chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Facial pain, Inflammation, Injection site reaction, Pain in jaw, Rash erythematous
Clinical narrative: -Extreme Pain in my right cheek/jaw area came on 5 Days after receiving the shot.   Pain was so bad that it would wake me in the middle of the night at its worst, throbbing.  Had to take Motrin and Tylenol every 2-3 hours to get some relief.   Applied Ice packs to my right cheek to help with inflammation.  Severe pain lasted for 3-4 days and as time went on the pain started to subside.  Over all 5-7 days it took for it to stop. -Itchy Red Rash developed 6 days after receiving the shot.   This was on the same arm and location of the shot.  Used Lotrimin to help soothe the itch and the redness went down.  This  lasted for 24 hours or so.   -Had this same reaction after having the actual flu in February of 2019.  I swear the 2019 virus is in this shot.  It is exactly the same extreme pain, same timing of starting the flu and the same timing of it going away, minus the rash.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: -Extreme Pain in my right cheek/jaw area came on 5 Days after receiving the shot.   Pain was so bad that it would wake me in the middle of the night at its worst, throbbing.  Had to take Motrin and Tylenol every 2-3 hours to get some relief.   Applied Ice packs to my right cheek to help with inflammation.  Severe pain lasted for 3-4 days and as time went on the pain started to subside.  Over all 5-7 days it took for it to stop. -Itchy Red Rash developed 6 days after receiving the shot.   This was on the same arm and location of the shot.  Used Lotrimin to help soothe the itch and the redness went down.  This  lasted for 24 hours or so.   -Had this same reaction after having the actual flu in February of 2019.  I swear the 2019 virus is in this shot.  It is exactly the same extreme pain, same timing of starting the flu and the same timing of it going away, minus the rash.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia
Clinical narrative: Started feeling dizzy 6 days after the vaccine. Could not stand up. Went to ER. Said it could be from vaccine. They referred me to a specialist. Got meds. Doctor also said it could be from vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Covid arm    Red Swollen Painful
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Myalgia, Oropharyngeal pain, Palpitations
Clinical narrative: Fever, muscle aches, chills, Heart palpitations, heart racing, red sore throat, cough,
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema, Pyrexia
Clinical narrative: Fever, muscle aches, chills, Heart palpitations, heart racing, red sore throat, cough,
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Vomiting and headache on the third day after vaccine. Symptoms disappear by itself after taking a nap.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Pregnancy test urine positive, Ultrasound scan vagina
Clinical narrative: G5P3 at the time. One second trimester loss 2015 placental abruption. No history of early miscarriages.  LMP 1/29/2021    Positive urine pregnancy 2/26/2021.  Miscarriage/bleeding 3/5/2021. Negative urine pregnancy 3/8/2021
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium, Chest discomfort, Chills, Dyspnoea, Pain
Clinical narrative: Beginning at 2 pm the following day after 2nd injection, I had fever, chills and body aches, which lasted for 8 hours. On 11/10/2021 after working a normal day without fever and minimal body aches, I managed with Tylenol and Advil. At 5 pm on 11/10/2021, I noticed a diffuse rash across my chest, between my breast and across my stomach. It was flat and bright red. In conjunction with said rash I've have been experiencing tightness/pressure in my chest along with SOB even with O2 saturation at 97%.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Beginning at 2 pm the following day after 2nd injection, I had fever, chills and body aches, which lasted for 8 hours. On 11/10/2021 after working a normal day without fever and minimal body aches, I managed with Tylenol and Advil. At 5 pm on 11/10/2021, I noticed a diffuse rash across my chest, between my breast and across my stomach. It was flat and bright red. In conjunction with said rash I've have been experiencing tightness/pressure in my chest along with SOB even with O2 saturation at 97%.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Low grade fever, moderate to severe headache, and swelling under left armpit (swollen lymph node?)  The headache started within hours of the 3rd dose (this lasted about 4 days).   The low grade fever started about 8 hours later and lasted less than 12 hours.  The swollen lymph nodes/pain in armpit began by next morning, November 2nd and lasted until Sat Nov 6th or Sun Nov 7th (don't remember exactly). I emailed my doctor on Nov 2nd and he said to take Tylenol every 6-8 hours.  I only emailed with him, I didn't see him.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy endometrium, Blood test, Polymenorrhoea, Smear cervix, Ultrasound scan
Clinical narrative: 14 days following vaccine I started having me steal cycle every 14 days. The cycles last 6-8 days.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Autoimmune disorder, Chronic spontaneous urticaria, Insomnia, Pruritus
Clinical narrative: I already told you my adverse reaction. Chronic  urticaria
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Influenza virus test negative, Respiratory disorder, SARS-CoV-2 test negative
Clinical narrative: I will have to locate the lot number.  Within 4 hours after injection, she developed respiratory illness and cough that has lasted  2 weeks now.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Hypomenorrhoea, Menstrual disorder, Menstruation irregular
Clinical narrative: Since having the covid vaccine I have not had a normal period. My periods now are like 1 day long,  between cycles the length is very long 50 + days some times and others 39 or so days.  I typically have long cycles but never so spuradical and my periods typically last 4-5 days and are heavy. Now they are 1 day and just like light pink and brown. I also feel that my hormones have shifted greatly. I'm tired all the time, anxious and cranky. Something is not right.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered
Clinical narrative: Since having the covid vaccine I have not had a normal period. My periods now are like 1 day long,  between cycles the length is very long 50 + days some times and others 39 or so days.  I typically have long cycles but never so spuradical and my periods typically last 4-5 days and are heavy. Now they are 1 day and just like light pink and brown. I also feel that my hormones have shifted greatly. I'm tired all the time, anxious and cranky. Something is not right.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Oxygen saturation decreased, Respiratory rate decreased
Clinical narrative: 11/10/2021 (at midnight): SOB, chest congestion/tightness, increased pulse, decreased oxygen saturation and increased respiration rate.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: 11/10/2021 (at midnight): SOB, chest congestion/tightness, increased pulse, decreased oxygen saturation and increased respiration rate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Nausea
Clinical narrative: 3 hours of elevated heart rate 118 - 135 bpm from 1am to 4am.   Chills 12:30-1am. Chills 4am- 8 am.   Fever 101.3 from 4am - 8pm.  Headache.  Nausea. Light sensitivity.  Fatigue  Hydration, Tylenol, sleep
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia
Clinical narrative: 3 hours of elevated heart rate 118 - 135 bpm from 1am to 4am.   Chills 12:30-1am. Chills 4am- 8 am.   Fever 101.3 from 4am - 8pm.  Headache.  Nausea. Light sensitivity.  Fatigue  Hydration, Tylenol, sleep
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Feeling hot, Lymphadenopathy, Swelling
Clinical narrative: Started a couple hours after vaccine with right axillary pain. The following day it felt hot and swollen. 48 hours later there was a tennis ball sized lump in right axillary.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives widespread over body two and a half days after dose. Pediatrician unsure if related. Wanted reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I came down with shingles
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Feeling dizzy, light headed with rapid heart rate of 143 less than an hour after shot. Feeling resolved, then returned with HR at 108 BPM 3 hours later at rest.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test, Chest X-ray, Electrocardiogram
Clinical narrative: Within one day, I started having intense pain on my LEFT side including shoulder blade, side of neck, upper back, shoulder, and left arm. My left hand and left arm were tingling and numb. This got worse as the week went on and I finally went to urgent care 5 days after the vaccine.  I also had a severe right leg vein cramp- where my upper inner thigh leg vein literally cramps during the night. I used to have leg cramps and have been taking potassium chloride and magnesium for a long time. After I had a left hip replacement in June 2021, my left cramps disappeared entirely for 2 months until I had the Modera vaccine.   I have had off and on the left shoulder blade and upper back pain (I've had to see a chiropractor and massage therapist regularly since August for this issue) since the first Moderna vaccine as well as another bad leg vein cramp in the past few weeks.  Because of these ongoing issues, I will not get the second Moderna vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Within one day, I started having intense pain on my LEFT side including shoulder blade, side of neck, upper back, shoulder, and left arm. My left hand and left arm were tingling and numb. This got worse as the week went on and I finally went to urgent care 5 days after the vaccine.  I also had a severe right leg vein cramp- where my upper inner thigh leg vein literally cramps during the night. I used to have leg cramps and have been taking potassium chloride and magnesium for a long time. After I had a left hip replacement in June 2021, my left cramps disappeared entirely for 2 months until I had the Modera vaccine.   I have had off and on the left shoulder blade and upper back pain (I've had to see a chiropractor and massage therapist regularly since August for this issue) since the first Moderna vaccine as well as another bad leg vein cramp in the past few weeks.  Because of these ongoing issues, I will not get the second Moderna vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: Within one day, I started having intense pain on my LEFT side including shoulder blade, side of neck, upper back, shoulder, and left arm. My left hand and left arm were tingling and numb. This got worse as the week went on and I finally went to urgent care 5 days after the vaccine.  I also had a severe right leg vein cramp- where my upper inner thigh leg vein literally cramps during the night. I used to have leg cramps and have been taking potassium chloride and magnesium for a long time. After I had a left hip replacement in June 2021, my left cramps disappeared entirely for 2 months until I had the Modera vaccine.   I have had off and on the left shoulder blade and upper back pain (I've had to see a chiropractor and massage therapist regularly since August for this issue) since the first Moderna vaccine as well as another bad leg vein cramp in the past few weeks.  Because of these ongoing issues, I will not get the second Moderna vaccine.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lethargy, Respiratory rate increased, Vomiting
Clinical narrative: 1005 emesis x2. Noon chest pain. 1303 increased respiration rate, using accessory muscles with breathing, lethargy.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Clinic on 11-9-2021 for Pfizer Pediatrics. 12 year old was given peds dose. Discovered 11-10-21 & reported 11-10-21. Was administrator
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: pt stated she had swelling at the sight on the second day and then it spreas to the lymph notes under the arm. she was taking aleve for it
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and very itchy at injection site. Hot to the touch. Swelling and redness lasted about 7 days and itching still present at day 13 post injection (severe at times).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Eczema, Headache
Clinical narrative: After 30 minutes soreness in injection site and most muscles in the rest of the body, after an hour headache and dizziness, after 6 hours nausea, vomiting, diarrhea, weakness, as well as an excema-like rash noticed at the injection site, after 8 hours mild fever at 99.4 degrees which gradually reached 100.7 over an hour.  Treated nausea with pepto bismol within 30 minutes of nausea which worked in preventing further vomiting and diarrhea, but did not end the general nausea. Tylenol was taken for the headache and fever when the fever was first noticed, after an hour temperature was back to normal and some of the body soreness had dissipated.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Myalgia, Nausea, Pyrexia
Clinical narrative: After 30 minutes soreness in injection site and most muscles in the rest of the body, after an hour headache and dizziness, after 6 hours nausea, vomiting, diarrhea, weakness, as well as an excema-like rash noticed at the injection site, after 8 hours mild fever at 99.4 degrees which gradually reached 100.7 over an hour.  Treated nausea with pepto bismol within 30 minutes of nausea which worked in preventing further vomiting and diarrhea, but did not end the general nausea. Tylenol was taken for the headache and fever when the fever was first noticed, after an hour temperature was back to normal and some of the body soreness had dissipated.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: After 30 minutes soreness in injection site and most muscles in the rest of the body, after an hour headache and dizziness, after 6 hours nausea, vomiting, diarrhea, weakness, as well as an excema-like rash noticed at the injection site, after 8 hours mild fever at 99.4 degrees which gradually reached 100.7 over an hour.  Treated nausea with pepto bismol within 30 minutes of nausea which worked in preventing further vomiting and diarrhea, but did not end the general nausea. Tylenol was taken for the headache and fever when the fever was first noticed, after an hour temperature was back to normal and some of the body soreness had dissipated.
Age: 15.0
Sex: U
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: clinic on 11-9-2021 for Pfizer Pediatrics. 15 year old was given peds dose. Discovered 11-10-21 & reported 11-10-21 was administrator
Age: 13.0
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: clinic on 11-9-2021 for Pfizer Pediatrics. 13 year old was given peds dose. Discovered 11-10-21 & reported 11-10-21.  was administrator
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Cardiac monitoring, Chest discomfort, Dyspnoea, Headache
Clinical narrative: Paramedics were called when I woke with extreme headache and  extreme shortness of breath and extreme pressure in chest followed by loss of consciousness and loss of bodily functions that lasted 35-40 mins for entire duration.  Heart rate dropped to 39
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Loss of consciousness
Clinical narrative: Paramedics were called when I woke with extreme headache and  extreme shortness of breath and extreme pressure in chest followed by loss of consciousness and loss of bodily functions that lasted 35-40 mins for entire duration.  Heart rate dropped to 39
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Chest pain, Movement disorder
Clinical narrative: On 6/3/21 I woke at about 3am and experienced severe chest pain. It was stabling and pressure. I couldn?t move, I was afraid to move. I thought I was dying. I was eventually able to move my hand to my heart and just prayed. Next thing I knew I woke up next morning. Since then my heart aches. Like a clamp at times. I had another event like that recently but not quite as bad. I have called my doctor for an appointment.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Pain in extremity
Clinical narrative: Sore arm for two days, loss of appetite. Weeks with decreased appetite. Not feeling hungry majority of the time. Feeling like you want to eat but don?t have an appetite for anything and don?t get hungry or hunger pangs.
Age: 34.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Condition aggravated, Extra dose administered, Fatigue, Headache, Herpes simplex
Clinical narrative: Hepetic whitlow present on finger 2 days after injection  General fatigue for less than 24 hrs, minor headache, moderate arm pain for 24 hrs mainly on covid vaccine arm
Age: 34.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity
Clinical narrative: Hepetic whitlow present on finger 2 days after injection  General fatigue for less than 24 hrs, minor headache, moderate arm pain for 24 hrs mainly on covid vaccine arm
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Ultrasound pelvis normal
Clinical narrative: Period like bleeding for about for over  4 months.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Rash papular
Clinical narrative: Experienced a rash across chest. Was raised and warm feeling. Began 2 hours after receiving vaccine, lasted approximately 4 hours.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Child had syncope
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fibrin D dimer increased, Ultrasound Doppler abnormal
Clinical narrative: Patient experienced blood clot on right calf. Blood clot located for DVT from femoral down to ankle. Unknown if related to vaccine, diagnosed 11/1/2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: -Tingling sensation after giving shot -BP -150/96 -Tingling lips and tongue
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient here to receive booster after J&J 1st shot. Requested Moderna. Patient given .5ml of Moderna instead of .25ml. Due to miscommunication. No adverse reaction observed.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood pressure decreased, Chills, Fatigue, Loss of consciousness
Clinical narrative: Terrible nausea; Passed out; Dry heaves; Arm was a little sore; Chilled; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore) and CHILLS (Chilled). On 05-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and RETCHING (Dry heaves). On 05-Mar-2021 at 6:00 AM, the patient experienced NAUSEA (Terrible nausea). In 2021, the patient experienced FATIGUE (Fatigued). On 05-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. At the time of the report, RETCHING (Dry heaves), PAIN IN EXTREMITY (Arm was a little sore), CHILLS (Chilled) and NAUSEA (Terrible nausea) outcome was unknown and FATIGUE (Fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 4.13 (normal) reactive: 4.13. In 2021, Blood pressure measurement: decreased (abnormal) blood pressure drop.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported patient received  oxygen when the paramedics came to her on 05 Mar 2021. It was reported that patient had severe reaction in that she passed out, became unconscious and had to call the paramedics. She had dry heaves, then she passed out for about 5 to 10 minutes. severe reaction in that she passed out. She was fatigued for a couple days.  Company comment: This case concerns a 74 year-old female patient with no reported medical history who experienced the unexpected serious event of loss of consciousness. The event occurred approximately I day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-369460 (Patient Link).; Sender's Comments: This case concerns a 74 year-old female patient with no reported medical history who experienced the unexpected serious event of loss of consciousness. The event occurred approximately I day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Retching
Clinical narrative: Terrible nausea; Passed out; Dry heaves; Arm was a little sore; Chilled; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore) and CHILLS (Chilled). On 05-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and RETCHING (Dry heaves). On 05-Mar-2021 at 6:00 AM, the patient experienced NAUSEA (Terrible nausea). In 2021, the patient experienced FATIGUE (Fatigued). On 05-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. At the time of the report, RETCHING (Dry heaves), PAIN IN EXTREMITY (Arm was a little sore), CHILLS (Chilled) and NAUSEA (Terrible nausea) outcome was unknown and FATIGUE (Fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 4.13 (normal) reactive: 4.13. In 2021, Blood pressure measurement: decreased (abnormal) blood pressure drop.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported patient received  oxygen when the paramedics came to her on 05 Mar 2021. It was reported that patient had severe reaction in that she passed out, became unconscious and had to call the paramedics. She had dry heaves, then she passed out for about 5 to 10 minutes. severe reaction in that she passed out. She was fatigued for a couple days.  Company comment: This case concerns a 74 year-old female patient with no reported medical history who experienced the unexpected serious event of loss of consciousness. The event occurred approximately I day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-369460 (Patient Link).; Sender's Comments: This case concerns a 74 year-old female patient with no reported medical history who experienced the unexpected serious event of loss of consciousness. The event occurred approximately I day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Imaging procedure abnormal, New daily persistent headache
Clinical narrative: Narrative:  Pt had severe headache 2 days after 1st covid vaccine (headache never went away). After second vaccine, got much worse. Seen by neurologist who did imaging and found blood clots in brain.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, Atrial flutter, COVID-19, COVID-19 pneumonia
Clinical narrative: Narrative:  82 yo male admitted to a hospital (other than this facility) 9/24/2021 with progressive dyspnea and cough. Found to be Covid positive and have Covid pneumonia, despite vaccination with Pfizer Covid vaccine on 1/27/2021 and 2/18/2021. He went into acute hypoxic respiratory failure, treated with convalescent plasma, dexamethasone, and antibiotic course. Patient stable clinically and discharged on 10/21/2021 with supplemental oxygen @ 3L nasal cannula. He developed A flutter with rapid ventricular rate in the hospital and was started on Eliquis 2.5mg twice daily.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Convalescent plasma transfusion, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Narrative:  82 yo male admitted to a hospital (other than this facility) 9/24/2021 with progressive dyspnea and cough. Found to be Covid positive and have Covid pneumonia, despite vaccination with Pfizer Covid vaccine on 1/27/2021 and 2/18/2021. He went into acute hypoxic respiratory failure, treated with convalescent plasma, dexamethasone, and antibiotic course. Patient stable clinically and discharged on 10/21/2021 with supplemental oxygen @ 3L nasal cannula. He developed A flutter with rapid ventricular rate in the hospital and was started on Eliquis 2.5mg twice daily.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative:  Booster dose was given at non-agency medical center - limited access to pfizer vaccine information therefore no lot, expiration, site of administration, etc. reported here.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Narrative:  Patient with breakthrough covid infection. 2 doses of pfizer covid vaccine given previously. treated with monoclonal antibody.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  Pt was a 71 YO male with a PMH of lymphadenopathy, carotid artery stenosis, head & neck cancer, stoke, DM, HLD, HTN, and obesity who received the COVID-19 vaccine. Facility was notified of patient's death by agency. No evidence that patient's death was caused by the COVID-19 vaccine.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient is COVID positive, but reports being asymptomatic.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Productive cough, Respiratory tract congestion
Clinical narrative: Narrative:  Covid infection after Covid vaccine 02/09: COVID infection #1 03/09: COVID infection #2 09/20: Chills, Cough, Runny nose (Rhinorrhea) 09/21: mild Cough 09/22: productive cough, "heavy cold", congestion 09/23: improved
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Covid infection after Covid vaccine 02/09: COVID infection #1 03/09: COVID infection #2 09/20: Chills, Cough, Runny nose (Rhinorrhea) 09/21: mild Cough 09/22: productive cough, "heavy cold", congestion 09/23: improved
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: Narrative:  COVID following COVID vaccine series 01/08 COVID vaccine dose #1 01/29 COVID vaccine dose #2 06/21-07/26 Tested for COVID every 3-4 days d/t CLC resident-NEGATIVE 07/29 COVID positive, admitted to inpatient for isolation 08/07 clinically resolved, asymptomatic entire course
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Base excess, Blood bicarbonate normal, Blood gases, Blood pH normal, COVID-19
Clinical narrative: Narrative:  COVID INFECTION after COVID vaccine series 01/18 COVID vaccine dose #1 02/09 COVID vaccine dose #2 07/16 started with fever, chills, fatigue, nausea, rhinitis, sore throat 07/19 seen in outside ED, diagnosed with COVID pneumonia 07/20 c/o dizziness, shortness of breath, muscle weakness and tremors 07/21 c/o worsening cough, low BP 07/22 c/o mild, infrequent, productive cough w/ clear sputum, fatigue, fever 07/23 reports o2 sat 72-73% w/ pulse of 71, hands cold and discolored, 30 minutes later, o2 sat 69%, BP 90/58, HR 60, admitted thru ED to ICU; CT showed bilateral pneumonia; o2 sat improved to 93% on non-rebreather mask, received cefepime, doxycycline, IV steroids during admission 08/13 clinically resolved infection 08/18 discharged from hospital
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Carbon dioxide normal, Cardiomegaly, Chills, Computerised tomogram thorax abnormal
Clinical narrative: Narrative:  COVID INFECTION after COVID vaccine series 01/18 COVID vaccine dose #1 02/09 COVID vaccine dose #2 07/16 started with fever, chills, fatigue, nausea, rhinitis, sore throat 07/19 seen in outside ED, diagnosed with COVID pneumonia 07/20 c/o dizziness, shortness of breath, muscle weakness and tremors 07/21 c/o worsening cough, low BP 07/22 c/o mild, infrequent, productive cough w/ clear sputum, fatigue, fever 07/23 reports o2 sat 72-73% w/ pulse of 71, hands cold and discolored, 30 minutes later, o2 sat 69%, BP 90/58, HR 60, admitted thru ED to ICU; CT showed bilateral pneumonia; o2 sat improved to 93% on non-rebreather mask, received cefepime, doxycycline, IV steroids during admission 08/13 clinically resolved infection 08/18 discharged from hospital
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Hypotension, Intensive care
Clinical narrative: Narrative:  COVID INFECTION after COVID vaccine series 01/18 COVID vaccine dose #1 02/09 COVID vaccine dose #2 07/16 started with fever, chills, fatigue, nausea, rhinitis, sore throat 07/19 seen in outside ED, diagnosed with COVID pneumonia 07/20 c/o dizziness, shortness of breath, muscle weakness and tremors 07/21 c/o worsening cough, low BP 07/22 c/o mild, infrequent, productive cough w/ clear sputum, fatigue, fever 07/23 reports o2 sat 72-73% w/ pulse of 71, hands cold and discolored, 30 minutes later, o2 sat 69%, BP 90/58, HR 60, admitted thru ED to ICU; CT showed bilateral pneumonia; o2 sat improved to 93% on non-rebreather mask, received cefepime, doxycycline, IV steroids during admission 08/13 clinically resolved infection 08/18 discharged from hospital
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Oropharyngeal pain, PCO2 normal, PO2 decreased
Clinical narrative: Narrative:  COVID INFECTION after COVID vaccine series 01/18 COVID vaccine dose #1 02/09 COVID vaccine dose #2 07/16 started with fever, chills, fatigue, nausea, rhinitis, sore throat 07/19 seen in outside ED, diagnosed with COVID pneumonia 07/20 c/o dizziness, shortness of breath, muscle weakness and tremors 07/21 c/o worsening cough, low BP 07/22 c/o mild, infrequent, productive cough w/ clear sputum, fatigue, fever 07/23 reports o2 sat 72-73% w/ pulse of 71, hands cold and discolored, 30 minutes later, o2 sat 69%, BP 90/58, HR 60, admitted thru ED to ICU; CT showed bilateral pneumonia; o2 sat improved to 93% on non-rebreather mask, received cefepime, doxycycline, IV steroids during admission 08/13 clinically resolved infection 08/18 discharged from hospital
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, Pneumonia, Productive cough, Pyrexia, Rhinitis
Clinical narrative: Narrative:  COVID INFECTION after COVID vaccine series 01/18 COVID vaccine dose #1 02/09 COVID vaccine dose #2 07/16 started with fever, chills, fatigue, nausea, rhinitis, sore throat 07/19 seen in outside ED, diagnosed with COVID pneumonia 07/20 c/o dizziness, shortness of breath, muscle weakness and tremors 07/21 c/o worsening cough, low BP 07/22 c/o mild, infrequent, productive cough w/ clear sputum, fatigue, fever 07/23 reports o2 sat 72-73% w/ pulse of 71, hands cold and discolored, 30 minutes later, o2 sat 69%, BP 90/58, HR 60, admitted thru ED to ICU; CT showed bilateral pneumonia; o2 sat improved to 93% on non-rebreather mask, received cefepime, doxycycline, IV steroids during admission 08/13 clinically resolved infection 08/18 discharged from hospital
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Scan with contrast abnormal, Skin discolouration, Tremor
Clinical narrative: Narrative:  COVID INFECTION after COVID vaccine series 01/18 COVID vaccine dose #1 02/09 COVID vaccine dose #2 07/16 started with fever, chills, fatigue, nausea, rhinitis, sore throat 07/19 seen in outside ED, diagnosed with COVID pneumonia 07/20 c/o dizziness, shortness of breath, muscle weakness and tremors 07/21 c/o worsening cough, low BP 07/22 c/o mild, infrequent, productive cough w/ clear sputum, fatigue, fever 07/23 reports o2 sat 72-73% w/ pulse of 71, hands cold and discolored, 30 minutes later, o2 sat 69%, BP 90/58, HR 60, admitted thru ED to ICU; CT showed bilateral pneumonia; o2 sat improved to 93% on non-rebreather mask, received cefepime, doxycycline, IV steroids during admission 08/13 clinically resolved infection 08/18 discharged from hospital
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Adenovirus test, Angiogram pulmonary abnormal, Aortic arteriosclerosis, Arteriosclerosis coronary artery
Clinical narrative: Narrative:  Admission Date: Nov 5,2021 Discharge Date: Nov 8,2021 Condition of patient at discharge: Stable Disposition of Patient at Discharge: Home Primary Diagnosis during Admission/Treatment: COVID-19 PNEUMONIA 62 y/o female w/ PMHx of COPD (FEV1 14%, 2L NC baseline), alcohol use disorder, tobacco use disorder, OSA (on BiPAP) who presents with fatigue and progressive SOB found to be positive for COVID and have COVID pneumonia despite vaccination x 3 with Pfizer COVID vaccine (03/24/2021, 04/15/2021, booster 10/28/2021). She got her 3rd booster seven days prior to the Emergency Room visit 11/4/21. She reported feeling lousy with myalgias since the booster shot. Two days prior to the ER visit, she noticed significant fatigue, dry cough and inability to play with her grandchildren. One day prior to the ED visit, she reported a fever of 102 and started taking Tylenol. She had another fever of 103 prior to her ER visit and noticed that her spO2 on her home pulse ox was dropping into the 80s. She came to the ER the morning of 11/4 and was found to be covid-19 positive. She was on her home o2 oxygen requirements of 2L nasal cannula. She denies HA, chest pain, abdominal pain, n/v/d/c, or peripheral edema. In the ER, she was initially satting 78% and was placed on 5L NC with pulse ox going to 98%. ABG on 98% 7.43/47/97/31.5. She was given dexamethasone and admitted to the hospital for Acute Hypoxemic Respiratory Failure (AHRF). Brief Summary of Hospital Course: Presented with worsening dyspnea and increased oxygen requirement  from baseline 2L NC up to 5L NC with movement. Patient reports being COVID-19 triple vaccinated. Pro-cal is neg. MRSA nares negative. D-dimer 2.86 and Ferritin 471 were elevated, but CTPE without PE. CT chest also showing atypical PNA consistent with COVID and pronounced emphysematous changes. Treated with dexamethasone 6 mg PO for 10 days and Remdesivir and therapeutic enoxaparin during the hospital course. Due to concern for possible COPD exacerbation on top of COVID PNA we gave 3-day course of azithromycin before transitioning back to home dose of 3x weekly. Walk test on day of discharge with no increased oxygen requirement, continue 2L NC. Stable for discharge.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood gases, Bordetella test negative, Breast calcifications, Bronchiectasis, COVID-19
Clinical narrative: Narrative:  Admission Date: Nov 5,2021 Discharge Date: Nov 8,2021 Condition of patient at discharge: Stable Disposition of Patient at Discharge: Home Primary Diagnosis during Admission/Treatment: COVID-19 PNEUMONIA 62 y/o female w/ PMHx of COPD (FEV1 14%, 2L NC baseline), alcohol use disorder, tobacco use disorder, OSA (on BiPAP) who presents with fatigue and progressive SOB found to be positive for COVID and have COVID pneumonia despite vaccination x 3 with Pfizer COVID vaccine (03/24/2021, 04/15/2021, booster 10/28/2021). She got her 3rd booster seven days prior to the Emergency Room visit 11/4/21. She reported feeling lousy with myalgias since the booster shot. Two days prior to the ER visit, she noticed significant fatigue, dry cough and inability to play with her grandchildren. One day prior to the ED visit, she reported a fever of 102 and started taking Tylenol. She had another fever of 103 prior to her ER visit and noticed that her spO2 on her home pulse ox was dropping into the 80s. She came to the ER the morning of 11/4 and was found to be covid-19 positive. She was on her home o2 oxygen requirements of 2L nasal cannula. She denies HA, chest pain, abdominal pain, n/v/d/c, or peripheral edema. In the ER, she was initially satting 78% and was placed on 5L NC with pulse ox going to 98%. ABG on 98% 7.43/47/97/31.5. She was given dexamethasone and admitted to the hospital for Acute Hypoxemic Respiratory Failure (AHRF). Brief Summary of Hospital Course: Presented with worsening dyspnea and increased oxygen requirement  from baseline 2L NC up to 5L NC with movement. Patient reports being COVID-19 triple vaccinated. Pro-cal is neg. MRSA nares negative. D-dimer 2.86 and Ferritin 471 were elevated, but CTPE without PE. CT chest also showing atypical PNA consistent with COVID and pronounced emphysematous changes. Treated with dexamethasone 6 mg PO for 10 days and Remdesivir and therapeutic enoxaparin during the hospital course. Due to concern for possible COPD exacerbation on top of COVID PNA we gave 3-day course of azithromycin before transitioning back to home dose of 3x weekly. Walk test on day of discharge with no increased oxygen requirement, continue 2L NC. Stable for discharge.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray abnormal, Chlamydia test negative, Computerised tomogram thorax abnormal, Cough
Clinical narrative: Narrative:  Admission Date: Nov 5,2021 Discharge Date: Nov 8,2021 Condition of patient at discharge: Stable Disposition of Patient at Discharge: Home Primary Diagnosis during Admission/Treatment: COVID-19 PNEUMONIA 62 y/o female w/ PMHx of COPD (FEV1 14%, 2L NC baseline), alcohol use disorder, tobacco use disorder, OSA (on BiPAP) who presents with fatigue and progressive SOB found to be positive for COVID and have COVID pneumonia despite vaccination x 3 with Pfizer COVID vaccine (03/24/2021, 04/15/2021, booster 10/28/2021). She got her 3rd booster seven days prior to the Emergency Room visit 11/4/21. She reported feeling lousy with myalgias since the booster shot. Two days prior to the ER visit, she noticed significant fatigue, dry cough and inability to play with her grandchildren. One day prior to the ED visit, she reported a fever of 102 and started taking Tylenol. She had another fever of 103 prior to her ER visit and noticed that her spO2 on her home pulse ox was dropping into the 80s. She came to the ER the morning of 11/4 and was found to be covid-19 positive. She was on her home o2 oxygen requirements of 2L nasal cannula. She denies HA, chest pain, abdominal pain, n/v/d/c, or peripheral edema. In the ER, she was initially satting 78% and was placed on 5L NC with pulse ox going to 98%. ABG on 98% 7.43/47/97/31.5. She was given dexamethasone and admitted to the hospital for Acute Hypoxemic Respiratory Failure (AHRF). Brief Summary of Hospital Course: Presented with worsening dyspnea and increased oxygen requirement  from baseline 2L NC up to 5L NC with movement. Patient reports being COVID-19 triple vaccinated. Pro-cal is neg. MRSA nares negative. D-dimer 2.86 and Ferritin 471 were elevated, but CTPE without PE. CT chest also showing atypical PNA consistent with COVID and pronounced emphysematous changes. Treated with dexamethasone 6 mg PO for 10 days and Remdesivir and therapeutic enoxaparin during the hospital course. Due to concern for possible COPD exacerbation on top of COVID PNA we gave 3-day course of azithromycin before transitioning back to home dose of 3x weekly. Walk test on day of discharge with no increased oxygen requirement, continue 2L NC. Stable for discharge.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diaphragmatic disorder, Dyspnoea, Emphysema, Fatigue, Fibrin D dimer
Clinical narrative: Narrative:  Admission Date: Nov 5,2021 Discharge Date: Nov 8,2021 Condition of patient at discharge: Stable Disposition of Patient at Discharge: Home Primary Diagnosis during Admission/Treatment: COVID-19 PNEUMONIA 62 y/o female w/ PMHx of COPD (FEV1 14%, 2L NC baseline), alcohol use disorder, tobacco use disorder, OSA (on BiPAP) who presents with fatigue and progressive SOB found to be positive for COVID and have COVID pneumonia despite vaccination x 3 with Pfizer COVID vaccine (03/24/2021, 04/15/2021, booster 10/28/2021). She got her 3rd booster seven days prior to the Emergency Room visit 11/4/21. She reported feeling lousy with myalgias since the booster shot. Two days prior to the ER visit, she noticed significant fatigue, dry cough and inability to play with her grandchildren. One day prior to the ED visit, she reported a fever of 102 and started taking Tylenol. She had another fever of 103 prior to her ER visit and noticed that her spO2 on her home pulse ox was dropping into the 80s. She came to the ER the morning of 11/4 and was found to be covid-19 positive. She was on her home o2 oxygen requirements of 2L nasal cannula. She denies HA, chest pain, abdominal pain, n/v/d/c, or peripheral edema. In the ER, she was initially satting 78% and was placed on 5L NC with pulse ox going to 98%. ABG on 98% 7.43/47/97/31.5. She was given dexamethasone and admitted to the hospital for Acute Hypoxemic Respiratory Failure (AHRF). Brief Summary of Hospital Course: Presented with worsening dyspnea and increased oxygen requirement  from baseline 2L NC up to 5L NC with movement. Patient reports being COVID-19 triple vaccinated. Pro-cal is neg. MRSA nares negative. D-dimer 2.86 and Ferritin 471 were elevated, but CTPE without PE. CT chest also showing atypical PNA consistent with COVID and pronounced emphysematous changes. Treated with dexamethasone 6 mg PO for 10 days and Remdesivir and therapeutic enoxaparin during the hospital course. Due to concern for possible COPD exacerbation on top of COVID PNA we gave 3-day course of azithromycin before transitioning back to home dose of 3x weekly. Walk test on day of discharge with no increased oxygen requirement, continue 2L NC. Stable for discharge.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Human metapneumovirus test, Human rhinovirus test, Influenza A virus test negative, Influenza B virus test, Interstitial lung disease
Clinical narrative: Narrative:  Admission Date: Nov 5,2021 Discharge Date: Nov 8,2021 Condition of patient at discharge: Stable Disposition of Patient at Discharge: Home Primary Diagnosis during Admission/Treatment: COVID-19 PNEUMONIA 62 y/o female w/ PMHx of COPD (FEV1 14%, 2L NC baseline), alcohol use disorder, tobacco use disorder, OSA (on BiPAP) who presents with fatigue and progressive SOB found to be positive for COVID and have COVID pneumonia despite vaccination x 3 with Pfizer COVID vaccine (03/24/2021, 04/15/2021, booster 10/28/2021). She got her 3rd booster seven days prior to the Emergency Room visit 11/4/21. She reported feeling lousy with myalgias since the booster shot. Two days prior to the ER visit, she noticed significant fatigue, dry cough and inability to play with her grandchildren. One day prior to the ED visit, she reported a fever of 102 and started taking Tylenol. She had another fever of 103 prior to her ER visit and noticed that her spO2 on her home pulse ox was dropping into the 80s. She came to the ER the morning of 11/4 and was found to be covid-19 positive. She was on her home o2 oxygen requirements of 2L nasal cannula. She denies HA, chest pain, abdominal pain, n/v/d/c, or peripheral edema. In the ER, she was initially satting 78% and was placed on 5L NC with pulse ox going to 98%. ABG on 98% 7.43/47/97/31.5. She was given dexamethasone and admitted to the hospital for Acute Hypoxemic Respiratory Failure (AHRF). Brief Summary of Hospital Course: Presented with worsening dyspnea and increased oxygen requirement  from baseline 2L NC up to 5L NC with movement. Patient reports being COVID-19 triple vaccinated. Pro-cal is neg. MRSA nares negative. D-dimer 2.86 and Ferritin 471 were elevated, but CTPE without PE. CT chest also showing atypical PNA consistent with COVID and pronounced emphysematous changes. Treated with dexamethasone 6 mg PO for 10 days and Remdesivir and therapeutic enoxaparin during the hospital course. Due to concern for possible COPD exacerbation on top of COVID PNA we gave 3-day course of azithromycin before transitioning back to home dose of 3x weekly. Walk test on day of discharge with no increased oxygen requirement, continue 2L NC. Stable for discharge.