chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Gingival bleeding, Headache, Lethargy, Nephrolithiasis
Clinical narrative: Bleeding gums for hours, pain in his side that seems similar to a kidney stone, headache, lethargy.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Syncope, Vital signs measurement
Clinical narrative: Patient received vaccine and was asked to move to observation area.  Shortly after sitting down the patient came back to pharmacy counter and stated he was feeling dizzy.  Just as the pharmacist was telling him to sit back down he fainted and fell on the floor.  He recovered rather quickly (matter of seconds?) and tried to sit up right away.  Pharmacist asked him to stay on the floor for a moment, the store's first responder (MIC) was called over to pharmacy.  After a minute of sitting on floor the patient got up on his own accord and transferred to a nearby chair.  His BP was taken twice per emergency protocol of pharmacy.  Patient initially appeared calmmy and BP  was 132/81, pulse 44, respirations 18 at 12:25p.   BP was 142/89, pulse 48, respirations 16 at 12:35.  Patient was given both a water and a Gatorade while he was seated.  Patient stated he had not eaten anything yet for the day.  Patient was repeatedly offered medical services (i.e. "Do you want a medic? Do we need to call an ambulance?") The patient repeatedly refused any further medical treatment.  After further observation patient was able to stand, check out at the pharmacy and left the store on his own accord.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Sore arm, onset 13 hours after injection. Severe enough to wake me up. Took Arnica 200, improved gradually over 12 hours. Flu-like body aches. Onset 15 hours after injection. Mild intensity. Improved gradually over next 15 hours. Intense fatigue. Onset 15 hours. Slept approx 6 hours day following vaccine, plus slept 6 hours next night.  Improved gradually over next 15 hours. Red, blotchy rash on chest and red rash back (waist to neck) 2 days after vaccine. Plainly visible. Improved but still present today (day 3)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Sleep disorder
Clinical narrative: Sore arm, onset 13 hours after injection. Severe enough to wake me up. Took Arnica 200, improved gradually over 12 hours. Flu-like body aches. Onset 15 hours after injection. Mild intensity. Improved gradually over next 15 hours. Intense fatigue. Onset 15 hours. Slept approx 6 hours day following vaccine, plus slept 6 hours next night.  Improved gradually over next 15 hours. Red, blotchy rash on chest and red rash back (waist to neck) 2 days after vaccine. Plainly visible. Improved but still present today (day 3)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site, low fever, severe headache. Treated with Tylenol. Duration ongoing
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Dizziness, Dysgeusia
Clinical narrative: When mom got home at 7:30 pm on 4/12, her left arm was very sore, extremely dizzy, then diarrhea, nausea, and weakness.  On 4/13, she was still very dizzy and weak.  On 4/14, she was extremely nauseated and very weak.  Other symptoms include a metallic taste, blurred vision, hoarseness, and a dry hacky cough.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Nausea, Pain in extremity, Vision blurred
Clinical narrative: When mom got home at 7:30 pm on 4/12, her left arm was very sore, extremely dizzy, then diarrhea, nausea, and weakness.  On 4/13, she was still very dizzy and weak.  On 4/14, she was extremely nauseated and very weak.  Other symptoms include a metallic taste, blurred vision, hoarseness, and a dry hacky cough.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysphagia, Dyspnoea, Hypertension
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Medium, Additional Details: OSat: 92 Respiratory Rate: 22 Temperature: 97.5 F Blood Pressure: 135/93 Pulse 117
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperventilation, Tachycardia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Medium, Additional Details: OSat: 92 Respiratory Rate: 22 Temperature: 97.5 F Blood Pressure: 135/93 Pulse 117
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: I am very concerned about the lasting joint pain in areas I have never had pain since the first dose of Pfizer. We are three weeks out and my hips ache, knees, and ankles after shot. This all began after first injection. All my in depth bloodwork done 3 weeks prior was normal (no unusual inflammation markers or CRP).  The usual side effects of headache and fatigue only lasted 24 hours, but all the joint pain is ongoing and concerning. I am awaiting second dose as I can't afford for symptoms to get worse. I've contact my primary doctor and functional medicine doctor and they provided suggestions such as tylenol, coq 10 etc. but this continues 3 weeks post vaccine #1.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Muscle fatigue, Myalgia
Clinical narrative: Muscle fatigue and pain, exhaustion, low pulse ox, high resting heart rate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Swollen tongue
Clinical narrative: Red rash on chest and face, tingling feet, tongue swollen (patient said), child.  Drove home. Refused transportation to hospital.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Patient presented with seizure like symptoms for 15 seconds. The health hub concierge noticed and called myself over. He was out of it for maybe 15-20 seconds. I asked him questions to see if he was coherent. He was able to tell me where he was and his name. Patient stated he has history of vasovagal syncope so no EMS was required. BP taken at 101/59 on right arm. He waited an hour before leaving with his mother.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swelling came up on the left side of neck/collarbone. Noticed very early Monday morning, 03/29/21.  Today, 04/15/21, the swelling is almost gone.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Parosmia, SARS-CoV-2 test positive, Sneezing
Clinical narrative: 6 days after the administration of the first dose of the Moderna vaccine, I felt ok, but just had a stuffy nose and some sneezing. I have bad allergies so I didn't worry too much. This continued until 11 days after the dose. That was the day I noticed I was having difficulty smelling some things. Some things smelt normal, others I couldn't smell at all.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Woke up Sunday morning with extremely swollen lip. Made virtual doctors appointment with picture of lip.  They said get to ER immediately bc i was having an allergic reaction to my blood pressure medicine Lisinopril even though i have been on it for almost 20 years.   When i got to unspecified Hospital they started me on an IV but the swelling would not go down.  They said they had to admit me for the night to continue  steroid treatments.   The doctors were not sure if  it was related to the Moderna shot i had 8 days prior.  I went to my primary care doctor who put me on a different BP med but was very sure it was from the shot.  After one day at unspecified hospital all the swelling was down and i was released .
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Headache, Nausea
Clinical narrative: Severe headache pain on the first to third day  and the fourth day back of my head the left side pain dizziness, nauseou, chill and stomach pain
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe headache pain on the first to third day  and the fourth day back of my head the left side pain dizziness, nauseou, chill and stomach pain
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypersomnia, Pain, Pyrexia
Clinical narrative: Woke up at 12:30 am with 102 fever, chills, body aches and severe headache.  Slept most of day and symptoms resolved by 4pm on Sunday of that day.   Took Tylenol and drank gatorade to help symptoms.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Mild, Additional Details: patient reported sweating, but not feeling hot about 10 min post vaccination, no further action needed
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Menstruation irregular
Clinical narrative: Chills, body ache, arm immobility, brain fog, extreme fatigue for first 24 hours after. Then sweats fever and headache briefly on second day after. Now 3 days after 2nd shot I started my menstruation 6 days early.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: Chills, body ache, arm immobility, brain fog, extreme fatigue for first 24 hours after. Then sweats fever and headache briefly on second day after. Now 3 days after 2nd shot I started my menstruation 6 days early.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Chest discomfort, Chest pain, Cough
Clinical narrative: Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn,  nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours.   Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday.  Nausea and diarrhea on and off until Tuesday.  Fever until Sunday afternoon.  Pain in back rt side.  About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn,  nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours.   Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday.  Nausea and diarrhea on and off until Tuesday.  Fever until Sunday afternoon.  Pain in back rt side.  About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, Rash erythematous, Ultrasound scan
Clinical narrative: Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn,  nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours.   Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday.  Nausea and diarrhea on and off until Tuesday.  Fever until Sunday afternoon.  Pain in back rt side.  About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn,  nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours.   Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday.  Nausea and diarrhea on and off until Tuesday.  Fever until Sunday afternoon.  Pain in back rt side.  About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Confusional state, Dyspnoea, Rash
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Significant fatigue and diarrhea experienced the morning after receiving the second dose. This only lasted for ~10 hours. No fever or other symptoms. Felt fine that evening.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Respiratory tract congestion
Clinical narrative: congestion and cough
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Slight fever, chills, body aches, and very sore arm  (Second dose) that happened the next day after vaccine was given
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Headache, Myalgia
Clinical narrative: Headache, sore muscles, feeling hot and cold, tiredness
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hypersomnia, Impaired work ability
Clinical narrative: Experienced normal side effects within first 24 hours (fever 100.4, body aches, headache, fatigue). Those side effects went away within a day. However, 5 days after vaccination I awoke with dizziness and fatigue. The dizziness was strong enough that I was unable to work and spent the day sleeping. I contacted my doctor and went in for a visit the next Day. No cause for the dizziness and fatigue was determined, but up one further reflection it is possible that it was a vaccine side effect which is why I?m reporting it here. The dizziness and fatigue was better the next day and completely gone two days later.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Experienced normal side effects within first 24 hours (fever 100.4, body aches, headache, fatigue). Those side effects went away within a day. However, 5 days after vaccination I awoke with dizziness and fatigue. The dizziness was strong enough that I was unable to work and spent the day sleeping. I contacted my doctor and went in for a visit the next Day. No cause for the dizziness and fatigue was determined, but up one further reflection it is possible that it was a vaccine side effect which is why I?m reporting it here. The dizziness and fatigue was better the next day and completely gone two days later.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Feeling hot
Clinical narrative: Started feeling warm and had aches in joints. Don't think temperature went over 100. Stopped early Saturday afternoon (less than 24 hours).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Hypoaesthesia, Sleep disorder
Clinical narrative: Around 8pm the day I got my shot, i started feeling chills while putting kids to bed. I went to bed and around midnight started sweating profusely. I tossed and turned, couldnt sleep. At one point, I tried to get up and had numbness in both legs. I made it to the bathroom and back to bed. I stayed in bed the entire next day drinking liquids but no appetite. By Sunday evening, I started feeling better.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: Started period about 1 week early. Started with spotting then was very heavy. Period is extremely regular so this was abnormal for me.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Severe
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Gastrointestinal pain, Headache, Hepatic pain
Clinical narrative: Started developing symptoms similar to those when autoimmune hepatitis was diagnosed.  Throbbing liver pain, nausea and stomach and intestinal pain, severe muscle cramping, aching muscles pain, no appetite, headache
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Muscle spasms, Myalgia, Nausea, Pain
Clinical narrative: Started developing symptoms similar to those when autoimmune hepatitis was diagnosed.  Throbbing liver pain, nausea and stomach and intestinal pain, severe muscle cramping, aching muscles pain, no appetite, headache
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Severe headache ( 1st time in my life I took 3 Midols in 1 day )and severe hypertension, Blood Pressure reading reached 150/101  My face feel numbed and I was dizzy all day until yesterday (4/14/2021)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Malaise
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Severe, Additional Details: Patient received vaccine, came back after 10 minutes and said he didnt feel good. Sitting BP was 232/112. 6 minutes later it was 245/119. Patient stayed seated, 5 minutes later BP was 247-132 HR 84. Called 911 and EMS responded and brought patient out on stretcher. He remainder conscious the entire time.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood electrolytes normal, Cough, Erythema, Febrile neutropenia, Haematocrit decreased
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presents to oncology clinic with four days of fevers (maximum temperature 103 degrees F), dry cough, left arm erythema and swelling and tachycardic after vaccination. Admitted to unspecified hospital for management of neutropenic fevers.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Neutrophil count decreased, Pyrexia, Red blood cell count decreased, SARS-CoV-2 test negative
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presents to oncology clinic with four days of fevers (maximum temperature 103 degrees F), dry cough, left arm erythema and swelling and tachycardic after vaccination. Admitted to unspecified hospital for management of neutropenic fevers.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Tachycardia, White blood cell count decreased
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presents to oncology clinic with four days of fevers (maximum temperature 103 degrees F), dry cough, left arm erythema and swelling and tachycardic after vaccination. Admitted to unspecified hospital for management of neutropenic fevers.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy+woozy, couldn't driver/nauseous, Paramedics taking vital signs, Father coming to pick her up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nail bed bleeding, Pain in extremity, Paraesthesia
Clinical narrative: On 3/27/2020, the patient received the second dose of the Pfizer COVID vaccine.  About 3 hours later she started to develop paresthesias in both hands and fingers, as well as pain.  She continued with the same paresthesias and pains; in about a week, she developed  subungual  hemorrhages
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Clots Ongoing
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Fatigue, Headache
Clinical narrative: Sore arm with moderate pain, redness and swelling, tired, muscle pain, headache, shivering, fever, stomach pain, and nausea. Patient had side effects that prevented regular activities.  Symptoms have persisted past 2 to 3 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore arm with moderate pain, redness and swelling, tired, muscle pain, headache, shivering, fever, stomach pain, and nausea. Patient had side effects that prevented regular activities.  Symptoms have persisted past 2 to 3 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Sore arm with moderate pain, redness and swelling, tired, muscle pain, headache, shivering, fever, stomach pain, and nausea. Patient had side effects that prevented regular activities.  Symptoms have persisted past 2 to 3 days.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccine positive rechallenge
Clinical narrative: Chills and body aches for about 24 hours
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: palpitations; e/o "racing heart";  h/o "weight loss surgery & low K+ level yesterday in which she was seen by provider & repleted & EKG performed.    no real TX & time & emotional support.  Remained in observation for 30 mins. total time.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: "Excruciating"  headache the evening of and morning after vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Deformity, Induration
Clinical narrative: My arm is hard,  disfigured larger looks like a big muscle
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache lasted from 3/25/21 until 4/9/21
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Fatigue, Head discomfort, Injection site pain
Clinical narrative: Tuesday, 4/13/2021 1:30 PM ? Second shot administered. 4:00 PM ? Pain and heat at injection site. Stiffness through upper arm and extending into shoulder. 5:00 PM ? Extreme feeling of heaviness affects the whole body. Limbs Sitting up or holding a phone/iPad take considerable effort. Had to lay down for the rest of the evening. 7:00-8:00 PM ? Begin to feel feverish and achy. Sensitive skin, muscle pain, sometimes joint pain.  Wednesday, 4/14/2021 The ?heaviness? had abated by Wednesday morning, but the fever and aches continue for a solid 30-32 hours. Fever peaks and stays at 100 degrees Fahrenheit for a considerable time. Normal body temperature is around 97.5.  Thursday, 4/15/2021 2:00-4:00 AM - The fever breaks at some point in the early morning.  Aches begin to subside after the fever breaks. As of 8:00 AM, body temperature is 98.0 degrees. Occasional sweats occurring after fever breaks.  Treatment: Bed rest, drinking fluids (water, Pedialyte, etc.). Did not take Advil or any other pain relievers during this period.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Limb discomfort, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Tuesday, 4/13/2021 1:30 PM ? Second shot administered. 4:00 PM ? Pain and heat at injection site. Stiffness through upper arm and extending into shoulder. 5:00 PM ? Extreme feeling of heaviness affects the whole body. Limbs Sitting up or holding a phone/iPad take considerable effort. Had to lay down for the rest of the evening. 7:00-8:00 PM ? Begin to feel feverish and achy. Sensitive skin, muscle pain, sometimes joint pain.  Wednesday, 4/14/2021 The ?heaviness? had abated by Wednesday morning, but the fever and aches continue for a solid 30-32 hours. Fever peaks and stays at 100 degrees Fahrenheit for a considerable time. Normal body temperature is around 97.5.  Thursday, 4/15/2021 2:00-4:00 AM - The fever breaks at some point in the early morning.  Aches begin to subside after the fever breaks. As of 8:00 AM, body temperature is 98.0 degrees. Occasional sweats occurring after fever breaks.  Treatment: Bed rest, drinking fluids (water, Pedialyte, etc.). Did not take Advil or any other pain relievers during this period.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin
Clinical narrative: Tuesday, 4/13/2021 1:30 PM ? Second shot administered. 4:00 PM ? Pain and heat at injection site. Stiffness through upper arm and extending into shoulder. 5:00 PM ? Extreme feeling of heaviness affects the whole body. Limbs Sitting up or holding a phone/iPad take considerable effort. Had to lay down for the rest of the evening. 7:00-8:00 PM ? Begin to feel feverish and achy. Sensitive skin, muscle pain, sometimes joint pain.  Wednesday, 4/14/2021 The ?heaviness? had abated by Wednesday morning, but the fever and aches continue for a solid 30-32 hours. Fever peaks and stays at 100 degrees Fahrenheit for a considerable time. Normal body temperature is around 97.5.  Thursday, 4/15/2021 2:00-4:00 AM - The fever breaks at some point in the early morning.  Aches begin to subside after the fever breaks. As of 8:00 AM, body temperature is 98.0 degrees. Occasional sweats occurring after fever breaks.  Treatment: Bed rest, drinking fluids (water, Pedialyte, etc.). Did not take Advil or any other pain relievers during this period.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Acute stress disorder, Herpes zoster, Paraesthesia, Sensitive skin, Skin irritation
Clinical narrative: Janssen COVID-19 Vaccine EUA  My skin (on top and going deeper) felt tingly, prickly, sensitive all over my abdomen. This began the day after the vaccine (4/9). By the afternoon of 4/12, it was feeling more intense. That's when I realized I had a skin irritation on my lower back and stomach. I went to my doctor and it was diagnosed as shingles.   My doctor said it was not caused by the vaccine but a stress reaction to the vaccine + normal stress in my life.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Fatigue, Hypersomnia, Injection site erythema
Clinical narrative: my daughter, 30 year old, on disability with POTS, MCAS, EDS, dysautonomia, received the JJ COVID vaccine at 1:30 PM on 4/9/2021.. She started vomiting 20 minutes after the vaccine was administered and the pharmacist said it was because she was anxious and has not eaten much. We went home, she was very tired and slept most of the afternoon. At 6 PM she started vomiting again. It continued till 10:30 PM when she could not drink anything. We went to the hospital where she exhibited what looked like a seizure in the waiting room and was admitted to the hospital for observation. Discharged 4/10/2021 evening. 4/11/2021 exhibited restless leg syndrome, could not sit, lay down, whole body aches. 4/12/2021 extremely sore arm, could not move it without pain. Area of injection looks read but not hot and no swelling.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Platelet count normal, Restless legs syndrome, Seizure like phenomena
Clinical narrative: my daughter, 30 year old, on disability with POTS, MCAS, EDS, dysautonomia, received the JJ COVID vaccine at 1:30 PM on 4/9/2021.. She started vomiting 20 minutes after the vaccine was administered and the pharmacist said it was because she was anxious and has not eaten much. We went home, she was very tired and slept most of the afternoon. At 6 PM she started vomiting again. It continued till 10:30 PM when she could not drink anything. We went to the hospital where she exhibited what looked like a seizure in the waiting room and was admitted to the hospital for observation. Discharged 4/10/2021 evening. 4/11/2021 exhibited restless leg syndrome, could not sit, lay down, whole body aches. 4/12/2021 extremely sore arm, could not move it without pain. Area of injection looks read but not hot and no swelling.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: my daughter, 30 year old, on disability with POTS, MCAS, EDS, dysautonomia, received the JJ COVID vaccine at 1:30 PM on 4/9/2021.. She started vomiting 20 minutes after the vaccine was administered and the pharmacist said it was because she was anxious and has not eaten much. We went home, she was very tired and slept most of the afternoon. At 6 PM she started vomiting again. It continued till 10:30 PM when she could not drink anything. We went to the hospital where she exhibited what looked like a seizure in the waiting room and was admitted to the hospital for observation. Discharged 4/10/2021 evening. 4/11/2021 exhibited restless leg syndrome, could not sit, lay down, whole body aches. 4/12/2021 extremely sore arm, could not move it without pain. Area of injection looks read but not hot and no swelling.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Limb injury, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient called to let the pharmacy knows that he has been feeling a lot of pain especially at the shoulder area since his shot on 4/5. He has been taking ibuprofen 800mg and it did not help with thre pain. He has a hard time putting his arm against the balcony at home. He reported that his symptoms are not getting better. I advise the patient to seek medical help from his primary doctor to assess his shoulder pain.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: 4/8 an hour after shot - fatigue. A few hours later arm pain. 4/9 arm pain 4/10 - 4/11 no pain or symptoms 4/12 - 4/15 fatigue, nausea, and mild constant headache
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Fatigue, Flushing
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Tremor, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Feeling abnormal, Immediate post-injection reaction, Paraesthesia oral, Rash
Clinical narrative: reported feeling "foggy" immediately following vaccination about 10 mins. in observation lot.  told observer she was having tingling lips & had broken out in a rash with increased " foggy feeling".  seen at 11:35- full facial hives & neck & chest hives with associated felling of throat tightening & dysphagia.  Given 0.3ml EPI via auto injector R. thight.  EMS activated & pt. monitored.   no contributory medical history.  only med PRN zyrtec
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: reported feeling "foggy" immediately following vaccination about 10 mins. in observation lot.  told observer she was having tingling lips & had broken out in a rash with increased " foggy feeling".  seen at 11:35- full facial hives & neck & chest hives with associated felling of throat tightening & dysphagia.  Given 0.3ml EPI via auto injector R. thight.  EMS activated & pt. monitored.   no contributory medical history.  only med PRN zyrtec
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Chills and fever (~101.0F) at initial onset which lasted approximately 8 hours.  Fatigue which lasted ~24 hours.  Nausea which lasted ~8 hours.  All resolved 48 hours after injection.
Sex: F
Vaccine: HPV9
Symptoms: Malaise
Clinical narrative: her little sister got GARDASIL 9 and felt a little sick after the immunization; This spontaneous report was received from other referring to a female patient of unknown age. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, batch/lot# and expiration date were unknown) for prophylaxis.   On an unknown date, the patient felt a little sick after the immunization. It was unknown if medical attention was sought. It was unknown if any treatment was given to the patient. It was unknown if any lab diagnostic/study was performed. The outcome of the event was unknown. The causality assessment was not provided.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: The patient did not experience any other adverse event; 6 month old patient received first dose of ROT ATEQ; This spontaneous report was received from a nurse via company representative and refers to a 6 (also reported as 7) month old female patient. The patient did not have any underlying health issues and was a full-term infant. Historical vaccine included birth dose of the hepatitis B vaccine (manufacturer unknown).      On 24-MAR-2021, the patient was vaccinated with a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # 1742460, expiration date 16-NOV-2021, 1 dosage form, for prophylaxis.    Concomitant therapies included pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX). The patient did not experience any other adverse event.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no signs or symptoms reported; temperature excursion on VAQTA/VAQTA was administered to three patients; This spontaneous report was received from a medical assistant 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 02-MAR-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA), dose: 0.5 milliliter, lot# T013546, expiry date: 28-OCT-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.3 degrees Fahrenheit for 20 minutes. There were no previous excursions related. Data logger was not involved. No adverse events were reported.   This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA007895: US-009507513-2103USA007896:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no signs or symptoms reported; temperature excursion on VAQTA/VAQTA was administered to three patients; This spontaneous report was received from a medical assistant 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 02-MAR-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA), dose: 0.5 milliliter, lot# T013546, expiry date: 28-OCT-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.3 degrees Fahrenheit for 20 minutes. There were no previous excursions related. Data logger was not involved. No adverse events were reported.   This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA007597: US-009507513-2103USA007896:
Sex: U
Vaccine: HEPA
Symptoms: Product administration error, Product storage error
Clinical narrative: no signs or symptoms reported; temperature excursion on VAQTA/VAQTA was administered to three patients; This spontaneous report was received from a medical assistant 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 02-MAR-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA), dose: 0.5 milliliter, lot# T013546, expiry date: 28-OCT-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.3 degrees Fahrenheit for 20 minutes. There were no previous excursions related. Data logger was not involved. No adverse events were reported.   This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA007895: US-009507513-2103USA007597:
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Blood test, Stomatitis, Wrong product administered
Clinical narrative: After the first shot a sore formed within the patient's mouth.; She thought the doctor's office was administering MMR 2, because her son only needed protection from measles, mumps and rubella; he didn't need protection from Varicella as well.; This spontaneous report was received from the patient's mother referring to a 14 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were reported as none.  On 14-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection into arm (0.5 ml, strength and route were not reported, lot# T005404, expiration date not reported, but upon internal validation established as 12-AUG-2021) to prevent measles, mumps or rubella, despite measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) not being approved for patients over the age of 12.  The reporter did not know that the patient was getting measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The reporter thought the doctor's office was administering measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), because the patient only needed protection from measles, mumps and rubella; he didn't need protection from varicella as well (wrong vaccine administered).   On 14-OCT-2020, after the first shot, a sore formed within the patient's mouth (sores mouth). On an unknown date, the patient did a blood work (result was not provided). The outcome of the event was reported as recovered on 21-OCT-2020. No treatment was given. The patient did not seek medical attention.  The relationship between sores mouth and both vaccines was not reported.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Itchy hands; red, itchy, puffy hands; red, itchy, puffy hands; This spontaneous report was received from a registered nurse referring to a 36 year old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies or concurrent conditions. Concomitant therapies included diphenhydramine hydrochloride (BENADRYL).     On 03-FEB-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).     On 04-FEB-2021 at 3:00 upon awakening, the patient experienced red, itchy, puffy hands (pruritus, peripheral swelling and erythema). Following event time, patient was administered diphenhydramine hydrochloride (BENADRYL) as treatment and at that time, only pruritus had resolved on an unspecified date in 2021; patient's hands had remained red and puffy "for a couple of days" and then, after few days, on an unspecified date in 2021, peripheral swelling and erythema also resolved.   Patient's next hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose was scheduled for 05-APR-2021, as confirmed by Nurse at call time.       The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was unknown.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: The patient did not require any medical attention and was not harmed in any way.; needle broke away from the base; poor quality device used; device breakage; This spontaneous report was received from a consumer via Regulatory Affairs and refers to a 13-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-FEB-2021, the patient was being vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (PFS), lot # 1687291, expiration date 11-SEP-2022 (strength, dose, anatomical location and route of administration were not reported) as prophylaxis. The customer reported that as they were using the product, the needle broke away from the base (needle issue, device breakage, poor quality device used) and the product broke into 2 or more pieces. A photo was provided by the customer and the product was available for evaluation. The patient did not require any medical attention and was not harmed in any way (no adverse event). The outcome of the events was unknown.  Causality was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other adverse events; Expired dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. The patient's concomitant therapies included sterile diluent.   On 01-APR-202,1 the patient was vaccinated with an expired dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S021620, expiration date 09-JAN-2021, for prophylaxis.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; inadvertently administered after its labeled expiry date; This spontaneous report was received from a pharmacist and refers to a younger aged male.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 31-MAR-2021, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rha) (M-M-R II) lot # R036581, expiration date 17-DEC-2020 (dose, route, vaccination site were not provided),  for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE/PQC reported.; temperature excursion on PROQUAD; This spontaneous report was received from an other referring to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On 05-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status of rHA, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # T013537, expiration date 17-OCT-2021) for prophylaxis. The vaccine administered experienced temperature excursions of -6.7 degrees Celsius for 2 hours as recorded by a data logger. There was no previous temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Cognitive disorder
Clinical narrative: stroke; cognitive difficulties; Information has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age at the time of the events and unknown gender. The patient's past medical history, concurrent conditions and concomitant therapies were not reported. On or about 21-OCT-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (strength, lot #, expiration date, dosage, route of administration, and anatomical location were not reported), at a pharmacy, for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a stroke (cerebrovascular accident) and had continued to suffer from cognitive difficulties (cognitive disorder) as a result. As a result of those symptoms, the patient was seen and treated by medical providers in and at the time of the report was still under their care. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The lawyer reported the cerebrovascular accident and cognitive disorder as disabling events.  Upon internal review, the event cerebrovascular accident was considered to be medically significant.