chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema
Clinical narrative: Two red areas on left shoulder appeared 12 days after the first vaccination. (One oval area was at shot site about 1 inch by 2 inches.  Second area was below the first area and in the shape of a band  around my arm 1 inch wide by 4 inches long . Treatment was Benadryl ointment on red areas and baby aspirin Also, I had headaches almost daily until the red areas appeared.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Flu-like symptoms, Headache, muscle ache, Joint pain, injection site pain, fatigue. No treatment, eventually went away.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Flu-like symptoms, Headache, muscle ache, Joint pain, injection site pain, fatigue. No treatment, eventually went away.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (101.8), body aches, chills onset about 8 hours after injection. Treated successfully with nsaid
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: Within 1-2 minutes of receiving the vaccine in my right arm (while sitting in the passenger seat of our car), my husband pulled forward in the lot, and I immediately felt a wave of heat come from my chest, up through my neck and into my face. I started sweating, got light-headed, very nauseous, and the left side of my face (everything under my cheekbone) felt "tingly". When we parked, I opened the car door, we opened the windows I drank water, and did some deep breathing. If I had been standing up after the shot, I think I would have fainted. I'm not sure what that reaction was.......I have had similar reactions when I've had my triptan-class injection medication or even the triptan medication in pill form. In those instances, I think my blood pressure dropped because of the vasodilation . I am not scared of shots, needles, or getting blood drawn at all. It wasn't fear and I had eaten plenty that morning as well as drank a lot of water. As far as the numbless/tingly feeling in my face, I do have damage to my trigeminal nerve that occurred during my craniotomy in 2016, so that area doesn't ever feel 100% normal, however the change to a more intense "tingliness" after the injection was pronounced and lasted about 3-4 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Within 1-2 minutes of receiving the vaccine in my right arm (while sitting in the passenger seat of our car), my husband pulled forward in the lot, and I immediately felt a wave of heat come from my chest, up through my neck and into my face. I started sweating, got light-headed, very nauseous, and the left side of my face (everything under my cheekbone) felt "tingly". When we parked, I opened the car door, we opened the windows I drank water, and did some deep breathing. If I had been standing up after the shot, I think I would have fainted. I'm not sure what that reaction was.......I have had similar reactions when I've had my triptan-class injection medication or even the triptan medication in pill form. In those instances, I think my blood pressure dropped because of the vasodilation . I am not scared of shots, needles, or getting blood drawn at all. It wasn't fear and I had eaten plenty that morning as well as drank a lot of water. As far as the numbless/tingly feeling in my face, I do have damage to my trigeminal nerve that occurred during my craniotomy in 2016, so that area doesn't ever feel 100% normal, however the change to a more intense "tingliness" after the injection was pronounced and lasted about 3-4 days.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Bradyphrenia, Dizziness, Dysarthria, Feeling abnormal
Clinical narrative: Headache, dizziness, temporary tingling and numbness of lips and loss of smell;  foggy brain , inability to complete sentence and thoughts lasting 3-5 hours with slightly slurred speech
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Headache, dizziness, temporary tingling and numbness of lips and loss of smell;  foggy brain , inability to complete sentence and thoughts lasting 3-5 hours with slightly slurred speech
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Influenza like illness, Retching
Clinical narrative: Sick in stomach , flu like symptoms , dry heaves -
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Heart rate increased, Hypertension
Clinical narrative: Stabbing pain in back increased heart rate leading to high blood pressure readings
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Chest pain, Echocardiogram, Hypertensive urgency, Laboratory test
Clinical narrative: Stabbing pain in back increased heart rate leading to high blood pressure readings
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Joint range of motion decreased, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Today is March 10 - 10 days after the vaccine - my eyes are red, I have some rash on my face and my throat is red and sore.  It?s very painful. I went to the doctor gave me cough medicine. I only cough 2-3 times. But the pain and redness in my throat  is constant. Day 2 - I have shorthness of breath ( that was one morning only) a d I could not move my arm until day 3 . It?s was painful and sore.- I need to know if I t is safe to take the second dosis
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema, Rash
Clinical narrative: Today is March 10 - 10 days after the vaccine - my eyes are red, I have some rash on my face and my throat is red and sore.  It?s very painful. I went to the doctor gave me cough medicine. I only cough 2-3 times. But the pain and redness in my throat  is constant. Day 2 - I have shorthness of breath ( that was one morning only) a d I could not move my arm until day 3 . It?s was painful and sore.- I need to know if I t is safe to take the second dosis
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Painful respiration
Clinical narrative: Extreme chest pain Hard to breath and painful
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Wheezing
Clinical narrative: Wheezing, moderate trouble breathing, tightness in chest- onset approximately 1.5-2 hours after receiving the vaccination
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Glycosylated haemoglobin, Headache, Tremor
Clinical narrative: Low blood sugar episode and tremors extreme headache
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Pain in injection site, mild fever, nausea
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Headache, body aches, chills, fatigue
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Dizziness, Feeling hot, Hyperhidrosis, Hypoacusis
Clinical narrative: Vasovagal syncope, onset 1 hour after vaccine administration. Resolved in ~15 minutes, upon lying down. Sudden lightheadedness, seeing stars; tunnel hearing, then tinnitus; leaned forward and lightheadedness continued to worsen, so I laid the car seat back; suddenly felt hot and started sweating profusely; slight nausea; bradycardia (which I never have - I am on a prescription stimulant, and usually run >80 when seated). Called roommate to pick me up and take me back to the vaccine site to check with paramedics there before continuing home.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Staring, Syncope, Tinnitus
Clinical narrative: Vasovagal syncope, onset 1 hour after vaccine administration. Resolved in ~15 minutes, upon lying down. Sudden lightheadedness, seeing stars; tunnel hearing, then tinnitus; leaned forward and lightheadedness continued to worsen, so I laid the car seat back; suddenly felt hot and started sweating profusely; slight nausea; bradycardia (which I never have - I am on a prescription stimulant, and usually run >80 when seated). Called roommate to pick me up and take me back to the vaccine site to check with paramedics there before continuing home.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Pain
Clinical narrative: Dizziness for 5 days, Migraine for 4  Body aches  4
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, chills, tired, headache
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Palpitations
Clinical narrative: Fever of 102, chills, aches, minor heart racing, injection site pain, headache
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102, chills, aches, minor heart racing, injection site pain, headache
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral coldness
Clinical narrative: Strong headache; cold feet
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Herpes zoster, Injection site mass
Clinical narrative: A few hours after the vaccine my arm swelled. The following day I had a headache, chills and  fever that lasted about 18 hours along with a very swollen, lumpy injection site with a red bullseye mark. Now five days later, the injection site is swollen, itchy and still a bit painful. On Sunday, March 7, I woke up with a patch of shingles on the right side of my chest. Very painful and still hasn't gone away. I believe it is connected to the vaccine (speculation, I know). I don't feel well.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: A few hours after the vaccine my arm swelled. The following day I had a headache, chills and  fever that lasted about 18 hours along with a very swollen, lumpy injection site with a red bullseye mark. Now five days later, the injection site is swollen, itchy and still a bit painful. On Sunday, March 7, I woke up with a patch of shingles on the right side of my chest. Very painful and still hasn't gone away. I believe it is connected to the vaccine (speculation, I know). I don't feel well.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Cardiovascular evaluation, Chest pain, Cough
Clinical narrative: Fatigue swelling of face  Shortness of breath Cough Joint pain Headache Chest pain dizziness
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Swelling face
Clinical narrative: Fatigue swelling of face  Shortness of breath Cough Joint pain Headache Chest pain dizziness
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Fever, injection site pain, body aches, headache, nausea
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Retching
Clinical narrative: Severe pain in lower right back, will last 1-2 hours as pain subsides, dry heaves begin. This has happened on 3/8, 3/9 and 3/10.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Paraesthesia, Vital signs measurement
Clinical narrative: Pt. stated she started feeling tingling in her fingers 5 min. after getting vaccinated.  The tingling on her fingers went away but she started feeling tingling in her knees.  Vital signs were taken.  O2 sat 100%, BP 134/63, HR 86.  Patient stated she was nervous when vaccinated, but the tingling was new.  At 3:53 pm patient stated the tingling is going away on its own.  At 4:01 pm she stated she was feeling ok and is ready to go home.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Injection site movement impairment, Injection site pain
Clinical narrative: Injection site soreness began within 15 minutes and worsened through the day and night. Sore to lift arm Headache and back ache began about 2 hours after the injection  Fatigue  Entire body aches and headache upon waking the next day Used Tylenol and Ibuprofen to lessen the pain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Injection site soreness began within 15 minutes and worsened through the day and night. Sore to lift arm Headache and back ache began about 2 hours after the injection  Fatigue  Entire body aches and headache upon waking the next day Used Tylenol and Ibuprofen to lessen the pain
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: After client received the vaccine client stated that she feels dizzy and anxious.  Client has a history of anxiety attacks.  Vital signs obtained by EMS.  BP 131/85, HR 83, O2 sat 100%.  Client stated that she feels better.  Client discharged home.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea
Clinical narrative: I was nauseous from 8am until about 7pm. Couldn?t even get out of bed. Prior to 8am I felt fine.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Mild redness of skin with itching; both forearms, palms hands and neck.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Body cramps..started early that morning by the time I got to work the cramps were worse.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Red rash developed in the area of the shot 2 weeks after the shot.  The area is slightly raised and slightly hard.  Minor iching.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Pyrexia
Clinical narrative: Stomachache, very bad chills, headache, fever 102.5
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Rosacea Papular on face.  Never had this before
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Breast pain, Chest discomfort, Chest pain, Lymphadenopathy
Clinical narrative: Swelling in left rib cage and pain that travels from left breast into left arm.  I have had an ultrasound to rule out swollen lymph nodes  and breast cancer. I have breast implants as well.  I work for a Plastic surgeon,  I know this is not my implants. My mammogram in early January,(before my first vaccine shot) showed no issues. I also had a Thermagram for more views after my first Moderna vaccine and that showed my breast was clear. I have continued to have pain and pressure in my left rib cage when moving my left arm. It has been going on for three weeks. I had my shot in the opposite arm. I see a specialist on Monday March 5th. My blood work I had last week showed my total T3 was very low.  I am sure this all started after my first shot. I have never had a breathing issue or left rib cage swelling with left arm pain.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Ultrasound scan
Clinical narrative: Swelling in left rib cage and pain that travels from left breast into left arm.  I have had an ultrasound to rule out swollen lymph nodes  and breast cancer. I have breast implants as well.  I work for a Plastic surgeon,  I know this is not my implants. My mammogram in early January,(before my first vaccine shot) showed no issues. I also had a Thermagram for more views after my first Moderna vaccine and that showed my breast was clear. I have continued to have pain and pressure in my left rib cage when moving my left arm. It has been going on for three weeks. I had my shot in the opposite arm. I see a specialist on Monday March 5th. My blood work I had last week showed my total T3 was very low.  I am sure this all started after my first shot. I have never had a breathing issue or left rib cage swelling with left arm pain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Cough, Fatigue, Mobility decreased, Myalgia
Clinical narrative: Cough & runny nose Bone pain  (intense pain where I literally wanted back shoulder blade removed) Muscle pain Hard swelling & tenderness Fatigue Unable to lift arm  Neck sore.  Can?t turn
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Rhinorrhoea, Swelling, Tenderness
Clinical narrative: Cough & runny nose Bone pain  (intense pain where I literally wanted back shoulder blade removed) Muscle pain Hard swelling & tenderness Fatigue Unable to lift arm  Neck sore.  Can?t turn
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Fall, Head injury, Heart rate decreased, Loss of consciousness
Clinical narrative: After patient was vaccinated, she stood up and had loss of consciousness, falling backwards onto floor and +hit back of her head.  She does report history of syncope after injections. BP 96/58, P48, R17, O2=98%. Alert and oriented. No deformity.  Moving all extremities. Denies headache, nausea. She was on stretcher and after 15 minutes felt better.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever: 100.4 Chills Headache Fatigue Body aches Treatment: OTC/naproxen
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Vision blurred
Clinical narrative: - extreme neck pain,. Comparable to pinched nerve  type of pain in neck. Originated on the left side but now primarily on the right side - blurred vision in right eye.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Hyperhidrosis, Palpitations
Clinical narrative: Client presented with shortness of breath, anxiety, diaphoresis at 12:00 pm, 15 minutes after receiving first dose of Moderna vaccine at outreach clinic at her apartment residence.   12:03 VS 152/94, 94 bpm regular.  12:05 50 mg of dyphenhydramine IM in her left arm 12:15 Her nebulizer was retrieved from her apartment, during which time client contacted her daughter to come for assistance.  12:20 Reported continued breathing difficulties, but felt the "benadryl was helping" and appeared less anxious. HR 94 (BP deferred while client was calling her daughter)  12:23 she obtained her nebulizer and took an albuterol treatment over 15 minutes, reporting good effect and improvement in symptoms.  12:36  112/68 95 HR sinus rhythm.   She still felt like her heart was racing, w/ 95 bpm.  Reported feeling "light headed" (counseled that benadryl and albuterol could contribute to this symptom), but "better" and "can breathe easier".   12:50 Daughter arrived, was given report on above, advised to check client's blood glucose, administer insulin if indicated, as ordered and follow with something to eat.  Advised to contact client's PCP for further concerns. We will contact client tomorrow to F/U
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Diarrhoea, Ear pain, Headache
Clinical narrative: Fever of 101.6, chills, body aches, back ache, head ache, diarrhea, ear ache.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 101.6, chills, body aches, back ache, head ache, diarrhea, ear ache.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Chills, body aches and fever about 7 hours after the shot. I took Tylenol and it made the symptoms more mild. I was fever free at about 11am the next day. My injection site and arm still hurts 3 days later and I have  a swollen and sore gland in my collar bone on the same side as my shot was given.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills, body aches and fever about 7 hours after the shot. I took Tylenol and it made the symptoms more mild. I was fever free at about 11am the next day. My injection site and arm still hurts 3 days later and I have  a swollen and sore gland in my collar bone on the same side as my shot was given.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood sugars, normal before, are now extremely high (220-295) no matter what I do to lower them.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Systemic: Arm heaviness, numbness, and tingling in vaccination arm-Medium
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Systemic: Arm heaviness, numbness, and tingling in vaccination arm-Medium
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Systemic: Arm heaviness, numbness, and tingling in vaccination arm-Medium
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Systemic: Arm heaviness, numbness, and tingling in vaccination arm-Medium
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 5 days after vaccine i had a 3" round red spot at injection site.  Spot is sore and has heat.  This is the 14th day and site is still red, sore and has heat
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Sleep disorder
Clinical narrative: Headache. Severe. Level 9 of 10 (10 being worse). Unable to sleep because the headache was so sever I could not lay my head on a pillow.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Immediate post-injection reaction
Clinical narrative: Heavy menstrual period occurred right after shot was administered. My cycle is usually regular, I was not supposed to have a period for two weeks. Nothing else would have affected it (no birth control, no chance of pregnancy).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Injection site pain, Lymphadenopathy, Paraesthesia, Throat tightness
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient did not have any anaphylaxis, main complaint was mild tightness under chin between jaw and lymph nodes 20 minutes post immunization lasting for a max of 30 minutes. Also mild tingling in forearm a few minutes after injection.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product lot number issue, Product storage error
Clinical narrative: No other AE; temperature excursion for ROTATEQ that was administered.; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis.  Lot #166011, expiration date reported as 5.30/2021. Lot number 166011 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and does not match any Company product.   There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 1.6 Celsius for 31 hours and 25 minutes. There were no previous excursions reported. The outcome of the event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Poor quality sleep, Pruritus, Sleep disorder
Clinical narrative: itching on my back; keeping me awake at night; This case was reported by a consumer and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced pruritus and wakefulness. The patient was treated with dermatologicals nos (Anti-Itch Lotions) and dermatologicals nos (Anti-Itch Cream (Medication Unknown)). On an unknown date, the outcome of the pruritus and wakefulness were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and wakefulness to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. A few weeks later, the patient experience itching on back and was suffered from this itching, 24 hours a day. It was kept awake at night.  The patient apply some anti itch lotions and creams to it for relief, but only to have it wake up a few hours later to repeat. The patient had to also apply things to it all day to seek relief. The patient consulted with doctors as to the itching, and so far all they had been able to provide was information about ways to reduce the discomfort, but there had been no conclusions as to the cause. The reporter stated that, it was important to find the cause of this and even more important to find a solution to this constant itching. The reporter consented to follow up.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Haematochezia, Mucous stools
Clinical narrative: bloody mucous loose stools; diarrhea; bloody mucous loose stools; This case was reported by a nurse via sales rep and described the occurrence of blood in stool in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3CR3S, expiry date 12th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 2nd March 2021, the patient received the 1st dose of Rotarix lyophilized formulation (oral) 1 ml and Rotarix Oral Applicator Device. In March 2021, less than a week after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced blood in stool (serious criteria GSK medically significant), diarrhea and mucus stools. On an unknown date, the outcome of the blood in stool, diarrhea and mucus stools were not recovered/not resolved.   It was unknown if the reporter considered the blood in stool, diarrhea and mucus stools to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On 7th March 2021, the patient mother called complaining of bloody mucous loose stools, diarrhea 2 to 3 days after receiving the Rotarix vaccine. They are awaiting on a stool culture from the patient. The reporter reported that there are no new events. The reporter consented to follow up. This case was 1 of the 3 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058813:same reporter US-GLAXOSMITHKLINE-US2021AMR058850:same reporter
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Culture stool, Diarrhoea, Haematochezia
Clinical narrative: bloody stools; diarrhea; This case was reported by a nurse via sales rep and described the occurrence of blood in stool in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3CR3S, expiry date 12th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 1st March 2021, the patient received the 2nd dose of Rotarix lyophilized formulation (oral) 1 ml and Rotarix Oral Applicator Device. In March 2021, less than a week after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced blood in stool (serious criteria GSK medically significant) and diarrhea. On an unknown date, the outcome of the blood in stool and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the blood in stool and diarrhea to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Two days after receiving Rotarix vaccine the patient mother came into the office complaining of bloody stools, diarrhea. Stool cultures were ordered and was pending. The reporter reported that there are no new events. The reporter consented to follow up. This case was 1 of the 3 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058802:same reporter US-GLAXOSMITHKLINE-US2021AMR058850:same reporter
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Culture stool, Dehydration, Diarrhoea, Haematochezia
Clinical narrative: bloody stools; mucus diarrhea; Patient was sent to the ER by provider to get IV rehydration; This case was reported by a nurse via sales rep and described the occurrence of blood in stool in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3CR3S, expiry date 12th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 1st March 2021, the patient received the 2nd dose of Rotarix lyophilized formulation (oral) 1 ml and Rotarix Oral Applicator Device. In March 2021, less than a week after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced blood in stool (serious criteria GSK medically significant), mucous diarrhea and dehydration. The patient was treated with rehydration fluid (nos) (Intravenous Rehydration Therapy (Nos)). On an unknown date, the outcome of the blood in stool, mucous diarrhea and dehydration were not recovered/not resolved.   It was unknown if the reporter considered the blood in stool, mucous diarrhea and dehydration to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On Friday 5th March 2021, the nurse was seen in the office for complaints of bloody stools, mucus diarrhea after receiving Rotarix vaccine. Stool cultures were taken and are still pending. The patient was sent to the emergency room (ER) by provider to get intravenous (IV) rehydration. The reporter reported that there are no new events. The reporter consented to follow up. This case was 1 of the 3 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058802:same reporter US-GLAXOSMITHKLINE-US2021AMR058813:same reporter
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st vaccine on 10/24/2019 and have not received 2nd or 3rd doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose on 24th October 2019, intramuscularly).   On an unknown date, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was not recovered/not resolved.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received 2nd and 3rd dose, which led to incomplete course of vaccination. The reporter consented to follow-up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Tremor
Clinical narrative: Systemic: Shakiness-Severe, Additional Details: Pt reported feeling extremely shaky a few hours after receiving her dose, so much that she could not drive anymore. She called the EMTs, they checked her vitals and said she was fine. However, she did get a hotel room becuase she did not feel safe driving home. only allergy is to pet dander. She will call back tomorrow just to give an update. She is going to call her PCP for further clarification as to what to do for the 2nd dose.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dry mouth, Hyperventilation, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient was extremely anxious when she came in for vaccine informing vaccinator that this was her second appointment because she had cancelled the first appointment due to anxiety of side effects (was worried she \"was going to die\"). She stated that her mouth was slightly numb/itchy and that for a moment it was her whole body. Then stated that her mouth had become dry from being anxious about the vaccine. After giving a dose of diphenhydramine & getting the patient to calm down the rxn subsided
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient was extremely anxious when she came in for vaccine informing vaccinator that this was her second appointment because she had cancelled the first appointment due to anxiety of side effects (was worried she \"was going to die\"). She stated that her mouth was slightly numb/itchy and that for a moment it was her whole body. Then stated that her mouth had become dry from being anxious about the vaccine. After giving a dose of diphenhydramine & getting the patient to calm down the rxn subsided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Laryngitis, Nasal congestion
Clinical narrative: "CC: cold covid shot x2. 2nd shot 2/26, 1st shot 4 weeks prior Moderna HISTORY  Age: 59 Gender:F Symptoms:  Cough:Y thinks form post nasal drip and had some laryngitis Shortness of breath:Y Difficulty breathing:Y wheeze at HS Loss of taste:N Loss of smell:N ------------------------ Fever > 100.4:N Subjective fever:N Chills:N Rigors:N Myalgias:N Headache:Y sinus teeth hurt Sore throat:N Diarrhea:N Nausea/Vomiting:N Nasal congestion/rhinorrhea:Y, yellow mucous constant  Additional symptoms:  Onset and duration: 3/1  Recently in an area with COVID-19 community spread (within past 14 days): If YES, where?N If YES, what were the specific dates of travel (or does the patient live in this area)? Close contact with a suspected or laboratory-confirmed COVID-19 patient: If YES, in what capacity?N Healthcare worker with potential exposure to a person with suspected COVID-19? If YES, in what capacity?Y pharmacy tech If YES, was PPE (personal protective equipment) used?Y  Chronic medical conditions/Immunocompromised? List: Seasonal allergies/allergic rhinitis High blood pressure Arthritis Anxiety If female, currently pregnant:NA Smoking history:N Has the patient had the flu vaccine this year?y If YES, approximate date of flu vaccine?Oct"
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Toothache, Upper-airway cough syndrome, Wheezing
Clinical narrative: "CC: cold covid shot x2. 2nd shot 2/26, 1st shot 4 weeks prior Moderna HISTORY  Age: 59 Gender:F Symptoms:  Cough:Y thinks form post nasal drip and had some laryngitis Shortness of breath:Y Difficulty breathing:Y wheeze at HS Loss of taste:N Loss of smell:N ------------------------ Fever > 100.4:N Subjective fever:N Chills:N Rigors:N Myalgias:N Headache:Y sinus teeth hurt Sore throat:N Diarrhea:N Nausea/Vomiting:N Nasal congestion/rhinorrhea:Y, yellow mucous constant  Additional symptoms:  Onset and duration: 3/1  Recently in an area with COVID-19 community spread (within past 14 days): If YES, where?N If YES, what were the specific dates of travel (or does the patient live in this area)? Close contact with a suspected or laboratory-confirmed COVID-19 patient: If YES, in what capacity?N Healthcare worker with potential exposure to a person with suspected COVID-19? If YES, in what capacity?Y pharmacy tech If YES, was PPE (personal protective equipment) used?Y  Chronic medical conditions/Immunocompromised? List: Seasonal allergies/allergic rhinitis High blood pressure Arthritis Anxiety If female, currently pregnant:NA Smoking history:N Has the patient had the flu vaccine this year?y If YES, approximate date of flu vaccine?Oct"
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain, Pain in extremity, Walking aid user
Clinical narrative: extreme pain in joints particularly left arm, elbow, hand, shoulder .   Pain throughout rest of body, so debilitating that I could hardly walk.   Need to use walker ever since
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: After client received her vaccine client complained of itchy chest no rash.  Vital signs obtained:  BP 150/69, HR 58, O2 sat 97%.  Client stated that she feels better.  Client discharge home by EMS.  Advised to follow up with her PCP.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt was escorted to waiting area and sat in chair. Within 5 mins of sitting down, pt's head fell backwards and hit the wall behind her slightly, slipped out of the chair and fell on floor. Pt got up as soon as she was on the floor. The incident transpired in less than one minute and she regained consciousness. Pt was given water and said she felt \" the blood rushing back\" and felt \"much better\". Had pt stay around for > 30 minutes and was picked up by friend. Per pt, she was not hurt
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Roughly 6 hours after the shot I started feeling side effects which included; achy joints, low fever, mild headache, tired and run down like I was getting a cold. The symptoms laster through the night and into this morning when I woke up feeling a bit better. It's been 13 hours since the first side effects and at this point I feel run down but most of the other symptoms have subsided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Hyperventilation, Hypoaesthesia, Malaise
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: Patient alerted me that he was feeling unwell, he started hyperventilating, sweating, shaking, experiencing tingling and numbness throughout his body.  Patient was dizziness.  He received an epinephrine shot in which he then layed on the floor and started calming down.  Paramedics came and checked him out and found him to be alert and well.  Patient left store fully recoverd and consulted to go to emergency room if he had any symptoms of an analyphylatic reacction.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: Patient alerted me that he was feeling unwell, he started hyperventilating, sweating, shaking, experiencing tingling and numbness throughout his body.  Patient was dizziness.  He received an epinephrine shot in which he then layed on the floor and started calming down.  Paramedics came and checked him out and found him to be alert and well.  Patient left store fully recoverd and consulted to go to emergency room if he had any symptoms of an analyphylatic reacction.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and a 102 degree fever for at least 8 hours
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After receiving vaccine, client stated he feels dizzy.  Vital signs obtained.  BP 160/81, HR 80, O2 sat 93%. Client states he feels better.  Client discharged home by EMS.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Migraine
Clinical narrative: Moderate headache for two days following, then a full blown migraine in the early evening on second day after vaccination.  Sore arm muscle at vaccination site for a day and half.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Syncope
Clinical narrative: Syncope after getting vaccine. BP 95/60, P 100, O2sat 96%. Improved after 2 minutes but monitored for 20 minutes.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Headache, Myalgia
Clinical narrative: Janssen COVID-19 Vaccine EUA Six hours after I received the vaccine I began to feel full body muscle aches and shivers. I took 2 Advil. I went to bed at 9:30 p.m. and woke up at 11:30 p.m. feeling as though I had slept 8 hours because I had a 102 fever. My face was burning from the heat and I was shaking. I took two more Advil. About 30 minutes later I threw up. I waited 30 more minutes and threw up again. As a result, of having Addison's disease, I have an emergency steroid injection that I use during crises such as this. I took my shot and immediately began feeling slightly better. I was able to go back to bed and at some point the fever went down overnight. I am currently feeling weak and with no fever. I also have a slight headache.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: Janssen COVID-19 Vaccine EUA Six hours after I received the vaccine I began to feel full body muscle aches and shivers. I took 2 Advil. I went to bed at 9:30 p.m. and woke up at 11:30 p.m. feeling as though I had slept 8 hours because I had a 102 fever. My face was burning from the heat and I was shaking. I took two more Advil. About 30 minutes later I threw up. I waited 30 more minutes and threw up again. As a result, of having Addison's disease, I have an emergency steroid injection that I use during crises such as this. I took my shot and immediately began feeling slightly better. I was able to go back to bed and at some point the fever went down overnight. I am currently feeling weak and with no fever. I also have a slight headache.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: I have a really sore throat and pains in my lower calf muscles. I have been taking tylenol every 4 hours since yesterday
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Lethargy
Clinical narrative: 1:20am: woke up with full body chills and felt feverish. Temperature was 99.1 4:30am: woke up with full body chills. Temperature 101.7. full body aches. headache. 6:30am: took ibuprofen.  8:00am-4pm: fever went away. aches and headache remained.  12:00pm: took ibuprofen 4pm: diarrhea 7pm: achy and lethargic. took ibuprofen 8pm: went to bed. 6:00am: woke up sweaty. Felt 99% back to normal. Left arm still sore.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: 1:20am: woke up with full body chills and felt feverish. Temperature was 99.1 4:30am: woke up with full body chills. Temperature 101.7. full body aches. headache. 6:30am: took ibuprofen.  8:00am-4pm: fever went away. aches and headache remained.  12:00pm: took ibuprofen 4pm: diarrhea 7pm: achy and lethargic. took ibuprofen 8pm: went to bed. 6:00am: woke up sweaty. Felt 99% back to normal. Left arm still sore.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea- most of the day Vomiting- >6 times in 6 hours  Diarrhea- >2 times in 3 hours
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: On 2/25 he started having severe itching all over for the knees up. On Friday he had facial swelling and swelling with both hands and puffy fingers. Between his fingers he became very red and his face was red.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Days 1, 2 had chills, headache, aches.  Fine for Days 3, 4, 5, 6, Day 7 headache and chills returned
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Very sore shoulder (no other vaccines have done this to me) Stiff joints
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vital signs measurement
Clinical narrative: Pt. c/o itching to the left palm of hand which then progressed to generalized itching.  No rash noted on pt. skin.  Pt. seen and assessed by EMT and vital signs are BP 118/80, HR 65, O2 sat 98.  Pt. stated that no other symptom was felt.  Pt. observed scratching body.  Pt. advised to call MD or go to ER if symptoms worsen and cleared to go home by EMT.  Pt. verbalized understanding.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pancytopenia, Platelet count decreased
Clinical narrative: Weakness, headache, pancytopenia 89
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol use, Dizziness, Lethargy, Vomiting
Clinical narrative: Approximately 24 hours after receiving the second dose of the Moderna vaccine the patient consumed alcohol (3 alcoholic beverages over the course of 2.5 hours which is a typical consumption rate for the patient). The patient then experienced a sudden onset of vomiting and dizziness. Vomiting continued for approximately 12 hours. Lethargy was present for the following 36 hours. Symptoms then resolved on their own without treatment.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Syncope
Clinical narrative: Syncope and fell on her hands and knees. No head trauma. No other injuries. BP 110/77, 85, O2 sat 96%. She was observed for 35 minutes. She felt better and went home.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness and slight pain and hardness just below injection site.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the ears
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red  Circle under shot site, hot to touch , started itching few days before it subsided. Appeared maybe 2 days after shot and lasted a little over a week
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Mobility decreased, Nausea, Photophobia
Clinical narrative: Received shot at 7:15 in the evening on March 8th. When I woke up March 9th I had a basic headache.  Starting at around 1:30 on that headache worsened to debilitating, migraine like. I couldn?t get out of bad, I felt nauseated on and off. I couldn?t look at electronics and had a little bit of light sensitivity.  I slept as much as I could. The headache lasted all evening. When I woke up today, March 10th, the headache was almost gone and no nausea.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: leg cramp
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Muscles aches, fever to 102F, chills, sweats, severe headache.  6 days to resolve.