chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pulmonary embolism, Thrombosis, Ultrasound Doppler
Clinical narrative: burning sensation in the lung; had labored breathing,they found several clots in right leg and lungs; It was shiny and hard and calf blewup twice the size,they found several clots in right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (had labored breathing,they found several clots in right leg and lungs) and THROMBOSIS (It was shiny and hard and calf blewup twice the size,they found several clots in right leg) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Clot blood (Family history of clots; her father and his sister had clots after surgery).  Concurrent medical conditions included Burning sensation.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Apr-2021, the patient experienced PULMONARY EMBOLISM (had labored breathing,they found several clots in right leg and lungs) (seriousness criterion medically significant) and THROMBOSIS (It was shiny and hard and calf blewup twice the size,they found several clots in right leg) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (burning sensation in the lung). At the time of the report, PULMONARY EMBOLISM (had labored breathing,they found several clots in right leg and lungs), THROMBOSIS (It was shiny and hard and calf blewup twice the size,they found several clots in right leg) and BURNING SENSATION (burning sensation in the lung) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound Doppler: several clots in right leg and lungs (abnormal) several clots in right leg and lungs.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported.  Patient was taken to the ER (emergency room).  The physician  suspected blood clots and treatment included was blood thinner.  Patient reported that "patient got ultrasound done on Monday, and they found several clots in right leg and lungs".; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: diagnosis of polymyalgia rheumatica; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (diagnosis of polymyalgia rheumatica) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event. Previously administered products included for an unreported indication: NABUMETONE since an unknown date. Concomitant products included NABUMETONE for Fibromyalgia.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (unknown route) 2 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (diagnosis of polymyalgia rheumatica) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (diagnosis of polymyalgia rheumatica) outcome was unknown. Not Provided          It was reported that concomitant drugs were not provided because they have been taking it for many years and it does not have to do with what Moderna vaccine did to them..  Treatment medication included Nabunetone for fibromyalgia and to treat also this diagnose. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-072076 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of polymyalgia rheumatica, a causal relationship cannot be excluded. Underlying condition may have been contributory.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Myalgia, SARS-CoV-2 test
Clinical narrative: Atrial fibrillation; Tested positive for COVID; Minor Aches like he was getting a cold; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) and COVID-19 (Tested positive for COVID) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (Minor Aches like he was getting a cold). On 25-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion hospitalization) and COVID-19 (Tested positive for COVID) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), COVID-19 (Tested positive for COVID) and MYALGIA (Minor Aches like he was getting a cold) outcome was unknown.   She said they had been very careful, but had met with some friends and 2 of their friends also tested positive.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      The day after he received the vaccine he felt minor aches, like he was coming down with a cold. On that Thursday he went into a fib. She took him to the ER and it took several hours to regulate his heart rate. While making arrangement to transfer him to a new hospital they did a COVID test and it was positive. They were shocked as he had not been showing any symptoms. He spent the night in the hospital.  Very limited information regarding the even tof A fib has been provided at this time.  Further information has been requested. However the event of Covid 19 and myalgia is unlikely related to vaccine. Covid 19 is  a confounding factor for the event of myalgia and base of the available information, the vaccine is not known cause of Covid 19.; Sender's Comments: Very limited information regarding the even tof A fib has been provided at this time.  Further information has been requested. However the event of Covid 19 and myalgia is unlikely related to vaccine. Covid 19 is  a confounding factor for the event of myalgia and base of the available information, the vaccine is not known cause of Covid 19.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Small stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Small stroke) in a  patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Small stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Small stroke) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding this event has been provided at this time. No follow up is possible.   This case was linked to MOD21-068562, MOD21-068587, MOD21-068589, MOD21-072303, MOD21-072304 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. No follow up is possible. MOD21-068562:same reporter MOD21-068587:same reporter MOD21-068589:same reporter MOD21-072303:same reporter MOD21-072304:same reporter
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Skin warm
Clinical narrative: I have been experiencing the subjective sensation internally of heat on the top of my ears and scalp. My ears also feel warm to the touch compared to my fingers.  Sometimes it makes me feel like the room is hot when I know it is not.  This has been happening on and off for 6 weeks since shortly after my first shot.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Hypoaesthesia, Limb discomfort, Pain
Clinical narrative: Played tennis on Sun 4/11 (entire left leg felt numb; didn't fully support my weight)  Played tennis on Tue 4/13 (had diarrhea beforehand; left calf throbbed and then "popped"; had to stop immediately)  Overnight Tue/Wed upset stomach
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: About 6 hours later, started to developed major chills,  body aches, headache and fever. The headache was intolerable. Tylenol and Motrin helped slightly. Felt better around the 24 hour mark and almost back to normal at 48 hours.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: I had no reaction during my wait time. But 4 1/2 hrs. later, I had a large golf ball sized bump, redness hot, hives and very itchy with hives on vaccine site. That evening, I had fever of 100 & vomiting. Next morning, still had fever & vomiting & arm was still red, hot, itchy and now the size of a peach. I took Benadryl pill and my prednisone for next 2 days. Fever & vomiting went away.  Hives on arm have gone away with swelling, but now on day six there is still itching and redness, even after intravenous Benadryl at my infusion treatment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pyrexia, Vomiting
Clinical narrative: I had no reaction during my wait time. But 4 1/2 hrs. later, I had a large golf ball sized bump, redness hot, hives and very itchy with hives on vaccine site. That evening, I had fever of 100 & vomiting. Next morning, still had fever & vomiting & arm was still red, hot, itchy and now the size of a peach. I took Benadryl pill and my prednisone for next 2 days. Fever & vomiting went away.  Hives on arm have gone away with swelling, but now on day six there is still itching and redness, even after intravenous Benadryl at my infusion treatment.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Severe Headache lasted 5 to 6 Days Severe Dizziness
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: At site location ; COVID19 Vaccination, 1st shot light headache for a day. second shot symptoms of mild headache for 2-3 days, right arm sore for a few days, both feets swollen with red rashes top of both foots. (right top foot darker rash). Still have swelling on both foot.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: Pt received her 1st Moderna covid 19 vaccination on 3/12/21. She developed sudden Left lower extremity swelling on 3/17 which progressed to her hospitalization for a left lower extremity DVT on 4/6/21. she was placed on eliquiss and eventually discharged home.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash, Rash macular, Rash pruritic
Clinical narrative: I developed a moderate headache 3-4 hours after receiving the vaccine that became more painful over time. At 8 PM, I developed a rash on the left side of my face, neck and chest that lasted through the night and into the morning (about 12 hours). The rash did not look like hives, but it was itchy and blotchy red patches. I also spiked a 101 degree fever that lasted until the morning (about 12 hours).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: My left arm has been numb and tingly since the vaccine was administered.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Dyspnoea, Headache, Pulmonary pain
Clinical narrative: Headache, couldn?t breathe, lung pain, chills, fever, went to local emergency room
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, couldn?t breathe, lung pain, chills, fever, went to local emergency room
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Day 1--Pain/ache in LT calf muscle a few hours after shot.  Lasted for at least 8-12 hrs.  Very tired  Day2-Day3--Muscles in both legs ached.   Diarrhea lasted for several days
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I started menstruating on 4/11/2021, which was about 10 days early.  I have had regular menstruation for decades until this occurrence.  This was not a side effect disclosed to me when I received the vaccine, but I have heard many other reports of this anecdotally.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fatigue, Headache, Muscle pain, joint pain, Nausea  for two days.   Stayed home and rested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on arms, legs, hands, feet, face.   Prednisone  tablets and shot HYDROCYCLIN Benedryl Claritin
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cholelithiasis, Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: admitted to hospital on 3/25/21 for Cholelithiasis and during the workups had an Ultrasound - VL Lower Ext Veenous Duplex Bilateral study on 3/26/21.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Migraine, Vital signs measurement
Clinical narrative: Regular Migraine Headache B/P 150/110, HR 60, O2Sat 95% Pt. left at 9:10am stat that he was feeling better, refused second B/P saying that , "It's okay."
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Catheterisation cardiac, Heart rate increased
Clinical narrative: Extremely high heart rate that lasted for more then 8hours
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Gait disturbance, Hyperhidrosis, Loss of consciousness
Clinical narrative: I woke up in a very heavy sweat and got up to use the bathroom. I felt unsteady. After washing my hands, I turned to the towel and vaguely remember falling to the floor. When I came to, I was too weak to get up. I laid there for 5 minutes before struggling to sit. After some time I was able to weakly return to bed and drank some rehydration tablets. My best guess was I had been drinking water but not replenishing my electrolytes.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Moderate Anaphylaxis. Treated with Epinephrine, Diphenhydramine and Solumedrol. Symptoms mostly resolved within 30 minutes and stable for 4 hours.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Epistaxis, Mucosal disorder, Secretion discharge
Clinical narrative: rough, unusual cough, green/yellow solid mucus clumps being coughed up or expelled when blowing nose, bleeding when blowing nose (unusual for this time of year)
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Rash, Swelling face, Urticaria
Clinical narrative: Face, lip, & throat swelled. Rash, and hives.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chills, Feeling cold, Hypoaesthesia, Paraesthesia
Clinical narrative: After I received my first dose within 5 minutes I lost feeling in both of my arms and my legs (similar feeling of when your arm falls "asleep"...it was a tingling feeling).    Then is started to go to my face a little bit.      10 minutes after my teeth started chattering and I started to get cold.  Followed by severe shaking which lasted a few hours.   Required me to go to the ER or evaluation.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urinary tract infection
Clinical narrative: After I received my first dose within 5 minutes I lost feeling in both of my arms and my legs (similar feeling of when your arm falls "asleep"...it was a tingling feeling).    Then is started to go to my face a little bit.      10 minutes after my teeth started chattering and I started to get cold.  Followed by severe shaking which lasted a few hours.   Required me to go to the ER or evaluation.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gastrointestinal haemorrhage, Haemoglobin decreased, Helicobacter test
Clinical narrative: Patient active-duty military on deployment at time of vaccination. Patient to return to later this week. Dr. and I remains on deployment and are best reached via e-mail or above phone number. 34 y/o active-duty male received the Jannsen COVID 19 vaccination on 29-Mar-2021. He describes expected symptoms of fatigue and body aches overnight, but reports development of melena the next morning, 30-Mar. On 31-Mar-2021, he developed nausea/vomiting and persistent diarrhea/ melena. He presented for care after an episode of syncope with extreme pallor and hypotension (BP 70s/40s). Hypotension and pallor resolved with 2L NS bolus and patient felt well and was dispositioned to quarters without further workup. On the night of 01-Apr, patient had a recurrent episode of syncope with recurrent hypotension. He was transferred to the ED and found to have a Hgb 5.0 secondary to GI bleeding due x3 peptic ulcers in different stages of healing. He received x4 units PRBCs and started on a proton-pump inhibitor. He continues omeprazole and iron supplementation. Hgb is now stable at 11.6. H. pylori pending. He will follow-up with GI physician. Of note, patient has had a voluntary weight loss of 30 pounds over the past x3 months. He has aggressive supplement use as above and reports exercising twice daily.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Melaena, Nausea, Packed red blood cell transfusion, Pain
Clinical narrative: Patient active-duty military on deployment at time of vaccination. Patient to return to later this week. Dr. and I remains on deployment and are best reached via e-mail or above phone number. 34 y/o active-duty male received the Jannsen COVID 19 vaccination on 29-Mar-2021. He describes expected symptoms of fatigue and body aches overnight, but reports development of melena the next morning, 30-Mar. On 31-Mar-2021, he developed nausea/vomiting and persistent diarrhea/ melena. He presented for care after an episode of syncope with extreme pallor and hypotension (BP 70s/40s). Hypotension and pallor resolved with 2L NS bolus and patient felt well and was dispositioned to quarters without further workup. On the night of 01-Apr, patient had a recurrent episode of syncope with recurrent hypotension. He was transferred to the ED and found to have a Hgb 5.0 secondary to GI bleeding due x3 peptic ulcers in different stages of healing. He received x4 units PRBCs and started on a proton-pump inhibitor. He continues omeprazole and iron supplementation. Hgb is now stable at 11.6. H. pylori pending. He will follow-up with GI physician. Of note, patient has had a voluntary weight loss of 30 pounds over the past x3 months. He has aggressive supplement use as above and reports exercising twice daily.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Peptic ulcer, Syncope, Vomiting, Weight decreased
Clinical narrative: Patient active-duty military on deployment at time of vaccination. Patient to return to later this week. Dr. and I remains on deployment and are best reached via e-mail or above phone number. 34 y/o active-duty male received the Jannsen COVID 19 vaccination on 29-Mar-2021. He describes expected symptoms of fatigue and body aches overnight, but reports development of melena the next morning, 30-Mar. On 31-Mar-2021, he developed nausea/vomiting and persistent diarrhea/ melena. He presented for care after an episode of syncope with extreme pallor and hypotension (BP 70s/40s). Hypotension and pallor resolved with 2L NS bolus and patient felt well and was dispositioned to quarters without further workup. On the night of 01-Apr, patient had a recurrent episode of syncope with recurrent hypotension. He was transferred to the ED and found to have a Hgb 5.0 secondary to GI bleeding due x3 peptic ulcers in different stages of healing. He received x4 units PRBCs and started on a proton-pump inhibitor. He continues omeprazole and iron supplementation. Hgb is now stable at 11.6. H. pylori pending. He will follow-up with GI physician. Of note, patient has had a voluntary weight loss of 30 pounds over the past x3 months. He has aggressive supplement use as above and reports exercising twice daily.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head injury, Nausea, Pain
Clinical narrative: Janssen COVID-19 Vaccine EUA  The morning after getting the vaccine I woke up feeling very tired and sore/achey all over. I got to work (I lifeguard at the pool on campus) at around 6:15am and helped get the pool set up. When I sat down to try to do homework I started feeling very dizzy and nauseous. The pool deck is very hot, so I decided to try to go into the pool office where it would be cooler. I remember walking through the door and into the office, and then laying down next to the trash can because I thought I might be sick. One of my coworkers brought me some water and Goldfish, and I layed on the office floor for the rest of my 45 minute shift. Afterwards, when I was looking for my laptop, my other coworker said that when I had tried to go through the door into the pool office I had run into the door (I later got a small lump on my head from this) and that I had dropped my latptop. I do not remember either of these happening, so I believe that I blacked out for a moment, and it was likely hitting my head on the door that woke me up. A small scratch and some mild pain in my foot leads me to believe I dropped the laptop partially, but not completely, on my foot. I felt very tired for the rest of the day, and a little dizzy up until about mid-afternoon. I spent most of the day in bed sleeping. Waking up the next morning I felt completely fine, and was able to go about all of my normal activities with no side effects at all.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Janssen COVID-19 Vaccine EUA  The morning after getting the vaccine I woke up feeling very tired and sore/achey all over. I got to work (I lifeguard at the pool on campus) at around 6:15am and helped get the pool set up. When I sat down to try to do homework I started feeling very dizzy and nauseous. The pool deck is very hot, so I decided to try to go into the pool office where it would be cooler. I remember walking through the door and into the office, and then laying down next to the trash can because I thought I might be sick. One of my coworkers brought me some water and Goldfish, and I layed on the office floor for the rest of my 45 minute shift. Afterwards, when I was looking for my laptop, my other coworker said that when I had tried to go through the door into the pool office I had run into the door (I later got a small lump on my head from this) and that I had dropped my latptop. I do not remember either of these happening, so I believe that I blacked out for a moment, and it was likely hitting my head on the door that woke me up. A small scratch and some mild pain in my foot leads me to believe I dropped the laptop partially, but not completely, on my foot. I felt very tired for the rest of the day, and a little dizzy up until about mid-afternoon. I spent most of the day in bed sleeping. Waking up the next morning I felt completely fine, and was able to go about all of my normal activities with no side effects at all.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Diluent Administered Instead of Vaccine
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Okay left voicemail with cdc and wrote this email  I?m not sure how to report symptoms I had after taking the jannsen vaccine March 6. Because of the new reports I thought it may be helpful.  To begin in late nov 2020 my roommate was confirmed covid.  I was exposed tremendously and never tested because if I did not get it from him, I was immune.  He was very ill.  He talked of getting head pains as well.  I got sick for a weekend but not super ill.  Tired, headache and head pains in one spot.   After my vaccine I felt the same illness but ran a fever with the shot.  My main recognition was I had the exact same head pains, same exact spot I had when I?m sure I had Covid. 1 unusual symptom I had after the shot was I felt like I had a 4? metal plate wrapped around my arm where I got the shot for a half day.   Hope this helps.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Intermenstrual bleeding, Myalgia, Oropharyngeal pain
Clinical narrative: sore throat started at 4:00 pm, followed by severe chills and fever of over 101. Fever lasted for 24 hours. Muscle aches, extreme tiredness lasted for 5 days. spotting of period began 72 hours after vaccine and lasted 5 days. I have an iud and don?t typically spot or have menstrual flow.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore throat started at 4:00 pm, followed by severe chills and fever of over 101. Fever lasted for 24 hours. Muscle aches, extreme tiredness lasted for 5 days. spotting of period began 72 hours after vaccine and lasted 5 days. I have an iud and don?t typically spot or have menstrual flow.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: sore throat fatigue feels like I am coming down with a cold
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Condition aggravated, Electrocardiogram normal, Feeling abnormal
Clinical narrative: Severe headache woke me up in the night after vaccine -resolved after putting ice pack on neck and head, night 2 woke again in the night with severe headache repeated ice pack felt better but I felt like something was wrong so made apt with my PCP that morning.  BP was very high, was shaky and had low grade pain in back neck/ spine.  BP slowly came down.  Day 3 had 2 episodes of chest pain in am  had an ekg later that day and it came out ok. No events detected.  Going into week after vaccine (days 5-8) ongoing pain mid back/ spine and developed a cold sore ( had not had one in over a year) 4/12 woke with   Head and neck pain but not as severe as first couple days. Still don?t feel ?quite right? but functioning ok.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Neck pain, Nervousness, Oral herpes
Clinical narrative: Severe headache woke me up in the night after vaccine -resolved after putting ice pack on neck and head, night 2 woke again in the night with severe headache repeated ice pack felt better but I felt like something was wrong so made apt with my PCP that morning.  BP was very high, was shaky and had low grade pain in back neck/ spine.  BP slowly came down.  Day 3 had 2 episodes of chest pain in am  had an ekg later that day and it came out ok. No events detected.  Going into week after vaccine (days 5-8) ongoing pain mid back/ spine and developed a cold sore ( had not had one in over a year) 4/12 woke with   Head and neck pain but not as severe as first couple days. Still don?t feel ?quite right? but functioning ok.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Spinal pain
Clinical narrative: Severe headache woke me up in the night after vaccine -resolved after putting ice pack on neck and head, night 2 woke again in the night with severe headache repeated ice pack felt better but I felt like something was wrong so made apt with my PCP that morning.  BP was very high, was shaky and had low grade pain in back neck/ spine.  BP slowly came down.  Day 3 had 2 episodes of chest pain in am  had an ekg later that day and it came out ok. No events detected.  Going into week after vaccine (days 5-8) ongoing pain mid back/ spine and developed a cold sore ( had not had one in over a year) 4/12 woke with   Head and neck pain but not as severe as first couple days. Still don?t feel ?quite right? but functioning ok.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccines given at local college students. this person was not 18, he was 17
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: patient called said pain from vaccine hurts badly had to go to doctor and now see physcial therapist; claims was given too high on arm
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen / painful lymph nodes in both armpits
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Chills started around 9pm the evening of the vaccine.  uncontrollable shivering until around 2am when the fever hit. Headache, body aches and  103 temperature when taken at 3:30 am.  took Tylenol and got the sweats around 6am.  Continued  the next full day not feeling well - headache, body aches and low grade fever.  went to bed on the night of the 13th with a 101 fever.  sweating throughout the night.  woke on the 14th feeling much better.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swollen injection site on the left upper arm after one week. It is slightly sore.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Face injury, Fall, Loss of consciousness, Seizure
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: patient passed out and fell over and hit the floor face forward. bruised face and chipped tooth.911 was called and patient was taken to er. Not sure on final outcome. Called husband to check on patient and have not received a call back. will call again.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tooth fracture, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: patient passed out and fell over and hit the floor face forward. bruised face and chipped tooth.911 was called and patient was taken to er. Not sure on final outcome. Called husband to check on patient and have not received a call back. will call again.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pt rec'd vaccination to LUE on 4.9.21. Pt denies any trauma to LUE. Pt reports L wrist/hand pain, swelling, numbing, burning, tingling that started 4.13.2021 (Friday at around 1700 hrs). In our ED now, awaiting to be seen by our Hospitalist for possible admission to the hospital.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Pt rec'd vaccination to LUE on 4.9.21. Pt denies any trauma to LUE. Pt reports L wrist/hand pain, swelling, numbing, burning, tingling that started 4.13.2021 (Friday at around 1700 hrs). In our ED now, awaiting to be seen by our Hospitalist for possible admission to the hospital.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium, Additional Details: Pt has experience some lymph node swelling 3 weeks after the first dose. She experience it in her left axillary.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash of face
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Injection site bruising, Pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Additional Details: Patient presented to pharmacy with a large bruise (about 4 inches diameter) on the left arm at injection site. Patient reported no initial discomfort at time of vaccination, but the following day noticed the bruising in addition to mild flu-like symptoms of body ache, headache, fatigue, and fever.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Medium, Additional Details: Patient presented to pharmacy with a large bruise (about 4 inches diameter) on the left arm at injection site. Patient reported no initial discomfort at time of vaccination, but the following day noticed the bruising in addition to mild flu-like symptoms of body ache, headache, fatigue, and fever.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash, Rash pruritic, Swelling, Wheezing
Clinical narrative: 55 yo F reported rash with 2-3 cm wheel that first appeared 2-4 hours after 1st dose of Pfizer COVID vaccine.  Rash first appeared on L palm, then right palm, then L foot.  Rash cleared in approximately 1 week.  She endorsed mild pruritis without dyspnea, swelling, wheezing.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache; body ache; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of headache in an adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were unknown.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the shot a day before date of reporting.  The reporter asked was it OK to take aspirin or Tylenol for headache, body ache.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: I had " severe " allergic reaction to second dose of Shingrix; This case was reported by a consumer via (Shingrix Facebook) interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The reporter had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had severe allergic reaction. The patient was trying to figure out if there might be a common ingredient with any of the three covid vaccines to avoid another similar reaction. The reporter wanted to know what it was folks might be reacting to Shingrix vaccine.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nervousness, Rash
Clinical narrative: first dose of Shingrix on 3/30/2019 / experienced a slight rash on her back; every time / gets a rash / gets nervous; This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymph node excision, breast operation (knot removed in 1999 and 1989) and rash. Previously administered products included Zostavax (received on an  unknown date). Concurrent medical conditions included herpes virus infection and breast cancer. Concomitant products included valaciclovir (Valacyclovir).   On 30th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash and nervous. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the nervous was unknown.   It was unknown if the reporter considered the rash and nervous to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient. The patient experienced slight rash, few days after receiving 1st dose. The rash was resolved after months. The patient stated that, every time she got a rash, she gor nervous because she had history of rashes. The patient waited for a year to get 2nd dose, for tolerance refer case US2021AMR080144.  The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR080144:same reporter
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes virus infection, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: first dose of Shingrix on 3/30/2019 / experienced a slight rash on her back; every time / gets a rash / gets nervous; This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymph node excision, breast operation (knot removed in 1999 and 1989) and rash. Previously administered products included Zostavax (received on an  unknown date). Concurrent medical conditions included herpes virus infection and breast cancer. Concomitant products included valaciclovir (Valacyclovir).   On 30th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash and nervous. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the nervous was unknown.   It was unknown if the reporter considered the rash and nervous to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient. The patient experienced slight rash, few days after receiving 1st dose. The rash was resolved after months. The patient stated that, every time she got a rash, she gor nervous because she had history of rashes. The patient waited for a year to get 2nd dose, for tolerance refer case US2021AMR080144.  The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR080144:same reporter
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Rash erythematous
Clinical narrative: 2:40pm red area visible, light red rash, P 62, O2Sat 98, BP 132/82. 2:50pm redden rash somewhat disappeared.  Ice pack given for redness.   2:55pm EMS advised Benadryl for right deltoid redness.  Stated feeling better.  Allowed to leave observation with instruction to seek medical attention if rash or reddened area increases.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness for 4 days.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Injection site swelling
Clinical narrative: Severe Pain in armpit and swelling in the same area the symptoms started on Monday evening and still occurring. I am taking 2 Ibuprofen every 4 hours to relieve the pain. I am in my 3 day of experiencing this along with a headache.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Laboratory test, Musculoskeletal stiffness
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Stiff Neck-Severe, Additional Details: PT went to Emergency Dept 5 days post vaccination for severe Chest Pain and Stiff Neck, tests were ran, but nothing came up. ED dr said the J&J COVID vaccine was the likely culprit. Pt has since recovered, was not admitted to hospital.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 30 minutes after vaccination heart started racing very fast and got extremely dizzy. This lasted from 30 mins after injection until the following evening of 4/8/2021. About 1 hour after the vaccination my face, lips and mouth felt numb and were tingling. This lasted a few hours. About 3 hours after the vaccination, was having difficulty breathing. Throat was itchy and felt like was being blocked and my airway closing up. This lasted a few hours. About 3 hours after the vaccination came down with a severe headache that would not subside. This severe headache lasted from day of vaccination 4/07/2021 until Sunday 4/11/2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia oral, Throat irritation, Throat tightness
Clinical narrative: 30 minutes after vaccination heart started racing very fast and got extremely dizzy. This lasted from 30 mins after injection until the following evening of 4/8/2021. About 1 hour after the vaccination my face, lips and mouth felt numb and were tingling. This lasted a few hours. About 3 hours after the vaccination, was having difficulty breathing. Throat was itchy and felt like was being blocked and my airway closing up. This lasted a few hours. About 3 hours after the vaccination came down with a severe headache that would not subside. This severe headache lasted from day of vaccination 4/07/2021 until Sunday 4/11/2021.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: second dose given one week early.....no side effects
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Severe headache, 102 fever, chills, body aches  Lasted for approximately 3 days post vaccination
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Burning sensation, Compression garment application, Deep vein thrombosis, Gait disturbance
Clinical narrative: I HAD THE PFIZER VACCINE ADMINITERED AT FACILITY ON 3/31/21. THIS WAS THE FIRST DOSAGE. ON DAY 5 I HAD PAIN IN MY LEFT LEG FROM GROIN TO CALF. BY DAY 5, I BEGIN TO LIMP, MY LEG WAS BURNING, INCREASED PAIN AND I COULD FEEL WHAT I BELIEVE TO BE BLOOD CLOTS AND MY LYMP NODE IN MY LEFT GROIN FELT SWOLLEN. OVER THE COURSE OF 2 DAYS, THE PAIN BECAME WORSE. I CONTACTED MY DOCTOR AT FACILITY FOR A TELEPHONE INTERVIEW IN REGARDS TO WHAT I STATED ABOUT THE PAIN. CLOTS, SWOLLEN LYMP NODES ETC.. AND EXPLAINED THAT THIS OCCURED AFTER OBTAINING THE COVID-19 VACCINE. I WAS ADVISED TO HAVE A DOPPLER PERFORMED AT THE ER. I WENT TO THE ER LATER THAT EVENING AND WAS TOLD THAT DOPPLERS WERE NOT COMPLETED AFTER 4 P.M. BLOOD WORK WAS PERFORMED BY HOSPITAL. MY LAB WORK WAS NORMAL AND I WAS ADVISED THAT I WOULD BE CONTACTED THE NEXT MORNING FOR AN APPOINTMENT FOR THE DOPPLER. ON 4/8@1:00 PM, I HAD THE DOPPLER PERFORMED AT HOSPITAL. I WAS TAKEN BACK TO THE ER AND WAS INFORMED THAT I HAVE DVT AND THIS WAS POSSIBLY LIFE THREATING. I HAD NO PRIOR HISTORY OF CLOTS. I'M CURRENTLY TAKING ELIQUIS FOR THE BLOOD CLOTS, WEARING A COMPRESSION GARMENT AND TYLENOL FOR PAIN. I WAS ADVISED TO HAVE ANOTHER DOPPLER COMPLETED IN 6 MONTHS
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Ultrasound Doppler
Clinical narrative: I HAD THE PFIZER VACCINE ADMINITERED AT FACILITY ON 3/31/21. THIS WAS THE FIRST DOSAGE. ON DAY 5 I HAD PAIN IN MY LEFT LEG FROM GROIN TO CALF. BY DAY 5, I BEGIN TO LIMP, MY LEG WAS BURNING, INCREASED PAIN AND I COULD FEEL WHAT I BELIEVE TO BE BLOOD CLOTS AND MY LYMP NODE IN MY LEFT GROIN FELT SWOLLEN. OVER THE COURSE OF 2 DAYS, THE PAIN BECAME WORSE. I CONTACTED MY DOCTOR AT FACILITY FOR A TELEPHONE INTERVIEW IN REGARDS TO WHAT I STATED ABOUT THE PAIN. CLOTS, SWOLLEN LYMP NODES ETC.. AND EXPLAINED THAT THIS OCCURED AFTER OBTAINING THE COVID-19 VACCINE. I WAS ADVISED TO HAVE A DOPPLER PERFORMED AT THE ER. I WENT TO THE ER LATER THAT EVENING AND WAS TOLD THAT DOPPLERS WERE NOT COMPLETED AFTER 4 P.M. BLOOD WORK WAS PERFORMED BY HOSPITAL. MY LAB WORK WAS NORMAL AND I WAS ADVISED THAT I WOULD BE CONTACTED THE NEXT MORNING FOR AN APPOINTMENT FOR THE DOPPLER. ON 4/8@1:00 PM, I HAD THE DOPPLER PERFORMED AT HOSPITAL. I WAS TAKEN BACK TO THE ER AND WAS INFORMED THAT I HAVE DVT AND THIS WAS POSSIBLY LIFE THREATING. I HAD NO PRIOR HISTORY OF CLOTS. I'M CURRENTLY TAKING ELIQUIS FOR THE BLOOD CLOTS, WEARING A COMPRESSION GARMENT AND TYLENOL FOR PAIN. I WAS ADVISED TO HAVE ANOTHER DOPPLER COMPLETED IN 6 MONTHS
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Right arm pain- not Left- GI distress exhaustion, headache, finger numbness
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Right arm pain- not Left- GI distress exhaustion, headache, finger numbness
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Injection site pain, Malaise
Clinical narrative: Received 2nd dose of the Pfizer-BioNTech vaccination at 12:00 noon on 4/12, ate lunch, and by 2:30 pm felt flush in face, headache, achy, and tiredness - general feeling of being unwell.  Sore arm from the site of the injection.  These symptoms continued all day on 4/12 and 4/13.  I felt better on 4/14 when I woke up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Received 2nd dose of the Pfizer-BioNTech vaccination at 12:00 noon on 4/12, ate lunch, and by 2:30 pm felt flush in face, headache, achy, and tiredness - general feeling of being unwell.  Sore arm from the site of the injection.  These symptoms continued all day on 4/12 and 4/13.  I felt better on 4/14 when I woke up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Systemic: Tinnitus-Mild, Additional Details: sounds like butterfly in ear
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Balance disorder, Blood alkaline phosphatase increased, Ear pain
Clinical narrative: right ear and right neck pain.right foot pain and swelling.fatique. dysequilibrium. diffuse pruritis
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain, Pain in extremity, Peripheral swelling, Pneumonia klebsiella
Clinical narrative: right ear and right neck pain.right foot pain and swelling.fatique. dysequilibrium. diffuse pruritis
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urinary tract infection, White blood cell count increased
Clinical narrative: right ear and right neck pain.right foot pain and swelling.fatique. dysequilibrium. diffuse pruritis
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Paraesthesia, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted briefly and was weak and had tingling in both arms and hands-tried hydration and fan cooled air circulation-revived within 10-15 min-kept for observation for 30 -45 minutes and had mother pick her up so she didnt drive
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Polymenorrhoea
Clinical narrative: Menstruation one day early and especially intense. Lightheadedness.  No treatment.