected drunk driving.  At this point, I had broken out in the cold sweats even though it was rather chilly.  The police quickly determined that I was sober but having a medical emergency so they called the EMS.  BP 140/78, normal heart rate & whatever they also checked.  I refused transport to the hospital.  The police went and got my wife who drove me home.  I returned to normality the very next day.  Called my doctor to report this & he recommended not having  the 2nd shingles shot in December.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, C-reactive protein normal, Neck pain, Pain
Clinical narrative: Acute shoulder/neck pain beginning that evening, following administration of vaccine.  Chronic shoulder/neck pain; pain along upper back near neck, along clavicle, in joint of shoulder near armpit, shooting pain down arm towards elbow.  Can no longer sleep on side or sit in chair without pain -  In pain when at rest, not while active. - over 30 days and continuing to date.  Mildly improving.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Sitting disability, Sleep disorder, Ultrasound joint normal
Clinical narrative: Acute shoulder/neck pain beginning that evening, following administration of vaccine.  Chronic shoulder/neck pain; pain along upper back near neck, along clavicle, in joint of shoulder near armpit, shooting pain down arm towards elbow.  Can no longer sleep on side or sit in chair without pain -  In pain when at rest, not while active. - over 30 days and continuing to date.  Mildly improving.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: swelling and blisters at vaccination site, fever polysporin on blisters Motrin and Tylenol for fever
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Injection site swelling
Clinical narrative: arm with injection site swollen and stomach cramps
Age: 7.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: none
Age: 7.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: none
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling cold
Clinical narrative: She got her vaccine, in the evening a little tired.  Saturday night felt cold/chills but sweated a little. Then Sunday she was totally wiped out, complete fatigue and was lying on the couch, which is something she never does.  She had no energy whatsoever.  That night when she went to bed and 12:45 AM Monday morning she woke up freezing to death, real chills, super chills and yet at the same time she was sweating so that her entire flanel nightgown was ringing wet, and shaking so bad that she was barely able to stand up.  She got into the living room, got throws and put them on the wet sheets, and wrapped up and felt so bad that she felt like she was going to die, which she has never said before in her life. She got under the covers and began to shake like a leaf.  She was shaking so that she was incapable in taking off her wet nightgown and putting on a dry nightgown, and was glad she was able to get up and get the covers.  She said to God that if she died good.  Then she finally stopped shaking and fell asleep thinking that she was dying.  Then all of a sudden it was 6:00 AM, she was ringing wet, the bed was ringing wet, pillows as well.  She took off her wet nightgown, put on another dry nightgown, put on her bathroom and went outside and sat for a while. She had terrible fatigue, but she was alive.  The rest of the week she was extremely tired all the time, but she had to do what she had to do.  When she went to clean the floor on Friday, down on her hands and knees to clean the floor and she started to get dizzy.  She got up and that's when vertigo set in. She had that the entire evening, all day Saturday and Sunday morning she was back to normal, but she is not herself and still not right.  She does not feel that well, she is tired, it has been a horrid experience and feels that it should be taken off the market.  She is a very active 80 year old woman and never goes to the doctor and is not a frail woman.  This is the worst thing and mentally scarry and she was shaking so that it was unbelievable and does not know how she made it to the living room.  She is still very fatigued, and it definitely has upset her mentally as it was one bad week.    She did call her doctor on Saturday, she was not there and kicked over to another Dr, got called back and was told that they did not know the side effects of the shot, which now has turned her off totally about any of the other shots since they don't know the reactions of the vaccines.  She told the clinic that she had Meclizine tablets, and told her that she was taking 1/4 of them as they tend to make you go to sleep and she did not want to go to sleep, just wanted to stop being dizzy.  She had dizziness from Friday afternoon, all day Saturday and Sunday morning it was better, but still has the fatigue.    She does not want to see an advertisement for a vaccine that you don't know the side effects from, and you don't.  She is going to call the Regulatory Authority.    She asked her doctor if she should get the RSV vaccine, and she was told due to her age that she had it.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Hyperhidrosis, Tremor, Vertigo
Clinical narrative: She got her vaccine, in the evening a little tired.  Saturday night felt cold/chills but sweated a little. Then Sunday she was totally wiped out, complete fatigue and was lying on the couch, which is something she never does.  She had no energy whatsoever.  That night when she went to bed and 12:45 AM Monday morning she woke up freezing to death, real chills, super chills and yet at the same time she was sweating so that her entire flanel nightgown was ringing wet, and shaking so bad that she was barely able to stand up.  She got into the living room, got throws and put them on the wet sheets, and wrapped up and felt so bad that she felt like she was going to die, which she has never said before in her life. She got under the covers and began to shake like a leaf.  She was shaking so that she was incapable in taking off her wet nightgown and putting on a dry nightgown, and was glad she was able to get up and get the covers.  She said to God that if she died good.  Then she finally stopped shaking and fell asleep thinking that she was dying.  Then all of a sudden it was 6:00 AM, she was ringing wet, the bed was ringing wet, pillows as well.  She took off her wet nightgown, put on another dry nightgown, put on her bathroom and went outside and sat for a while. She had terrible fatigue, but she was alive.  The rest of the week she was extremely tired all the time, but she had to do what she had to do.  When she went to clean the floor on Friday, down on her hands and knees to clean the floor and she started to get dizzy.  She got up and that's when vertigo set in. She had that the entire evening, all day Saturday and Sunday morning she was back to normal, but she is not herself and still not right.  She does not feel that well, she is tired, it has been a horrid experience and feels that it should be taken off the market.  She is a very active 80 year old woman and never goes to the doctor and is not a frail woman.  This is the worst thing and mentally scarry and she was shaking so that it was unbelievable and does not know how she made it to the living room.  She is still very fatigued, and it definitely has upset her mentally as it was one bad week.    She did call her doctor on Saturday, she was not there and kicked over to another Dr, got called back and was told that they did not know the side effects of the shot, which now has turned her off totally about any of the other shots since they don't know the reactions of the vaccines.  She told the clinic that she had Meclizine tablets, and told her that she was taking 1/4 of them as they tend to make you go to sleep and she did not want to go to sleep, just wanted to stop being dizzy.  She had dizziness from Friday afternoon, all day Saturday and Sunday morning it was better, but still has the fatigue.    She does not want to see an advertisement for a vaccine that you don't know the side effects from, and you don't.  She is going to call the Regulatory Authority.    She asked her doctor if she should get the RSV vaccine, and she was told due to her age that she had it.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Blood test, Catheterisation cardiac, Chest X-ray, Coronary arterial stent insertion
Clinical narrative: 25Jun2023: ST Elevation Myocardial Infarction resulting in emergency room visit, 2 x stent placement in Left Anterior Descending coronary artery, cardiac intensive care unit hospitalization
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Intensive care
Clinical narrative: 25Jun2023: ST Elevation Myocardial Infarction resulting in emergency room visit, 2 x stent placement in Left Anterior Descending coronary artery, cardiac intensive care unit hospitalization
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Decreased appetite, Dysphagia, Fatigue, Myalgia
Clinical narrative: Difficult swallowing, tightness in my throat for several minutes. I waiting in parking lot before I drove home . I took 1 Benadryl and it helped. The feeling in my throat was similar to my reaction to aspirin but not as severe.  I still feel tired and have some muscle soreness in back but hopefully in a few more days, I will return to normal.  Tired, weak feeling, no appetite, continued for several days Fasted to clear my body of toxins for 2 days. Drank lots of water to flush my body
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Throat tightness
Clinical narrative: Difficult swallowing, tightness in my throat for several minutes. I waiting in parking lot before I drove home . I took 1 Benadryl and it helped. The feeling in my throat was similar to my reaction to aspirin but not as severe.  I still feel tired and have some muscle soreness in back but hopefully in a few more days, I will return to normal.  Tired, weak feeling, no appetite, continued for several days Fasted to clear my body of toxins for 2 days. Drank lots of water to flush my body
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Blood lactic acid, Metabolic function test, Pyrexia, Respiratory viral panel, Seizure
Clinical narrative: seizure activity, fever
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Urine analysis, White blood cell count
Clinical narrative: seizure activity, fever
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Pallor, Urticaria
Clinical narrative: Mother reports patient had hives scattered throughout body, was pale and clammy. Patient responded well to oral Benadryl.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given high dose vaccine outside of indicated age range
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Brain scan normal, Paraesthesia
Clinical narrative: Patient described feeling of tingling in fingers that spread to cheek all on the left side starting on Friday. She reported to the ER on Friday with concerns of a stroke. All tests came back normal. Tingling lasted 5 minutes.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A thrid dose of Rotarix was given to child.  First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine  guidelines- 3rd dose however was inadvertently given.     No adverse event was reported by parent or guardian.  As vaccine was given outside of label instructions, it is being reported today.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event, Off label use
Clinical narrative: A thrid dose of Rotarix was given to child.  First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine  guidelines- 3rd dose however was inadvertently given.     No adverse event was reported by parent or guardian.  As vaccine was given outside of label instructions, it is being reported today.
Age: 57.0
Sex: M
Vaccine: COVID19-2, FLUC4, PNC20
Symptoms: Erythema, Eye pain, Neck pain, Pain
Clinical narrative: Neck pain, body pain eye pain, and redness
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Confusional state, Fall, Febrile convulsion, Pyrexia, Urinary incontinence
Clinical narrative: PATIENT WAS GIVEN NEW COVID 19 VACCINE ALONG WITH FLU VACCINE. PATIENT WOKE UP THE NEXT MORNING, FELL OUT OF BED AND WET HIMSELF. PATIENT ALSO HAD FEVER OF 102. PATIENT WAS SENT TO MEDICAL CENTER FOR FEBRIAL SEIZURE WITH CONFUSION AND FALL
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A thrid dose of Rotarix was given to child.  First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine  guidelines- 3rd dose however was inadvertently given.     No adverse event was reported by parent or guardian.  As vaccine was given outside of label instructions, it is being reported today.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event, Off label use
Clinical narrative: A thrid dose of Rotarix was given to child.  First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine  guidelines- 3rd dose however was inadvertently given.     No adverse event was reported by parent or guardian.  As vaccine was given outside of label instructions, it is being reported today.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at the site about 3" wide and 1" high that has persisted (albeit reduced since Saturday) through Monday (for a shot received Friday morning). I have not previously had site reactions to covid vaccines.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A thrid dose of Rotarix was given to child.  First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine  guidelines- 3rd dose however was inadvertently given.     No adverse event was reported by parent or guardian.  As vaccine was given outside of label instructions, it is being reported today.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Chills
Clinical narrative: Mother took patient to ED at 6:00PM same day for possible seizure activity. ED diagnosed with Rigors.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: A thrid dose of Rotarix was given to child.  First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine  guidelines- 3rd dose however was inadvertently given.     No adverse event was reported by parent or guardian.  As vaccine was given outside of label instructions, it is being reported today.
Age: 11.0
Sex: M
Vaccine: FLUC4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness coving a 4x3 inch area on right arm around vaccine site. No warmth. Benadryl did not help with reaction. Patient brought in for inspection and observation. No treatment considered warranted.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Borrelia test negative, CSF glucose increased, CSF protein increased, CSF test abnormal
Clinical narrative: 84 year old male presented to hospital complaining of weakness after the flu shot given 9/14/23 (manufacturer: Seqirus, LOT#: 371600). He described it as progressive, starting at his toes, and moved upwards, till his groin, he was not able to sit or stand and reported bilateral lower extremity swelling and pain. He also reported urinary retention and constipation. Findings: MRI lumbar spine without contrast (solitary kidney, CKD IIIb) revealed multilevel degenerative changes with severe central canal stenosis at L3/4 and L4/5 with mild stenosis at L1/2. Unremarkable appearance of terminal cord and cauda equina. EMG/NCV test shows compatible, though not conclusive, of GBS LP: elevated Glucose 123, elevated Protein 63. Per neurology, diagnostic tests and patient presentation highly suggestive of Guillain-Barre syndrome and plasmapheresis was initiated for 5 rounds every other day. Patient has currently completed plasmapheresis session 3 of 5 and reports feeling stronger. Of note, patient reports similar weakness after receiving a COVID vaccination in the past but that the symptoms improved with time.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Constipation, Demyelinating polyneuropathy, Dysstasia, Electromyogram abnormal, Guillain-Barre syndrome
Clinical narrative: 84 year old male presented to hospital complaining of weakness after the flu shot given 9/14/23 (manufacturer: Seqirus, LOT#: 371600). He described it as progressive, starting at his toes, and moved upwards, till his groin, he was not able to sit or stand and reported bilateral lower extremity swelling and pain. He also reported urinary retention and constipation. Findings: MRI lumbar spine without contrast (solitary kidney, CKD IIIb) revealed multilevel degenerative changes with severe central canal stenosis at L3/4 and L4/5 with mild stenosis at L1/2. Unremarkable appearance of terminal cord and cauda equina. EMG/NCV test shows compatible, though not conclusive, of GBS LP: elevated Glucose 123, elevated Protein 63. Per neurology, diagnostic tests and patient presentation highly suggestive of Guillain-Barre syndrome and plasmapheresis was initiated for 5 rounds every other day. Patient has currently completed plasmapheresis session 3 of 5 and reports feeling stronger. Of note, patient reports similar weakness after receiving a COVID vaccination in the past but that the symptoms improved with time.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Intervertebral disc degeneration, Lumbar puncture abnormal, Lumbar spinal stenosis, Magnetic resonance imaging spinal abnormal, Myelopathy
Clinical narrative: 84 year old male presented to hospital complaining of weakness after the flu shot given 9/14/23 (manufacturer: Seqirus, LOT#: 371600). He described it as progressive, starting at his toes, and moved upwards, till his groin, he was not able to sit or stand and reported bilateral lower extremity swelling and pain. He also reported urinary retention and constipation. Findings: MRI lumbar spine without contrast (solitary kidney, CKD IIIb) revealed multilevel degenerative changes with severe central canal stenosis at L3/4 and L4/5 with mild stenosis at L1/2. Unremarkable appearance of terminal cord and cauda equina. EMG/NCV test shows compatible, though not conclusive, of GBS LP: elevated Glucose 123, elevated Protein 63. Per neurology, diagnostic tests and patient presentation highly suggestive of Guillain-Barre syndrome and plasmapheresis was initiated for 5 rounds every other day. Patient has currently completed plasmapheresis session 3 of 5 and reports feeling stronger. Of note, patient reports similar weakness after receiving a COVID vaccination in the past but that the symptoms improved with time.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Nerve conduction studies abnormal, Neurological examination abnormal, Pain in extremity, Peripheral sensorimotor neuropathy, Peripheral swelling
Clinical narrative: 84 year old male presented to hospital complaining of weakness after the flu shot given 9/14/23 (manufacturer: Seqirus, LOT#: 371600). He described it as progressive, starting at his toes, and moved upwards, till his groin, he was not able to sit or stand and reported bilateral lower extremity swelling and pain. He also reported urinary retention and constipation. Findings: MRI lumbar spine without contrast (solitary kidney, CKD IIIb) revealed multilevel degenerative changes with severe central canal stenosis at L3/4 and L4/5 with mild stenosis at L1/2. Unremarkable appearance of terminal cord and cauda equina. EMG/NCV test shows compatible, though not conclusive, of GBS LP: elevated Glucose 123, elevated Protein 63. Per neurology, diagnostic tests and patient presentation highly suggestive of Guillain-Barre syndrome and plasmapheresis was initiated for 5 rounds every other day. Patient has currently completed plasmapheresis session 3 of 5 and reports feeling stronger. Of note, patient reports similar weakness after receiving a COVID vaccination in the past but that the symptoms improved with time.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Plasmapheresis, Radiculopathy, Sitting disability, Spinal stenosis, Urinary retention
Clinical narrative: 84 year old male presented to hospital complaining of weakness after the flu shot given 9/14/23 (manufacturer: Seqirus, LOT#: 371600). He described it as progressive, starting at his toes, and moved upwards, till his groin, he was not able to sit or stand and reported bilateral lower extremity swelling and pain. He also reported urinary retention and constipation. Findings: MRI lumbar spine without contrast (solitary kidney, CKD IIIb) revealed multilevel degenerative changes with severe central canal stenosis at L3/4 and L4/5 with mild stenosis at L1/2. Unremarkable appearance of terminal cord and cauda equina. EMG/NCV test shows compatible, though not conclusive, of GBS LP: elevated Glucose 123, elevated Protein 63. Per neurology, diagnostic tests and patient presentation highly suggestive of Guillain-Barre syndrome and plasmapheresis was initiated for 5 rounds every other day. Patient has currently completed plasmapheresis session 3 of 5 and reports feeling stronger. Of note, patient reports similar weakness after receiving a COVID vaccination in the past but that the symptoms improved with time.
Age: 86.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Blister, Erythema, Peripheral swelling, Pruritus
Clinical narrative: I came home and the arm was red, it was itching . I had on a long sleeve shirt and I took the shirt off and the arm is swollen a little and it is red. It looks like a bunch of blisters, and it's one that came out. It was a bunch of tiny blisters and one came out, and that's what prompted my call to you. Last nibht I saw a whole bunch of red spots.
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: No adverse event
Clinical narrative: None reported by the patient
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood pressure decreased, Electrocardiogram, Nausea, Presyncope, Syncope
Clinical narrative: Fainted moments after shot, blood pressure dropped, vision blurred, nasuea
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Vision blurred
Clinical narrative: Fainted moments after shot, blood pressure dropped, vision blurred, nasuea
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Fatigue, Hyperhidrosis, Immediate post-injection reaction, Pallor, Posture abnormal
Clinical narrative: Fainted moments after shot, blood pressure dropped, vision blurred, nasuea
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Presyncope, Unresponsive to stimuli
Clinical narrative: Fainted moments after shot, blood pressure dropped, vision blurred, nasuea
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient started with a sore arm and reported back to pharmacy 2 weeks later that her arm was still hurting and it was hard to move it.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Dyskinesia
Clinical narrative: patient stated that she felt like she had no control over her muscles and felt like it was a neurological thing happen
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: local reaction, redness, swelling and warmth, patient was evaluated at 6 days post vaccination and still  had redness, swelling and warmth at vaccination site
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric vaccine was inadvertently given to adult patient (0.25 mL), patient was subsequently given second dose (0.25 mL) to equal an adult dose. Tolerated without issue as of 10/16/23 at 0905.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Influenza, Oropharyngeal pain, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: Itchy throat on the day of shot during at night. Then next morning starting to have a sore throat and developed flu like symptom.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Biopsy, Emotional distress, Endoscopy normal, Eructation
Clinical narrative: Nausea, inability to eat and dry heaving, muscle pain for 24 hours after the vaccination.  Starting immediately afterwards I have suffered from chronic abdominal bloating and excessive burping.  This has caused weight loss (from 175 pounds to 150 pounds), sleep loss due to burping at night, and severe distress and loss of quality of life.  The effects seem to be permanent.  Things I have tried to mitigate with little/no success:  Probiotics Activated Charcoal pills Spice teas FODMAP diet Low-sugar diet Dairy-free diet Fasting Endoscopy Breath test Antibiotics Peppermint oil pills Herbal bitters and other homeopathic remedies Adjusting food schedule Keeping a food diary Epsom Salt flush
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Hydrogen breath test normal, Immediate post-injection reaction, Impaired quality of life, Insomnia
Clinical narrative: Nausea, inability to eat and dry heaving, muscle pain for 24 hours after the vaccination.  Starting immediately afterwards I have suffered from chronic abdominal bloating and excessive burping.  This has caused weight loss (from 175 pounds to 150 pounds), sleep loss due to burping at night, and severe distress and loss of quality of life.  The effects seem to be permanent.  Things I have tried to mitigate with little/no success:  Probiotics Activated Charcoal pills Spice teas FODMAP diet Low-sugar diet Dairy-free diet Fasting Endoscopy Breath test Antibiotics Peppermint oil pills Herbal bitters and other homeopathic remedies Adjusting food schedule Keeping a food diary Epsom Salt flush
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Retching, Weight decreased
Clinical narrative: Nausea, inability to eat and dry heaving, muscle pain for 24 hours after the vaccination.  Starting immediately afterwards I have suffered from chronic abdominal bloating and excessive burping.  This has caused weight loss (from 175 pounds to 150 pounds), sleep loss due to burping at night, and severe distress and loss of quality of life.  The effects seem to be permanent.  Things I have tried to mitigate with little/no success:  Probiotics Activated Charcoal pills Spice teas FODMAP diet Low-sugar diet Dairy-free diet Fasting Endoscopy Breath test Antibiotics Peppermint oil pills Herbal bitters and other homeopathic remedies Adjusting food schedule Keeping a food diary Epsom Salt flush
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Oedema peripheral, Rash
Clinical narrative: Delayed Hypersenstivity Rheumatoid Reaction.  Inflammatory edema hands and feet, rash on legs, severe muscle and joint pain.  Worst joint and muscle ever. Pain worse than a case of chikungunya virus in the past.
Age: 62.0
Sex: M
Vaccine: FLUR4
Symptoms: Erythema, Oral herpes, Pruritus
Clinical narrative: Full body turned pink and itchy for 2 days, got fever blisters on mouth after 4 days. no medication. no md visits.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Mobility decreased
Clinical narrative: fatigue, nausea, diarrhea, headache, left arm extremely swollen and painful. Needed to stay in bed for 2 days straight. Left arm still continues to have a large redden area. Also still very fatigued.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: fatigue, nausea, diarrhea, headache, left arm extremely swollen and painful. Needed to stay in bed for 2 days straight. Left arm still continues to have a large redden area. Also still very fatigued.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular
Clinical narrative: 10/14/2023 Morning: Localized raised rash above armpit on left arm. Itchy and textured.  Still present as of 10/16/2023. Not spreading.  10/14/2023 Evening: Raised rash above armpit noted on right arm (injection site). Same Sx. Still present as of 10/16/2023 No treatment used.  No change in deodorant or exposure to allergens.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rash
Clinical narrative: Development of rash over trunk, arms and legs
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Wheezing,  difficulty breathing deeply.
Age: 66.0
Sex: F
Vaccine: FLU4, RSV, VARZOS
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: She got her vaccines, the arm was a little sore on site.  She woke up Friday and she had a 3" shape from front to back of extreme sunburn redness, and it itched.  She didn't scratch it but it itched.  By Friday night it started going down her arm.  Saturday it got to her elbow.  She put Cortisone cream as even with a washcloth over that section, and as much as it itched if she wiped it in the shower it hurt to touch.  She did not go to an UC or ER.  The redness is not red on site, it's below where the shots were given.  She continues to have the redness and the itching.  She has not notified her doctor, called us first to report it.