chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started feeling sick (light headed, anxious, felt like he was coming down with illness and chest pressure) on 518, by 6am on 6/19 he woke up crying with massive chest pressure, we took him to urgent care at 12:30p, immediately sent to ER due to abnormal EKG, admitted in ER with more tests & blood work taken(troponin was 1300) so he then was send via ambulance transport to cardiac unit at Hospital where he spent the night and on 5/20 they did a battery of tests to figure out what his diagnosis was. Confirmed a  minor heart attack caused by a cardiac embolism. Echocardiogram showed minor heart damage. He was prescribed a ZIO patch to wear for 2 weeks resulting in no issues. Dr confirmed this event was Covid vaccine related.
I had a sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (I had a sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (I had a sore arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (I had a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded   This case was linked to MOD-2021-289014 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Pfizer-BioNTech COVID-19 Vaccine EUA. Ocular/retinal migraine (kaleidoscope vision) in right eye. Lasted 10 -20 minutes. Went away on its own.
Patient was waiting in line at the checkout and mother was talking to him.  He was glossy eyed, and unresponsive to her questions.  He then said that everything looked blurry and he was dizzy.  She then sat him on the floor and an employee ran back to the pharmacy to get the pharmacist.  Upon arrival of the pharmacist he was given 25mg of diphenhydramine and a cool compress to the back of the neck.  He was moved to chair where he sat for 20 minutes.  He eventually cooled down and normal vision returned.  Mother called family doctor but he was on a flight, so he was going to call her later.  Mother was given diphenhydramine to take home and a cool instant pack.  She was called today and he was fine and even went to school today.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 3:24 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Nov-2021 at 3:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient allergies were unknown. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. The patient was administered vaccine that was stored at temperature between minus 80 degree F to minus 84 degree F.  No concomitant medications were reported. No treatment details were reported.
Had (R) arm swelling & redness after vaccination. 3 1/2 cm x 2 1/2 cm local rxn area of induration.
Injection at 2:11p,m Home at 2:15pm Noticed quick onset of redness, fever at 225pm Tylenol given at 230pm Generalized redness: face, chest, abdomen:  Facial Swelling more pronounced could barely open eyes: 2:56pm Injection site  Left leg very swollen and red to the point that pants were tight almost couldn't remove Headed to E.R. 3:02pm Hives/Shortness of Breath 3:10pm Registered/Triaged in the ER at 3:25pm  Epi given at 3:45 (roughly) Patient was put under observation and symptoms started to subside at 5p.m. Patient was discharged at 823 p.m
Information has been received from a licensed practical nurse who reported that in the "last 3 months" (from approximately May, 2008) she had been administering zoster vaccine live (Oka/Merck) 0.65 ml SQ to an unspecified number of male and female patients over 60 years old. Subsequently, the nurse experienced shingles. On 07-AUG-2008 the nurse experienced pain in the right leg, buttocks and lower back. On 11-AUG-2008, the nurse went for a Doppler test because she thought something was wrong with her leg. Results of the test were unknown. On 14-AUG-2008 the nurse broke out in a rash (unspecified areas). The nurse did have some fluid filled vesicles but they have all dried up and now they looked like little red pimples, The nurse had taken VALTREX. As of 20-AUG-2008 the nurse had not recovered.  This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a licensed practical nurse who reported that in the "last 3 months" (from approximately May, 2008) she had been administering ZOSTAVAX (Merck) 0.65 ml SQ to an unspecified number of male and female patients over 60 years old. Subsequently, the nurse experienced shingles. On 29-JUL-2009, the nurse gave ZOSTAVAX (Merck) to a patient who had bleeding. The nurse wiped the patient's arm with an alcohol swab. About 2 weeks later, around the week of 11-AUG-2008 the nurse experienced pain in the right leg, buttocks and lower back. On 11-AUG-2008, the nurse went for a Doppler test because she thought something was wrong with her leg. Results of the test were unknown. On 14-AUG-2008 the nurse broke out in a rash at her buttock and back. The nurse did have some fluid filled vesicles but they have all dried up and now they looked like little red pimples. The nurse had taken VALTREX. Subsequently, the nurse recovered, though she was off of work for one week. Additional information is not expected.
Approximately 24 hours after receiving FLUVIRIN vaccine, patient reported lethargy, aches and 101 degree fever. 2 days later patient reports back to normal.
5 minutes after administering Moderna Civid-19 vaccine , patient complained of feeling  dizzy, lost composure, responsive to questions for a few seconds  and  lost consciousness with in next minute and became unresponsive and stopped breathing. Administered CPR and called 911. 1 dose of Epipen 0.3mg administered before arrival of EMS.  continued administering CPR until ems arrived and by then she gained back her consciousness became responsive. EMS took her to ER
A rash appeared more intensely at injection site but all over limbs and body.  Went to general practioner who administered cetirizine 10mg 1x/day montelukast 10 mg 1x/day rash is drying and not as bright currently
Evening of vaccine, developed hives. Mother treated with Benadryl OTC. Resolved by noon 8/21/08. No reaction noted at inj. site. On 8/23/08 developed fever (low-grade), HA, fatigue occas. dizziness with standing, neck stiffness and mild SOB. Seen in office 8/25/08- temo 99.8, all other exam WNL.
Flu shoot-9/24 noon. Fever 9/25 and incessant crying. Fever up to 103+.
This infant had lethargy, was vomiting, irregular breathing (periodic) symptoms started 3 days after vaccination. Hospitalized to rule out sepsis. All ex (-). Got antibiotics for 48 hours. Cousin had same reaction after 4 mos shot, same lot number. Vaccine of HiB and DTaP.
Received vaccine on Friday. Developed hives on Sat. Went to urgent care. He was told to take BENADRYL q 6 hours for hives.
After administering patient stated he felt fine. Father brought pt back and said he got dizziness while walking to car.
Chills; Sore arm; Tired; 2nd booster dose 3 months after the 1st booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (Chills), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd booster dose 3 months after the 1st booster dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A and 056A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 28-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced CHILLS (Chills), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd booster dose 3 months after the 1st booster dose). At the time of the report, CHILLS (Chills), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd booster dose 3 months after the 1st booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. Pharmacist did not know if patient was taking medication. No treatment medication were provided.
Patient stopped at the pharmacy and said she is having a rash that worsened around 2am then she went to her doctor this morning who told the patient to buy Benadryl OTC. Patient requested the pharmacy report the rash to VARES.
11 x 6.5 cm erythema, warmth, mild edema, pruritus (R) deltoid. Tx with BENADRYL and KEFLEX for local reaction. Resolved on follow up on 1/2/15.
At check in, he was alert, conscious, outgoing, nka or medical concerns. He indicated he did not want to watch injection. In waiting area, approximatly 10 minutes into waiting, he suddenly feel to the floor from the chair. At not time did he lose consciousness, but he was lying in a prone postition. Stated he was having difficulty breathing, but RN who observed, noticed no shortness of breath or dyspnea. EMS called. BB 110/68, HR 62 and regular. Diaphoresis and paleness noted. Denied pain. Denied hitting his head. Stated he did not eat or drink anything that morning.  EMS arrived and assessed pt and transported to hospital. Patient able to sit up and get himself on stretcher with assistance from EMS.
Injection site turned, hot, red and swollen. The redness spread over 2 days to like a 2 x 4 Inch patch with itching and muscle soreness. Was sensitive to touch, could feel shirt rubbing it. Had a slight headache on Saturday and on Sunday noticed leg muscle (thigh) weakness going up and down the stairs doing laundry. An ice pack did help some with the swelling
Patient was given Fluzone, flu shot. He is just shy of 2 months old. Patient was not supposed to receive shot until 6 months of age.
Day 2 after receiving 2nd dose of above vaccine patient experienced generalized tonic clonic seizure lasting under 1 minute.
I took my first Pfizer dose vaccine on April-20-2021, after that I had dizziness along with blood pressure fluctuation, first it was high and then low to normal in 10 minutes interval and dizziness continued for a week I took 2nd dose on May-11-2021 and then I felt dizzy with mild abdomen pain, and pain got severe. On day 3 onwards I had heavy back pain and stabbing pain in the middle of the chest that continued for next 2 days. On day 5 pain was intolerable chest pain& shortness of breath and I visited Emergency care for the treatment at midnight with the pulse rate of 145 ( checked at home) took EKG, blood test and chest X-ray. But in blood test D-dimer was normal after 2 hrs in emergency care I was discharged with same level of pain. Next day visited Primary care to seek the consultation and she advised to take the CT scan but the pain got severe. Again I went to ER, this time D-Dimer was higher(2 times) than previous day.  So they took the CT scan to ruled out Pulmonary embolism. But ER doctor doubted Bronchial wall thickening which  may reflect bronchitis or reactive airvey disease.  On day 7 I had numbness on my right side and felt tingling sensation on my chin with blurred vision, dizziness,  heavy headache with visible veins. After all the test, Primary care told I had costochondritis because of the irritation caused by vaccine.  I'm yet to visit eye and neurologist to check the other symptons.  Though I was normal before as I took the full body checkup which was clear, because of this vaccine I have these adverse side effects which affects my daily activities. I can provide the documents if needed.
Dtap#4, IPV #4, MMR #2. 1) 10/26/05 7:55pm, Hives. Diagnosis Urticaria probably secondary to codeine Benadryl TID. 2) 10/17/05 7:30pm Hives Diagnosis urticaria Zyrtec 1/2-1 tsp QD
Case number PHEH2016US030428, is an initial spontaneous report received from a pharmacist on 16 Nov 2016. This report refers to a 12-years-old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620501) intramuscularly on 15 Nov 2016. On the same day when administering FLUVIRIN, the child (patient) jerked away and only received a partial dose. No adverse event was reported following this administration error.
bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arterial calcification (Patient do have some calcification in my arteries, but, not enough to treat.), Non-smoker and Cholesterol (ratio 2.1). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.). At the time of the report, CHEST PAIN (bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2021, Mammogram: normal (normal) no suspicious calcifications were identified. On an unknown date, Blood cholesterol: 148 148. On an unknown date, Blood triglycerides: 57 57. On an unknown date, High density lipoprotein: 69 69. On an unknown date, Low density lipoprotein: 68 68. On an unknown date, Non-high-density lipoprotein cholesterol: 79 79. On an unknown date, Very low density lipoprotein: 11 11.         Patient experienced the event after the second dose, while sleeping that lasted 15 seconds and didn't came back when turned over.  Patient received booster dose of Pfizer on 11 Nov 2021 (batch no FJ1611) and on the second day experienced serious pain. First, patient said that it was in her heart, but then she retracted and said it was in the arteries of the breast. At the time of this report, patient felt that the lining around the heart was inflamed.  Patient doesn't have a history of COVID-19 infection and doesn't have a history of myocarditis or pericarditis.  Patient's regular medication included cholesterol pill and provided the cholesterol levels.  Patient don't drink and eat healthy food.  No treatment medications were taken by the patient after Moderna vaccine.
Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Three hours post injection pt experienced severe pain throughout his muscles and joints, and said his head felt "fuzzy".  He was seen at Hospital Emergency Room that night, blood was taken.  Over the course of the next three days he was seen by his pediatrician, a pediatric neurologist, had a CT scan, EEG and MRI.  He has also been seen by an infectious disease specialst.  During the period 9/24-9/27 his body pain persisted and he started to lose his memory.  By the morning of 9/27 he had complete episodic memory loss.  He has no recollection of who he is, where he was born, who family and friends are, nor of any events prior to 9/27.  He can read, write, do math, has normal body functions and can do routine tasks. He forgot how to use the computer. He can retain new memories. His body pain has lessened and is now localized in his arms and legs.  He has developed severe headaches (that cause dizziness and nausea), at times cannot tolerate light and noise.  His headaches are not relieved by over the counter medication. He was being home tutored, which had to be discontinued as he is having difficulty concentrating, and due to the headaches. Exposure to people and familiar things does not trigger his memory. No history of head injury (routine falls from skates, bike, always wears a helmet).  No psychiatric history.  No severe illnesses (mild chickenpox at 3 years, no high fevers. No recent illness, no recent injuries. No life-changing events.  No depression.  Very athletic. Doing well in school.  Good friends.  No drugs or alcohol.  Happy kid.
Stroke; No vision on one eye; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS UNILATERAL (No vision on one eye) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant) and BLINDNESS UNILATERAL (No vision on one eye) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS UNILATERAL (No vision on one eye) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Caller stated that she talked with someone who also received the Moderna Covid 19 vaccine who also had this problem No treatment medication was reported.  Company Comment: This spontaneous case concerns a patient (age and gender not specified) with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of Cerebrovascular accident and unexpected, serious (medically significant) event of Blindness unilateral that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of the mRNA 1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient (age and gender not specified) with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of Cerebrovascular accident and unexpected, serious (medically significant) event of Blindness unilateral that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of the mRNA 1273 vaccine is not affected by this report.
The next day (12/29) I woke up with a headache and a fever. The fever started at low grade (99.0-100.0)  then later rose up to 102.1. I spent the day mostly sleeping and taking 2 extra strength tylenol every 6 hours as well as pushing fluids. Today (12/30) the fever has subsided but the headache is still present and may be due to not eating yesterday.  I am 14 weeks 6 days pregnant. Due June 24 2021.  I have contacted the midwife department to report the reaction and expect to hear back from them later today.